MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION LYNX SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR

Model Number M0068503000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Erosion (1750); Fatigue (1849); Micturition Urgency (1871); Headache (1880); Pyrosis/Heartburn (1883); Low Blood Pressure/ Hypotension (1914); Unspecified Infection (1930); Inflammation (1932); Muscle Weakness (1967); Nausea (1970); Nerve Damage (1979); Neuropathy (1983); Pain (1994); Rash (2033); Sepsis (2067); Urinary Tract Infection (2120); Burning Sensation (2146); Dizziness (2194); Urinary Frequency (2275); Anxiety (2328); Injury (2348); Depression (2361); Numbness (2415); Respiratory Tract Infection (2420); Obstruction/Occlusion (2422); Prolapse (2475); Hematuria (2558); Abdominal Distention (2601); Weight Changes (2607); Dysuria (2684); Constipation (3274); Balance Problems (4401); Paresthesia (4421); Gastrointestinal Regurgitation (4477); Urethral Stenosis/Stricture (4501); Unspecified Kidney or Urinary Problem (4503); Dyspareunia (4505); Cramp(s) /Muscle Spasm(s) (4521); Urinary Incontinence (4572); Insufficient Information (4580)

Event Date 08/03/2017

Event Type  Injury  

Manufacturer Narrative

The event date was approximated to (b)(6) 2017, implant date, as no event date was reported.(b)(4).The complaint device is not expected to be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that a lynx suprapubic mid-urethral sling was implanted into the patient during a procedure performed on (b)(6) 2017.As reported by the patient's attorney, the patient has experienced an unknown injury.Boston scientific has been unable to obtain additional information regarding the event to date.

Manufacturer Narrative

Block b3: the event date was approximated to (b)(6) 2017, implant date, as no event date was reported.Block e1: this event was reported by the patient's legal representation.The device was implanted at: (b)(6).Block h6: patient code e2401 captures the reportable event of unspecified injury.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the complaint device is not expected to be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that a lynx suprapubic mid-urethral sling was implanted into the patient during a procedure performed on (b)(6) 2017.As reported by the patient's attorney, the patient has experienced an unknown injury.Boston scientific has been unable to obtain additional information regarding the event to date.

Manufacturer Narrative

Block a4: patient's weight: 140.8 lbs.Block b3: the event date was approximated to (b)(6) 2017, implant date, as no event date was reported.Block e1: this event was reported by the patient's legal representation.The device was implanted at: (b)(6).Rheumatologist: dr.(b)(6).Block h6: patient codes e2330, e1002, e1405, e0126, e1307, e1310, e0306, e1311, e2328, e2326,e1714, e020201, and e020202 capture the reportable events of pain (chronic pelvic pain, bladder pain, perineal pain, joint pain), pain, abdominal, dyspareunia, neuropathy (peripheral neuropathy), urethral stenosis/stricture (urethral stenosis), infection, urinary tract, sepsis, unspecified kidney or urinary problem (pyelonephritis), obstruction, ureter/urethra (kidney stones), inflammation (cystitis ,appendicitis ), rash, anxiety, depression.Impact codes f19, f1903, f2303, and f22 capture the reportable events of surgical intervention (cystourethroscopy, urethral dilation, hydrodistention of bladder), device explantation (excision of mid-urethral sling), medication required (bactrim, macrobid, doxycycline, dilaudid, percocet 5mg tablet, ketamine injection), unexpected diagnostic intervention (mri, cystoscopy).Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the excised mesh is not expected to be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that a lynx suprapubic mid-urethral sling was implanted during a placement of mid-urethral sling and cystourethroscopy procedure performed on (b)(6) 2017 for the treatment of stress urinary incontinence.On (b)(6) 2017, the patient had a follow-up visit for her chronic pain management and peripheral neuropathy.During examination, she displayed pain upon rising from the seated position and transitioning through the first few steps of ambulation.She was also referred to a pain specialist to check for possible tarsal tunnel syndrome and to determine the candidacy for the following procedures: nerve conduction study.On (b)(6) 2018, she called the physician regarding her urinary tract infection (uti), and stated that she kept getting infections even though she had done urgent care, and she needed to see a physician.The patient was instructed to return visit when she's off on antibiotics.She took bactrim and macrobid but neither of them helped.The patient had taken doxycycline currently, but it was for her arthritis.The walk-in clinic report showed a large amount of blood, and her leukocytes were high, there were a lot of bacteria.They told her if the bactrim did not help, she was instructed to call the physician.This was her 5th infection, and she had this since she had the bladder sling.She would like an appointment as soon as possible.On (b)(6) 2018, the patient presented uti, hematuria, dysuria and urinary frequency for 4 months.She stated that starting october 2017 she has had several episodes of uti.She had been on multiple courses of antibiotics in which for the past 2 months, she had been on a full course of macrobid/bactrim, and stated that she was currently on her 3rd day of doxycycline.Moreover, the patient still continue to have symptoms, and had a nickel size nodule/tenderness with palpation in the suprapubic region.During the review of her systems, the differential diagnoses were appendicitis, kidney stone, pelvic inflammatory disease, pyelonephritis, sepsis, bacteremia, and altered mental status.On (b)(6) 2018, she underwent cystourethroscopy, urethral dilation and hydrodistention of bladder for the treatment of her chronic pelvic pain, recurrent urinary tract infections, microhematuria, and recurrent stress urinary incontinence.In the past several months, she had developed chronic left greater than right pelvic pain, as well, as recurrent utis.She had demonstrated good bladder emptying in the clinic.After the discussion in clinic, she elected to proceed with the above procedures to rule out mesh erosion as well as to evaluate her urethra and bladder.Furthermore, her operative findings were minimal urethral stenosis, and the bladder was distended twice with capacities of 450 and 350, respectively.The urethra was dilated to 30-french.The bladder and urethra were normal without any evidence of mesh erosion whatsoever on inspection with a 30- and 70-degree lenses.On (b)(6) 2019, the patient was in for her complaint of recurring uti and pelvic pain with tender path of purapubic sling.On (b)(6) 2019, she had a follow-up visit for her pain or burning with urination, and dyspareunia.She first noticed the symptom approximately (b)(6) 2018.She did urinate more frequently than once every 4 hours in the daytime.She did not have to strain or bear down to start her urinary stream.Moreover, she did dribble at the end of urination.She did have an abnormal sensation when needing to urinate.She usually gets up at night to urinate 1 time.She had not previously had an indwelling catheter in for more than two weeks at a time.The patient had severe pain all the time, including when she urinates and when she doesn't.The pain radiates up to her abdomen and on the left side of her stomach and has been present since january.The patient saw her gynecologist yesterday, and stated that they told her the pain was may because of her sling.Reportedly, the patient had taken urimart, hyoscymaine, and elmiron, which were not helping.During her review of systems, the patient mentioned that she had experienced fatigue, generalized weakness, weight loss, balance problems, dizzy spells, headache, numbness, tingling, skin rash, arthritis, joint pain, back pain, muscle weakness, urethra and abdominal tenderness, anxiety and depression.On (b)(6) 2019, the patient was in for complaints of bladder pain, and low abdominal/pelvic pain.She had mri, and pelvic exam by both her urologist and her gynecologist.Also, she had been taking medications to help with the pain and the the medication would wear off.On (b)(6) 2019, she underwent cystoscopy, and excision of mid-urethral sling via vaginal approach to treat her chronic pelvic pain, and stress urinary incontinence status post mid urethral sling placement.It was observed that the mesh was located in good position, and there were no other abnormalities noted.The mesh was excised in the midline, as well as limbs extending toward the retropubic space bilaterally.There was no evidence of mesh erosion or any urethral injury on cystoscopy.On (b)(6) 2019, the patient had a follow-up visit for her chronic pain management and pelvic pain.The patient was miserable with pelvic pain and abdominal pain.She had sustained the pain levels of an 8 or 9 constantly.She did have to use percocet 5mg tablet, which she stated did cause her to wake up sweating and feeling like she was in withdrawal.The physician authorized the patient to get ketamine injection.Reportedly, the patient would like to process a referral to another urologist for a second opinion.On (b)(6) 2019, the patient had a follow-up visit for her chronic pain management.Her chronic pain symptoms were about the same.Her chronic pain syndrome was nearly controlled at this point.She rated her pain at its worst in the last 30 days at a 8.She rated her lowest pain at a 6 in the last 30 days.The patient's most severe pain location was the following: abdominal region (currently).She characterizes the pain as the following: moderate to severe in intensity, constant, aching, sharp, tearing, and throbbing.No visits to any other healthcare providers since the last clinic visit.The patient needs the following medications refilled today: clonidine patch, pilocarpine and diazepam.No medication changes from the last visit.The patient was experiencing the following symptoms/side-effects: sweating, constipation, sleeping disturbance, mental fogginess.Last dose of pain medication was taken at 07:30am percocet 5mg.No one accompanied the patient to her visit today.Patient would like to discuss with physician to prescribe her plaquenil for her sjogren's syndrome.On (b)(6) 2019, during the phone call, the patient mentioned that she had been in a lot of pain since then and went to her physician yesterday, however, she was not able to take opiates.She rated her pain at 8 or 9, and was having some burning with urination.On(b)(6) 2019, the patient was in for follow-up visit for her pain or burning with urination.She first noticed the symptom approximately (b)(6) 2018.She did not urinate more frequently than once every 4 hours in the daytime.She did not have to strain or bear down to start her urinary stream.She did not dribble at the end of urination.She did not have an abnormal sensation when needing to urinate.She usually gets up at night to urinate 1 time.She had not previously had an indwelling catheter in for more than two weeks at a time.Also, the patient experienced pelvic pain on both sides, and this was first noticed approximately on (b)(6) 2018.She has had this kind of pain before.The pain was not related to her menstrual period.Her pain was sharp, and the intensity of her pain was rated as a 10.Her pain was not intermittent.Walking, standing, urinating, and full bladder made her pain worse.Nothing seems to make the pain better.She did not have pain with bowel movements, and she did not have trouble with constipation.On (b)(6) 2021, the patient had another follow-up visit to address the following: chronic pain management and chronic pelvic pain.Also, during her assessment, she had mentioned that she experienced other long term (current) drug therapy, and migraine without aura, not intractable.Her chronic pain symptoms were slightly and significantly better controlled.She rated her pain at its worst in the last 30 days at 9.She rated her lowest pain at a 4 in the last 30 days.She rated her pain most of the time on medication in the last 30 days at 8.The patient's most severe pain location is the following: pelvic region.She characterizes the pain as the following: moderate to severe in intensity and constant.She reported that the following activities were now possible since being placed on her current medication regimen whereas they weren't before due to her chronic pain condition: able to suffer less daily.The last dose of pain medication was taken at (b)(6) 2021.No one accompanied the patient to her visit today.

Event Description

It was reported to boston scientific corporation that a lynx suprapubic mid-urethral sling was implanted during a placement of mid-urethral sling and cystourethroscopy procedure performed on (b)(6) 2017, for the treatment of stress urinary incontinence.Relevant medical and surgical history included pelvic pain with a gynecological workup that was negative for any concerning findings, low grade cystocele, chronic low back pain, chronic neck pain, chronic thoracic back pain, raynaud's, anxiety, rheumatoid arthritis, depression, fibromyalgia, migraines, ibs, hemorrhoidectomy, dural puncture, nerve ablation (thoracic and lumber), lupus, and cholecystectomy.On (b)(6) 2017, the patient had a follow-up visit for her chronic pain management and peripheral neuropathy.During examination, she displayed pain upon rising from the seated position and transitioning through the first few steps of ambulation.She was also referred to a pain specialist to check for possible tarsal tunnel syndrome and to determine the candidacy for the following procedures: nerve conduction study.On (b)(6) 2018, she called the physician regarding her urinary tract infection (uti) and stated that she kept getting infections for which she had gone to urgent care.The patient was instructed to return visit when she's off on antibiotics.She took bactrim and macrobid but neither of them helped.The patient had taken doxycycline currently, but it was for her arthritis.The walk-in clinic report showed a large amount of blood, and her leukocytes were high, there were a lot of bacteria.They told her if the bactrim did not help, she was instructed to call the physician.This was her 5th infection, and she had this since she had the bladder sling.On (b)(6) 2018, the patient presented to the emergency room (er) with uti, hematuria, dysuria and urinary frequency for 4 months.She stated that starting (b)(6) 2017 she has had several episodes of uti.She had been on multiple courses of antibiotics in which for the past 2 months, she had been on a full course of macrobid/bactrim and stated that she was currently on her 3rd day of doxycycline.Moreover, the patient continued to have symptoms, and had a nickel size nodule/tenderness with palpation in the suprapubic region.Urinalysis showed bacteria and white blood cells and shew as advised to continue her current doxycycline.She was administered iv fluids and zofran for nausea.Computed tomography (ct) showed no acute abdominal or pelvic abnormality.The patient requested pain medications and was advised to take the already prescribed medications for pain control.She was discharged home with the impression of dysuria and advised to follow up with her urologist.On (b)(6) 2018, she underwent cystourethroscopy, urethral dilation and hydrodistention of bladder for the treatment of her chronic pelvic pain, recurrent urinary tract infections, microhematuria, and recurrent stress urinary incontinence.In the past several months, she had developed chronic left greater than right pelvic pain, as well, as recurrent utis.She had demonstrated good bladder emptying in the clinic.After the discussion in clinic, she elected to proceed with the above procedures to rule out mesh erosion as well as to evaluate her urethra and bladder.Operative findings were minimal urethral stenosis, and the bladder was distended twice with capacities of 450 and 350, respectively.The urethra was dilated to 30-french.The bladder and urethra were normal without any evidence of mesh erosion whatsoever on inspection with a 30- and 70-degree lenses.On (b)(6) 2019, the patient was in for her complaint of recurring uti and pelvic pain.Exam revealed suburethral and periurethral tenderness in the vagina.On (b)(6) 2019, she had a follow-up visit for her pain or burning with urination, and dyspareunia.She first noticed the symptom approximately (b)(6) 2018.She did urinate more frequently than once every 4 hours in the daytime.She did not have to strain or bear down to start her urinary stream.Moreover, she did dribble at the end of urination.She did have an abnormal sensation when needing to urinate.She usually gets up at night to urinate 1 time.She had not previously had an indwelling catheter in for more than two weeks at a time.The patient had severe pain all the time, including when she urinates and when she doesn't.The pain radiates up to her abdomen and on the left side of her stomach and has been present since january.The patient saw her gynecologist yesterday and stated that they told her the pain may be because of her sling.Reportedly, the patient had taken urimart, hyoscymaine, and elmiron, which were not helping.During her review of systems, the patient mentioned that she had experienced fatigue, generalized weakness, weight loss, balance problems, dizzy spells, headache, numbness, tingling, skin rash, arthritis, joint pain, back pain, muscle weakness, urethra and abdominal tenderness, anxiety and depression.Exam revealed abdominal tenderness, urethral tenderness, and no mesh erosion.The plan was for mri, urethrolysis, excision of midurethral sling, cystoscopy.On (b)(6) 2019, the patient presented to the emergency department for complaints of bladder pain, and low abdominal/pelvic pain.She had mri, and pelvic exam by both her urologist and her gynecologist.Also, she had been taking medications to help with the pain and the medication would wear off.On (b)(6) 2019, she underwent cystoscopy, and excision of mid-urethral sling via vaginal approach to treat her chronic pelvic pain, and stress urinary incontinence status post mid urethral sling placement.It was observed that the mesh was located in good position, and there were no other abnormalities noted.The mesh was excised in the midline, as well as limbs extending toward the retropubic space bilaterally.There was no evidence of mesh erosion or any urethral injury on cystoscopy.On (b)(6) 2019, the patient had a follow-up visit for her chronic pain management and pelvic pain.The patient was miserable with pelvic pain and abdominal pain.She had been doing really well post mesh excision until 1 week ago.She had sustained the pain levels of an 8 or 9 constantly.She did have to use percocet 5mg tablet, which she stated did cause her to wake up sweating and feeling like she was in withdrawal.Reportedly, the patient would like to process a referral to another urologist for a second opinion.An abdominal and pelvic ultrasound was ordered, and the patient was administered toradol and two doses of ketamine.On (b)(6) 2019, the patient had a follow-up visit for her chronic pain management.Her chronic pain symptoms were about the same.Her chronic pain syndrome was nearly controlled at this point.She rated her pain at its worst in the last 30 days at a 8.She rated her lowest pain at a 6 in the last 30 days.The patient's most severe pain location was the following: abdominal region (currently).She characterizes the pain as the following: moderate to severe in intensity, constant, aching, sharp, tearing, and throbbing.No visits to any other healthcare providers since the last clinic visit.The patient needs the following medications refilled today: clonidine patch, pilocarpine and diazepam.No medication changes from the last visit.The patient was experiencing the following symptoms/side-effects: sweating, constipation, sleeping disturbance, mental fogginess.Last dose of pain medication was taken at 07:30am percocet 5mg.No one accompanied the patient to her visit today.Patient would like to discuss with physician to prescribe her plaquenil for her sjogren's syndrome.The patient was administered toradol and two doses of ketamine.On (b)(6) 2019, during the phone call, the patient mentioned that she had been in a lot of pain since then and went to her physician yesterday, however, she was not able to take opiates.She rated her pain at 8 or 9 and was having some burning with urination.On (b)(6) 2019, the patient was in for follow-up visit for her pain or burning with urination.She first noticed the symptom approximately (b)(6) 2018.She did not urinate more frequently than once every 4 hours in the daytime.She did not have to strain or bear down to start her urinary stream.She did not dribble at the end of urination.She did not have an abnormal sensation when needing to urinate.She usually gets up at night to urinate 1 time.She had not previously had an indwelling catheter in for more than two weeks at a time.Also, the patient experienced pelvic pain on both sides, and this was first noticed approximately on (b)(6) 2018.She has had this kind of pain before.The pain was not related to her menstrual period.Her pain was sharp, and the intensity of her pain was rated as a 10.Her pain was not intermittent.Walking, standing, urinating, and full bladder made her pain worse.Nothing seems to make the pain better.She did not have pain with bowel movements, and she did not have trouble with constipation.Urinalysis was negative and postvoid residual was 0 ml.The patient believed that her pain was related to the mesh, but the physician advised her continued pain is likely not related to mesh or a genitourinary problem.The patient was offered a referral for pelvic floor physical therapy (pfpt).On (b)(6) 2021, the patient had another follow-up visit to address the following: chronic pain management and chronic pelvic pain.Her chronic pain symptoms were slightly and significantly better controlled.She rated her pain at its worst in the last 30 days at 9.She rated her lowest pain at a 4 in the last 30 days.She rated her pain most of the time on medication in the last 30 days at 8.The patient's most severe pain location is the following: pelvic region.She characterizes the pain as the following: moderate to severe in intensity and constant.She reported that the following activities were now possible since being placed on her current medication regimen whereas they weren't before due to her chronic pain condition: able to suffer less daily.

