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BOSTON SCIENTIFIC CORPORATION SOLYX SIS SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEMA
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Back to Search Results |
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| Model Number M0068507001 |
| Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Positioning Problem (3009)
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| Patient Problems
Abdominal Pain (1685); Diarrhea (1811); Fatigue (1849); Micturition Urgency (1871); Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Nausea (1970); Nerve Damage (1979); Pain (1994); Urinary Retention (2119); Urinary Tract Infection (2120); Vomiting (2144); Hot Flashes/Flushes (2153); Urinary Frequency (2275); Anxiety (2328); Discomfort (2330); Injury (2348); Numbness (2415); Prolapse (2475); Hematuria (2558); Weight Changes (2607); Dysuria (2684); Foreign Body In Patient (2687); Constipation (3274); Dyspareunia (4505); Unspecified Musculoskeletal problem (4535); Localized Skin Lesion (4542); Urinary Incontinence (4572); Swelling/ Edema (4577)
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| Event Date 12/07/2016 |
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Event Type
Injury
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Manufacturer Narrative
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Date of event was approximated to (b)(6) 2016, 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.
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Event Description
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It was reported to boston scientific corporation that a solyx sis system device was implanted into the patient during a procedure performed on (b)(6) 2016.As reported by the patient's attorney, the patient has experienced an unspecified injury.Boston scientific has been unable to obtain additional information regarding the event to date.
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Manufacturer Narrative
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Additional information: block e1: initial reporter information, physician and healthcare facility information.(below) block b3 date of event: date of event was approximated to (b)(6) 2016, implant date, as no event date was reported.Block e1: this event was reported by the patient's legal representation.The surgeon is: (b)(6).Block h6: patient code 2348 captures the reportable event of unknown injury.Conclusion code 4316 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.
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Event Description
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It was reported to boston scientific corporation that a solyx sis system device was implanted into the patient during a procedure performed on (b)(6) 2016.As reported by the patient's attorney, the patient has experienced an unspecified injury.Boston scientific has been unable to obtain additional information regarding the event to date.
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Manufacturer Narrative
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Blocks a1, a4, b2, b5, b6, b7, e1 below and h6: patient codes and impact codes have been updated based on the additional information received on september 27, 2022.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: dr.(b)(6) (b)(6) hospital logansport, in mesh excision surgeon is: dr.(b)(6) (b)(6) hospital (b)(6) block h6: patient codes e1002, e2330, e0123, e1310, e1309, e2311, e1301, e0127, e2326 and e1405 capture the reportable events of chronic abdominal pain, obturator neuralgia, uti, unable to the bladder, urethral discomfort and patient fell due to the discomfort, pelvic pain, arthralgia/myalgia and back pain, painful to urinate, intermittent numbness to bilateral lower legs, acute cecal inflammation and painful intercourse.Impact codes f1905 and f1901 capture the reportable events of mesh excision and cystocele repair, laparoscopic cholecystectomy, laparoscopic total hysterectomy with lso and right salpingectomy, urethral dilation with cystoscopy.Block 11: blocks e4 and g2 report source have been corrected.
