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

BOSTON SCIENTIFIC CORPORATION LYNX SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR

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Model Number M0068503000

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

Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Anemia (1706); Erosion (1750); Bruise/Contusion (1754); Fatigue (1849); Micturition Urgency (1871); Hemorrhage/Bleeding (1888); Muscle Weakness (1967); Nausea (1970); Nerve Damage (1979); Pain (1994); Rash (2033); Scar Tissue (2060); Urinary Retention (2119); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Burning Sensation (2146); Hernia (2240); Urinary Frequency (2275); Anxiety (2328); Discomfort (2330); Depression (2361); Numbness (2415); Obstruction/Occlusion (2422); Prolapse (2475); Sleep Dysfunction (2517); Dysuria (2684); Constipation (3274); Balance Problems (4401); Urethral Stenosis/Stricture (4501); Dyspareunia (4505); Cramp(s) /Muscle Spasm(s) (4521); Skin Inflammation/ Irritation (4545); Fecal Incontinence (4571); Urinary Incontinence (4572); Insufficient Information (4580)

Event Date 06/02/2020

Event Type Injury

Manufacturer Narrative

There was no information available regarding the event date.Therefore, it was approximated to (b)(6) 2020, the implant date has been selected.This event was reported by the patient's legal representation.The surgeon is: (b)(6).(b)(4).The complaint device is implanted and 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 system was implanted during a procedure performed on (b)(6) 2020.As reported by the patient's attorney, the patient has experienced unspecified injury.