Manufacturer Narrative

Correction to blocks b5 and h6: patient codes.Block a4: patient's weight: 140.8 lbs.Block b3: the event date was approximated to august 3, 2017, implant date, as no event date was reported.Block e1: this event was reported by the patient's legal representation.The device was implanted at: (b)(6).Dr.(b)(6).Dr.(b)(6).Rheumatologist: dr.(b)(6).Block h6: patient codes e2330, e1002, e1405, e0126, e1307, e1310, e1714, e020201, and e020202 capture the reportable events of pain (chronic pelvic pain, bladder pain, perineal pain, joint pain), pain, abdominal, dyspareunia, neuropathy (peripheral neuropathy), urethral stenosis/stricture (urethral stenosis), infection, urinary tract, rash, anxiety, and depression, respectively.Impact codes f19, f1903, f2303, and f22 capture the reportable events of surgical intervention (cystourethroscopy, urethral dilation, hydrodistention of bladder), device explantation (excision of mid-urethral sling), medication required (bactrim, macrobid, doxycycline, dilaudid, percocet 5mg tablet, ketamine injection), unexpected diagnostic intervention (mri, cystoscopy).Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the excised mesh is not expected to be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that a lynx suprapubic mid-urethral sling was implanted during a placement of mid-urethral sling and cystourethroscopy procedure performed on (b)(6) 2017, for the treatment of stress urinary incontinence.Relevant medical and surgical history included pelvic pain with a gynecological workup that was negative for any concerning findings, low-grade cystocele, chronic low back pain, chronic neck pain, chronic thoracic back pain, raynaud's, anxiety, rheumatoid arthritis, depression, fibromyalgia, migraines, ibs, hemorrhoidectomy, dural puncture, nerve ablation (thoracic and lumbar), lupus, and cholecystectomy.On (b)(6) 2017, the patient had a follow-up visit for her chronic pain management and peripheral neuropathy.During the examination, she displayed pain upon rising from the seated position and transitioning through the first few steps of ambulation.She was also referred to a pain specialist to check for possible tarsal tunnel syndrome and to determine the candidacy for the following procedures: nerve conduction study.On (b)(6) 2018, she called the physician regarding her urinary tract infection (uti) and stated that she kept getting infections for which she had gone to urgent care.The patient was instructed to return to visit when she is off on antibiotics.She took bactrim and macrobid but neither of them helped.The patient had taken doxycycline currently, but it was for her arthritis.The walk-in clinic report showed a large amount of blood, and her leukocytes were high, there were a lot of bacteria.They told her if the bactrim did not help, she was instructed to call the physician.This was her 5th infection, and she had this since she had the bladder sling.On (b)(6) 2018, the patient presented to the emergency room (er) with uti, hematuria, dysuria, and urinary frequency for 4 months.She stated that starting (b)(6) 2017 she has had several episodes of uti.She had been on multiple courses of antibiotics in which for the past 2 months, she had been on a full course of macrobid/bactrim and stated that she was currently on her 3rd day of doxycycline.Moreover, the patient continued to have symptoms and had a nickel size nodule/tenderness with palpation in the suprapubic region.Urinalysis showed bacteria and white blood cells and she was advised to continue her current doxycycline.She was administered iv fluids and zofran for nausea.Computed tomography (ct) showed no acute abdominal or pelvic abnormality.The patient requested pain medications and was advised to take the already prescribed medications for pain control.She was discharged home with the impression of dysuria and advised to follow up with her urologist.On (b)(6) 2018, she underwent cystourethroscopy, urethral dilation, and hydrodistention of the bladder for the treatment of her chronic pelvic pain, recurrent urinary tract infections, microhematuria, and recurrent stress urinary incontinence.In the past several months, she had developed chronic left greater than right pelvic pain, as well, as recurrent utis.She had demonstrated good bladder emptying in the clinic.After the discussion in the clinic, she elected to proceed with the above procedures to rule out mesh erosion as well as to evaluate her urethra and bladder.Operative findings were minimal urethral stenosis, and the bladder was distended twice with capacities of 450 and 350, respectively.The urethra was dilated to 30-french.The bladder and urethra were normal without any evidence of mesh erosion whatsoever on the inspection with 30- and 70-degree lenses.On (b)(6) 2019, the patient was in for her complaint of recurring uti and pelvic pain.Exam revealed suburethral and periurethral tenderness in the vagina.On (b)(6) 2019, she had a follow-up visit for her pain or burning with urination and dyspareunia.She first noticed the symptom approximately (b)(6) 2018.She did urinate more frequently than once every 4 hours in the daytime.She did not have to strain or bear down to start her urinary stream.Moreover, she did dribble at the end of her urination.She did have an abnormal sensation when needing to urinate.She usually gets up at night to urinate 1 time.She had not previously had an indwelling catheter in for more than two weeks at a time.The patient had severe pain all the time, including when she urinates and when she doesn't.The pain radiates up to her abdomen and on the left side of her stomach and has been present since (b)(6).The patient saw her gynecologist yesterday and stated that they told her the pain maybe because of her sling.Reportedly, the patient had taken urimart, hyoscymaine, and elmiron, which were not helping.During her review of systems, the patient mentioned that she had experienced fatigue, generalized weakness, weight loss, balance problems, dizzy spells, headache, numbness, tingling, skin rash, arthritis, joint pain, back pain, muscle weakness, urethra and abdominal tenderness, anxiety, and depression.Exam revealed abdominal tenderness, urethral tenderness, and no mesh erosion.The plan was for mri, urethrolysis, excision of the mid-urethral sling, and cystoscopy.On (b)(6) 2019, the patient had a follow-up visit for her chronic pain management.Her chronic pain symptoms were slightly better controlled.Her symptoms were not controlled as well as she would like.She rated her pain at its worst in the last 30 days at an 8.She rated her lowest pain at a 6 in the last 30 days.The patient's most severe pain location was the following: pelvic region.She characterized the pain as moderate to severe in intensity, constant, aching, burning, cramping, like a pressure sensation, sharp, and throbbing.She recently had an appointment with urologist.The patient was seen for further evaluation of urinary tract infection (uti) symptoms and pain.There were no medication changes from the last visit.The patient experienced the following symptoms/side-effects; however, she did not take any pain medication.Reportedly, the patient was accompanied by her friend.The patient stated that she had a bladder sling placed that was recalled in (b)(6) 2016, and she mentioned that she was just made aware of the recall had existed.She has had been battling with chronic abdominal pain and urinary tract symptoms for over a year.Moreover, she has had multiple confirmed infections as well as infection symptoms that did not result in infections via the urine specimens obtained.She was scheduled to have the bladder sling removed on (b)(6) 2019.However, she does have a lot of concern for her post operation pain medication options.The patient would also like to discuss further her clonidine regimen and how long should she be continuing it.She had tried in the past to discontinue the patch; however, it had increased her withdrawal symptoms like hypertension and sweating.Additionally, the patient would also like a ketamine injection during this visit.She did also see a physician for consultation and for follow-up which she did appreciate his input and guidance; however, the medication he prescribed required a pa and the patient was going to be charged (b)(4) for this to be completed.During the musculoskeletal exam, the patient showed mild pain when seated by shifting and changing her body position in a behavior consistent with pain.Also, the patient displayed pain upon arising from a seated position and transitioning through the first few steps of ambulation.Reportedly, the patient had a mild left sided pain upon palpation at the thoracic spine and was disabled.Overall, the patient was doing considerately better.As for the patient's pain management recommendations, she had a stellate ganglion block a physician a few weeks ago and this helped tremendously on one side of her body.She reported that all the hyperhidrosis in limb sensitivity completely resolved.She was scheduled to have the other side done in 2 days.She was going to have her bladder sling revised and she was very concerned about taking opiates after surgery.The physician discussed with her that they could try a nasal spray for post-operation pain as she had received.The patient had responded very favorably to ketamine in the past.In addition, she had seen the psychiatrist for consultation.The most beneficial thing for her depression has been the ketamine.On (b)(6) 2019, the patient presented to the emergency department with complaints of bladder pain, and low abdominal/pelvic pain.She had mri and pelvic exam by both her urologist and her gynecologist.Also, she had been taking medications to help with the pain and the medication would wear off.On (b)(6) 2019, she underwent cystoscopy, and excision of mid-urethral sling via vaginal approach to treat her chronic pelvic pain and stress urinary incontinence status post-mid-urethral sling placement.It was observed that the mesh was located in a good position, and there were no other abnormalities noted.The mesh was excised in the midline, as well as limbs extending toward the retropubic space bilaterally.There was no evidence of mesh erosion or any urethral injury on cystoscopy.On (b)(6) 2019, the patient had a follow-up visit for her chronic pain management and pelvic pain.The patient was miserable with pelvic pain and abdominal pain.She had been doing really well post mesh excision until 1 week ago.She had sustained the pain levels of an 8 or 9 constantly.She did have to use percocet 5mg tablet, which she stated did cause her to wake up sweating and feeling like she was in withdrawal.Reportedly, the patient would like to process a referral to another urologist for a second opinion.An abdominal and pelvic ultrasound was ordered, and the patient was administered toradol and two doses of ketamine.On (b)(6) 2019, the patient had a follow-up visit for her chronic pain management.Her chronic pain symptoms were about the same.Her chronic pain syndrome was nearly controlled at this point.She rated her pain at its worst in the last 30 days at an 8.She rated her lowest pain at a 6 in the last 30 days.The patient's most severe pain location was the following: abdominal region (currently).She characterizes the pain as the following: moderate to severe in intensity, constant, aching, sharp, tearing, and throbbing.No visits to any other healthcare providers since the last clinic visit.The patient needs the following medications refilled today: clonidine patch, pilocarpine, and diazepam.No medication changes from the last visit.The patient was experiencing the following symptoms/side effects: sweating, constipation, sleeping disturbance, and mental fogginess.The last dose of pain medication was taken at 07:30 am percocet 5mg.No one accompanied the patient to her visit today.The patient would like to discuss with the physician to prescribe her plaquenil for her sjogren's syndrome.The patient was administered toradol and two doses of ketamine.On (b)(6) 2019, during the phone call, the patient mentioned that she had been in a lot of pain since then and went to her physician yesterday, however, she was not able to take opiates.She rated her pain at 8 or 9 and was having some burning with urination.On (b)(6) 2019, the patient was in for a follow-up visit for her pain or burning with urination.She first noticed the symptom approximately (b)(6) 2018.She did not urinate more frequently than once every 4 hours in the daytime.She did not have to strain or bear down to start her urinary stream.She did not dribble at the end of her urination.She did not have an abnormal sensation when needing to urinate.She usually gets up at night to urinate 1 time.She had not previously had an indwelling catheter in for more than two weeks at a time.Also, the patient experienced pelvic pain on both sides, and this was first noticed approximately on (b)(6) 2018.She has had this kind of pain before.The pain was not related to her menstrual period.Her pain was sharp, and the intensity of her pain was rated as a 10.Her pain was not intermittent.Walking, standing, urinating, and full bladder made her pain worse.Nothing seems to make the pain better.She did not have pain with bowel movements, and she did not have trouble with constipation.Urinalysis was negative and postvoid residual was 0 ml.The patient believed that her pain was related to the mesh, but the physician advised her continued pain is likely not related to mesh or a genitourinary problem.The patient was offered a referral for pelvic floor physical therapy (pfpt).In addition, the pathophysiology of pain complaints is associated with the placement of mesh.The has had extensive conservative treatment with both pudendal and left-sided ilioinguinal nerve blocks which gave temporary pain relief only.The patient has also undergone multiple ablations of the left ilioinguinal nerve, which gave temporary pain relief only lasting up to 2 months.However, will take 3 to 4 weeks for the patient to note pain relief after the procedure.At this juncture, the most logical next step in treatment was complete mesh removal with a left-sided ilioinguinal/iliohypogastric neurectomy.Surgical risks such as bleeding, infection, and damage to internal organs, especially the bladder, were reviewed.Postoperative restrictions and recovery time were also reviewed.The patient was aware that some of her symptoms were consistent with a pudendal nerve issue, which may not resolve with mesh removal.Approximately 80% of patients will see significant pain relief after this procedure.On (b)(6) 2020, the patient had another follow-up visit for her chronic pain management.Her chronic pain symptoms were slightly worse.The change in condition was due to increased pelvic pain.Her symptoms were not controlled as well as she would like.She rated her pain at its worst in the last 30 days at a 9.She rated her lowest pain at a 7 in the last 30 days.She rated her pain most of the time on medication in the last 30 days as an 8.The patient's most severe pain location was pelvic region.She characterized the pain as severe in intensity, constant, aching, cramping, sharp, shooting, stabbing, and throbbing.She recently had an appointment with an oncologist.The patient was seen for further medical workup explained later in the note.The patient needed her pain medications to be refilled, and for further discussion during that visit.Reportedly, there were no medication changes from the last visit.The patient has had to use oxycodone 3 times total this week.She has been undergoing further evaluations and her most recent pet scan was cancer free; however, she stated her oncologist informed her that she had fluid in her pelvis, fluid in her lungs and bursa sac of her left hip with inflammation.She was scheduled with a gynecologist specialist for further help with her pain from the recalled mesh sling she had, but her appointment was not until (b)(6).As for the patient's pain management recommendations, the patient did display meaningful benefit to justify opioid medication continuation currently.There does not appear to be apparent undue risk of abuse, addiction, or diversion identified at this time.The patient did not appear to be having problems with physical or psychological dependence at this time.The risks of combining sedatives, alcohol, benzodiazepines, and sleeping pills with opioids and the associated risks of accidental overdose which could result in death were discussed.Overall, she was doing remarkably better since her ketamine infusions.She was off clonidine and taking percocet sparingly.She has been taking ibuprofen 800mg tid which was not the best for her heart.Reportedly, the patient did not see a urogynecologist until march, and she was not on plaquenil at that time.On (b)(6) 2021, the patient had another follow-up visit to address the following: chronic pain management and chronic pelvic pain.Her chronic pain symptoms were slightly and significantly better controlled.She rated her pain at its worst in the last 30 days at 9.She rated her lowest pain at a 4 in the last 30 days.She rated her pain most of the time on medication in the last 30 days at 8.The patient's most severe pain location is the following: pelvic region.She characterizes the pain as the following: moderate to severe in intensity and constant.She reported that the following activities were now possible since being placed on her current medication regimen whereas they weren't before due to her chronic pain condition: ability to suffer less daily.On (b)(6) 2022, the patient underwent left-sided ilioinguinal/iliohypogastric neurectomy, retropubic dissection with mesh excision for the treatment of dysuria, dyspareunia, pelvic pain, and left ilioinguinal neuralgia.Firstly, on the patient's right side, the sling mesh was identified.It was grasped with a right-angle clamp, and predominantly sharp dissection was used to free the mesh as it was perforating the fascia and the rectus muscle.With traction and sharp dissection, the end of the mesh was eventually reached and was freed.Moreover, the end of the mesh was grasped with a kocher clamp, and used a combination of blunt and sharp dissection, stripping the mesh out of the retropubic space until it came free at the level of the periurethral region because the patient already had the vaginal portion of the mesh removed.Furthermore, the area was inspected carefully, and indeed, the entire piece of mesh had been removed.This was saved for pathology.Then, attention was moved to the patient's left side and performed essentially identical dissection for complete excision of the mesh.This was also then saved for pathology.Reportedly, 2 pieces of surgicel were placed in the deep portions of the dissection in the paravesical space near the bladder neck.The muscle was then reapproximated with interrupted 2-0 vicryl sutures, closed the fascia with a running 0 vicryl suture, closed the subcutaneous fat with a running 3-0 vicryl suture, and closed the skin with a running 4-0 subcuticular monocryl suture.Steri-strips and a bandage were placed.The patient was awakened in the operating room, brought to the recovery room awake, alert, and in apparent stable condition.Additionally, the surgical pathology report of the specimens from the left ilioinguinal nerve and retropubic mesh presented that there were large nerve fibers and adipose tissue.Also, there were fibrous tissue with chronic inflammation, foreign body giant cell reaction, and foreign body consistent with mesh.On (b)(6) 2022, the patient had another follow-up visit for her chronic pain management and chronic pelvic pain.Her chronic pain symptoms were worse.She rated her pain at its worst in the last 30 days at a 9.She rated her lowest pain at a 7 in the last 30 days.She rated her pain most of the time on medication in the last 30 days as a 9.The patient's most severe pain location was the following: pelvic region.She characterized the pain as moderate to severe in intensity, constant, and just painful and difficult to describe.Since patient was last seen in the physician's office, she went in for surgery, then the physician removed several inches of mesh from her pelvic area, and the patient was still in so much pain and cannot hardly walk.The patient needed her pain medications to be refilled today.There were no medication changes from the last visit.She reported that she was able to suffer less daily since being placed on her current medication regimen whereas they were not before due to her chronic pain condition.The patient experienced the following symptoms/side-effects: sweating, constipation, mental fogginess.Pertinent negatives include the following: nausea, breathing difficulty, drowsiness, heartburn, nervousness, itching, changes in mood, emotions, or personality, urinary hesitancy, sleeping disturbance, nightmares, dizziness, abdominal pain or heartburn, rash, retaining fluid or edema.She had her abdominal mesh removed by a physician.She seems to be doing well and was not on pain medication for post operation.The patient had a televisit today since she just had surgery.Her medication regimen will be continued without change at this time.The patient does display meaningful benefit to justify opioid medication continuation at this time.The clinical justification for continuation of opioid medication for pain management was the following: improved mobility and less suffering on a daily basis.On (b)(6) 2022, she had a follow-up visit to address her chronic pain management and chronic pelvic pain.Her chronic pain symptoms were about the same, worse.The change in condition was due to the following: still a lot of pain from the surgery, but also feeling better in some areas.She rated her pain at its worst in the last 30 days at a 10.She rated her lowest pain at a 9 in the last 30 days.The patient's most severe pain location was the pelvic region.She characterized the pain as moderate to severe in intensity, constant, and aching.Since patient was last seen in our office, she went in for her surgery with a physician, he removed 10 inches of mesh.The patient needed her pain medications to be refilled today.No medication changes from the last visit.She reported that she was able to suffer less daily now since being placed on her current medication regimen whereas they were not before due to her chronic pain condition.Last dose of pain medication was taken last month.Reportedly, no one accompanied the patient to her visit at this time.As for the patient's pain management recommendations, she was continuing to recover from abdominal surgery 5 weeks ago and was slowly making progress.She remained off from the pain medication and was continuing valium at night.