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Event Description
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It was reported to boston scientific corporation that a solyx sis system device was implanted into the patient during a hysteroscopy with dilation and curettage + novasure endometrial ablator + single incision bladder neck sling procedure performed on (b)(6) 2016 for the treatment of menorrhagia and stress urinary incontinence.On (b)(6) 2016, the patient presented to the emergency department with cramping and shooting pains from lower abdomen.Onset of symptoms (b)(6) 2016 when the patient had an endometria l ablation with bladder sling and d&c 10 days ago and is just had not feeling right.Medications prescribed include alprazolam oral, phenazopyridine by mouth 200 mg and ciprofloxacinai by mouth 500 mg.Discussed pain, treatment goals, expectations, and care.Patient had some dysuria, urgency and urinary frequency.Patient appeared to be in moderate amount of discomfort.She rated pain 5/10 which was continuous discomfort.She had stable vital signs, afebrile and ambulatory.She had clearing vaginal discharge that went from pink and bloody and became clear.Symptoms did not improve with antacids.Confirmed acute lower urinary tract infection.Medications prescribed: alprazolam oral phenazopyridine by mouth 200 mg ciprofloxacinai by mouth 500 mg primary diagnosis: urgent desire to urinate dysuria abdominal pain acute lower urinary tract infection medication ordered: sodium chloride ketorolac injection levofloxacin phenazopyridine on february 20, 2017, it was reported that the patient was treated for urinary tract infection and believed that she improved.After running out of the antibiotic, symptoms recurred.She, however, denied any dysuria.She stated initially that she took motrin for the discomfort but that did not seem to be strong enough.She was given a limited prescription for percocet which helped somewhat but that medication was gone.Movement and jarring motions as well as direct pressure into the abdomen seemed to exacerbate her pain.Continued upper abdominal workup to rule out gallbladder disease or biliary dysfunction.On (b)(6) 2019, the abdominal pain that started on the left side now moved to the right.Patient reported to also experience nausea with vomiting.The pain was sharp, constant, worse with movement and nothing made it better.She stated the pain was severe.She started to vomit roughly an hour prior to arrival.Patient was post cholecystectomy, hysterectomy, single oophorectomy.She stated that she also had a history of a bladder sling and was supposed to be on antibiotics for recurrent urinary tract infections.Patient denied any urinary symptoms currently, fevers and did not believe that it was a kidney infection as she had had those before.Patient was worried about appendicitis.Review of systems showed positive for abdominal pain, nausea, vomiting.Denies dysuria.Ct scan abdomen with iv contrast only, no oral contrast.She initially had some voluntary guarding.An iv was established and the patient was given dilaudid and zofran.On re - evaluation her pain had resolved.Patient labs showed mild leukocytosis.Patient had taken for ct imaging to evaluate for possible surgical pathology such as appendicitis, bowel perforation, obstruction, volvulus, etc.Radiology read this as a question of acute cecal inflammation as well as some nonspecific enteritis in the proximal jejunum.Started on flagyl in the meantime.The patient denies any significant daily diarrhea but has had intermittent diarrhea for the past two years.On (b)(6) 2019, patient underwent cystoscopy and urethral dilatation to 32 - french due to urethral sling with pelvic pain and urethral discomfort.The physician reported that there was no sling erosion.On june 13, 2019, patient stated she had a ct scan last week and found nothing.Also stated had chronic diarrhea for 3 years.Complained of rapid weight loss.Review of systems showed positive for dysuria.On (b)(6) 2020, patient presented to the emergency department complaining of dysuria and diagnosed with urinary tract infection with hematuria.Also reported pain when urinating for one week, not emptying bladder and incontinence issues.Patient stated since her sling placement three years ago, she had been having chronic complications with recurrent utis, lower abdominal cramping, lower back pain, dysuria and unable to completely empty her bladder over the last few days.She also had episodes of incontinence.These were symptoms consistent with her previous uti.On (b)(6) 2020, patient experienced further intermittent numbness to bilateral lower legs.She was scheduled to see a specialist regarding the mesh in her abdomen.Review of system was positive for arthralgia/myalgia, back pain, pain, stiffness.On (b)(6) 2020, patient was complaining of burning urination, difficult or painful urination.This was chronic in nature for at least over a year but worse over the past three days.Urinalysis was negative for any signs of infection.She had seen multiple specialists regarding this.On (b)(6) 2021, patient was diagnosed with dyspareunia and vaginal pain.The patient always felt as if the mesh was too tight.In 2018, she underwent a laparoscopic hysterectomy with rso, but pain still continued.She noted continued urinary urgency and frequency, lancinating pain radiating down the groin and medial thigh.Sometimes, she actually fell because of the discomfort.She noted sitting pain and painful intercourse.She had a history of ibs (irritable bowel syndrome), alternating between diarrhea and constipation since the surgery.Because of the nature of this sling, where the ends did not perforate beyond the obturator internus muscle, patient could proceed with transvaginal mesh excision including excision of the anchors if possible.On (b)(6) 2021, mesh excision surgery was performed with cystocele repair.The vast majority of the mesh was removed.On the left side the anchor in the obturator intermus muscle was dislodged and fell into the retropubic space and could not be retrieved or palpated.The physician did not feel this would be problematic to the patient.The mesh was removed from the right side but the anchor was deeply invested in the pubic bone and could not be removed.The pathology report indicates fibrous tissue with chronic inflammation, foreign body giant cell reaction, and foreign body consistent with mesh.