Event Description

Manufacturer Narrative

Additional information to blocks a1: patient identifier, a2: date of birth, a4: weight, a6: race, b2, b5, d6b: explant date, e1: physician, and h6: patient codes.Block b3: there was no information available regarding the event date.Therefore, it was approximated to june 02, 2020, the implant date has been selected.Block e1: this event was reported by the patient's legal representation.The surgeon is: primary care: dr.(b)(6).Block h6: patient codes e1715, e1310, e1309, e2328, e1307, e2330, e0123, e1405, e1002, e0506, e020201, and e020202 capture the reportable events of scar tissue (cicatrix), infection, urinary tract (chronic), urinary retention (might not be emptying bladder, incomplete emptying, inability to empty her bladder), obstruction, ureter/urethra (bladder neck obstruction), urethral stenosis/stricture (mild trabeculations), pain (pain in urethra, top of vagina [cutting/digging sensation], pelvic, groin, low back, pubic & coccyx), nerve damage (pudendal neuralgia), dyspareunia (painful intercourse), abdominal pain, hemorrhage, major (bleeding), anxiety, and depression respectively.Impact codes f1903, f1905, f19, f23, and f2303, capture the reportable events of device explantation (lynx sling removal, removal of abdominal wall mesh), device revision or replacement (abdominal paravaginal defect repair, anterior colporrhaphy, paravaginal dissection), surgical intervention (urethrolysis), and medication required, respectively.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the removed 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 system was implanted during a laparoscopic-assisted vaginal hysterectomy, bilateral, salpingectomy, anterior colporrhaphy, posterior colporrhaphy, perineoplasty, lynx pubovaginal sling, abdominoplasty and suction assisted lipectomy procedure performed on june 02, 2020.On examination of the uterus, it showed classic evidence of adenomyosis with multiple areas of transmural glands.There was a left paratubal cyst measuring 2 cm in diameter.The peritoneal surfaces were smooth, and there was no evidence of endometriosis.The uterus was boggy and mushy in architecture.There was a moderate cystocele and a large rectocele.The perineal body showed significant thinning and dissolution.At cystoscopy, the bladder showed mild trabeculations and there was no evidence of malignancy.The patient had no problem encountered until one-month post-procedure.She had a urinary tract infection (uti) with two rounds of medications, and it was getting worse.Also, she felt like her vagina was always straining and it seems to be pushing out.On (b)(6) 2020, the patient experienced dysuria, frequency of micturition, hesitancy of micturition, incontinence without sensory awareness, nocturia, poor urinary stream, the urgency of urination, and bladder neck obstruction.In addition, she also had anemia and anxiety disorder due to known physiological conditions.On (b)(6) 2020, she had a follow-up visit and was in for a cystoscopy and examination.She presented problems encountered after the bladder sling and vaginal repair surgery that were experienced since july 2020.During the review of systems, the patient mentioned that she had uti, constant sensation to urinate, soreness when urinating, constant burning sensation, urethra constantly felt irritated, incontinence, cloudy urine, pain in the urethra and top of the vagina, urethra spasms after urinating, clear discharge, not emptying the bladder, and painful intercourse.Furthermore, the patient also had vaginal prolapse, urinary urgency, urinary hesitancy, poor urinary flow, intermittency, post-void dribbling, inability to empty her bladder, inability to stop her urinary stream, the bladder is full, leaked urine, vaginal burning, and vaginal discharge.Flexible cystoscopy was performed.The lower urinary tract was carefully examined.The procedure was well-tolerated and without complications.Colposcopy performed.No vaginal mucosal lesions were noted.No evidence of mesh erosion.Hydrodistension/dilation of the bladder was performed at 50 cm water pressure.The capacity was 400 cc.The bladder was drained.Upon re-inspection, there were no pain or post-distention dilation mucosal changes.The assessment included poor urinary stream, the hesitancy of urination, nocturia, the urgency of urination, frequency of micturition, incontinence without sensory awareness, dysuria, and bladder neck obstruction.Medical records note the exam supported hyperurethrovesical angle as the likely cause of the patient's symptoms.The physician recommended sling incision/urethrolysis.On (b)(6) 2021, the patient mentioned that the symptoms began 10 months ago and had been present for 10 months.The symptoms were reported as being moderate, and the symptoms occurred daily.She stated that the symptoms were chronic and uncontrolled.The patient reported that she had pelvic pain, groin pain (more on the right), vaginal pain (cutting/digging sensation), and discomfort with intercourse.She also had pressure in her vagina when sitting.In addition, the patient reported urinary urgency, dysuria, feelings of uti, weak stream, feelings of incomplete bladder emptying, and nocturia.During the review of systems, the patient stated that she also experienced fatigue, vision changes, abdominal pain, constipation, fecal incontinence, nausea, dysuria, incomplete emptying, nocturia, urge incontinence, urgency, urinary frequency, numbness in extremity, anxiety, depression, rash, back pain, easy bruising, seasonal allergies, dyspareunia, and had a history of abnormal pap smear.Exam revealed suburethral pain, pain at the right and left obturator internus muscle, and painful cords palpated left and right.The patient elected to proceed with surgical mesh removal.On (b)(6) 2021, the patient underwent lynx sling removal, urethral lysis, anterior colporrhaphy, paravaginal dissection, and removal of abdominal wall mesh procedure for the preoperative diagnoses of vaginal pain, pelvic pain, and groin pain.The postoperative diagnoses also included urinary stricture.The operative note indicated this was a very difficult surgery due to the scarring and the right sling arm being deep in the obturator internus muscle, as well as the left arm in the left obturator muscle and abdominally the right sling arm, being very lateral abdominally.Urethral lysis was performed with sharp dissection to further free the urethra and scar tissue on the left and on the right.Attention was then directed to the abdominal component.A transverse skin incision was made, and this incision was sharply taken down to the level of the fascia.The mesh was identified in the scar tissue from previous surgery and in the fascia, the fascia was incised around the mesh and the mesh was dissected free exposing the rectus muscles.The mesh was freed from the muscle tissue.The retropubic space was opened bilaterally to visualize the mesh trajectory, it was freed from the bladder wall and progressive dissection completely freed the left sling arm from the bladder wall and obturator muscle.The vaginal clamp was released, and the entire sling arm was handed off the operative field.The right sling arm was identified and also freed from the fascia and rectus muscles.The mesh was followed as it entered the right obturator internus muscle and was dissected free.Bleeding was controlled with cautery.The vaginal clamp was released, and the entire sling arm was handed off the operative field.Copious irrigation was performed.The entire lynx sling was removed.The patient tolerated the procedure well and was transferred to the recovery room in excellent condition.On the night of the surgery, the patient was doing well, resting comfortably in bed.Pain was well controlled with po meds.She tolerated a general diet without nausea or vomiting.Moreover, the patient denied chest pain, shortness of breath, or calf pain.She stated that her throat was dry, but otherwise had no complaints at this time.The physician and the patient discussed vaginal packing and catheter management.The patient had an unremarkable post-operative hospital course.She was tolerating a regular diet and ambulating without difficulty prior to discharge.On (b)(6) 2021, the day of discharge, the patient was instructed on the care and use of her plugged foley catheter.The patient felt comfortable using her catheter for interval voids.Reportedly, the patient's discharge condition was improving.Furthermore, the patient is to follow-up in 6 weeks in the office.She is to call the exchange/office for any concerns, no matter how unrelated to the reconstructive surgery.Call the exchange/office for a temperature greater than 100.6 as well as for vaginal bleeding.The pathology report findings from the lynx tvt sling removal revealed that there was a benign fibro adipose tissue with foreign body giant cell response to polarizable foreign material which was consistent with mesh.On (b)(6) 2021, the patient had a postoperative follow-up visit.The patient came in for packing and foley removal.The nurse removed vaginal packing first, then deflated and removed foley.She then instructed the patient to void within 4 hours and to call the office if she was unable to or to go to the emergency room if it was after office hours.The staples were removed, steris applied, and the patient was instructed to keep steris intact for 7 days.The jp drain output was <20ml for the past 2 days.Per the physician, the jp drain was removed, and the nurse applied a gauze dressing.The patient was to keep covered and dried for 24 hours, and for follow-up or sooner if symptoms persist or worsen as needed.On (b)(6) 2021, the patient presented for a physical therapy evaluation.She reported urinary symptoms including stress/exertional/urge incontinence, urgency, frequency, hesitancy, poor stream, incomplete emptying, and nocturia.Bowel symptoms were reported as poor frequency, straining, incomplete emptying, poor stool consistency, excessive wiping, delayed smearing, urgency, and fecal incontinence.Vaginal symptoms included painful intercourse and poor vaginal exam tolerance.The pain was reported in the lower back, coccyx, pubic area, and vaginal and vulvar areas.Moreover, the progression of the patient's symptoms worsened over time with mild improvement in pelvic pain after sling removal surgery in (b)(6) 2021.After surgery, symptom progression continued.The patient's urinary symptoms prevent her from traveling more than 30 minutes without stopping, putting her at risk for falls, social isolation, embarrassment, and skin breakdown.Her fecal function puts her at risk for social isolation, hemorrhoids, fissures, impaction, or sepsis due to the difficulty and infrequency of passing stool.She was unable to participate in intercourse, tampon usage, or speculum exam without pain if she chooses to participate at all.She was at risk for pelvic organ prolapse due to insufficiency of muscle activity and constant reflexive need to bear down.The patient was unable to perform transfers, bed mobility, static positioning for more than 30 minutes, household chores, or childcare activities without pain.A neurovascular exam of the pudendal nerve noted that the tinel's test was positive and produced severe, sharp tingling pain along the nerve path.The patient's colon had mild and non-painful restrictions laterally.Rectal mobility was moderate and painful restrictions in all directions, and bladder mobility was noted to have moderate to severe and painful restrictions in all directions.She had multiple trigger areas of trigger points, spasms, restriction, and pain.The si joint line, sacrotuberous ligament, and ischial tuberosities were painful on palpation.Additionally, during the internal pelvic exam, the patient had moderate to severe spasms and moderate pain with palpation of superficial and deep transverse perineum, puborectalis, pubococcygeus, iliococcygeus, coccygeus, and obturator internus muscles bilaterally.The sensation was increased throughout.The patient experienced a reflexive "bearing down" sensation during palpation, and an attempt at pelvic floor eccentric contraction was noted but inefficient.The assessment was overactive, non-relaxing pelvic floor musculature which contributes to bladder, bowel, sexual, pelvic organ support, and pelvic (including the coccyx) pain dysfunction.She demonstrated muscle spasm, pain, weakness, and incoordination of the pelvic floor related to surrounding pelvic and diaphragmatic muscles.The patient had symptoms listed above due to poor muscle rom, control, and coordination with chronically increased intra-abdominal pressure.Palpation of obturator internus reproduced pelvic girdle pain better than si joint form or force closure testing, indicating symptoms originating from muscle spasm instead of joint instability.She will benefit from skilled pt in order to promote pelvic muscle and joint mobility, stability, and function.Treatment can consist of manual therapy to improve muscle length and full relaxation, therapeutic exercise to build strength, therapeutic activity for functional training, neuromuscular reeducation to improve timing and coordination, cognitive-behavioral retraining, and patient education to promote understanding, participation, and compliance.On (b)(6) 2021, the patient had an office visit for the reason of possible hernia.The patient stated that she thought that she may have a hernia to her right side of the groin.She had a bladder sling removed in (b)(6) 2021 and the bulging hernia type was to the right of that along with a burning sensation.She had been prescribed estradiol after the removal surgery to apply to the vaginal wall which she continued using 1-3 times per week.The patient reported that the bulge was reducible, and she noticed that it was most often with increased intra-abdominal pressure.She planned to have a revision of the tummy tuck soon and will be seeing her plastic surgeon soon for consult.The patient also mentioned that she had vaginal dryness, increased urinary frequency, and urinary irritation.However, the patient was unsure if vaginal dryness was related to hysterectomy versus her uti-like symptoms.During the review of systems, the patient had dysuria, pelvic pain and vaginal dryness.She also reported she had a chronic uti and was currently taking augmentin.Exam revealed a bulge located at the lateral lower transverse incision on the right which was reducible.The assessment included incisional hernia for which an abdominal/pelvis ct was ordered.On (b)(6) 2022, the patient had an office visit and stated that she needed a referral to a urologist.The patient had recurrent uti, and she needed a referral for possible cystoscopy.She also wanted to ask about when she will have a vaginal surgery, because she was having a lot of nerve pain and had pudendal nerve damage from the sling removal.The patient also wanted to know if was there a medication that she can take for the nerve pain.She has had a significant neck pain since having surgery.The patient had an underlying history of depression.Reportedly, she has been stable on medications.During the review of systems, it was mentioned that the patient had dysuria, pelvic pain, urinary urgency, and anxiety.The assessment included chronic uti, pudendal nerve injury, depression, and hormonal imbalance.The plan included a referral to urology, continuing her current medications, and starting amitriptyline at night.