Manufacturer Narrative

Block a4: patient's weight: 140.8 lbs.Block b3: the event date was approximated to (b)(6) 2017, implant date, as no event date was reported.Block e1: this event was reported by the patient's legal representation.The device was implanted at: (b)(6).Block h6: patient codes e2330, e1002, e0126, e1307, e1310, e0123, e2326, e1714, e020201, e020202, e1405, e1311, e0744 and e1906 capture the reportable events of pain (chronic pelvic pain, bladder pain, perineal pain, joint pain), pain, abdominal, neuropathy (peripheral neuropathy), urethral stenosis/stricture (urethral stenosis), infection, urinary tract, nerve damage (left-sided ilioinguinal neuralgia), inflammation (chronic inflammation), rash, anxiety, depression, dyspareunia, unspecified kidney or urinary problem (urinary tract symptoms), nfection, upper respiratory tract (acute upper respiratory infection, unspecified), and infection (multiple confirmed infections), respectively.Impact codes f19, f1903, f2303, f22, f23 and f1202 capture the reportable events of surgical intervention (cystourethroscopy, urethral dilation, hydrodistention of bladder), device explantation (excision of mid-urethral sling), medication required (bactrim, macrobid, doxycycline, dilaudid, percocet 5mg tablet, ketamine injection), unexpected diagnostic intervention (mri, cystoscopy), and f23: unexpected medical intervention (extensive conservative treatment with both pudendal, left-sided ilioinguinal nerve blocks, multiple ablations of the left ilioinguinal nerve), and disability (disabled).Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the excised mesh is not expected to be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Manufacturer Narrative

Block a4: patient's weight: 140.8 lbs.Block b3: the event date was approximated to (b)(6) 2017, implant date, as no event date was reported.Block e1: this event was reported by the patient's legal representation.The device was implanted at: (b)(6).Block h6: patient codes e2330, e1002, e0126, e1307, e1310, e0123, e2326, e1714, e020201, e020202, e1405, e1311, e0744 and e1906 capture the reportable events of pain (chronic pelvic pain, bladder pain, perineal pain, joint pain, groin pain), pain, abdominal (lower abdomen), neuropathy (peripheral neuropathy), urethral stenosis/stricture (urethral stenosis), infection, urinary tract, nerve damage (left-sided ilioinguinal neuralgia), inflammation (chronic inflammation), rash, anxiety, depression, dyspareunia, unspecified kidney or urinary problem (urinary tract symptoms), infection, upper respiratory tract (acute upper respiratory infection, unspecified), and infection (multiple confirmed infections), respectively.Impact codes f19, f1903, f2303, f22, f23 and f1202 capture the reportable events of surgical intervention (cystourethroscopy, urethral dilation, hydrodistention of bladder), device explantation (excision of mid-urethral sling), medication required (bactrim, macrobid, doxycycline, dilaudid, percocet 5mg tablet, ketamine injection), unexpected diagnostic intervention (mri, cystoscopy), and f23: unexpected medical intervention (extensive conservative treatment with both pudendal, left-sided ilioinguinal nerve blocks, multiple ablations of the left ilioinguinal nerve), and disability (disabled).Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the excised mesh is not expected to be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that a lynx suprapubic mid-urethral sling was implanted during a placement of mid-urethral sling and cystourethroscopy procedure performed on (b)(6) 2017, for the treatment of stress urinary incontinence.Relevant medical and surgical history included pelvic pain with a gynecological workup that was negative for any concerning findings, low-grade cystocele, chronic low back pain, chronic neck pain, chronic thoracic back pain, raynaud's, anxiety, rheumatoid arthritis, depression, fibromyalgia, migraines, ibs, hemorrhoidectomy, dural puncture, nerve ablation (thoracic and lumbar), lupus, and cholecystectomy.On (b)(6) 2017, the patient had a follow-up visit for her chronic pain management and peripheral neuropathy.During the examination, she displayed pain upon rising from the seated position and transitioning through the first few steps of ambulation.She was also referred to a pain specialist to check for possible tarsal tunnel syndrome and to determine the candidacy for the following procedures: nerve conduction study.On (b)(6) 2018, she called the physician regarding her urinary tract infection (uti) and stated that she kept getting infections for which she had gone to urgent care.The patient was instructed to return to visit when she is off on antibiotics.She took bactrim and macrobid but neither of them helped.The patient had taken doxycycline currently, but it was for her arthritis.The walk-in clinic report showed a large amount of blood, and her leukocytes were high, there were a lot of bacteria.They told her if the bactrim did not help, she was instructed to call the physician.This was her 5th infection, and she had this since she had the bladder sling.On (b)(6) 2018, the patient presented to the emergency room (er) with uti, hematuria, dysuria, and urinary frequency for 4 months.She stated that starting (b)(6) 2017 she has had several episodes of uti.She had been on multiple courses of antibiotics in which for the past 2 months, she had been on a full course of macrobid/bactrim and stated that she was currently on her 3rd day of doxycycline.Moreover, the patient continued to have symptoms and had a nickel size nodule/tenderness with palpation in the suprapubic region.Urinalysis showed bacteria and white blood cells and she was advised to continue her current doxycycline.She was administered iv fluids and zofran for nausea.Computed tomography (ct) showed no acute abdominal or pelvic abnormality.The patient requested pain medications and was advised to take the already prescribed medications for pain control.She was discharged home with the impression of dysuria and advised to follow up with her urologist.On (b)(6) 2018, she underwent cystourethroscopy, urethral dilation, and hydrodistention of the bladder for the treatment of her chronic pelvic pain, recurrent urinary tract infections, microhematuria, and recurrent stress urinary incontinence.In the past several months, she had developed chronic left greater than right pelvic pain, as well, as recurrent utis.She had demonstrated good bladder emptying in the clinic.After the discussion in the clinic, she elected to proceed with the above procedures to rule out mesh erosion as well as to evaluate her urethra and bladder.Operative findings were minimal urethral stenosis, and the bladder was distended twice with capacities of 450 and 350, respectively.The urethra was dilated to 30-french.The bladder and urethra were normal without any evidence of mesh erosion whatsoever on the inspection with 30- and 70-degree lenses.On (b)(6) 2019, the patient was in for her complaint of recurring uti and pelvic pain.Exam revealed suburethral and periurethral tenderness in the vagina.On (b)(6) 2019, she had a follow-up visit for her pain or burning with urination and dyspareunia.She first noticed the symptom approximately (b)(6) 2018.She did urinate more frequently than once every 4 hours in the daytime.She did not have to strain or bear down to start her urinary stream.Moreover, she did dribble at the end of her urination.She did have an abnormal sensation when needing to urinate.She usually gets up at night to urinate 1 time.She had not previously had an indwelling catheter in for more than two weeks at a time.The patient had severe pain all the time, including when she urinates and when she doesn't.The pain radiates up to her abdomen and on the left side of her stomach and has been present since january.The patient saw her gynecologist yesterday and stated that they told her the pain maybe because of her sling.Reportedly, the patient had taken urimart, hyoscymaine, and elmiron, which were not helping.During her review of systems, the patient mentioned that she had experienced fatigue, generalized weakness, weight loss, balance problems, dizzy spells, headache, numbness, tingling, skin rash, arthritis, joint pain, back pain, muscle weakness, urethra and abdominal tenderness, anxiety, and depression.Exam revealed abdominal tenderness, urethral tenderness, and no mesh erosion.The plan was for mri, urethrolysis, excision of the mid-urethral sling, and cystoscopy.On (b)(6) 2019, the patient had a follow-up visit for her chronic pain management.Her chronic pain symptoms were slightly better controlled.Her symptoms were not controlled as well as she would like.She rated her pain at its worst in the last 30 days at an 8.She rated her lowest pain at a 6 in the last 30 days.The patient's most severe pain location was the following: pelvic region.She characterized the pain as moderate to severe in intensity, constant, aching, burning, cramping, like a pressure sensation, sharp, and throbbing.She recently had an appointment with urologist.The patient was seen for further evaluation of urinary tract infection (uti) symptoms and pain.There were no medication changes from the last visit.The patient experienced the following symptoms/side-effects; however, she did not take any pain medication.Reportedly, the patient was accompanied by her friend.The patient stated that she had a bladder sling placed that was recalled in february 2016, and she mentioned that she was just made aware of the recall had existed.She has had been battling with chronic abdominal pain and urinary tract symptoms for over a year.Moreover, she has had multiple confirmed infections as well as infection symptoms that did not result in infections via the urine specimens obtained.She was scheduled to have the bladder sling removed on (b)(6) 2019.However, she does have a lot of concern for her post operation pain medication options.The patient would also like to discuss further her clonidine regimen and how long should she be continuing it.She had tried in the past to discontinue the patch; however, it had increased her withdrawal symptoms like hypertension and sweating.Additionally, the patient would also like a ketamine injection during this visit.She did also see a physician for consultation and for follow-up which she did appreciate his input and guidance; however, the medication he prescribed required a pa and the patient was going to be charged (b)(6) for this to be completed.During the musculoskeletal exam, the patient showed mild pain when seated by shifting and changing her body position in a behavior consistent with pain.Also, the patient displayed pain upon arising from a seated position and transitioning through the first few steps of ambulation.Reportedly, the patient had a mild left sided pain upon palpation at the thoracic spine and was disabled.Overall, the patient was doing considerately better.As for the patient's pain management recommendations, she had a stellate ganglion block a physician a few weeks ago and this helped tremendously on one side of her body.She reported that all the hyperhidrosis in limb sensitivity completely resolved.She was scheduled to have the other side done in 2 days.She was going to have her bladder sling revised and she was very concerned about taking opiates after surgery.The physician discussed with her that they could try a nasal spray for post-operation pain as she had received.The patient had responded very favorably to ketamine in the past.In addition, she had seen the psychiatrist for consultation.The most beneficial thing for her depression has been the ketamine.On (b)(6) 2019, the patient presented to the emergency department with complaints of bladder pain, and low abdominal/pelvic pain.She had mri and pelvic exam by both her urologist and her gynecologist.Also, she had been taking medications to help with the pain and the medication would wear off.On (b)(6) 2019, she underwent cystoscopy, and excision of mid-urethral sling via vaginal approach to treat her chronic pelvic pain and stress urinary incontinence status post-mid-urethral sling placement.It was observed that the mesh was located in a good position, and there were no other abnormalities noted.The mesh was excised in the midline, as well as limbs extending toward the retropubic space bilaterally.There was no evidence of mesh erosion or any urethral injury on cystoscopy.On (b)(6) 2019, the patient stated that she was no longer having any dysuria.She had complaints of enuresis, which she did not have before the procedure, and she was having pain in her lower abdomen and groin area, but not as before.Additionally, the patient also had incontinence when she coughed or sneezed.She had a clear urine analysis, a post-void residual (pvr) of 3, and an rtc of 6 months for follow-up.On (b)(6) 2019, the patient had a follow-up visit for her chronic pain management and pelvic pain.The patient was miserable with pelvic pain and abdominal pain.She had been doing really well post mesh excision until 1 week ago.She had sustained the pain levels of an 8 or 9 constantly.She did have to use percocet 5mg tablet, which she stated did cause her to wake up sweating and feeling like she was in withdrawal.Reportedly, the patient would like to process a referral to another urologist for a second opinion.An abdominal and pelvic ultrasound was ordered, and the patient was administered toradol and two doses of ketamine.On (b)(6) 2019, the patient had a follow-up visit for her chronic pain management.Her chronic pain symptoms were about the same.Her chronic pain syndrome was nearly controlled at this point.She rated her pain at its worst in the last 30 days at an 8.She rated her lowest pain at a 6 in the last 30 days.The patient's most severe pain location was the following: abdominal region (currently).She characterizes the pain as the following: moderate to severe in intensity, constant, aching, sharp, tearing, and throbbing.No visits to any other healthcare providers since the last clinic visit.The patient needs the following medications refilled today: clonidine patch, pilocarpine, and diazepam.No medication changes from the last visit.The patient was experiencing the following symptoms/side effects: sweating, constipation, sleeping disturbance, and mental fogginess.The last dose of pain medication was taken at 07:30 am percocet 5mg.No one accompanied the patient to her visit today.The patient would like to discuss with the physician to prescribe her plaquenil for her sjogren's syndrome.The patient was administered toradol and two doses of ketamine.On (b)(6) 2019, during the phone call, the patient mentioned that she had been in a lot of pain since then and went to her physician yesterday, however, she was not able to take opiates.She rated her pain at 8 or 9 and was having some burning with urination.On (b)(6) 2019, the patient was in for a follow-up visit for her pain or burning with urination.She first noticed the symptom approximately (b)(6) 2018.She did not urinate more frequently than once every 4 hours in the daytime.She did not have to strain or bear down to start her urinary stream.She did not dribble at the end of her urination.She did not have an abnormal sensation when needing to urinate.She usually gets up at night to urinate 1 time.She had not previously had an indwelling catheter in for more than two weeks at a time.Also, the patient experienced pelvic pain on both sides, and this was first noticed approximately on (b)(6) 2018.She has had this kind of pain before.The pain was not related to her menstrual period.Her pain was sharp, and the intensity of her pain was rated as a 10.Her pain was not intermittent.Walking, standing, urinating, and full bladder made her pain worse.Nothing seems to make the pain better.She did not have pain with bowel movements, and she did not have trouble with constipation.Urinalysis was negative and postvoid residual was 0 ml.The patient believed that her pain was related to the mesh, but the physician advised her continued pain is likely not related to mesh or a genitourinary problem.The patient was offered a referral for pelvic floor physical therapy (pfpt).In addition, the pathophysiology of pain complaints is associated with the placement of mesh.The has had extensive conservative treatment with both pudendal and left-sided ilioinguinal nerve blocks which gave temporary pain relief only.The patient has also undergone multiple ablations of the left ilioinguinal nerve, which gave temporary pain relief only lasting up to 2 months.However, will take 3 to 4 weeks for the patient to note pain relief after the procedure.At this juncture, the most logical next step in treatment was complete mesh removal with a left-sided ilioinguinal/iliohypogastric neurectomy.Surgical risks such as bleeding, infection, and damage to internal organs, especially the bladder, were reviewed.Postoperative restrictions and recovery time were also reviewed.The patient was aware that some of her symptoms were consistent with a pudendal nerve issue, which may not resolve with mesh removal.Approximately 80% of patients will see significant pain relief after this procedure.On (b)(6) 2020, the patient had another follow-up visit for her chronic pain management.Her chronic pain symptoms were slightly worse.The change in condition was due to increased pelvic pain.Her symptoms were not controlled as well as she would like.She rated her pain at its worst in the last 30 days at a 9.She rated her lowest pain at a 7 in the last 30 days.She rated her pain most of the time on medication in the last 30 days as an 8.The patient's most severe pain location was pelvic region.She characterized the pain as severe in intensity, constant, aching, cramping, sharp, shooting, stabbing, and throbbing.She recently had an appointment with an oncologist.The patient was seen for further medical workup explained later in the note.The patient needed her pain medications to be refilled, and for further discussion during that visit.Reportedly, there were no medication changes from the last visit.The patient has had to use oxycodone 3 times total this week.She has been undergoing further evaluations and her most recent pet scan was cancer free; however, she stated her oncologist informed her that she had fluid in her pelvis, fluid in her lungs and bursa sac of her left hip with inflammation.She was scheduled with a gynecologist specialist for further help with her pain from the recalled mesh sling she had, but her appointment was not until (b)(6).As for the patient's pain management recommendations, the patient did display meaningful benefit to justify opioid medication continuation currently.There does not appear to be apparent undue risk of abuse, addiction, or diversion identified at this time.The patient did not appear to be having problems with physical or psychological dependence at this time.The risks of combining sedatives, alcohol, benzodiazepines, and sleeping pills with opioids and the associated risks of accidental overdose which could result in death were discussed.Overall, she was doing remarkably better since her ketamine infusions.She was off clonidine and taking percocet sparingly.She has been taking ibuprofen 800mg tid which was not the best for her heart.Reportedly, the patient did not see a urogynecologist until march, and she was not on plaquenil at that time.On (b)(6) 2021, the patient had another follow-up visit to address the following: chronic pain management and chronic pelvic pain.Her chronic pain symptoms were slightly and significantly better controlled.She rated her pain at its worst in the last 30 days at 9.She rated her lowest pain at a 4 in the last 30 days.She rated her pain most of the time on medication in the last 30 days at 8.The patient's most severe pain location is the following: pelvic region.She characterizes the pain as the following: moderate to severe in intensity and constant.She reported that the following activities were now possible since being placed on her current medication regimen whereas they were not before due to her chronic pain condition: ability to suffer less daily.On (b)(6) 2021, the patient was here for evaluation on a telehealth visit for pelvic pain.The patient has a history of mixed connective tissue disorders, sjogren's, and breast cancer.In 2017, the patient underwent a mid-urethral suprapubic sling with the lynx system.After this procedure, she developed severe, debilitating pelvic pain.In 2019, she had the vaginal portion of the sling removed without any improvement in her symptoms.She has since been diagnosed with 2 conditions: ilioinguinal neuralgia and pudendal neuralgia.In regard to the ilioinguinal neuralgia, the pain is predominantly on the left side and extends into the groin and vulva.It is a constant neuropathic pain and feels like the groin is being torn apart.She has sensitivity to clothing, and it is difficult to walk.She has had ilioinguinal nerve blocks that significantly reduced her pain temporarily.She has undergone 2 radiofrequency ablations that improved her symptoms for several months.Her pudendal pain is primarily experienced rectally, mostly on the left side, but she does have pain in the urethra and clitoris.The pain is constant but gets worse with sitting or standing.She has excruciating pain with bowel movements and cannot have intercourse.She has a burning pain in the clitoris and feels like she is urinating razor blades.She has had pudendal nerve blocks that gave her temporary relief from her pain.The patient has mild urinary incontinence symptoms even after the vaginal portion was removed.She does have frequent urgency symptoms.Consent was provided for the patient for laparoscopic robotic mesh removal, possible botox injections into the pelvic floor muscles, possible pudendal nerve block, possible ilioinguinal nerve block, and possible ilioinguinal neurectomy for an estimated duration of 4 hours.On (b)(6) 2022, the patient underwent left-sided ilioinguinal/iliohypogastric neurectomy, retropubic dissection with mesh excision for the treatment of dysuria, dyspareunia, pelvic pain, and left ilioinguinal neuralgia.Firstly, on the patient's right side, the sling mesh was identified.It was grasped with a right-angle clamp, and predominantly sharp dissection was used to free the mesh as it was perforating the fascia and the rectus muscle.With traction and sharp dissection, the end of the mesh was eventually reached and was freed.Moreover, the end of the mesh was grasped with a kocher clamp, and used a combination of blunt and sharp dissection, stripping the mesh out of the retropubic space until it came free at the level of the periurethral region because the patient already had the vaginal portion of the mesh removed.Furthermore, the area was inspected carefully, and indeed, the entire piece of mesh had been removed.This was saved for pathology.Then, attention was moved to the patient's left side and performed essentially identical dissection for complete excision of the mesh.This was also then saved for pathology.Reportedly, 2 pieces of surgicel were placed in the deep portions of the dissection in the paravesical space near the bladder neck.The muscle was then reapproximated with interrupted 2-0 vicryl sutures, closed the fascia with a running 0 vicryl suture, closed the subcutaneous fat with a running 3-0 vicryl suture, and closed the skin with a running 4-0 subcuticular monocryl suture.Steri-strips and a bandage were placed.The patient was awakened in the operating room, brought to the recovery room awake, alert, and in apparent stable condition.Additionally, the surgical pathology report of the specimens from the left ilioinguinal nerve and retropubic mesh presented that there were large nerve fibers and adipose tissue.Also, there were fibrous tissue with chronic inflammation, foreign body giant cell reaction, and foreign body consistent with mesh.On (b)(6) 2022, the patient had another follow-up visit for her chronic pain management and chronic pelvic pain.Her chronic pain symptoms were worse.She rated her pain at its worst in the last 30 days at a 9.She rated her lowest pain at a 7 in the last 30 days.She rated her pain most of the time on medication in the last 30 days as a 9.The patient's most severe pain location was the following: pelvic region.She characterized the pain as moderate to severe in intensity, constant, and just painful and difficult to describe.Since patient was last seen in the physician's office, she went in for surgery, then the physician removed several inches of mesh from her pelvic area, and the patient was still in so much pain and cannot hardly walk.The patient needed her pain medications to be refilled today.There were no medication changes from the last visit.She reported that she was able to suffer less daily since being placed on her current medication regimen whereas they were not before due to her chronic pain condition.The patient experienced the following symptoms/side-effects: sweating, constipation, mental fogginess.Pertinent negatives include the following: nausea, breathing difficulty, drowsiness, heartburn, nervousness, itching, changes in mood, emotions, or personality, urinary hesitancy, sleeping disturbance, nightmares, dizziness, abdominal pain or heartburn, rash, retaining fluid or edema.She had her abdominal mesh removed by a physician.She seems to be doing well and was not on pain medication for post operation.The patient had a televisit today since she just had surgery.Her medication regimen will be continued without change at this time.The patient does display meaningful benefit to justify opioid medication continuation at this time.The clinical justification for continuation of opioid medication for pain management was the following: improved mobility and less suffering on a daily basis.On (b)(6) 2022, the physician spoke to the patient, and the patient left a message to cancel her surgery since she was able to have it done sooner with a doctor in (b)(6).On (b)(6) 2022, she had a follow-up visit to address her chronic pain management and chronic pelvic pain.Her chronic pain symptoms were about the same, worse.The change in condition was due to the following: still a lot of pain from the surgery, but also feeling better in some areas.She rated her pain at its worst in the last 30 days at a 10.She rated her lowest pain at a 9 in the last 30 days.The patient's most severe pain location was the pelvic region.She characterized the pain as moderate to severe in intensity, constant, and aching.Since patient was last seen in our office, she went in for her surgery with a physician, he removed 10 inches of mesh.The patient needed her pain medications to be refilled today.No medication changes from the last visit.She reported that she was able to suffer less daily now since being placed on her current medication regimen whereas they were not before due to her chronic pain condition.Last dose of pain medication was taken last month.Reportedly, no one accompanied the patient to her visit at this time.As for the patient's pain management recommendations, she was continuing to recover from abdominal surgery 5 weeks ago and was slowly making progress.She remained off from the pain medication and was continuing valium at night.