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Manufacturer Narrative
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Block e1: this event was reported by the patient's legal representation.The implant surgeon is: dr.(b)(6).Mesh excision surgeon is: dr.(b)(6).Block h6: patient codes e1002, e2330, e0123, e1310, e1309, e2311, e1301, e0127, e2326 and e1405 capture the reportable events of chronic abdominal pain, obturator neuralgia, uti, unable to the bladder, urethral discomfort and patient fell due to the discomfort, pelvic pain, arthralgia/myalgia and back pain, painful to urinate, intermittent numbness to bilateral lower legs, acute cecal inflammation and painful intercourse.Impact codes f1905 and f1901 capture the reportable events of mesh excision and cystocele repair, laparoscopic cholecystectomy, laparoscopic total hysterectomy with lso and right salpingectomy, urethral dilation with cystoscopy.Block 11: blocks b5, b7 and h6: patient codes have been corrected.
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Event Description
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It was reported to boston scientific corporation that a solyx sis system device was implanted into the patient during a hysteroscopy with dilation and curettage + novasure endometrial ablator + single incision bladder neck sling procedure performed on (b)(6) 2016 for the treatment of menorrhagia and stress urinary incontinence.On (b)(6) 2016, the patient presented to the emergency department with cramping and shooting pains from lower abdomen.Onset of symptoms (b)(6) 2016 when the patient had an endometrial ablation with bladder sling and d and c 10 days ago and is just had not feeling right.Medications prescribed include alprazolam oral, phenazopyridine by mouth 200 mg and ciprofloxacinai by mouth 500 mg.Discussed pain, treatment goals, expectations, and care.Patient had some dysuria, urgency and urinary frequency.Patient appeared to be in moderate amount of discomfort.She rated pain 5/10 which was continuous discomfort.She had stable vital signs, afebrile and ambulatory.She had clearing vaginal discharge that went from pink and bloody and became clear.Symptoms did not improve with antacids.Confirmed acute lower urinary tract infection.Medications prescribed: alprazolam oral, phenazopyridine by mouth 200 mg, ciprofloxacinai by mouth 500 mg.Primary diagnosis: urgent desire to urinate, dysuria, abdominal pain, acute lower urinary tract infection.Medication ordered: sodium chloride, ketorolac injection, levofloxacin, phenazopyridine.On (b)(6) 2017, the patient presented to the ed with upper abdominal pain present for the past 2 months.She had been treated for urinary tract infection and believed that she improved.After running out of the antibiotic, symptoms recurred.She, however, denied any dysuria.She stated initially that she took motrin for the discomfort but that did not seem to be strong enough.She was given a limited prescription for percocet which helped somewhat but that medication was gone.Movement and jarring motions as well as direct pressure into the abdomen seemed to exacerbate her pain.Physical exam revealed diffuse tenderness across the epigastrium and upper quadrants.Urinalysis and kidney/urinary bladder x - rays were performed.The patient was to follow - up with another provider to continue upper abdominal workup to rule out gallbladder disease or biliary dysfunction.The patient was discharged with dicyclomine and advised to avoid caffeinated beverages and spicy foods.On an unspecified date in 2017, the patient underwent a laparoscopic cholecystectomy.On (b)(6) 2019, the patient presented to the ed with abdominal pain that started on the left side now moved to the right.Patient reported to also experience nausea with vomiting.The pain was sharp, constant, worse with movement and nothing made it better.She stated the pain was severe.She started to vomit roughly an hour prior to arrival.Patient was post cholecystectomy, hysterectomy, single oophorectomy.She stated that she also had a history of a bladder sling and was supposed to be on antibiotics for recurrent urinary tract infections.Patient denied any urinary symptoms currently, fevers and did not believe that it was a kidney infection as she had those before.Patient