Manufacturer Narrative

Additional information to block b5.Block b3: there was no information available regarding the event date.Therefore, it was approximated to (b)(6) 2020, the implant date has been selected.Block e1: (b)(6).Block h6: patient codes e1715, e1310, e1309, e2328, e1307, e2330, e0123, e1405, e1002, e0506, e2101, e232401, e232401 and e020202 capture the reportable events of scar tissue (cicatrix)to capture scarring, infection, urinary tract (chronic), urinary retention (might not be emptying bladder, incomplete emptying, inability to empty her bladder), obstruction, ureter/urethra (bladder neck obstruction), urethral stenosis/stricture (mild trabeculations), pain (pain in urethra, top of vagina [cutting/digging sensation], pelvic, groin, low back, pubic & coccyx), nerve damage (pudendal neuralgia), dyspareunia (painful intercourse), abdominal pain, hemorrhage, major (bleeding), adhesions (painful restrictions in all directions), fecal incontinence, anxiety and depression, respectively.Impact codes f1202, f1903, f1905, f19, f23, and f2303, capture the reportable events of disability (the patient was unable to perform transfers, bed mobility, static positioning more than 30 minutes, household chores, or childcare activities without pain.), device explantation (lynx sling removal, removal of abdominal wall mesh), device revision or replacement (abdominal paravaginal defect repair, anterior colporrhaphy, paravaginal dissection), surgical intervention (urethrolysis), and medication required, respectively.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the removed 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

Correction and additional information to blocks b2: outcomes attrib to adv event, b5, and h6: patient codes.Block b3: there was no information available regarding the event date.Therefore, it was approximated to june 02, 2020, the implant date has been selected.Block e1: this event was reported by the patient's legal representation.The surgeon is: primary care: dr.(b)(6).(b)(6) hospital.(b)(6).(b)(6) urology llc.(b)(6).(b)(6).Clinic tower b.(b)(6).(b)(6).Block h6: patient codes e1715, e1310, e1309, e2328, e1307, e2330, e0123, e1405, e1002, e0506, e2101, e232401, e232401 and e020202 capture the reportable events of scar tissue (cicatrix)to capture scarring, infection, urinary tract (chronic), urinary retention (might not be emptying bladder, incomplete emptying, inability to empty her bladder), obstruction, ureter/urethra (bladder neck obstruction), urethral stenosis/stricture (mild trabeculations), pain (pain in urethra, top of vagina [cutting/digging sensation], pelvic, groin, low back, pubic & coccyx), nerve damage (pudendal neuralgia), dyspareunia (painful intercourse), abdominal pain, hemorrhage, major (bleeding), adhesions (painful restrictions in all directions), fecal incontinence, anxiety and depression, respectively.Impact codes f1202, f1903, f1905, f19, f23, and f2303, capture the reportable events of disability (the patient was unable to perform transfers, bed mobility, static positioning more than 30 minutes, household chores, or childcare activities without pain.), device explantation (lynx sling removal, removal of abdominal wall mesh), device revision or replacement (abdominal paravaginal defect repair, anterior colporrhaphy, paravaginal dissection), surgical intervention (urethrolysis), and medication required, respectively.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the removed 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 system was implanted during a laparoscopic-assisted vaginal hysterectomy, bilateral, salpingectomy, anterior colporrhaphy, posterior colporrhaphy, perineoplasty, lynx pubovaginal sling, abdominoplasty and suction assisted lipectomy procedure performed on (b)(6), 2020.On examination of the uterus, it showed classic evidence of adenomyosis with multiple areas of transmural glands.There was a left paratubal cyst measuring 2 cm in diameter.The peritoneal surfaces were smooth, and there was no evidence of endometriosis.The uterus was boggy and mushy in architecture.There was a moderate cystocele and a large rectocele.The perineal body showed significant thinning and dissolution.At cystoscopy, the bladder showed mild trabeculations and there was no evidence of malignancy.The patient had no problem encountered until one-month post-procedure.She had a urinary tract infection (uti) with two rounds of medications, and it was getting worse.Also, she felt like her vagina was always straining and it seems to be pushing out.On (b)(6), 2020, the patient experienced dysuria, frequency of micturition, hesitancy of micturition, incontinence without sensory awareness, nocturia, poor urinary stream, the urgency of urination, and bladder neck obstruction.In addition, she also had anemia and anxiety disorder due to known physiological conditions.On (b)(6), 2020, she had a follow-up visit and was in for a cystoscopy and examination.She presented problems encountered after the bladder sling and vaginal repair surgery that were experienced since (b)(6) 2020.During the review of systems, the patient mentioned that she had uti, constant sensation to urinate, soreness when urinating, constant burning sensation, urethra constantly felt irritated, incontinence, cloudy urine, pain in the urethra and top of the vagina, urethra spasms after urinating, clear discharge, not emptying the bladder, and painful intercourse.Furthermore, the patient also had vaginal prolapse, urinary urgency, urinary hesitancy, poor urinary flow, intermittency, post-void dribbling, inability to empty her bladder, inability to stop her urinary stream, the bladder is full, leaked urine, vaginal burning, and vaginal discharge.Flexible cystoscopy was performed.The lower urinary tract was carefully examined.The procedure was well-tolerated and without complications.Colposcopy performed.No vaginal mucosal lesions were noted.No evidence of mesh erosion.Hydrodistension/dilation of the bladder was performed at 50 cm water pressure.The capacity was 400 cc.The bladder was drained.Upon re-inspection, there were no pain or post-distention dilation mucosal changes.The assessment included poor urinary stream, the hesitancy of urination, nocturia, the urgency of urination, frequency of micturition, incontinence without sensory awareness, dysuria, and bladder neck obstruction.Medical records note the exam supported hyperurethrovesical angle as the likely cause of the patient's symptoms.The physician recommended sling incision/urethrolysis.On (b)(6), 2021, the patient mentioned that the symptoms began 10 months ago and had been present for 10 months.The symptoms were reported as being moderate, and the symptoms occurred daily.She stated that the symptoms were chronic and uncontrolled.The patient reported that she had pelvic pain, groin pain (more on the right), vaginal pain (cutting/digging sensation), and discomfort with intercourse.She also had pressure in her vagina when sitting.In addition, the patient reported urinary urgency, dysuria, feelings of uti, weak stream, feelings of incomplete bladder emptying, and nocturia.During the review of systems, the patient stated that she also experienced fatigue, vision changes, abdominal pain, constipation, fecal incontinence, nausea, dysuria, incomplete emptying, nocturia, urge incontinence, urgency, urinary frequency, numbness in extremity, anxiety, depression, rash, back pain, easy bruising, seasonal allergies, dyspareunia, and had a history of abnormal pap smear.Exam revealed suburethral pain, pain at the right and left obturator internus muscle, and painful cords palpated left and right.The patient elected to proceed with surgical mesh removal.On (b)(6), 2021, the patient underwent lynx sling removal, urethral lysis, anterior colporrhaphy, paravaginal dissection, and removal of abdominal wall mesh procedure for the preoperative diagnoses of vaginal pain, pelvic pain, and groin pain.The postoperative diagnoses also included urinary stricture.The operative note indicated this was a very difficult surgery due to the scarring and the right sling arm being deep in the obturator internus muscle, as well as the left arm in the left obturator muscle and abdominally the right sling arm, being very lateral abdominally.Urethral lysis was performed with sharp dissection to further free the urethra and scar tissue on the left and on the right.Attention was then directed to the abdominal component.A transverse skin incision was made, and this incision was sharply taken down to the level of the fascia.The mesh was identified in the scar tissue from previous surgery and in the fascia, the fascia was incised around the mesh and the mesh was dissected free exposing the rectus muscles.The mesh was freed from the muscle tissue.The retropubic space was opened bilaterally to visualize the mesh trajectory, it was freed from the bladder wall and progressive dissection completely freed the left sling arm from the bladder wall and obturator muscle.The vaginal clamp was released, and the entire sling arm was handed off the operative field.The right sling arm was identified and also freed from the fascia and rectus muscles.The mesh was followed as it entered the right obturator internus muscle and was dissected free.Bleeding was controlled with cautery.The vaginal clamp was released, and the entire sling arm was handed off the operative field.Copious irrigation was performed.The entire lynx sling was removed.The patient tolerated the procedure well and was transferred to the recovery room in excellent condition.The pathology report findings from the lynx tvt sling removal revealed that there was a benign fibro adipose tissue with foreign body giant cell response to polarizable foreign material which was consistent with mesh.On (b)(6), 2021, the patient had a postoperative follow-up visit.The patient came in for packing and foley removal.The nurse removed vaginal packing first, then deflated and removed foley.She then instructed the patient to void within 4 hours and to call the office if she was unable to or to go to the emergency room if it was after office hours.The staples were removed, steris applied, and the patient was instructed to keep steris intact for 7 days.The jp drain output was <20ml for the past 2 days.Per the physician, the jp drain was removed, and the nurse applied a gauze dressing.The patient was to keep covered and dried for 24 hours, and for follow-up or sooner if symptoms persist or worsen as needed.On (b)(6), 2021, the patient presented for a physical therapy evaluation.She reported urinary symptoms including stress/exertional/urge incontinence, urgency, frequency, hesitancy, poor stream, incomplete emptying, and nocturia.Bowel symptoms were reported as poor frequency, straining, incomplete emptying, poor stool consistency, excessive wiping, delayed smearing, urgency, and fecal incontinence.Vaginal symptoms included painful intercourse and poor vaginal exam tolerance.The pain was reported in the lower back, coccyx, pubic area, and vaginal and vulvar areas.Moreover, the progression of the patient's symptoms worsened over time with mild improvement in pelvic pain after sling removal surgery in (b)(6) 2021.After surgery, symptom progression continued.The patient's urinary symptoms prevent her from traveling more than 30 minutes without stopping, putting her at risk for falls, social isolation, embarrassment, and skin breakdown.Her fecal function puts her at risk for social isolation, hemorrhoids, fissures, impaction, or sepsis due to the difficulty and infrequency of passing stool.She was unable to participate in intercourse, tampon usage, or speculum exam without pain if she chooses to participate at all.She was at risk for pelvic organ prolapse due to insufficiency of muscle activity and constant reflexive need to bear down.The patient was unable to perform transfers, bed mobility, static positioning for more than 30 minutes, household chores, or childcare activities without pain.A neurovascular exam of the pudendal nerve noted that the tinel's test was positive and produced severe, sharp tingling pain along the nerve path.The patient's colon had mild and non-painful restrictions laterally.Rectal mobility was moderate and painful restrictions in all directions, and bladder mobility was noted to have moderate to severe and painful restrictions in all directions.She had multiple trigger areas of trigger points, spasms, restriction, and pain.The si joint line, sacrotuberous ligament, and ischial tuberosities were painful on palpation.Additionally, during the internal pelvic exam, the patient had moderate to severe spasms and moderate pain with palpation of superficial and deep transverse perineum, puborectalis, pubococcygeus, iliococcygeus, coccygeus, and obturator internus muscles bilaterally.The sensation was increased throughout.The patient experienced a reflexive "bearing down" sensation during palpation, and an attempt at pelvic floor eccentric contraction was noted but inefficient.The assessment was overactive, non-relaxing pelvic floor musculature which contributes to bladder, bowel, sexual, pelvic organ support, and pelvic (including the coccyx) pain dysfunction.She demonstrated muscle spasm, pain, weakness, and incoordination of the pelvic floor related to surrounding pelvic and diaphragmatic muscles.The patient had symptoms listed above due to poor muscle rom, control, and coordination with chronically increased intra-abdominal pressure.Palpation of obturator internus reproduced pelvic girdle pain better than si joint form or force closure testing, indicating symptoms originating from muscle spasm instead of joint instability.She will benefit from skilled pt in order to promote pelvic muscle and joint mobility, stability, and function.Treatment can consist of manual therapy to improve muscle length and full relaxation, therapeutic exercise to build strength, therapeutic activity for functional training, neuromuscular reeducation to improve timing and coordination, cognitive-behavioral retraining, and patient education to promote understanding, participation, and compliance.On (b)(6), 2021, the patient had an office visit for the reason of possible hernia.The patient stated that she thought that she may have a hernia to her right side of the groin.She had a bladder sling removed in (b)(6) 2021 and the bulging hernia type was to the right of that along with a burning sensation.She had been prescribed estradiol after the removal surgery to apply to the vaginal wall which she continued using 1-3 times per week.The patient reported that the bulge was reducible, and she noticed that it was most often with increased intra-abdominal pressure.She planned to have a revision of the tummy tuck soon and will be seeing her plastic surgeon soon for consult.The patient also mentioned that she had vaginal dryness, increased urinary frequency, and urinary irritation.However, the patient was unsure if vaginal dryness was related to hysterectomy versus her uti-like symptoms.During the review of systems, the patient had dysuria, pelvic pain and vaginal dryness.She also reported she had a chronic uti and was currently taking augmentin.Exam revealed a bulge located at the lateral lower transverse incision on the right which was reducible.The assessment included incisional hernia for which an abdominal/pelvis ct was ordered.On (b)(6), 2022, the patient had an office visit and stated that she needed a referral to a urologist.The patient had recurrent uti, and she needed a referral for possible cystoscopy.She also wanted to ask about when she will have a vaginal surgery, because she was having a lot of nerve pain and had pudendal nerve damage from the sling removal.The patient also wanted to know if was there a medication that she can take for the nerve pain.She has had a significant neck pain since having surgery.The patient had an underlying history of depression.Reportedly, she has been stable on medications.During the review of systems, it was mentioned that the patient had dysuria, pelvic pain, urinary urgency, and anxiety.The assessment included chronic uti, pudendal nerve injury, depression, and hormonal imbalance.The plan included a referral to urology, continuing her current medications, and starting amitriptyline at night.