Event Description

It was reported to boston scientific corporation that a lynx suprapubic mid-urethral sling was implanted during a placement of mid-urethral sling and cystourethroscopy procedure performed on (b)(6) 2017, for the treatment of stress urinary incontinence.Relevant medical and surgical history included pelvic pain with a gynecological workup that was negative for any concerning findings, low-grade cystocele, chronic low back pain, chronic neck pain, chronic thoracic back pain, raynaud's, anxiety, rheumatoid arthritis, depression, fibromyalgia, migraines, ibs, hemorrhoidectomy, dural puncture, nerve ablation (thoracic and lumbar), lupus, and cholecystectomy.On (b)(6) 2017, the patient had a follow-up visit for her chronic pain management and peripheral neuropathy.During the examination, she displayed pain upon rising from the seated position and transitioning through the first few steps of ambulation.She was also referred to a pain specialist to check for possible tarsal tunnel syndrome and to determine the candidacy for the following procedures: nerve conduction study.On (b)(6) 2018, she called the physician regarding her urinary tract infection (uti) and stated that she kept getting infections for which she had gone to urgent care.The patient was instructed to return to visit when she is off on antibiotics.She took bactrim and macrobid but neither of them helped.The patient had taken doxycycline currently, but it was for her arthritis.The walk-in clinic report showed a large amount of blood, and her leukocytes were high, there were a lot of bacteria.They told her if the bactrim did not help, she was instructed to call the physician.This was her 5th infection, and she had this since she had the bladder sling.On (b)(6) 2018, the patient presented to the emergency room (er) with uti, hematuria, dysuria, and urinary frequency for 4 months.She stated that starting (b)(6) 2017 she has had several episodes of uti.She had been on multiple courses of antibiotics in which for the past 2 months, she had been on a full course of macrobid/bactrim and stated that she was currently on her 3rd day of doxycycline.Moreover, the patient continued to have symptoms and had a nickel size nodule/tenderness with palpation in the suprapubic region.Urinalysis showed bacteria and white blood cells and she was advised to continue her current doxycycline.She was administered iv fluids and zofran for nausea.Computed tomography (ct) showed no acute abdominal or pelvic abnormality.The patient requested pain medications and was advised to take the already prescribed medications for pain control.She was discharged home with the impression of dysuria and advised to follow up with her urologist.On (b)(6) 2018, she underwent cystourethroscopy, urethral dilation, and hydrodistention of the bladder for the treatment of her chronic pelvic pain, recurrent urinary tract infections, microhematuria, and recurrent stress urinary incontinence.In the past several months, she had developed chronic left greater than right pelvic pain, as well, as recurrent utis.She had demonstrated good bladder emptying in the clinic.After the discussion in the clinic, she elected to proceed with the above procedures to rule out mesh erosion as well as to evaluate her urethra and bladder.Operative findings were minimal urethral stenosis, and the bladder was distended twice with capacities of 450 and 350, respectively.The urethra was dilated to 30-french.The bladder and urethra were normal without any evidence of mesh erosion whatsoever on the inspection with 30- and 70-degree lenses.On (b)(6) 2019, the patient was in for her complaint of recurring uti and pelvic pain.Exam revealed suburethral and periurethral tenderness in the vagina.On (b)(6) 2019, she had a follow-up visit for her pain or burning with urination and dyspareunia.She first noticed the symptom approximately (b)(6) 2018.She did urinate more frequently than once every 4 hours in the daytime.She did not have to strain or bear down to start her urinary stream.Moreover, she did dribble at the end of her urination.She did have an abnormal sensation when needing to urinate.She usually gets up at night to urinate 1 time.She had not previously had an indwelling catheter in for more than two weeks at a time.The patient had severe pain all the time, including when she urinates and when she doesn't.The pain radiates up to her abdomen and on the left side of her stomach and has been present since (b)(6).The patient saw her gynecologist yesterday and stated that they told her the pain maybe because of her sling.Reportedly, the patient had taken urimart, hyoscymaine, and elmiron, which were not helping.During her review of systems, the patient mentioned that she had experienced fatigue, generalized weakness, weight loss, balance problems, dizzy spells, headache, numbness, tingling, skin rash, arthritis, joint pain, back pain, muscle weakness, urethra and abdominal tenderness, anxiety, and depression.Exam revealed abdominal tenderness, urethral tenderness, and no mesh erosion.The plan was for mri, urethrolysis, excision of the mid-urethral sling, and cystoscopy.On (b)(6) 2019, the patient had a follow-up visit for her chronic pain management.Her chronic pain symptoms were slightly better controlled.Her symptoms were not controlled as well as she would like.She rated her pain at its worst in the last 30 days at an 8.She rated her lowest pain at a 6 in the last 30 days.The patient's most severe pain location was the following: pelvic region.She characterized the pain as moderate to severe in intensity, constant, aching, burning, cramping, like a pressure sensation, sharp, and throbbing.She recently had an appointment with urologist.The patient was seen for further evaluation of urinary tract infection (uti) symptoms and pain.There were no medication changes from the last visit.The patient experienced the following symptoms/side-effects; however, she did not take any pain medication.Reportedly, the patient was accompanied by her friend.The patient stated that she had a bladder sling placed that was recalled in february 2016, and she mentioned that she was just made aware of the recall had existed.She has had been battling with chronic abdominal pain and urinary tract symptoms for over a year.Moreover, she has had multiple confirmed infections as well as infection symptoms that did not result in infections via the urine specimens obtained.She was scheduled to have the bladder sling removed on (b)(6) 2019.However, she does have a lot of concern for her post operation pain medication options.The patient would also like to discuss further her clonidine regimen and how long should she be continuing it.She had tried in the past to discontinue the patch; however, it had increased her withdrawal symptoms like hypertension and sweating.Additionally, the patient would also like a ketamine injection during this visit.She did also see a physician for consultation and for follow-up which she did appreciate his input and guidance; however, the medication he prescribed required a pa and the patient was going to be charged (b)(6) for this to be completed.During the musculoskeletal exam, the patient showed mild pain when seated by shifting and changing her body position in a behavior consistent with pain.Also, the patient displayed pain upon arising from a seated position and transitioning through the first few steps of ambulation.Reportedly, the patient had a mild left sided pain upon palpation at the thoracic spine and was disabled.Overall, the patient was doing considerately better.As for the patient's pain management recommendations, she had a stellate ganglion block a physician a few weeks ago and this helped tremendously on one side of her body.She reported that all the hyperhidrosis in limb sensitivity completely resolved.She was scheduled to have the other side done in 2 days.She was going to have her bladder sling revised and she was very concerned about taking opiates after surgery.The physician discussed with her that they could try a nasal spray for post-operation pain as she had received.The patient had responded very favorably to ketamine in the past.In addition, she had seen the psychiatrist for consultation.The most beneficial thing for her depression has been the ketamine.On (b)(6) 2019, the patient presented to the emergency department with complaints of bladder pain, and low abdominal/pelvic pain.She had mri and pelvic exam by both her urologist and her gynecologist.Also, she had been taking medications to help with the pain and the medication would wear off.On (b)(6) 2019, she underwent cystoscopy, and excision of mid-urethral sling via vaginal approach to treat her chronic pelvic pain and stress urinary incontinence status post-mid-urethral sling placement.It was observed that the mesh was located in a good position, and there were no other abnormalities noted.The mesh was excised in the midline, as well as limbs extending toward the retropubic space bilaterally.There was no evidence of mesh erosion or any urethral injury on cystoscopy.On (b)(6) 2019, the patient stated that she was no longer having any dysuria.She had complaints of enuresis, which she did not have before the procedure, and she was having pain in her lower abdomen and groin area, but not as before.Additionally, the patient also had incontinence when she coughed or sneezed.She had a clear urine analysis, a post-void residual (pvr) of 3, and an rtc of 6 months for follow-up.On (b)(6) 2019, the patient had a follow-up visit for her chronic pain management and pelvic pain.The patient was miserable with pelvic pain and abdominal pain.She had been doing really well post mesh excision until 1 week ago.She had sustained the pain levels of an 8 or 9 constantly.She did have to use percocet 5mg tablet, which she stated did cause her to wake up sweating and feeling like she was in withdrawal.Reportedly, the patient would like to process a referral to another urologist for a second opinion.An abdominal and pelvic ultrasound was ordered, and the patient was administered toradol and two doses of ketamine.On (b)(6) 2019, the patient had a follow-up visit for her chronic pain management.Her chronic pain symptoms were about the same.Her chronic pain syndrome was nearly controlled at this point.She rated her pain at its worst in the last 30 days at an 8.She rated her lowest pain at a 6 in the last 30 days.The patient's most severe pain location was the following: abdominal region (currently).She characterizes the pain as the following: moderate to severe in intensity, constant, aching, sharp, tearing, and throbbing.No visits to any other healthcare providers since the last clinic visit.The patient needs the following medications refilled today: clonidine patch, pilocarpine, and diazepam.No medication changes from the last visit.The patient was experiencing the following symptoms/side effects: sweating, constipation, sleeping disturbance, and mental fogginess.The last dose of pain medication was taken at 07:30 am percocet 5mg.No one accompanied the patient to her visit today.The patient would like to discuss with the physician to prescribe her plaquenil for her sjogren's syndrome.The patient was administered toradol and two doses of ketamine.On (b)(6) 2019, the patient presented with urinary tract infection (uti) without hematuria.Additionally, the patient had her bladder sling removed in (b)(6) 2019 with uti symptoms.When the patient arrived, she had complaints of burning with urination with last onset.The patient stated that she has had belly pain since her bladder sling removed in (b)(6), and her abdominal pain was unchanged.She also had acid reflux, but that too was unchanged from usual and has been ongoing for 1 year.The patient denied any flank pain, no nausea or vomiting, no fever or chills.The patient denied any other associated symptoms or modifying factors.The patient has chronic abdominal pain, her abdominal pain was unchanged from normal chronic abdominal pain.The patient has had complete work-up to include a computerized tomography (cat) scan and esophagogastroduodenoscopy (egd) that were negative.The patient's main complaint was dysuria and she thought that she had uti because she used to be macrobid prophylactically before she had a bladder sling and her bladder sling was removed in (b)(6).Therefore, she felt concerned that she may have a uti.Furthermore, the patient was hypotensive with blood pressure (bp) of 85/52, and she stated that her normal systolic bp is 98.Additionally, the patient took clonidine prior to arrival.Since she was hypotensive, iv line was established, and the patient was given with 1l ns bolus.Fentanyl was ordered but discontinued since she was hypotensive, and urinalysis showed that the patient had mild uti.On (b)(6) 2019, during the phone call, the patient mentioned that she had been in a lot of pain since then and went to her physician yesterday, however, she was not able to take opiates.She rated her pain at 8 or 9 and was having some burning with urination.On (b)(6) 2019, the patient was in for a follow-up visit for her pain or burning with urination.She first noticed the symptom approximately (b)(6) 2018.She did not urinate more frequently than once every 4 hours in the daytime.She did not have to strain or bear down to start her urinary stream.She did not dribble at the end of her urination.She did not have an abnormal sensation when needing to urinate.She usually gets up at night to urinate 1 time.She had not previously had an indwelling catheter in for more than two weeks at a time.Also, the patient experienced pelvic pain on both sides, and this was first noticed approximately on (b)(6) 2018.She has had this kind of pain before.The pain was not related to her menstrual period.Her pain was sharp, and the intensity of her pain was rated as a 10.Her pain was not intermittent.Walking, standing, urinating, and full bladder made her pain worse.Nothing seems to make the pain better.She did not have pain with bowel movements, and she did not have trouble with constipation.Urinalysis was negative and postvoid residual was 0 ml.The patient believed that her pain was related to the mesh, but the physician advised her continued pain is likely not related to mesh or a genitourinary problem.The patient was offered a referral for pelvic floor physical therapy (pfpt).In addition, the pathophysiology of pain complaints is associated with the placement of mesh.The has had extensive conservative treatment with both pudendal and left-sided ilioinguinal nerve blocks which gave temporary pain relief only.The patient has also undergone multiple ablations of the left ilioinguinal nerve, which gave temporary pain relief only lasting up to 2 months.However, will take 3 to 4 weeks for the patient to note pain relief after the procedure.At this juncture, the most logical next step in treatment was complete mesh removal with a left-sided ilioinguinal/iliohypogastric neurectomy.Surgical risks such as bleeding, infection, and damage to internal organs, especially the bladder, were reviewed.Postoperative restrictions and recovery time were also reviewed.The patient was aware that some of her symptoms were consistent with a pudendal nerve issue, which may not resolve with mesh removal.Approximately 80% of patients will see significant pain relief after this procedure.On (b)(6) 2020, the patient had another follow-up visit for her chronic pain management.Her chronic pain symptoms were slightly worse.The change in condition was due to increased pelvic pain.Her symptoms were not controlled as well as she would like.She rated her pain at its worst in the last 30 days at a 9.She rated her lowest pain at a 7 in the last 30 days.She rated her pain most of the time on medication in the last 30 days as an 8.The patient's most severe pain location was pelvic region.She characterized the pain as severe in intensity, constant, aching, cramping, sharp, shooting, stabbing, and throbbing.She recently had an appointment with an oncologist.The patient was seen for further medical workup explained later in the note.The patient needed her pain medications to be refilled, and for further discussion during that visit.Reportedly, there were no medication changes from the last visit.The patient has had to use oxycodone 3 times total this week.She has been undergoing further evaluations and her most recent pet scan was cancer free; however, she stated her oncologist informed her that she had fluid in her pelvis, fluid in her lungs and bursa sac of her left hip with inflammation.She was scheduled with a gynecologist specialist for further help with her pain from the recalled mesh sling she had, but her appointment was not until (b)(6).As for the patient's pain management recommendations, the patient did display meaningful benefit to justify opioid medication continuation currently.There does not appear to be apparent undue risk of abuse, addiction, or diversion identified at this time.The patient did not appear to be having problems with physical or psychological dependence at this time.The risks of combining sedatives, alcohol, benzodiazepines, and sleeping pills with opioids and the associated risks of accidental overdose which could result in death were discussed.Overall, she was doing remarkably better since her ketamine infusions.She was off clonidine and taking percocet sparingly.She has been taking ibuprofen 800mg tid which was not the best for her heart.Reportedly, the patient did not see a urogynecologist until (b)(6), and she was not on plaquenil at that time.On (b)(6) 2021, the patient had another follow-up visit to address the following: chronic pain management and chronic pelvic pain.Her chronic pain symptoms were slightly and significantly better controlled.She rated her pain at its worst in the last 30 days at 9.She rated her lowest pain at a 4 in the last 30 days.She rated her pain most of the time on medication in the last 30 days at 8.The patient's most severe pain location is the following: pelvic region.She characterizes the pain as the following: moderate to severe in intensity and constant.She reported that the following activities were now possible since being placed on her current medication regimen whereas they were not before due to her chronic pain condition: ability to suffer less daily.On (b)(6) 2021, the patient was here for evaluation on a telehealth visit for pelvic pain.The patient has a history of mixed connective tissue disorders, sjogren's, and breast cancer.In 2017, the patient underwent a mid-urethral suprapubic sling with the lynx system.After this procedure, she developed severe, debilitating pelvic pain.In 2019, she had the vaginal portion of the sling removed without any improvement in her symptoms.She has since been diagnosed with 2 conditions: ilioinguinal neuralgia and pudendal neuralgia.In regard to the ilioinguinal neuralgia, the pain is predominantly on the left side and extends into the groin and vulva.It is a constant neuropathic pain and feels like the groin is being torn apart.She has sensitivity to clothing, and it is difficult to walk.She has had ilioinguinal nerve blocks that significantly reduced her pain temporarily.She has undergone 2 radiofrequency ablations that improved her symptoms for several months.Her pudendal pain is primarily experienced rectally, mostly on the left side, but she does have pain in the urethra and clitoris.The pain is constant but gets worse with sitting or standing.She has excruciating pain with bowel movements and cannot have intercourse.She has a burning pain in the clitoris and feels like she is urinating razor blades.She has had pudendal nerve blocks that gave her temporary relief from her pain.The patient has mild urinary incontinence symptoms even after the vaginal portion was removed.She does have frequent urgency symptoms.Consent was provided for the patient for laparoscopic robotic mesh removal, possible botox injections into the pelvic floor muscles, possible pudendal nerve block, possible ilioinguinal nerve block, and possible ilioinguinal neurectomy for an estimated duration of 4 hours.On (b)(6) 2022, the patient underwent left-sided ilioinguinal/iliohypogastric neurectomy, retropubic dissection with mesh excision for the treatment of dysuria, dyspareunia, pelvic pain, and left ilioinguinal neuralgia.Firstly, on the patient's right side, the sling mesh was identified.It was grasped with a right-angle clamp, and predominantly sharp dissection was used to free the mesh as it was perforating the fascia and the rectus muscle.With traction and sharp dissection, the end of the mesh was eventually reached and was freed.Moreover, the end of the mesh was grasped with a kocher clamp, and used a combination of blunt and sharp dissection, stripping the mesh out of the retropubic space until it came free at the level of the periurethral region because the patient already had the vaginal portion of the mesh removed.Furthermore, the area was inspected carefully, and indeed, the entire piece of mesh had been removed.This was saved for pathology.Then, attention was moved to the patient's left side and performed essentially identical dissection for complete excision of the mesh.This was also then saved for pathology.Reportedly, 2 pieces of surgicel were placed in the deep portions of the dissection in the paravesical space near the bladder neck.The muscle was then reapproximated with interrupted 2-0 vicryl sutures, closed the fascia with a running 0 vicryl suture, closed the subcutaneous fat with a running 3-0 vicryl suture, and closed the skin with a running 4-0 subcuticular monocryl suture.Steri-strips and a bandage were placed.The patient was awakened in the operating room, brought to the recovery room awake, alert, and in apparent stable condition.Additionally, the surgical pathology report of the specimens from the left ilioinguinal nerve and retropubic mesh presented that there were large nerve fibers and adipose tissue.Also, there were fibrous tissue with chronic inflammation, foreign body giant cell reaction, and foreign body consistent with mesh.On (b)(6) 2022, the patient had another follow-up visit for her chronic pain management and chronic pelvic pain.Her chronic pain symptoms were worse.She rated her pain at its worst in the last 30 days at a 9.She rated her lowest pain at a 7 in the last 30 days.She rated her pain most of the time on medication in the last 30 days as a 9.The patient's most severe pain location was the following: pelvic region.She characterized the pain as moderate to severe in intensity, constant, and just painful and difficult to describe.Since patient was last seen in the physician's office, she went in for surgery, then the physician removed several inches of mesh from her pelvic area, and the patient was still in so much pain and cannot hardly walk.The patient needed her pain medications to be refilled today.There were no medication changes from the last visit.She reported that she was able to suffer less daily since being placed on her current medication regimen whereas they were not before due to her chronic pain condition.The patient experienced the following symptoms/side-effects: sweating, constipation, mental fogginess.Pertinent negatives include the following: nausea, breathing difficulty, drowsiness, heartburn, nervousness, itching, changes in mood, emotions, or personality, urinary hesitancy, sleeping disturbance, nightmares, dizziness, abdominal pain or heartburn, rash, retaining fluid or edema.She had her abdominal mesh removed by a physician.She seems to be doing well and was not on pain medication for post operation.The patient had a televisit today since she just had surgery.Her medication regimen will be continued without change at this time.The patient does display meaningful benefit to justify opioid medication continuation at this time.The clinical justification for continuation of opioid medication for pain management was the following: improved mobility and less suffering on a daily basis.On (b)(6) 2022, the physician spoke to the patient, and the patient left a message to cancel her surgery since she was able to have it done sooner with a doctor in (b)(6).On (b)(6) 2022, she had a follow-up visit to address her chronic pain management and chronic pelvic pain.Her chronic pain symptoms were about the same, worse.The change in condition was due to the following: still a lot of pain from the surgery, but also feeling better in some areas.She rated her pain at its worst in the last 30 days at a 10.She rated her lowest pain at a 9 in the last 30 days.The patient's most severe pain location was the pelvic region.She characterized the pain as moderate to severe in intensity, constant, and aching.Since patient was last seen in our office, she went in for her surgery with a physician, he removed 10 inches of mesh.The patient needed her pain medications to be refilled today.No medication changes from the last visit.She reported that she was able to suffer less daily now since being placed on her current medication regimen whereas they were not before due to her chronic pain condition.Last dose of pain medication was taken last month.Reportedly, no one accompanied the patient to her visit at this time.As for the patient's pain management recommendations, she was continuing to recover from abdominal surgery 5 weeks ago and was slowly making progress.She remained off from the pain medication and was continuing valium at night.