was worried about appendicitis.Review of systems showed positive for abdominal pain, nausea, vomiting.Denies dysuria.Ct scan abdomen with iv contrast only, no oral contrast.She initially had some voluntary guarding.An iv was established and the patient was given dilaudid and zofran.On re - evaluation her pain had resolved.Patient labs showed mild leukocytosis.Patient had taken for ct imaging to evaluate for possible surgical pathology such as appendicitis, bowel perforation, obstruction, volvulus, etc.Radiology read this as a question of acute cecal inflammation as well as some nonspecific enteritis in the proximal jejunum.Started on flagyl in the meantime.The patient denies any significant daily diarrhea but has had intermittent diarrhea for the past two years.She was to be referred to gastroenterology.On (b)(6) 2019, patient underwent cystoscopy and urethral dilatation to 32 - french due to urethral sling with pelvic pain and urethral discomfort.The physician reported that there was no sling erosion.On (b)(6) 2019, the patient presented to the ed with abdominal pain.The patient stated she had a ct scan last week and found nothing.Also stated had chronic diarrhea for 3 years.Complained of rapid weight loss (20 pounds over 6 weeks).Review of systems showed positive for dysuria.The patient described tight restrictive pain to mid abdominal area with shortness to bilateral flanks, nausea with vomiting, diarrhea, and hunger but any oral nutrition rushed right through her.Her past medical history was positive for crohn's disease/irritable bowel disease.Pain regimen was provided in the ed with pain improvement.The patient was already scheduled for an mri the following week and was discharged with promethazine and norco.On (b)(6) 2020, patient presented to the emergency department complaining of dysuria and diagnosed with urinary tract infection with hematuria.Also reported pain when urinating for one week, not emptying bladder and incontinence issues.Patient stated since her sling placement three years ago, she had been having chronic complications with recurrent utis, lower abdominal cramping, lower back pain, dysuria and unable to completely empty her bladder over the last few days.She also had episodes of incontinence.These were symptoms consistent with her previous uti.The diagnoses was urinary tract infection with hematuria.The patient was discharged with bactrim and prescriptions for pyridium and tramadol and was to follow up with her urologist.On (b)(6) 2020, the patient presented to the ed for shooting pain to her left hip, buttock and outer thigh x 1 week.She reported chronic abdominal and back pain secondary to mesh surgery.She also reported intermittent numbness to bilateral lower legs and upper extremities.She felt that her low back pain and sciatica may be connected to the mesh.She was scheduled to see a specialist regarding the mesh in her abdomen.Review of system was positive for arthralgia/myalgia, back pain, pain, stiffness.Lumbar spine x - rays showed mild disc space narrowing and moderate facet degeneration at the l5 - s1 level.Mri was recommended if further work - up was warranted.The diagnosis was lumbar radiculopathy, and the patient was prescribed tramadol, prednisone, diclofenac, and cyclobenzaprine.She was advised to follow up with a spinal surgeon.On (b)(6) 2020, the patient presented to the ed with burning urination, difficult or painful urination.This painful urination was chronic in nature for at least over a year but worse over the past three days.She also reported chronic numbness and tingling of both hands and arms for which she was seeing a specialist.Exam revealed sensation was intact to all fingers and both thumbs and negative tinel and phalen's tests.Urinalysis was negative for any signs of infection.On (b)(6) 2021, patient presented for a history and physical prior to surgery for dyspareunia and vaginal pain.The patient always felt as if the mesh was too tight.In 2018, she underwent a laparoscopic hysterectomy with rso, but pain continued.She noted continued urinary urgency and frequency, felt that she did not fully empty her bladder and voiding was slow.She also had a tight sensation across her lower abdomen and described lancinating pain radiating down the groin and medial