Event Description

It was reported to boston scientific corporation that a lynx suprapubic mid-urethral sling system was implanted during a laparoscopic-assisted vaginal hysterectomy, bilateral, salpingectomy, anterior colporrhaphy, posterior colporrhaphy, perineoplasty, lynx pubovaginal sling, abdominoplasty and suction assisted lipectomy procedure performed on (b)(6) 2020.On examination of the uterus, it showed classic evidence of adenomyosis with multiple areas of transmural glands.There was a left paratubal cyst measuring 2 cm in diameter.The peritoneal surfaces were smooth, and there was no evidence of endometriosis.The uterus was boggy and mushy in architecture.There was a moderate cystocele and a large rectocele.The perineal body showed significant thinning and dissolution.At cystoscopy, the bladder showed mild trabeculations and there was no evidence of malignancy.The patient had no problem encountered until one-month post-procedure.She had a urinary tract infection (uti) with two rounds of medications, and it was getting worse.Also, she felt like her vagina was always straining and it seems to be pushing out.On (b)(6), 2020, the patient experienced dysuria, frequency of micturition, hesitancy of micturition, incontinence without sensory awareness, nocturia, poor urinary stream, the urgency of urination, and bladder neck obstruction.In addition, she also had anemia and anxiety disorder due to known physiological conditions.On (b)(6) 2020, she had a follow-up visit and was in for a cystoscopy and examination.She presented problems encountered after the bladder sling and vaginal repair surgery that were experienced since (b)(6) 2020.During the review of systems, the patient mentioned that she had uti, constant sensation to urinate, soreness when urinating, constant burning sensation, urethra constantly felt irritated, incontinence, cloudy urine, pain in the urethra and top of the vagina, urethra spasms after urinating, clear discharge, not emptying the bladder, and painful intercourse.Furthermore, the patient also had vaginal prolapse, urinary urgency, urinary hesitancy, poor urinary flow, intermittency, post-void dribbling, inability to empty her bladder, inability to stop her urinary stream, the bladder is full, leaked urine, vaginal burning, and vaginal discharge.Flexible cystoscopy was performed.The lower urinary tract was carefully examined.The procedure was well-tolerated and without complications.Colposcopy performed.No vaginal mucosal lesions were noted.No evidence of mesh erosion.Hydrodistension/dilation of the bladder was performed at 50 cm water pressure.The capacity was 400 cc.The bladder was drained.Upon re-inspection, there were no pain or post-distention dilation mucosal changes.The assessment included poor urinary stream, the hesitancy of urination, nocturia, the urgency of urination, frequency of micturition, incontinence without sensory awareness, dysuria, and bladder neck obstruction.Medical records note the exam supported hyperurethrovesical angle as the likely cause of the patient's symptoms.The physician recommended sling incision/urethrolysis.On (b)(6) 2021, the patient mentioned that the symptoms began 10 months ago and had been present for 10 months.The symptoms were reported as being moderate, and the symptoms occurred daily.She stated that the symptoms were chronic and uncontrolled.The patient reported that she had pelvic pain, groin pain (more on the right), vaginal pain (cutting/digging sensation), and discomfort with intercourse.She also had pressure in her vagina when sitting.In addition, the patient reported urinary urgency, dysuria, feelings of uti, weak stream, feelings of incomplete bladder emptying, and nocturia.During the review of systems, the patient stated that she also experienced fatigue, vision changes, abdominal pain, constipation, fecal incontinence, nausea, dysuria, incomplete emptying, nocturia, urge incontinence, urgency, urinary frequency, numbness in extremity, anxiety, depression, rash, back pain, easy bruising, seasonal allergies, dyspareunia, and had a history of abnormal pap smear.Exam revealed suburethral pain, pain at the right and left obturator internus muscle, and painful cords palpated left and right.The patient elected to proceed with surgical mesh removal.On (b)(6) 2021, the patient underwent lynx sling removal, urethral lysis, anterior colporrhaphy, paravaginal dissection, and removal of abdominal wall mesh procedure for the preoperative diagnoses of vaginal pain, pelvic pain, and groin pain.The postoperative diagnoses also included urinary stricture.The operative note indicated this was a very difficult surgery due to the scarring and the right sling arm being deep in the obturator internus muscle, as well as the left arm in the left obturator muscle and abdominally the right sling arm, being very lateral abdominally.Urethral lysis was performed with sharp dissection to further free the urethra and scar tissue on the left and on the right.Attention was then directed to the abdominal component.A transverse skin incision was made, and this incision was sharply taken down to the level of the fascia.The mesh was identified in the scar tissue from previous surgery and in the fascia, the fascia was incised around the mesh and the mesh was dissected free exposing the rectus muscles.The mesh was freed from the muscle tissue.The retropubic space was opened bilaterally to visualize the mesh trajectory, it was freed from the bladder wall and progressive dissection completely freed the left sling arm from the bladder wall and obturator muscle.The vaginal clamp was released, and the entire sling arm was handed off the operative field.The right sling arm was identified and also freed from the fascia and rectus muscles.The mesh was followed as it entered the right obturator internus muscle and was dissected free.Bleeding was controlled with cautery.The vaginal clamp was released, and the entire sling arm was handed off the operative field.Copious irrigation was performed.The entire lynx sling was removed.The patient tolerated the procedure well and was transferred to the recovery room in excellent condition.On the night of the surgery, the patient was doing well, resting comfortably in bed.Pain was well controlled with po meds.She tolerated a general diet without nausea or vomiting.Moreover, the patient denied chest pain, shortness of breath, or calf pain.She stated that her throat was dry, but otherwise had no complaints at this time.The physician and the patient discussed vaginal packing and catheter management.The patient had an unremarkable post-operative hospital course.She was tolerating a regular diet and ambulating without difficulty prior to discharge.On (b)(6), 2021, the day of discharge, the patient was instructed on the care and use of her plugged foley catheter.The patient felt comfortable using her catheter for interval voids.Reportedly, the patient's discharge condition was improving.Furthermore, the patient is to follow-up in 6 weeks in the office.She is to call the exchange/office for any concerns, no matter how unrelated to the reconstructive surgery.Call the exchange/office for a temperature greater than 100.6 as well as for vaginal bleeding.The pathology report findings from the lynx tvt sling removal revealed that there was a benign fibro adipose tissue with foreign body giant cell response to polarizable foreign material which was consistent with mesh.On (b)(6) 2021, the patient had a postoperative follow-up visit.The patient came in for packing and foley removal.The nurse removed vaginal packing first, then deflated and removed foley.She then instructed the patient to void within 4 hours and to call the office if she was unable to or to go to the emergency room if it was after office hours.The staples were removed, steris applied, and the patient was instructed to keep steris intact for 7 days.The jp drain output was <20ml for the past 2 days.Per the physician, the jp drain was removed, and the nurse applied a gauze dressing.The patient was to keep covered and dried for 24 hours, and for follow-up or sooner if symptoms persist or worsen as needed.On (b)(6), 2021, the patient presented for a physical therapy evaluation.She reported urinary symptoms including stress/exertional/urge incontinence, urgency, frequency, hesitancy, poor stream, incomplete emptying, and nocturia.Bowel symptoms were reported as poor frequency, straining, incomplete emptying, poor stool consistency, excessive wiping, delayed smearing, urgency, and fecal incontinence.Vaginal symptoms