Manufacturer Narrative

Additional information to blocks b5 and h6.Block a4: patient's weight: 140.8 lbs.Block b3: the event date was approximated to august 3, 2017, implant date, as no event date was reported.Block e1: this event was reported by the patient's legal representation.The device was implanted at: (b)(6).Dr.(b)(6) (urologist).(b)(6) hospital.Dr.(b)(6).(b)(6).Rheumatologist: dr.(b)(6).Dr.(b)(6).Dr.(b)(6).Dr.(b)(6).Dr.(b)(6).Phone number: (b)(6).(b)(6).Phone: (b)(6).Dr.(b)(6).(b)(6).Telephone no: (b)(6).Block h6: patient codes e2330, e1002, e0126, e1307, e1310, e0123, e2326, e1714, e020201, e020202, e1405, e1311, e0744 and e1906 capture the reportable events of pain (chronic pelvic pain, bladder pain, perineal pain, joint pain, groin pain), pain, abdominal (lower abdomen), neuropathy (peripheral neuropathy), urethral stenosis/stricture (urethral stenosis), infection, urinary tract, nerve damage (left-sided ilioinguinal neuralgia), inflammation (chronic inflammation), rash, anxiety, depression, dyspareunia, unspecified kidney or urinary problem (urinary tract symptoms), infection, upper respiratory tract (acute upper respiratory infection, unspecified), and infection (multiple confirmed infections), respectively.Impact codes f19, f1903, f2303, f22, f23 and f1202 capture the reportable events of surgical intervention (cystourethroscopy, urethral dilation, hydrodistention of bladder), device explantation (excision of mid-urethral sling), medication required (bactrim, macrobid, doxycycline, dilaudid, percocet 5mg tablet, ketamine injection), unexpected diagnostic intervention (mri, cystoscopy), and f23: unexpected medical intervention (extensive conservative treatment with both pudendal, left-sided ilioinguinal nerve blocks, multiple ablations of the left ilioinguinal nerve), and disability (disabled).Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the excised mesh is not expected to be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that a lynx suprapubic mid-urethral sling was implanted during a placement of mid-urethral sling and cystourethroscopy procedure performed on (b)(6) 2017, for the treatment of stress urinary incontinence.Relevant medical and surgical history included pelvic pain with a gynecological workup that was negative for any concerning findings, low-grade cystocele, chronic low back pain, chronic neck pain, chronic thoracic back pain, raynaud's, anxiety, rheumatoid arthritis, depression, fibromyalgia, migraines, ibs, hemorrhoidectomy, dural puncture, nerve ablation (thoracic and lumbar), lupus, and cholecystectomy.On (b)(6) 2017, the patient had a follow-up visit for her chronic pain management and peripheral neuropathy.During the examination, she displayed pain upon rising from the seated position and transitioning through the first few steps of ambulation.She was also referred to a pain specialist to check for possible tarsal tunnel syndrome and to determine the candidacy for the following procedures: nerve conduction study.On (b)(6) 2018, she called the physician regarding her urinary tract infection (uti) and stated that she kept getting infections for which she had gone to urgent care.The patient was instructed to return to visit when she is off on antibiotics.She took bactrim and macrobid but neither of them helped.The patient had taken doxycycline currently, but it was for her arthritis.The walk-in clinic report showed a large amount of blood, and her leukocytes were high, there were a lot of bacteria.They told her if the bactrim did not help, she was instructed to call the physician.This was her 5th infection, and she had this since she had the bladder sling.On (b)(6), 2018, the patient presented to the emergency room (er) with uti, hematuria, dysuria, and urinary frequency for 4 months.She stated that starting october 2017 she has had several episodes of uti.She had been on multiple courses of antibiotics in which for the past 2 months, she had been on a full course of macrobid/bactrim and stated that she was currently on her 3rd day of doxycycline.Moreover, the patient continued to have symptoms and had a nickel size nodule/tenderness with palpation in the suprapubic region.Urinalysis showed bacteria and white blood cells and she was advised to continue her current doxycycline.She was administered iv fluids and zofran for nausea.Computed tomography (ct) showed no acute abdominal or pelvic abnormality.The patient requested pain medications and was advised to take the already prescribed medications for pain control.She was discharged home with the impression of dysuria and advised to follow up with her urologist.On (b)(6) 2018, she underwent cystourethroscopy, urethral dilation, and hydrodistention of the bladder for the treatment of her chronic pelvic pain, recurrent urinary tract infections, microhematuria, and recurrent stress urinary incontinence.In the past several months, she had developed chronic left greater than right pelvic pain, as well, as recurrent utis.She had demonstrated good bladder emptying in the clinic.After the discussion in the clinic, she elected to proceed with the above procedures to rule out mesh erosion as well as to evaluate her urethra and bladder.Operative findings were minimal urethral stenosis, and the bladder was distended twice with capacities of 450 and 350, respectively.The urethra was dilated to 30-french.The bladder and urethra were normal without any evidence of mesh erosion whatsoever on the inspection with 30- and 70-degree lenses.On (b)(6), 2019, the patient was in for her complaint of recurring uti and pelvic pain.Exam revealed suburethral and periurethral tenderness in the vagina.On (b)(6), 2019, she had a follow-up visit for her pain or burning with urination and dyspareunia.She first noticed the symptom approximately may 01, 2018.She did urinate more frequently than once every 4 hours in the daytime.She did not have to strain or bear down to start her urinary stream.Moreover, she did dribble at the end of her urination.She did have an abnormal sensation when needing to urinate.She usually gets up at night to urinate 1 time.She had not previously had an indwelling catheter in for more than two weeks at a time.The patient had severe pain all the time, including when she urinates and when she doesn't.The pain radiates up to her abdomen and on the left side of her stomach and has been present since january.The patient saw her gynecologist yesterday and stated that they told her the pain maybe because of her sling.Reportedly, the patient had taken urimart, hyoscymaine, and elmiron, which were not helping.During her review of systems, the patient mentioned that she had experienced fatigue, generalized weakness, weight loss, balance problems, dizzy spells, headache, numbness, tingling, skin rash, arthritis, joint pain, back pain, muscle weakness, urethra and abdominal tenderness, anxiety, and depression.Exam revealed abdominal tenderness, urethral tenderness, and no mesh erosion.The plan was for mri, urethrolysis, excision of the mid-urethral sling, and cystoscopy.On (b)(6), 2019, the patient had a follow-up visit for her chronic pain management.Her chronic pain symptoms were slightly better controlled.Her symptoms were not controlled as well as she would like.She rated her pain at its worst in the last 30 days at an 8.She rated her lowest pain at a 6 in the last 30 days.The patient's most severe pain location was the following: pelvic region.She characterized the pain as moderate to severe in intensity, constant, aching, burning, cramping, like a pressure sensation, sharp, and throbbing.She recently had an appointment with urologist.The patient was seen for further evaluation of urinary tract infection (uti) symptoms and pain.There were no medication changes from the last visit.The patient experienced the following symptoms/side-effects; however, she did not take any pain medication.Reportedly, the patient was accompanied by her friend.The patient stated that she had a bladder sling placed that was recalled in (b)(6) 2016, and she mentioned that she was just made aware of the recall had existed.She has had been battling with chronic abdominal pain and urinary tract symptoms for over a year.Moreover, she has had multiple confirmed infections as well as infection symptoms that did not result in infections via the urine specimens obtained.She was scheduled to have the bladder sling removed on (b)(6), 2019.However, she does have a lot of concern for her post operation pain medication options.The patient would also like to discuss further her clonidine regimen and how long should she be continuing it.She had tried in the past to discontinue the patch; however, it had increased her withdrawal symptoms like hypertension and sweating.Additionally, the patient would also like a ketamine injection during this visit.She did also see a physician for consultation and for follow-up which she did appreciate his input and guidance; however, the medication he prescribed required a pa and the patient was going to be charged (b)(4) for this to be completed.During the musculoskeletal exam, the patient showed mild pain when seated by shifting and changing her body position in a behavior consistent with pain.Also, the patient displayed pain upon arising from a seated position and transitioning through the first few steps of ambulation.Reportedly, the patient had a mild left sided pain upon palpation at the thoracic spine and was disabled.Overall, the patient was doing considerately better.As for the patient's pain management recommendations, she had a stellate ganglion block a physician a few weeks ago and this helped tremendously on one side of her body.She reported that all the hyperhidrosis in limb sensitivity completely resolved.She was scheduled to have the other side done in 2 days.She was going to have her bladder sling revised and she was very concerned about taking opiates after surgery.The physician discussed with her that they could try a nasal spray for post-operation pain as she had received.The patient had responded very favorably to ketamine in the past.In addition, she had seen the psychiatrist for consultation.The most beneficial thing for her depression has been the ketamine.On (b)(6), 2019, the patient presented to the emergency department with complaints of bladder pain, and low abdominal/pelvic pain.She had mri and pelvic exam by both her urologist and her gynecologist.Also, she had been taking medications to help with the pain and the medication would wear off.On (b)(6), 2019, she underwent cystoscopy, and excision of mid-urethral sling via vaginal approach to treat her chronic pelvic pain and stress urinary incontinence status post-mid-urethral sling placement.It was observed that the mesh was located in a good position, and there were no other abnormalities noted.The mesh was excised in the midline, as well as limbs extending toward the retropubic space bilaterally.There was no evidence of mesh erosion or any urethral injury on cystoscopy.On (b)(6) 2019, the patient stated that she was no longer having any dysuria.She had complaints of enuresis, which she did not have before the procedure, and she was having pain in her lower abdomen and groin area, but not as before.Additionally, the patient also had incontinence when she coughed or sneezed.She had a clear urine analysis, a post-void residual (pvr) of 3, and an rtc of 6 months for follow-up.On (b)(6), 2019, the patient had a follow-up visit for her chronic pain management and pelvic pain.The patient was miserable with pelvic pain and abdominal pain.She had been doing really well post mesh excision until 1 week ago.She had sustained the pain levels of an 8 or 9 constantly.She did have to use percocet 5mg tablet, which she stated did cause her to wake up sweating and feeling like she was in withdrawal.Reportedly, the patient would like to process a referral to another urologist for a second opinion.An abdominal and pelvic ultrasound was ordered, and the patient was administered toradol and two doses of ketamine.On (b)(6), 2019, the patient had a follow-up visit for her chronic pain management.Her chronic pain symptoms were about the same.Her chronic pain syndrome was nearly controlled at this point.She rated her pain at its worst in the last 30 days at an 8.She rated her lowest pain at a 6 in the last 30 days.The patient's most severe pain location was the following: abdominal region (currently).She characterizes the pain as the following: moderate to severe in intensity, constant, aching, sharp, tearing, and throbbing.No visits to any other healthcare providers since the last clinic visit.The patient needs the following medications refilled today: clonidine patch, pilocarpine, and diazepam.No medication changes from the last visit.The patient was experiencing the following symptoms/side effects: sweating, constipation, sleeping disturbance, and mental fogginess.The last dose of pain medication was taken at 07:30 am percocet 5mg.No one accompanied the patient to her visit today.The patient would like to discuss with the physician to prescribe her plaquenil for her sjogren's syndrome.The patient was administered toradol and two doses of ketamine.On (b)(6) 2019, the patient presented with urinary tract infection (uti) without hematuria.Additionally, the patient had her bladder sling removed in (b)(6), 2019 with uti symptoms.When the patient arrived, she had complaints of burning with urination with last onset.The patient stated that she has had belly pain since her bladder sling removed in april, and her abdominal pain was unchanged.She also had acid reflux, but that too was unchanged from usual and has been ongoing for 1 year.The patient denied any flank pain, no nausea or vomiting, no fever or chills.The patient denied any other associated symptoms or modifying factors.The patient has chronic abdominal pain, her abdominal pain was unchanged from normal chronic abdominal pain.The patient has had complete work-up to include a computerized tomography (cat) scan and esophagogastroduodenoscopy (egd) that were negative.The patient's main complaint was dysuria and she thought that she had uti because she used to be macrobid prophylactically before she had a bladder sling and her bladder sling was removed in april.Therefore, she felt concerned that she may have a uti.Furthermore, the patient was hypotensive with blood pressure (bp) of 85/52, and she stated that her normal systolic bp is 98.Additionally, the patient took clonidine prior to arrival.Since she was hypotensive, iv line was established, and the patient was given with 1l ns bolus.Fentanyl was ordered but discontinued since she was hypotensive, and urinalysis showed that the patient had mild uti.On (b)(6), 2019, during the phone call, the patient mentioned that she had been in a lot of pain since then and went to her physician yesterday, however, she was not able to take opiates.She rated her pain at 8 or 9 and was having some burning with urination.On (b)(6), 2019, the patient was in for a follow-up visit for her pain or burning with urination.She first noticed the symptom approximately (b)(6) 2018.She did not urinate more frequently than once every 4 hours in the daytime.She did not have to strain or bear down to start her urinary stream.She did not dribble at the end of her urination.She did not have an abnormal sensation when needing to urinate.She usually gets up at night to urinate 1 time.She had not previously had an indwelling catheter in for more than two weeks at a time.Also, the patient experienced pelvic pain on both sides, and this was first noticed approximately on (b)(6) 2018.She has had this kind of pain before.The pain was not related to her menstrual period.Her pain was sharp, and the intensity of her pain was rated as a 10.Her pain was not intermittent.Walking, standing, urinating, and full bladder made her pain worse.Nothing seems to make the pain better.She did not have pain with bowel movements, and she did not have trouble with constipation.Urinalysis was negative and postvoid residual was 0 ml.The patient believed that her pain was related to the mesh, but the physician advised her continued pain is likely not related to mesh or a genitourinary problem.The patient was offered a referral for pelvic floor physical therapy (pfpt).In addition, the pathophysiology of pain complaints is associated with the placement of mesh.The has had extensive conservative treatment with both pudendal and left-sided ilioinguinal nerve blocks which gave temporary pain relief only.The patient has also undergone multiple ablations of the left ilioinguinal nerve, which gave temporary pain relief only lasting up to 2 months.However, will take 3 to 4 weeks for the patient to note pain relief after the procedure.At this juncture, the most logical next step in treatment was complete mesh removal with a left-sided ilioinguinal/iliohypogastric neurectomy.Surgical risks such as bleeding, infection, and damage to internal organs, especially the bladder, were reviewed.Postoperative restrictions and recovery time were also reviewed.The patient was aware that some of her symptoms were consistent with a pudendal nerve issue, which may not resolve with mesh removal.Approximately 80% of patients will see significant pain relief after this procedure.On (b)(6), 2020, the patient had another follow-up visit for her chronic pain management.Her chronic pain symptoms were slightly worse.The change in condition was due to increased pelvic pain.Her symptoms were not controlled as well as she would like.She rated her pain at its worst in the last 30 days at a 9.She rated her lowest pain at a 7 in the last 30 days.She rated her pain most of the time on medication in the last 30 days as an 8.The patient's most severe pain location was pelvic region.She characterized the pain as severe in intensity, constant, aching, cramping, sharp, shooting, stabbing, and throbbing.She recently had an appointment with an oncologist.The patient was seen for further medical workup explained later in the note.The patient needed her pain medications to be refilled, and for further discussion during that visit.Reportedly, there were no medication changes from the last visit.The patient has had to use oxycodone 3 times total this week.She has been undergoing further evaluations and her most recent pet scan was cancer free; however, she stated her oncologist informed her that she had fluid in her pelvis, fluid in her lungs and bursa sac of her left hip with inflammation.She was scheduled with a gynecologist specialist for further help with her pain from the recalled mesh sling she had, but her appointment was not until march 31st.As for the patient's pain management recommendations, the patient did display meaningful benefit to justify opioid medication continuation currently.There does not appear to be apparent undue risk of abuse, addiction, or diversion identified at this time.The patient did not appear to be having problems with physical or psychological dependence at this time.The risks of combining sedatives, alcohol, benzodiazepines, and sleeping pills with opioids and the associated risks of accidental overdose which could result in death were discussed.Overall, she was doing remarkably better since her ketamine infusions.She was off clonidine and taking percocet sparingly.She has been taking ibuprofen 800mg tid which was not the best for her heart.Reportedly, the patient did not see a urogynecologist until march, and she was not on plaquenil at that time.On (b)(6), 2020, the patient presented with a chief complaint of pelvic pain.She said that she had constant utis and pain.She felt like it was coming out of her urethra.She stated that the pain was exacerbated when she ate and the food was pushed down.Her pain is on her urethra, left side of vagina, left midline incision up to her umbilicus, and on her abdomen.The physician implanted the mesh on the patient for her prolapse, which was a boston scientific sling.Furthermore, the pain was constant (8/10) and lasted the entire time.The patient got off opioids after breast cancer, and she doesn't want to use them again.She leaked urine with a cough, laugh, and sneeze.She said she "pees the bed now".Her pain was so severe that she could not have intercourse.She had urinary urgency at times during the day.She was close to a bathroom.If she doesn't get there, she will leak.She drank g2 gatorade and hot water.Additionally, she had tried urimar and azo.Furthermore, the patient mentioned that she burned when she had a bowel movement.She had 2 to 3 times a week.The patient was on phillips caplets.She takes miralax daily.She said it was hard and cracked.She had sjogrens, so everything was dry.The patient still has her uterus and ovaries.During the review of the patient's systems, the patient had chills, fatigue, trouble swallowing, dry eyes, shortness of breath, palpitations, abdominal pain, chronic idiopathic constipation, dyspareunia, dysuria, back pain, pelvic pain, muscle spasm, and nervousness/anxiety.Moreover, during the physical exam, the patient had infrumbilical scars, mild atrophy, and walked with a stooped posture.On (b)(6), 2021, the patient had another follow-up visit to address the following: chronic pain management and chronic pelvic pain.Her chronic pain symptoms were slightly and significantly better controlled.She rated her pain at its worst in the last 30 days at 9.She rated her lowest pain at a 4 in the last 30 days.She rated her pain most of the time on medication in the last 30 days at 8.The patient's most severe pain location is the following: pelvic region.She characterizes the pain as the following: moderate to severe in intensity and constant.She reported that the following activities were now possible since being placed on her current medication regimen whereas they were not before due to her chronic pain condition: ability to suffer less daily.On (b)(6), 2021, the patient was here for evaluation on a telehealth visit for pelvic pain.The patient has a history of mixed connective tissue disorders, sjogren's, and breast cancer.In 2017, the patient underwent a mid-urethral suprapubic sling with the lynx system.After this procedure, she developed severe, debilitating pelvic pain.In 2019, she had the vaginal portion of the sling removed without any improvement in her symptoms.She has since been diagnosed with 2 conditions: ilioinguinal neuralgia and pudendal neuralgia.In regard to the ilioinguinal neuralgia, the pain is predominantly on the left side and extends into the groin and vulva.It is a constant neuropathic pain and feels like the groin is being torn apart.She has sensitivity to clothing, and it is difficult to walk.She has had ilioinguinal nerve blocks that significantly reduced her pain temporarily.She has undergone 2 radiofrequency ablations that improved her symptoms for several months.Her pudendal pain is primarily experienced rectally, mostly on the left side, but she does have pain in the urethra and clitoris.The pain is constant but gets worse with sitting or standing.She has excruciating pain with bowel movements and cannot have intercourse.She has a burning pain in the clitoris and feels like she is urinating razor blades.She has had pudendal nerve blocks that gave her temporary relief from her pain.The patient has mild urinary incontinence symptoms even after the vaginal portion was removed.She does have frequent urgency symptoms.Consent was provided for the patient for laparoscopic robotic mesh removal, possible botox injections into the pelvic floor muscles, possible pudendal nerve block, possible ilioinguinal nerve block, and possible ilioinguinal neurectomy for an estimated duration of 4 hours.On (b)(6) 2022, the patient underwent left-sided ilioinguinal/iliohypogastric neurectomy, retropubic dissection with mesh excision for the treatment of dysuria, dyspareunia, pelvic pain, and left ilioinguinal neuralgia.Firstly, on the patient's right side, the sling mesh was identified.It was grasped with a right-angle clamp, and predominantly sharp dissection was used to free the mesh as it was perforating the fascia and the rectus muscle.With traction and sharp dissection, the end of the mesh was eventually reached and was freed.Moreover, the end of the mesh was grasped with a kocher clamp, and used a combination of blunt and sharp dissection, stripping the mesh out of the retropubic space until it came free at the level of the periurethral region because the patient already had the vaginal portion of the mesh removed.Furthermore, the area was inspected carefully, and indeed, the entire piece of mesh had been removed.This was saved for pathology.Then, attention was moved to the patient's left side and performed essentially identical dissection for complete excision of the mesh.This was also then saved for pathology.Reportedly, 2 pieces of surgicel were placed in the deep portions of the dissection in the paravesical space near the bladder neck.The muscle was then reapproximated with interrupted 2-0 vicryl sutures, closed the fascia with a running 0 vicryl suture, closed the subcutaneous fat with a running 3-0 vicryl suture, and closed the skin with a running 4-0 subcuticular monocryl suture.Steri-strips and a bandage were placed.The patient was awakened in the operating room, brought to the recovery room awake, alert, and in apparent stable condition.Additionally, the surgical pathology report of the specimens from the left ilioinguinal nerve and retropubic mesh presented that there were large nerve fibers and adipose tissue.Also, there were fibrous tissue with chronic inflammation, foreign body giant cell reaction, and foreign body consistent with mesh.On (b)(6), 2022, the patient had another follow-up visit for her chronic pain management and chronic pelvic pain.Her chronic pain symptoms were worse.She rated her pain at its worst in the last 30 days at a 9.She rated her lowest pain at a 7 in the last 30 days.She rated her pain most of the time on medication in the last 30 days as a 9.The patient's most severe pain location was the following: pelvic region.She characterized the pain as moderate to severe in intensity, constant, and just painful and difficult to describe.Since patient was last seen in the physician's office, she went in for surgery, then the physician removed several inches of mesh from her pelvic area, and the patient was still in so much pain and cannot hardly walk.The patient needed her pain medications to be refilled today.There were no medication changes from the last visit.She reported that she was able to suffer less daily since being placed on her current medication regimen whereas they were not before due to her chronic pain condition.The patient experienced the following symptoms/side-effects: sweating, constipation, mental fogginess.Pertinent negatives include the following: nausea, breathing difficulty, drowsiness, heartburn, nervousness, itching, changes in mood, emotions, or personality, urinary hesitancy, sleeping disturbance, nightmares, dizziness, abdominal pain or heartburn, rash, retaining fluid or edema.She had her abdominal mesh removed by a physician.She seems to be doing well and was not on pain medication for post operation.The patient had a televisit today since she just had surgery.Her medication regimen will be continued without change at this time.The patient does display meaningful benefit to justify opioid medication continuation at this time.The clinical justification for continuation of opioid medication for pain management was the following: improved mobility and less suffering on a daily basis.On (b)(6), 2022, the physician spoke to the patient, and the patient left a message to cancel her surgery since she was able to have it done sooner with a doctor in new hampshire.On (b)(6), 2022, she had a follow-up visit to address her chronic pain management and chronic pelvic pain.Her chronic pain symptoms were about the same, worse.The change in condition was due to the following: still a lot of pain from the surgery, but also feeling better in some areas.She rated her pain at its worst in the last 30 days at a 10.She rated her lowest pain at a 9 in the last 30 days.The patient's most severe pain location was the pelvic region.She characterized the pain as moderate to severe in intensity, constant, and aching.Since patient was last seen in our office, she went in for her surgery with a physician, he removed 10 inches of mesh.The patient needed her pain medications to be refilled today.No medication changes from the last visit.She reported that she was able to suffer less daily now since being placed on her current medication regimen whereas they were not before due to her chronic pain condition.Last dose of pain medication was taken last month.Reportedly, no one accompanied the patient to her visit at this time.As for the patient's pain management recommendations, she was continuing to recover from abdominal surgery 5 weeks ago and was slowly making progress.She remained off from the pain medication and was continuing valium at night.