thigh.Sometimes, she actually fell because of the discomfort.She noted sitting pain, vaginal pain, decreased sensation with clitoral stimulation, and painful intercourse.She had a history of ibs (irritable bowel syndrome), alternating between diarrhea and constipation since the surgery.The impression was vaginal pain and postoperative obturator neuralgia secondary to sling placement.The plan was for transvaginal mesh removal.On (b)(6) 2021, mesh excision surgery was performed with cystocele repair for the preoperative diagnoses of obturator neuralgia, vaginal pain, and dyspareunia.The vast majority of the mesh was removed.On the left side the anchor in the obturator internus muscle was dislodged and fell into the retropubic space and could not be retrieved or palpated.The physician did not feel this would be problematic to the patient.The mesh was removed from the right side but the anchor was deeply invested in the pubic bone and could not be removed.The pathology report indicates fibrous tissue with chronic inflammation, foreign body giant cell reaction, and foreign body consistent with mesh.
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Event Description
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It was reported to boston scientific corporation that a solyx sis system device was implanted into the patient during a hysteroscopy with dilation and curettage + novasure endometrial ablator + single incision bladder neck sling procedure performed on (b)(6), 2016 for the treatment of menorrhagia and stress urinary incontinence.On (b)(6), 2016, the patient presented to the emergency department with cramping and shooting pains from lower abdomen.Onset of symptoms (b)(6), 2016 when the patient had an endometrial ablation with bladder sling and d and c 10 days ago and is just had not feeling right.Medications prescribed include alprazolam oral, phenazopyridine by mouth 200 mg and ciprofloxacinai by mouth 500 mg.Discussed pain, treatment goals, expectations, and care.Patient had some dysuria, urgency and urinary frequency.Patient appeared to be in moderate amount of discomfort.She rated pain 5/10 which was continuous discomfort.She had stable vital signs, afebrile and ambulatory.She had clearing vaginal discharge that went from pink and bloody and became clear.Symptoms did not improve with antacids.Confirmed acute lower urinary tract infection.Medications prescribed: alprazolam oral, phenazopyridine by mouth 200 mg , ciprofloxacinai by mouth 500 mg.Primary diagnosis: urgent desire to urinate, dysuria, abdominal pain, acute lower urinary tract infection.Medication ordered: sodium chloride, ketorolac injection , levofloxacin, phenazopyridine.On (b)(6), 2017, the patient presented to the ed with upper abdominal pain present for the past 2 months.She had been treated for urinary tract infection and believed that she improved.After running out of the antibiotic, symptoms recurred.She, however, denied any dysuria.She stated initially that she took motrin for the discomfort but that did not seem to be strong enough.She was given a limited prescription for percocet which helped somewhat but that medication was gone.Movement and jarring motions as well as direct pressure into the abdomen seemed to exacerbate her pain.Physical exam revealed diffuse tenderness across the epigastrium and upper quadrants.Urinalysis and kidney/urinary bladder x - rays were performed.The patient was to follow - up with another provider to continue upper abdominal workup to rule out gallbladder disease or biliary dysfunction.The patient was discharged with dicyclomine and advised to avoid caffeinated beverages and spicy foods.On an unspecified date in 2017, the patient underwent a laparoscopic cholecystectomy.On (b)(6), 2019, the patient presented to the ed with abdominal pain that started on the left side now moved to the right.Patient reported to also experience nausea with vomiting.The pain was sharp, constant, worse with movement and nothing made it better.She stated the pain was severe.She started to vomit roughly an hour prior to arrival.Patient was post cholecystectomy, hysterectomy, single oophorectomy.She stated that she also had a history of a bladder sling and was supposed to be on antibiotics for recurrent urinary tract infections.Patient