included painful intercourse and poor vaginal exam tolerance.The pain was reported in the lower back, coccyx, pubic area, and vaginal and vulvar areas.Moreover, the progression of the patient's symptoms worsened over time with mild improvement in pelvic pain after sling removal surgery in (b)(6) 2021.After surgery, symptom progression continued.The patient's urinary symptoms prevent her from traveling more than 30 minutes without stopping, putting her at risk for falls, social isolation, embarrassment, and skin breakdown.Her fecal function puts her at risk for social isolation, hemorrhoids, fissures, impaction, or sepsis due to the difficulty and infrequency of passing stool.She was unable to participate in intercourse, tampon usage, or speculum exam without pain if she chooses to participate at all.She was at risk for pelvic organ prolapse due to insufficiency of muscle activity and constant reflexive need to bear down.The patient was unable to perform transfers, bed mobility, static positioning for more than 30 minutes, household chores, or childcare activities without pain.A neurovascular exam of the pudendal nerve noted that the tinel's test was positive and produced severe, sharp tingling pain along the nerve path.The patient's colon had mild and non-painful restrictions laterally.Rectal mobility was moderate and painful restrictions in all directions, and bladder mobility was noted to have moderate to severe and painful restrictions in all directions.She had multiple trigger areas of trigger points, spasms, restriction, and pain.The si joint line, sacrotuberous ligament, and ischial tuberosities were painful on palpation.Additionally, during the internal pelvic exam, the patient had moderate to severe spasms and moderate pain with palpation of superficial and deep transverse perineum, puborectalis, pubococcygeus, iliococcygeus, coccygeus, and obturator internus muscles bilaterally.The sensation was increased throughout.The patient experienced a reflexive "bearing down" sensation during palpation, and an attempt at pelvic floor eccentric contraction was noted but inefficient.The assessment was overactive, non-relaxing pelvic floor musculature which contributes to bladder, bowel, sexual, pelvic organ support, and pelvic (including the coccyx) pain dysfunction.She demonstrated muscle spasm, pain, weakness, and incoordination of the pelvic floor related to surrounding pelvic and diaphragmatic muscles.The patient had symptoms listed above due to poor muscle rom, control, and coordination with chronically increased intra-abdominal pressure.Palpation of obturator internus reproduced pelvic girdle pain better than si joint form or force closure testing, indicating symptoms originating from muscle spasm instead of joint instability.She will benefit from skilled pt in order to promote pelvic muscle and joint mobility, stability, and function.Treatment can consist of manual therapy to improve muscle length and full relaxation, therapeutic exercise to build strength, therapeutic activity for functional training, neuromuscular reeducation to improve timing and coordination, cognitive-behavioral retraining, and patient education to promote understanding, participation, and compliance.On (b)(6) 2021, the patient had a visit using telemedicine.The patient underwent vaginal hysterectomy with lynx retropubic sling and rectocele repair in (b)(6) 2020.She was numb for 2 weeks after surgery, but when the numbness wore off, she noticed significant and constant pelvic pain and urinary urgency.Eventually, she had the mesh removed.Unfortunately, her pain and urgency sensation did not go away.The patient has pain and pressure in the perineum and rectum approximately 90% of the time.She also has a burning pain in her vagina and rectum.There was burning in her rectum with bowel movement, which went away after bowel movement.The patient also has a sensation of a foreign body in her rectum.It also felt like the tampon was coming out of her vagina.She often has a buzzing sensation in her pelvis.She has burning with urination which continues for a while after.She does have some tailbone pain.There was some pain with arousal, orgasm, and clitoral pain.She felt that her pain was most on the right side.There was a right-side burning pain.Furthermore, there was some pain with intercourse, usually at the beginning and approximately one hour after.The patient had nocturia thrice, but previously it was six times.The patient had pelvic floor physical therapy and was told her pelvic floor muscles were tight but now were relaxing.She was not doing pelvic physical therapy anymore but was doing the prescribed exercises at home.She had not tried any medications or suppositories.The patient was not examined since this consultation was done using telemedicine.The patient will be seen in the physician's office prior to any surgical intervention and examined then.Additionally, during assessment, the patient was diagnosed with pudendal neuralgia, spastic pelvic floor syndrome, and other specified complications due to other genitourinary prosthetic materials.The patient will be scheduled for bilateral pudendal nerve block, botox injection to the pelvic floor muscles, and valium 5mg/baclofen 4mg/ketamine 15mg suppositories.The physician had a long discussion with the patient, and the physician believed that the patient's biggest source of pain was pelvic floor muscle spasm.She developed it after the placement of a retropubic sling, but the pain did not go away after its removal.Most likely, if her spasm continues, the patient needs treatment of her pelvic floor muscles.The physician and the patient had to discuss treatment options, and the patient should start with a botox injection to the pelvic floor muscles.This is both therapeutic and diagnostic and was explained to the patient.If there is no improvement, it means that her pain is due to pelvic floor muscle spasm, and she may need to continue botox injections every few months as well as pelvic floor physical therapy.If there is no improvement, the patient will need an amniofix injection around the pudendal nerve and eventually pudendal neurolysis if there is no improvement.All this was discussed in significant detail with the patient.She understands and would like to proceed with the botox injection to the pelvic floor muscles.Vbk suppositories were also delivered to her local pharmacy.On (b)(6), 2021, the patient had an office visit for the reason of possible hernia.The patient stated that she thought that she may have a hernia to her right side of the groin.She had a bladder sling removed in (b)(6) 2021 and the bulging hernia type was to the right of that along with a burning sensation.She had been prescribed estradiol after the removal surgery to apply to the vaginal wall which she continued using 1-3 times per week.The patient reported that the bulge was reducible, and she noticed that it was most often with increased intra-abdominal pressure.She planned to have a revision of the tummy tuck soon and will be seeing her plastic surgeon soon for consult.The patient also mentioned that she had vaginal dryness, increased urinary frequency, and urinary irritation.However, the patient was unsure if vaginal dryness was related to hysterectomy versus her uti-like symptoms.During the review of systems, the patient had dysuria, pelvic pain and vaginal dryness.She also reported she had a chronic uti and was currently taking augmentin.Exam revealed a bulge located at the lateral lower transverse incision on the right which was reducible.The assessment included incisional hernia for which an abdominal/pelvis ct was ordered.On (b)(6) 2022, the patient had an office visit and stated that she needed a referral to a urologist.The patient had recurrent uti, and she needed a referral for possible cystoscopy.She also wanted to ask about when she will have a vaginal surgery, because she was having a lot of nerve pain and had pudendal nerve damage from the sling removal.The patient also wanted to know if was there a medication that she can take for the nerve pain.She has had a significant neck pain since having surgery.The patient had an underlying history of depression.Reportedly, she has been stable on medications.During the review of systems, it was mentioned that the patient had dysuria, pelvic pain, urinary urgency, and anxiety.The assessment included chronic uti, pudendal nerve injury, depression, and hormonal imbalance.The plan included a referral to urology, continuing her current medications, and starting amitriptyline at night.