Manufacturer Narrative

Blocks b5 and h6 have been updated based on the additional information received on august 15, 2022.Block a4: patient's weight: 140.8 lbs.Block b3: the event date was approximated to august 3, 2017, implant date, as no event date was reported.Block e1: this event was reported by the patient's legal representation.The device was implanted at: (b)(6).Phone number: (b)(6).Dr.(b)(6).(b)(6) hospital.(b)(6).Dr.(b)(6).(b)(6) center.Rheumatologist: dr.(b)(6).Dr.(b)(6).Dr.(b)(6).Dr.(b)(6).Dr.(b)(6).Phone number: (b)(6).(b)(6).Phone: (b)(6).Dr.(b)(6).(b)(6).United states.Telephone no.(b)(6).Block h6: patient codes e2006, e2330, e1002, e0126, e1307, e1310, e0123, e2326, e1714, e020201, e020202, e1405, e1311, e0744 and e1906 capture the reportable events of erosion (felt like it was coming out her urethra), pain (chronic pelvic pain, bladder pain, perineal pain, joint pain, groin pain), pain, abdominal (lower abdomen), neuropathy (peripheral neuropathy), urethral stenosis/stricture (urethral stenosis), infection, urinary tract, nerve damage (left-sided ilioinguinal neuralgia), inflammation (chronic inflammation), rash, anxiety, depression, dyspareunia, unspecified kidney or urinary problem (urinary tract symptoms), infection, upper respiratory tract (acute upper respiratory infection, unspecified), and infection (multiple confirmed infections), respectively.Impact codes f19, f1903, f2303, f22, f23 and f1202 capture the reportable events of surgical intervention (cystourethroscopy, urethral dilation, hydrodistention of bladder), device explantation (excision of mid-urethral sling), medication required (bactrim, macrobid, doxycycline, dilaudid, percocet 5mg tablet, ketamine injection), unexpected diagnostic intervention (mri, cystoscopy), and f23: unexpected medical intervention (extensive conservative treatment with both pudendal, left-sided ilioinguinal nerve blocks, multiple ablations of the left ilioinguinal nerve), and disability (disabled).