denied any urinary symptoms currently, fevers and did not believe that it was a kidney infection as she had had those before.Patient was worried about appendicitis.Review of systems showed positive for abdominal pain, nausea, vomiting.Denies dysuria.Ct scan abdomen with iv contrast only, no oral contrast.She initially had some voluntary guarding.An iv was established and the patient was given dilaudid and zofran.On re - evaluation her pain had resolved.Patient labs showed mild leukocytosis.Patient had taken for ct imaging to evaluate for possible surgical pathology such as appendicitis, bowel perforation, obstruction, volvulus, etc.Radiology read this as a question of acute cecal inflammation as well as some nonspecific enteritis in the proximal jejunum.Started on flagyl in the meantime.The patient denies any significant daily diarrhea but has had intermittent diarrhea for the past two years.She was to be referred to gastroenterology.On may 20, 2019, patient underwent cystoscopy and urethral dilatation to 32 - french due to urethral sling with pelvic pain and urethral discomfort.The physician reported that there was no sling erosion.On (b)(6), 2019, the patient presented to the ed with abdominal pain.The patient stated she had a ct scan last week and found nothing.Also stated had chronic diarrhea for 3 years.Complained of rapid weight loss (20 pounds over 6 weeks).Review of systems showed positive for dysuria.The patient described tight restrictive pain to mid abdominal area with shortness to bilateral flanks, nausea with vomiting, diarrhea, and hunger but any oral nutrition rushed right through her.Her past medical history was positive for crohn's disease/irritable bowel disease.Pain regimen was provided in the ed with pain improvement.The patient was already scheduled for an mri the following week and was discharged with promethazine and norco.On (b)(6), 2020, patient presented to the emergency department complaining of dysuria and diagnosed with urinary tract infection with hematuria.Also reported pain when urinating for one week, not emptying bladder and incontinence issues.Patient stated since her sling placement three years ago, she had been having chronic complications with recurrent utis, lower abdominal cramping, lower back pain, dysuria and unable to completely empty her bladder over the last few days.She also had episodes of incontinence.These were symptoms consistent with her previous uti.The diagnoses was urinary tract infection with hematuria.The patient was discharged with bactrim and prescriptions for pyridium and tramadol and was to follow up with her urologist.On (b)(6), 2020, the patient presented to the ed for shooting pain to her left hip, buttock and outer thigh x 1 week.She reported chronic abdominal and back pain secondary to mesh surgery.She also reported intermittent numbness to bilateral lower legs and upper extremities.She felt that her low back pain and sciatica may be connected to the mesh.She was scheduled to see a specialist regarding the mesh in her abdomen.Review of system was positive for arthralgia/myalgia, back pain, pain, stiffness.Lumbar spine x - rays showed mild disc space narrowing and moderate facet degeneration at the l5 - s1 level.Mri was recommended if further work - up was warranted.The diagnosis was lumbar radiculopathy, and the patient was prescribed tramadol, prednisone, diclofenac, and cyclobenzaprine.She was advised to follow up with a spinal surgeon.On (b)(6), 2020, the patient presented to the ed with burning urination, difficult or painful urination this painful urination was chronic in nature for at least over a year but worse over the past three days.She also reported chronic numbness and tingling of both hands and arms for which she was seeing a specialist.Exam revealed sensation was intact to all fingers and both thumbs and negative tinel and phalen's tests.Urinalysis was negative for any signs of infection.On (b)(6) 2021, patient presented for a history and physical prior to surgery for dyspareunia and vaginal pain.The patient always felt as if the mesh was too tight.In 2018, she underwent a laparoscopic hysterectomy with rso, but pain continued.She noted continued urinary urgency and frequency, felt that she did not fully empty her bladder and voiding was slow.She