Manufacturer Narrative

Additional information to blocks b5, e1 and h6.Block b3: there was no information available regarding the event date.Therefore, it was approximated to june 02, 2020, the implant date has been selected.Block e1: this event was reported by the patient's legal representation.The surgeon is: primary care: dr.(b)(6).Ob/gyn: dr.(b)(6).Surgeon: dr.(b)(6).Urogyn: dr.(b)(6).Woman's hospital (b)(6).Phone number: (b)(6).(b)(6) llc.(b)(6).Phone number: (b)(6).Fax number: (b)(6).(b)(6).Phone number: (b)(6).Fax number: (b)(6).(b)(6) physical therapist.(b)(6).Phone number: (b)(6).Fax number: (b)(6).Email: (b)(6).Dr.(b)(6).(b)(6).Block h6: patient codes e1715, e2006, e1310, e1309, e2328, e1307, e2330, e0123, e1405, e1002, e0506, e2101, e232401, e232401 and e020202 capture the reportable events of scar tissue (cicatrix)to capture scarring, erosion (sensation of the foreign body in her rectum), infection, urinary tract (chronic), urinary retention (might not be emptying bladder, incomplete emptying, inability to empty her bladder), obstruction, ureter/urethra (bladder neck obstruction), urethral stenosis/stricture (mild trabeculations), pain (pain in urethra, top of vagina [cutting/digging sensation], pelvic, groin, low back, pubic & coccyx), nerve damage (pudendal neuralgia), dyspareunia (painful intercourse), abdominal pain, hemorrhage, major (bleeding), adhesions (painful restrictions in all directions), fecal incontinence, anxiety and depression, respectively.Impact codes f1202, f1903, f1905, f19, f23, f2303 and f18, capture the reportable events of disability (the patient was unable to perform transfers, bed mobility, static positioning more than 30 minutes, household chores, or childcare activities without pain.), device explantation (lynx sling removal, removal of abdominal wall mesh), device revision or replacement (abdominal paravaginal defect repair, anterior colporrhaphy, paravaginal dissection), surgical intervention (urethrolysis), medication required, and rehabilitation (pelvic floor physical therapy), respectively.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the removed 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 system was implanted during a laparoscopic-assisted vaginal hysterectomy, bilateral, salpingectomy, anterior colporrhaphy, posterior colporrhaphy, perineoplasty, lynx pubovaginal sling, abdominoplasty and suction assisted lipectomy procedure performed on (b)(6) 2020.On examination of the uterus, it showed classic evidence of adenomyosis with multiple areas of transmural glands.There was a left paratubal cyst measuring 2 cm in diameter.The peritoneal surfaces were smooth, and there was no evidence of endometriosis.The uterus was boggy and mushy in architecture.There was a moderate cystocele and a large rectocele.The perineal body showed significant thinning and dissolution.At cystoscopy, the bladder showed mild trabeculations and there was no evidence of malignancy.The patient had no problem encountered until one-month post-procedure.She had a urinary tract infection (uti) with two rounds of medications, and it was getting worse.Also, she felt like her vagina was always straining and it seems to be pushing out.On (b)(6) 2020, the patient experienced dysuria, frequency of micturition, hesitancy of micturition, incontinence without sensory awareness, nocturia, poor urinary stream, the urgency of urination, and bladder neck obstruction.In addition, she also had anemia and anxiety disorder due to known physiological conditions.On (b)(6) 2020, she had a follow-up visit and was in for a cystoscopy and examination.She presented problems encountered after the bladder sling and vaginal repair surgery that were experienced since (b)(6) 2020.During the review of systems, the patient mentioned that she had uti, constant sensation to urinate, soreness when urinating, constant burning sensation, urethra constantly felt irritated, incontinence, cloudy urine, pain in the urethra and top of the vagina, urethra spasms after urinating, clear discharge, not emptying the bladder, and painful intercourse.Furthermore, the patient also had vaginal prolapse, urinary urgency, urinary hesitancy, poor urinary flow, intermittency, post-void dribbling, inability to empty her bladder, inability to stop her urinary stream, the bladder is full, leaked urine, vaginal burning, and vaginal discharge.Flexible cystoscopy was performed.The lower urinary tract was carefully examined.The procedure was well-tolerated and without complications.Colposcopy performed.No vaginal mucosal lesions were noted.No evidence of mesh erosion.Hydrodistension/dilation of the bladder was performed at 50 cm water pressure.The capacity was 400 cc.The bladder was drained.Upon re-inspection, there were no pain or post-distention dilation mucosal changes.The assessment included poor urinary stream, the hesitancy of urination, nocturia, the urgency of urination, frequency of micturition, incontinence without sensory awareness, dysuria, and bladder neck obstruction.Medical records note the exam supported hyperurethrovesical angle as the likely cause of the patient's symptoms.The physician recommended sling incision/urethrolysis.On (b)(6) 2021, the patient mentioned that the symptoms began 10 months ago and had been present for 10 months.The symptoms were reported as being moderate, and the symptoms occurred daily.She stated that the symptoms were chronic and uncontrolled.The patient reported that she had pelvic pain, groin pain (more on the right), vaginal pain (cutting/digging sensation), and discomfort with intercourse.She also had pressure in her vagina when sitting.In addition, the patient reported urinary urgency, dysuria, feelings of uti, weak stream, feelings of incomplete bladder emptying, and nocturia.During the review of systems, the patient stated that she also experienced fatigue, vision changes, abdominal pain, constipation, fecal incontinence, nausea, dysuria, incomplete emptying, nocturia, urge incontinence, urgency, urinary frequency, numbness in extremity, anxiety, depression, rash, back pain, easy bruising, seasonal allergies, dyspareunia, and had a history of abnormal pap smear.Exam revealed suburethral pain, pain at the right and left obturator internus muscle, and painful cords palpated left and right.The patient elected to proceed with surgical mesh removal.On (b)(6) 2021, the patient underwent lynx sling removal, urethral lysis, anterior colporrhaphy, paravaginal dissection, and removal of abdominal wall mesh procedure for the preoperative diagnoses of vaginal pain, pelvic pain, and groin pain.The postoperative diagnoses also included urinary stricture.The operative note indicated this was a very difficult surgery due to the scarring and the right sling arm being deep in the obturator internus muscle, as well as the left arm in the left obturator muscle and abdominally the right sling arm, being very lateral abdominally.Urethral lysis was performed with sharp dissection to further free the urethra and scar tissue on the left and on the right.Attention was then directed to the abdominal component.A transverse skin incision was made, and this incision was sharply taken down to the level of the fascia.The mesh was identified in the scar tissue from previous surgery and in the fascia, the fascia was incised around the mesh and the mesh was dissected free exposing the rectus muscles.The mesh was freed from the muscle tissue.The retropubic space was opened bilaterally to visualize the mesh trajectory, it was freed from the bladder wall and progressive dissection completely freed the left sling arm from the bladder wall and obturator muscle.The vaginal clamp was released, and the entire sling arm was handed off the operative field.The right sling arm was identified and also freed from the fascia and rectus muscles.The mesh was followed as it entered the right obturator internus muscle and was dissected free.Bleeding was controlled with cautery.The vaginal clamp was released, and the entire sling arm was handed off the operative field.Copious irrigation was performed.The entire lynx sling was removed.The patient tolerated the procedure well and was transferred to the recovery room in excellent condition.On the night of the surgery, the patient was doing well, resting comfortably in bed.Pain was well controlled with po meds.She tolerated a general diet without nausea or vomiting.Moreover, the patient denied chest pain, shortness of breath, or calf pain.She stated that her throat was dry, but otherwise had no complaints at this time.The physician and the patient discussed vaginal packing and catheter management.The patient had an unremarkable post-operative hospital course.She was tolerating a regular diet and ambulating without difficulty prior to discharge.On (b)(6) 2021, the day of discharge, the patient was instructed on the care and use of her plugged foley catheter.The patient felt comfortable using her catheter for interval voids.Reportedly, the patient's discharge condition was improving.Furthermore, the patient is to follow-up in 6 weeks in the office.She is to call the exchange/office for any concerns, no matter how unrelated to the reconstructive surgery.Call the exchange/office for a temperature greater than 100.6 as well as for vaginal bleeding.The pathology report findings from the lynx tvt sling removal revealed that there was a benign fibro adipose tissue with foreign body giant cell response to polarizable foreign material which was consistent with mesh.On (b)(6) 2021, the patient had a postoperative follow-up visit.The patient came in for