Event Description

It was reported to boston scientific corporation that a lynx suprapubic mid-urethral sling was implanted during a placement of mid-urethral sling and cystourethroscopy procedure performed on (b)(6) 2017, for the treatment of stress urinary incontinence.Relevant medical and surgical history included pelvic pain with a gynecological workup that was negative for any concerning findings, low-grade cystocele, chronic low back pain, chronic neck pain, chronic thoracic back pain, raynaud's, anxiety, rheumatoid arthritis, depression, fibromyalgia, migraines, ibs, hemorrhoidectomy, dural puncture, nerve ablation (thoracic and lumbar), lupus, and cholecystectomy.On (b)(6) 2017, the patient had a follow-up visit for her chronic pain management and peripheral neuropathy.During the examination, she displayed pain upon rising from the seated position and transitioning through the first few steps of ambulation.She was also referred to a pain specialist to check for possible tarsal tunnel syndrome and to determine the candidacy for the following procedures: nerve conduction study.On (b)(6) 2018, she called the physician regarding her urinary tract infection (uti) and stated that she kept getting infections for which she had gone to urgent care.The patient was instructed to return to visit when she is off on antibiotics.She took bactrim and macrobid but neither of them helped.The patient had taken doxycycline currently, but it was for her arthritis.The walk-in clinic report showed a large amount of blood, and her leukocytes were high, there were a lot of bacteria.They told her if the bactrim did not help, she was instructed to call the physician.This was her 5th infection, and she had this since she had the bladder sling.On (b)(6) 2018, the patient presented to the emergency room (er) with uti, hematuria, dysuria, and urinary frequency for 4 months.She stated that starting (b)(6) 2017 she has had several episodes of uti.She had been on multiple courses of antibiotics in which for the past 2 months, she had been on a full course of macrobid/bactrim and stated that she was currently on her 3rd day of doxycycline.Moreover, the patient continued to have symptoms and had a nickel size nodule/tenderness with palpation in the suprapubic region.Urinalysis showed bacteria and white blood cells and she was advised to continue her current doxycycline.She was administered iv fluids and zofran for nausea.Computed tomography (ct) showed no acute abdominal or pelvic abnormality.The patient requested pain medications and was advised to take the already prescribed medications for pain control.She was discharged home with the impression of dysuria and advised to follow up with her urologist.On (b)(6) 2018, the patient was evaluated for pain and burning with urination, flank pain on the left side, nausea, lower abdominal cramping, dysuria, hot flashes, and general malaise.She also reported frequency, dribbling at the end of urination, and an abnormal sensation when needing to urinate.Review of systems revealed the following relevant symptoms: generalized weakness, numbness/tingling, muscle weakness, anxiety and depression.Urinalysis showed green turbid urine with trace blood, leukocyte esterace, and protein.She was prescribed bactrim and the plan was for ct abdomen/pelvis and cystoscopy with hydrodistension.On (b)(6) 2018, she underwent cystourethroscopy, urethral dilation, and hydrodistention of the bladder for the treatment of her chronic pelvic pain, recurrent urinary tract infections, microhematuria, and recurrent stress urinary incontinence.In the past several months, she had developed chronic left greater than right pelvic pain, as well, as recurrent utis.She had demonstrated good bladder emptying in the clinic.After the discussion in the clinic, she elected to proceed with the above procedures to rule out mesh erosion as well as to evaluate her urethra and bladder.Operative findings were minimal urethral stenosis, and the bladder was distended twice with capacities of 450 and 350, respectively.The urethra was dilated to 30-french.The bladder and urethra were normal without any evidence of mesh erosion whatsoever on the inspection with 30- and 70-degree lenses.On (b)(6) 2019, the patient was in for her complaint of recurring uti and pelvic pain.Exam revealed suburethral and periurethral tenderness in the vagina.On (b)(6) 2019, she had a follow-up visit for her pain or burning with urination and dyspareunia.She first noticed the symptom approximately (b)(6) 2018.She did urinate more frequently than once every 4 hours in the daytime.She did not have to strain or bear down to start her urinary stream.Moreover, she did dribble at the end of her urination.She did have an abnormal sensation when needing to urinate.She usually gets up at night to urinate 1 time.She had not previously had an indwelling catheter in for more than two weeks at a time.The patient had severe pain all the time, including when she urinates and when she doesn't.The pain radiates up to her abdomen and on the left side of her stomach and has been present since january.The patient saw her gynecologist yesterday and stated that they told her the pain maybe because of her sling.Reportedly, the patient had taken urimart, hyoscymaine, and elmiron, which were not helping.During her review of systems, the patient mentioned that she had experienced fatigue, generalized weakness, weight loss, balance problems, dizzy spells, headache, numbness, tingling, skin rash, arthritis, joint pain, back pain, muscle weakness, urethra and abdominal tenderness, anxiety, and depression.Exam revealed abdominal tenderness, urethral tenderness, and no mesh erosion.The plan was for mri, urethrolysis, excision of the mid-urethral sling, and cystoscopy.On (b)(6) 2019, the patient had a follow-up visit for her chronic pain management.Her chronic pain symptoms were slightly better controlled.Her symptoms were not controlled as well as she would like.She rated her pain at its worst in the last 30 days at an 8.She rated her lowest pain at a 6 in the last 30 days.The patient's most severe pain location was the following: pelvic region.She characterized the pain as moderate to severe in intensity, constant, aching, burning, cramping, like a pressure sensation, sharp, and throbbing.She recently had an appointment with urologist.The patient was seen for further evaluation of urinary tract infection (uti) symptoms and pain.There were no medication changes from the last visit.The patient experienced the following symptoms/side-effects; however, she did not take any pain medication.Reportedly, the patient was accompanied by her friend.The patient stated that she had a bladder sling placed that was recalled in (b)(6) 2016, and she mentioned that she was just made aware of the recall had existed.She has had been battling with chronic abdominal pain and urinary tract symptoms for over a year.Moreover, she has had multiple confirmed infections as well as infection symptoms that did not result in infections via the urine specimens obtained.She was scheduled to have the bladder sling removed on (b)(6) 2019.However, she does have a lot of concern for her post operation pain medication options.The patient would also like to discuss further her clonidine regimen and how long should she be continuing it.She had tried in the past to discontinue the patch; however, it had increased her withdrawal symptoms like hypertension and sweating.Additionally, the patient would also like a ketamine injection during this visit.She did also see a physician for consultation and for follow-up which she did appreciate his input and guidance; however, the medication he prescribed required a pa and the patient was going to be charged $40 for this to be completed.During the musculoskeletal exam, the patient showed mild pain when seated by shifting and changing her body position in a behavior consistent with pain.Also, the patient displayed pain upon arising from a seated position and transitioning through the first few steps of ambulation.Reportedly, the patient had a mild left sided pain upon palpation at the thoracic spine and was disabled.Overall, the patient was doing considerately better.As for the patient's pain management recommendations, she had a stellate ganglion block a physician a few weeks ago and this helped tremendously on one side of her body.She reported that all the hyperhidrosis in limb sensitivity completely resolved.She was scheduled to have the other side done in 2 days.She was going to have her bladder sling revised and she was very concerned about taking opiates after surgery.The physician discussed with her that they could try a nasal spray for post-operation pain as she had received.The patient had responded very favorably to ketamine in the past.In addition, she had seen the psychiatrist for consultation.The most beneficial thing for her depression has been the ketamine.On (b)(6) 2019, the patient presented to the emergency department with complaints of bladder pain, and low abdominal/pelvic pain.She had mri and pelvic exam by both her urologist and her gynecologist.Also, she had been taking medications to help with the pain and the medication would wear off.On (b)(6) 2019, she underwent cystoscopy, and excision of mid-urethral sling via vaginal approach to treat her chronic pelvic pain and stress urinary incontinence status post-mid-urethral sling placement.It was observed that the mesh was located in a good position, and there were no other abnormalities noted.The mesh was excised in the midline, as well as limbs extending toward the retropubic space bilaterally.There was no evidence of mesh erosion or any urethral injury on cystoscopy.On (b)(6) 2019, the patient stated that she was no longer having any dysuria.She had complaints of enuresis, which she did not have before the procedure, and she was having pain in her lower abdomen and groin area, but not as before.Additionally, the patient also had incontinence when she coughed or sneezed.She had a clear urine analysis, a post-void residual (pvr) of 3, and an rtc of 6 months for follow-up.On (b)(6) 2019, the patient had a follow-up visit for her chronic pain management and pelvic pain.The patient was miserable with pelvic pain and abdominal pain.She had been doing really well post mesh excision until 1 week ago.She had sustained the pain levels of an 8 or 9 constantly.She did have to use percocet 5mg tablet, which she stated did cause her to wake up sweating and feeling like she was in withdrawal.Reportedly, the patient would like to process a referral to another urologist for a second opinion.An abdominal and pelvic ultrasound was ordered, and the patient was administered toradol and two doses of ketamine.On (b)(6) 2019, the patient had a follow-up visit for her chronic pain management.Her chronic pain symptoms were about the same.Her chronic pain syndrome was nearly controlled at this point.She rated her pain at its worst in the last 30 days at an 8.She rated her lowest pain at a 6 in the last 30 days.The patient's most severe pain location was the following: abdominal region (currently).She characterizes the pain as the following: moderate to severe in intensity, constant, aching, sharp, tearing, and throbbing.No visits to any other healthcare providers since the last clinic visit.The patient needs the following medications refilled today: clonidine patch, pilocarpine, and diazepam.No medication changes from the last visit.The patient was experiencing the following symptoms/side effects: sweating, constipation, sleeping disturbance, and mental fogginess.The last dose of pain medication was taken at 07:30 am percocet 5mg.No one accompanied the patient to her visit today.The patient would like to discuss with the physician to prescribe her plaquenil for her sjogren's syndrome.The patient was administered toradol and two doses of ketamine.On (b)(6) 2019, the patient presented with urinary tract infection (uti) without hematuria.Additionally, the patient had her bladder sling removed on (b)(6) 2019, with uti symptoms.When the patient arrived, she had complaints of burning with urination with last onset.The patient stated that she has had belly pain since her bladder sling removed in april, and her abdominal pain was unchanged.She also had acid reflux, but that too was unchanged from usual and has been ongoing for 1 year.The patient denied any flank pain, no nausea or vomiting, no fever or chills.The patient denied any other associated symptoms or modifying factors.The patient has chronic abdominal pain, her abdominal pain was unchanged from normal chronic abdominal pain.The patient has had complete work-up to include a computerized tomography (cat) scan and esophagogastroduodenoscopy (egd) that were negative.The patient's main complaint was dysuria and she thought that she had uti because she used to be macrobid prophylactically before she had a bladder sling, and her bladder sling was removed in april.Therefore, she felt concerned that she may have a uti.Furthermore, the patient was hypotensive with blood pressure (bp) of 85/52, and she stated that her normal systolic bp is 98.Additionally, the patient took clonidine prior to arrival.Since she was hypotensive, iv line was established, and the patient was given with 1l ns bolus.Fentanyl was ordered but discontinued since she was hypotensive, and urinalysis showed that the patient had mild uti.On (b)(6) 2019, during the phone call, the patient mentioned that she had been in a lot of pain since then and went to her physician yesterday, however, she was not able to take opiates.She rated her pain at 8 or 9 and was having some burning with urination.On (b)(6) 2019, the patient was in for a follow-up visit for her pain or burning with urination.She first noticed the symptom approximately (b)(6) 2018.She did not urinate more frequently than once every 4 hours in the daytime.She did not have to strain or bear down to start her urinary stream.She did not dribble at the end of her urination.She did not have an abnormal sensation when needing to urinate.She usually gets up at night to urinate 1 time.She had not previously had an indwelling catheter in for more than two weeks at a time.Also, the patient experienced pelvic pain on both sides, and this was first noticed approximately on (b)(6) 2018.She has had this kind of pain before.The pain was not related to her menstrual period.Her pain was sharp, and the intensity of her pain was rated as a 10.Her pain was not intermittent.Walking, standing, urinating, and full bladder made her pain worse.Nothing seems to make the pain better.She did not have pain with bowel movements, and she did not have trouble with constipation.Urinalysis was negative and postvoid residual was 0 ml.The patient believed that her pain was related to the mesh, but the physician advised her continued pain is likely not related to mesh or a genitourinary problem.The patient was offered a referral for pelvic floor physical therapy (pfpt).In addition, the pathophysiology of pain complaints is associated with the placement of mesh.The has had extensive conservative treatment with both pudendal and left-sided ilioinguinal nerve blocks which gave temporary pain relief only.The patient has also undergone multiple ablations of the left ilioinguinal nerve, which gave temporary pain relief only lasting up to 2 months.However, will take 3 to 4 weeks for the patient to note pain relief after the procedure.At this juncture, the most logical next step in treatment was complete mesh removal with a left-sided ilioinguinal/iliohypogastric neurectomy.Surgical risks such as bleeding, infection, and damage to internal organs, especially the bladder, were reviewed.Postoperative restrictions and recovery time were also reviewed.The patient was aware that some of her symptoms were consistent with a pudendal nerve issue, which may not resolve with mesh removal.Approximately 80% of patients will see significant pain relief after this procedure.On (b)(6) 2020, the patient had another follow-up visit for her chronic pain management.Her chronic pain