also had a tight sensation across her lower abdomen and described lancinating pain radiating down the groin and medial thigh.Sometimes, she actually fell because of the discomfort.She noted sitting pain, vaginal pain, decreased sensation with clitoral stimulation, and painful intercourse.She had a history of ibs (irritable bowel syndrome), alternating between diarrhea and constipation since the surgery.The impression was vaginal pain and postoperative obturator neuralgia secondary to sling placement.The plan was for transvaginal mesh removal.On (b)(6), 2021, mesh excision surgery was performed with cystocele repair for the preoperative diagnoses of obturator neuralgia, vaginal pain, and dyspareunia.The vast majority of the mesh was removed.On the left side the anchor in the obturator internus muscle was dislodged and fell into the retropubic space and could not be retrieved or palpated.The physician did not feel this would be problematic to the patient.The mesh was removed from the right side but the anchor was deeply invested in the pubic bone and could not be removed.The pathology report indicates fibrous tissue with chronic inflammation, foreign body giant cell reaction, and foreign body consistent with mesh.Additional information received on november 4, 2022: on (b)(6) 2020, presented for an examination for suprapubic pain.The patient reported that she has been visiting the emergency room about every 6 weeks.Patient also mentioned she thinks she maybe was allergic to the mesh.Review of systems showed patient was positive for fatigue, diarrhea, hot flashes and anxiety.She reported terrible abdominal pain, which was mostly above her umbilicus, leakage with and without urge sensation.She said that she felt like the bladder mesh was pulling on her across her abdomen, could not sleep or sit and her anxiety was terrible.She reports pain with intercourse.She was advised to do pelvic floor physical therapy and see a gastroenterologist, but she refused.She also declined catheterization and urodynamics.The patient requested pain medicine, but the physician advised her to try heat, ice, pelvic therapy, tylenol, and ibuprofen.The physician discussed pelvic floor myalgia with the patient and how nerves in the pelvic floor can affect back, leg, and abdominal pain.The physician advised the patient that a physical therapist could help with scar tissue and muscle pain.The patient provided the physician with past medical records which were reviewed as follows: in 2017, patient underwent hepatobiliary iminodiacetic acid scan low ejection fraction and normal ultrasound of the gallbladder for the right upper quadrant pain.Thickening of endometrium was also for right upper quadrant pain.A note in (b)(6) 2018 stated chronic fatigue, bilateral low back pain with sciatica.In (b)(6) 2018, vulvar lesion was removed in which exam was normal and no comment of pain.In the same year, postop visit after cholecystectomy, gallbladder was reported to be normal.Patient stated her symptoms significantly improved at that time; however, complaining of heartburn and non - specific abdominal pain but bentyl helped.
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Manufacturer Narrative
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Blocks b5, b7 and h6 patient codes have been updated based on the additional information received on november 4, 2022.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: dr.(b)(6), (b)(6) hospital, (b)(6).Mesh excision surgeon is: dr.(b)(6), (b)(6) hospital, (b)(6).Block h6: patient codes e1002, e2330, e0123, e1310, e1309, e2311, e1301, e0127, e2326, e1405, e1710 and e0402 capture the reportable events of chronic abdominal pain, obturator neuralgia, uti, unable to the bladder, urethral discomfort and patient fell due to the discomfort, pelvic pain, arthralgia/myalgia and back pain, painful to urinate, intermittent numbness to bilateral lower legs, acute cecal inflammation and painful intercourse, vulvar lesion, and allergic to the mesh.Impact codes f1905 and f1901 capture the reportable events of mesh excision and cystocele repair, laparoscopic cholecystectomy, laparoscopic total hysterectomy with lso and right salpingectomy, urethral dilation with cystoscopy.
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