packing and foley removal.The nurse removed vaginal packing first, then deflated and removed foley.She then instructed the patient to void within 4 hours and to call the office if she was unable to or to go to the emergency room if it was after office hours.The staples were removed, steris applied, and the patient was instructed to keep steris intact for 7 days.The jp drain output was <20ml for the past 2 days.Per the physician, the jp drain was removed, and the nurse applied a gauze dressing.The patient was to keep covered and dried for 24 hours, and for follow-up or sooner if symptoms persist or worsen as needed.On (b)(6) 2021, the patient presented for a physical therapy evaluation.She reported urinary symptoms including stress/exertional/urge incontinence, urgency, frequency, hesitancy, poor stream, incomplete emptying, and nocturia.Bowel symptoms were reported as poor frequency, straining, incomplete emptying, poor stool consistency, excessive wiping, delayed smearing, urgency, and fecal incontinence.Vaginal symptoms included painful intercourse and poor vaginal exam tolerance.The pain was reported in the lower back, coccyx, pubic area, and vaginal and vulvar areas.Moreover, the progression of the patient's symptoms worsened over time with mild improvement in pelvic pain after sling removal surgery in (b)(6) 2021.After surgery, symptom progression continued.The patient's urinary symptoms prevent her from traveling more than 30 minutes without stopping, putting her at risk for falls, social isolation, embarrassment, and skin breakdown.Her fecal function puts her at risk for social isolation, hemorrhoids, fissures, impaction, or sepsis due to the difficulty and infrequency of passing stool.She was unable to participate in intercourse, tampon usage, or speculum exam without pain if she chooses to participate at all.She was at risk for pelvic organ prolapse due to insufficiency of muscle activity and constant reflexive need to bear down.The patient was unable to perform transfers, bed mobility, static positioning for more than 30 minutes, household chores, or childcare activities without pain.A neurovascular exam of the pudendal nerve noted that the tinel's test was positive and produced severe, sharp tingling pain along the nerve path.The patient's colon had mild and non-painful restrictions laterally.Rectal mobility was moderate and painful restrictions in all directions, and bladder mobility was noted to have moderate to severe and painful restrictions in all directions.She had multiple trigger areas of trigger points, spasms, restriction, and pain.The si joint line, sacrotuberous ligament, and ischial tuberosities were painful on palpation.Additionally, during the internal pelvic exam, the patient had moderate to severe spasms and moderate pain with palpation of superficial and deep transverse perineum, puborectalis, pubococcygeus, iliococcygeus, coccygeus, and obturator internus muscles bilaterally.The sensation was increased throughout.The patient experienced a reflexive "bearing down" sensation during palpation, and an attempt at pelvic floor eccentric contraction was noted but inefficient.The assessment was overactive, non-relaxing pelvic floor musculature which contributes to bladder, bowel, sexual, pelvic organ support, and pelvic (including the coccyx) pain dysfunction.She demonstrated muscle spasm, pain, weakness, and incoordination of the pelvic floor related to surrounding pelvic and diaphragmatic muscles.The patient had symptoms listed above due to poor muscle rom, control, and coordination with chronically increased intra-abdominal pressure.Palpation of obturator internus reproduced pelvic girdle pain better than si joint form or force closure testing, indicating symptoms originating from muscle spasm instead of joint instability.She will benefit from skilled pt in order to promote pelvic muscle and joint mobility, stability, and function.Treatment can consist of manual therapy to improve muscle length and full relaxation, therapeutic exercise to build strength, therapeutic activity for functional training, neuromuscular reeducation to improve timing and coordination, cognitive-behavioral retraining, and patient education to promote understanding, participation, and compliance.On (b)(6) 2021, the patient had a visit using telemedicine.The patient underwent vaginal hysterectomy with lynx retropubic sling and rectocele repair in (b)(6) 2020.She was numb for 2 weeks after surgery, but when the numbness wore off, she noticed significant and constant pelvic pain and urinary urgency.Eventually, she had the mesh removed.Unfortunately, her pain and urgency sensation did not go away.The patient has pain and pressure in the perineum and rectum approximately 90% of the time.She also has a burning pain in her vagina and rectum.There was burning in her rectum with bowel movement, which went away after bowel movement.The patient also has a sensation of a foreign body in her rectum.It also felt like the tampon was coming out of her vagina.She often has a buzzing sensation in her pelvis.She has burning with urination which continues for a while after.She does have some tailbone pain.There was some pain with arousal, orgasm, and clitoral pain.She felt that her pain was most on the right side.There was a right-side burning pain.Furthermore, there was some pain with intercourse, usually at the beginning and approximately one hour after.The patient had nocturia thrice, but previously it was six times.The patient had pelvic floor physical therapy and was told her pelvic floor muscles were tight but now were relaxing.She was not doing pelvic physical therapy anymore but was doing the prescribed exercises at home.She had not tried any medications or suppositories.The patient was not examined since this consultation was done using telemedicine.The patient will be seen in the physician's office prior to any surgical intervention and examined then.Additionally, during assessment, the patient was diagnosed with pudendal neuralgia, spastic pelvic floor syndrome, and other specified complications due to other genitourinary prosthetic materials.The patient will be scheduled for bilateral pudendal nerve block, botox injection to the pelvic floor muscles, and valium 5mg/baclofen 4mg/ketamine 15mg suppositories.The physician had a long discussion with the patient, and the physician believed that the patient's biggest source of pain was pelvic floor muscle spasm.She developed it after the placement of a retropubic sling, but the pain did not go away after its removal.Most likely, if her spasm continues, the patient needs treatment of her pelvic floor muscles.The physician and the patient had to discuss treatment options, and the patient should start with a botox injection to the pelvic floor muscles.This is both therapeutic and diagnostic and was explained to the patient.If there is no improvement, it means that her pain is due to pelvic floor muscle spasm, and she may need to continue botox injections every few months as well as pelvic floor physical therapy.If there is no improvement, the patient will need an amniofix injection around the pudendal nerve and eventually pudendal neurolysis if there is no improvement.All this was discussed in significant detail with the patient.She understands and would like to proceed with the botox injection to the pelvic floor muscles.Vbk suppositories were also delivered to her local pharmacy.On november 23, 2021, the patient had an office visit for the reason of possible hernia.The patient stated that she thought that she may have a hernia to her right side of the groin.She had a bladder sling removed in april 2021 and the bulging hernia type was to the right of that along with a burning sensation.She had been prescribed estradiol after the removal surgery to apply to the vaginal wall which she continued using 1-3 times per week.The patient reported that the bulge was reducible, and she noticed that it was most often with increased intra-abdominal pressure.She planned to have a revision of the tummy tuck soon and will be seeing her plastic surgeon soon for consult.The patient also mentioned that she had vaginal dryness, increased urinary frequency, and urinary irritation.However, the patient was unsure if vaginal dryness was related to hysterectomy versus her uti-like symptoms.During the review of systems, the patient had dysuria, pelvic pain and vaginal dryness.She also reported she had a chronic uti and was currently taking augmentin.Exam revealed a bulge located at the lateral lower transverse incision on the right which was reducible.The assessment included incisional hernia for which an abdominal/pelvis ct was ordered.On february 11, 2022, the patient had an office visit and stated that she needed a referral to a urologist.The patient had recurrent uti, and she needed a referral for possible cystoscopy.She also wanted to ask about when she will have a vaginal surgery, because she was having a lot of nerve pain and had pudendal nerve damage from the sling removal.The patient also wanted to know if was there a medication that she can take for the nerve pain.She has had a significant neck pain since having surgery.The patient had an underlying history of depression.Reportedly, she has been stable on medications.During the review of systems, it was mentioned that the patient had dysuria, pelvic pain, urinary urgency, and anxiety.The assessment included chronic uti, pudendal nerve injury, depression, and hormonal imbalance.The plan included a referral to urology, continuing her current medications, and starting amitriptyline at night.