symptoms were slightly worse.The change in condition was due to increased pelvic pain.Her symptoms were not controlled as well as she would like.She rated her pain at its worst in the last 30 days at a 9.She rated her lowest pain at a 7 in the last 30 days.She rated her pain most of the time on medication in the last 30 days as an 8.The patient's most severe pain location was pelvic region.She characterized the pain as severe in intensity, constant, aching, cramping, sharp, shooting, stabbing, and throbbing.She recently had an appointment with an oncologist.The patient was seen for further medical workup explained later in the note.The patient needed her pain medications to be refilled, and for further discussion during that visit.Reportedly, there were no medication changes from the last visit.The patient has had to use oxycodone 3 times total this week.She has been undergoing further evaluations and her most recent pet scan was cancer free; however, she stated her oncologist informed her that she had fluid in her pelvis, fluid in her lungs and bursa sac of her left hip with inflammation.She was scheduled with a gynecologist specialist for further help with her pain from the recalled mesh sling she had, but her appointment was not until (b)(6).As for the patient's pain management recommendations, the patient did display meaningful benefit to justify opioid medication continuation currently.There does not appear to be apparent undue risk of abuse, addiction, or diversion identified at this time.The patient did not appear to be having problems with physical or psychological dependence at this time.The risks of combining sedatives, alcohol, benzodiazepines, and sleeping pills with opioids and the associated risks of accidental overdose which could result in death were discussed.Overall, she was doing remarkably better since her ketamine infusions.She was off clonidine and taking percocet sparingly.She has been taking ibuprofen 800mg tid which was not the best for her heart.Reportedly, the patient did not see a urogynecologist until (b)(6), and she was not on plaquenil at that time.On (b)(6) 2020, the patient presented with a chief complaint of pelvic pain.She said that she had constant utis and pain.She felt like it was coming out of her urethra.She stated that the pain was exacerbated when she ate, and the food was pushed down.Her pain is on her urethra, left side of vagina, left midline incision up to her umbilicus, and on her abdomen.The physician implanted the mesh on the patient for her prolapse, which was a boston scientific sling.Furthermore, the pain was constant (8/10) and lasted the entire time.The patient got off opioids after breast cancer, and she doesn't want to use them again.She leaked urine with a cough, laugh, and sneeze.She said she "pees the bed now".Her pain was so severe that she could not have intercourse.She had urinary urgency at times during the day.She was close to a bathroom.If she doesn't get there, she will leak.She drank g2 gatorade and hot water.Additionally, she had tried urimar and azo.Furthermore, the patient mentioned that she burned when she had a bowel movement.She had 2 to 3 times a week.The patient was on phillips caplets.She takes miralax daily.She said it was hard and cracked.She had sjogrens, so everything was dry.The patient still has her uterus and ovaries.During the review of the patient's systems, the patient had chills, fatigue, trouble swallowing, dry eyes, shortness of breath, palpitations, abdominal pain, chronic idiopathic constipation, dyspareunia, dysuria, back pain, pelvic pain, muscle spasm, and nervousness/anxiety.Moreover, during the physical exam, the patient had infraumbilical scars, mild atrophy, and walked with a stooped posture.The assessment pelvic floor muscle spasm for which the patient was recommended pfpt; pelvic pain for which cymbalta 30 mg was prescribed and abdominal trigger point injections were mentioned; chronic idiopathic constipation for which lifestyle changes (increased water, walking, fiber) and linzess were recommended; urge urinary incontinence for which pfpt for muscle spasms were to be tried with consideration of starting myrbetriq if no improvement; stress urinary incontinence for which pfpt was recommended; and dyspareunia which was primarily related to spasms but may have an atrophy component.On (b)(6) 2020, the patient underwent an esophagogastroduodenoscopy (eg) mucosa (endoscopy with biopsy), colonic mucosa, ascending (biopsy), and colonic mucosa, sigmoid (biopsy) procedure.The specimens received were distal esophagus biopsy, ascending colon polyp, and sigmoid colon polyp.Furthermore, the pathological findings revealed that there were two fragments of inflamed eg mucosa highlighting squamous and non-metaplastic glandular epithelium.The lamina propria was minimally cellular.There was no evidence of barrett's mucosa or malignancy.Also, there were multiple fragments of neoplastic mucosal tissue corresponding to polyps formed by crowded adenomatous-like glands.These glands have tubular profiles and are lined by partly vacuolated, pink-staining columnar cells.There was no evidence of malignancy.On (b)(6) 2020, the nurse spoke with the patient about the pathology tissue request results.The nurse told the patient that she had had 2 colon polyps removed and that it was okay.It also showed that the patient had mild esophagitis with esophageal dilation.Her biopsy result was okay.She also stated that swallowing for her had improved.The patient is to continue on dexilant daily if otherwise okay.Furthermore, the patient stated that she has been seeing a pain management doctor in which they have been looking into a new diagnosis for the patient's pain, specifically, ilioinguinal neuralgia (from bladder mesh removal).Additionally, the patient stated that she would keep us updated.The patient should follow-up with the physician as needed.On (b)(6) 2021, the patient had another follow-up visit to address the following: chronic pain management and chronic pelvic pain.Her chronic pain symptoms were slightly and significantly better controlled.She rated her pain at its worst in the last 30 days at 9.She rated her lowest pain at a 4 in the last 30 days.She rated her pain most of the time on medication in the last 30 days at 8.The patient's most severe pain location is the following: pelvic region.She characterizes the pain as the following: moderate to severe in intensity and constant.She reported that the following activities were now possible since being placed on her current medication regimen whereas they were not before due to her chronic pain condition: ability to suffer less daily.On (b)(6) 2021, the patient was here for evaluation on a telehealth visit for pelvic pain.The patient has a history of mixed connective tissue disorders, sjogren's, and breast cancer.In 2017, the patient underwent a mid-urethral suprapubic sling with the lynx system.After this procedure, she developed severe, debilitating pelvic pain.In 2019, she had the vaginal portion of the sling removed without any improvement in her symptoms.She has since been diagnosed with 2 conditions: ilioinguinal neuralgia and pudendal neuralgia.In regard to the ilioinguinal neuralgia, the pain is predominantly on the left side and extends into the groin and vulva.It is a constant neuropathic pain and feels like the groin is being torn apart.She has sensitivity to clothing, and it is difficult to walk.She has had ilioinguinal nerve blocks that significantly reduced her pain temporarily.She has undergone 2 radiofrequency ablations that improved her symptoms for several months.Her pudendal pain is primarily experienced rectally, mostly on the left side, but she does have pain in the urethra and clitoris.The pain is constant but gets worse with sitting or standing.She has excruciating pain with bowel movements and cannot have intercourse.She has a burning pain in the clitoris and feels like she is urinating razor blades.She has had pudendal nerve blocks that gave her temporary relief from her pain.The patient has mild urinary incontinence symptoms even after the vaginal portion was removed.She does have frequent urgency symptoms.Consent was provided for the patient for laparoscopic robotic mesh removal, possible botox injections into the pelvic floor muscles, possible pudendal nerve block, possible ilioinguinal nerve block, and possible ilioinguinal neurectomy for an estimated duration of 4 hours.On (b)(6) 2022, the patient underwent left sided ilioinguinal/iliohypogastric neurectomy, retropubic dissection with mesh excision for the treatment of dysuria, dyspareunia, pelvic pain, and left ilioinguinal neuralgia.Firstly, on the patient's right side, the sling mesh was identified.It was grasped with a right-angle clamp, and predominantly sharp dissection was used to free the mesh as it was perforating the fascia and the rectus muscle.With traction and sharp dissection, the end of the mesh was eventually reached and was freed.Moreover, the end of the mesh was grasped with a kocher clamp, and used a combination of blunt and sharp dissection, stripping the mesh out of the retropubic space until it came free at the level of the periurethral region because the patient already had the vaginal portion of the mesh removed.Furthermore, the area was inspected carefully, and indeed, the entire piece of mesh had been removed.This was saved for pathology.Then, attention was moved to the patient's left side and performed essentially identical dissection for complete excision of the mesh.This was also then saved for pathology.Reportedly, 2 pieces of surgicel were placed in the deep portions of the dissection in the paravesical space near the bladder neck.The muscle was then reapproximated with interrupted 2-0 vicryl sutures, closed the fascia with a running 0 vicryl suture, closed the subcutaneous fat with a running 3-0 vicryl suture, and closed the skin with a running 4-0 subcuticular monocryl suture.Steri-strips and a bandage were placed.The patient was awakened in the operating room, brought to the recovery room awake, alert, and in apparent stable condition.Additionally, the surgical pathology report of the specimens from the left ilioinguinal nerve and retropubic mesh presented that there were large nerve fibers and adipose tissue.Also, there were fibrous tissue with chronic inflammation, foreign body giant cell reaction, and foreign body consistent with mesh.On (b)(6) 2022, the patient had another follow-up visit for her chronic pain management and chronic pelvic pain.Her chronic pain symptoms were worse.She rated her pain at its worst in the last 30 days at a 9.She rated her lowest pain at a 7 in the last 30 days.She rated her pain most of the time on medication in the last 30 days as a 9.The patient's most severe pain location was the following: pelvic region.She characterized the pain as moderate to severe in intensity, constant, and just painful and difficult to describe.Since patient was last seen in the physician's office, she went in for surgery, then the physician removed several inches of mesh from her pelvic area, and the patient was still in so much pain and cannot hardly walk.The patient needed her pain medications to be refilled today.There were no medication changes from the last visit.She reported that she was able to suffer less daily since being placed on her current medication regimen whereas they were not before due to her chronic pain condition.The patient experienced the following symptoms/side-effects: sweating, constipation, mental fogginess.Pertinent negatives include the following: nausea, breathing difficulty, drowsiness, heartburn, nervousness, itching, changes in mood, emotions, or personality, urinary hesitancy, sleeping disturbance, nightmares, dizziness, abdominal pain or heartburn, rash, retaining fluid or edema.She had her abdominal mesh removed by a physician.She seems to be doing well and was not on pain medication for post operation.The patient had a televisit today since she just had surgery.Her medication regimen will be continued without change at this time.The patient does display meaningful benefit to justify opioid medication continuation at this time.The clinical justification for continuation of opioid medication for pain management was the following: improved mobility and less suffering on a daily basis.On (b)(6) 2022, the physician spoke to the patient, and the patient left a message to cancel her surgery since she was able to have it done sooner with a doctor in new hampshire.On (b)(6) 2022, she had a follow-up visit to address her chronic pain management and chronic pelvic pain.Her chronic pain symptoms were about the same, worse.The change in condition was due to the following: still a lot of pain from the surgery, but also feeling better in some areas.She rated her pain at its worst in the last 30 days at a 10.She rated her lowest pain at a 9 in the last 30 days.The patient's most severe pain location was the pelvic region.She characterized the pain as moderate to severe in intensity, constant, and aching.Since patient was last seen in our office, she went in for her surgery with a physician, he removed 10 inches of mesh.The patient needed her pain medications to be refilled today.No medication changes from the last visit.She reported that she was able to suffer less daily now since being placed on her current medication regimen whereas they were not before due to her chronic pain condition.Last dose of pain medication was taken last month.Reportedly, no one accompanied the patient to her visit at this time.As for the patient's pain management recommendations, she was continuing to recover from abdominal surgery 5 weeks ago and was slowly making progress.She remained off from the pain medication and was continuing valium at night.

Manufacturer Narrative

Block h11: block b5 event description has been corrected.Block a4: patient's weight: 140.8 lbs.Block b3: the event date was approximated to august 3, 2017, implant date, as no event date was reported.Block e1: this event was reported by the patient's legal representation.The device was implanted at: (b)(6).Block h6: patient codes e2006, e2330, e1002, e0126, e1307, e1310, e0123, e2326, e1714, e020201, e020202, e1405, e1311, e0744 and e1906 capture the reportable events of erosion (felt like it was coming out her urethra), pain (chronic pelvic pain, bladder pain, perineal pain, joint pain, groin pain), pain, abdominal (lower abdomen), neuropathy (peripheral neuropathy), urethral stenosis/stricture (urethral stenosis), infection, urinary tract, nerve damage (left-sided ilioinguinal neuralgia), inflammation (chronic inflammation), rash, anxiety, depression, dyspareunia, unspecified kidney or urinary problem (urinary tract symptoms), infection, upper respiratory tract (acute upper respiratory infection, unspecified), and infection (multiple confirmed infections), respectively.Impact codes f19, f1903, f2303, f22, f23 and f1202 capture the reportable events of surgical intervention (cystourethroscopy, urethral dilation, hydrodistention of bladder), device explantation (excision of mid-urethral sling), medication required (bactrim, macrobid, doxycycline, dilaudid, percocet 5mg tablet, ketamine injection), unexpected diagnostic intervention (mri, cystoscopy), and f23: unexpected medical intervention (extensive conservative treatment with both pudendal, left-sided ilioinguinal nerve blocks, multiple ablations of the left ilioinguinal nerve), and disability (disabled).

• Brand Name: LYNX SYSTEM
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 10711015
• MDR Text Key: 212302927
• Report Number: 3005099803-2020-04576
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 08714729718956
• UDI-Public: 08714729718949
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/10/2018
• Device Model Number: M0068503000
• Device Catalogue Number: 850-300
• Device Lot Number: 0020511334
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/10/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability; Other
• Patient Age: 54 YR
• Patient Sex: Female