Manufacturer Narrative

Correction to block h6: removed patient code e2006: erosion.Block b3: there was no information available regarding the event date.Therefore, it was approximated to(b)(6) 2020, the implant date has been selected.Block e1: this event was reported by the patient's legal representation.The surgeon is: primary care:(b)(6): (b)(6) hospital (b)(6) phone number: (b)(6) (b)(6) block h6: patient codes (b)(6).Capture the reportable events of scar tissue (cicatrix) to capture scarring, infection, urinary tract (chronic), urinary retention (might not be emptying bladder, incomplete emptying, inability to empty her bladder), obstruction, ureter/urethra (bladder neck obstruction), urethral stenosis/stricture (mild trabeculations), pain (pain in urethra, top of vagina [cutting/digging sensation], pelvic, groin, low back, pubic & coccyx), nerve damage (pudendal neuralgia), dyspareunia (painful intercourse), abdominal pain, hemorrhage, major (bleeding), adhesions (painful restrictions in all directions), fecal incontinence, anxiety and depression, respectively.Impact codes f1202, f1903, f1905, f19, f23, f2303 and f18, capture the reportable events of disability (the patient was unable to perform transfers, bed mobility, static positioning more than 30 minutes, household chores, or childcare activities without pain.), device explantation (lynx sling removal, removal of abdominal wall mesh), device revision or replacement (abdominal paravaginal defect repair, anterior colporrhaphy, paravaginal dissection), surgical intervention (urethrolysis), medication required, and rehabilitation (pelvic floor physical therapy), respectively.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the removed 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.

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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

12881672

MDR Text Key

281314600

Report Number

3005099803-2021-05963

Device Sequence Number

Product Code

OTN

UDI-Device Identifier

08714729718949

UDI-Public

08714729718949

Combination Product (y/n)

Reporter Country Code

PMA/PMN Number

K020110

Number of Events Reported

Summary Report (Y/N)

Report Source

Manufacturer

Source Type

Consumer,Company Representative

Reporter Occupation

Non-Healthcare Professional

Type of Report

Initial,Followup,Followup,Followup,Followup

Report Date

09/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

Is this an Adverse Event Report?

Yes

Is this a Product Problem Report?

Device Operator

Health Professional

Device Expiration Date

02/09/2023

Device Model Number

M0068503000

Device Catalogue Number

850-300

Device Lot Number

0025183341

Was Device Available for Evaluation?

Initial Date Manufacturer Received

11/02/2021

Initial Date FDA Received

11/29/2021

Supplement Dates Manufacturer Received

03/23/2022
04/26/2022
06/03/2022
07/18/2022
08/16/2022

Supplement Dates FDA Received

04/15/2022
05/23/2022
06/28/2022
08/15/2022
09/13/2022

Was Device Evaluated by Manufacturer?

Device Not Returned to Manufacturer

Date Device Manufactured

02/10/2020

Is the Device Single Use?

Yes

Type of Device Usage

Initial

Patient Sequence Number

Patient Outcome(s)

Required Intervention; Other; Disability;

Patient Age

32 YR

Patient Sex

Female

Patient Weight

64 KG

Patient Race

White

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

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