MAUDE Adverse Event Report: COLOPLAST A/S RESTORELLE - UNKNOWN; SURGICAL MESH

Model Number 5014401400

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Emotional Changes (1831); Incontinence (1928); Unspecified Infection (1930); Inflammation (1932); Nerve Damage (1979); Pain (1994); Tissue Damage (2104); Urinary Tract Infection (2120); Discharge (2225); Injury (2348); Deformity/ Disfigurement (2360); Prolapse (2475); No Information (3190); No Code Available (3191); Dyspareunia (4505); Fecal Incontinence (4571)

Event Type  Injury  

Manufacturer Narrative

Coloplast has not been provided any corroborating evidence to verify the information contained in this report.(b)(4).

Event Description

As reported to coloplast though not verified, patient's legal representative stated inter alia, severe pain with daily activities and intercourse, severe emotional pain and injury, increased risk for injuries, infections, pain, mental anguish, discharge, and multiple corrective surgeries.Underwent operations to locate and remove mesh, operations to attempt to repair pelvic organs, tissue, and nerve damage, the use of pain control and other medications, injections into various areas of the pelvis, spline and the vagina, and operations to remove portions of the female genitalia.Urinary incontinence, physical deformity and the loss of the ability to perform sexually.It was noted that the plaintiff required surgical revision of the mesh in (b)(6) 2019, and again in (b)(6) 2019.

Event Description

Additional information received further reported that between (b)(6) 2019 and (b)(6) 2020 the patient experienced sensation of vaginal bulge and heaviness, causing additional pain and deepconstant burning.The patient felt her bladder bulge out of the vaginal opening with pushing, felt burning inthe vaginal area which was described as nerve damage from previous surgery.The patient also experienced pelvic pressure, myofascial pain, vaginal pain, full incontinence of feces, chronic pelvic pain, neuropathy, and grade two cystocele/recurrent.Additional information further reported that in september 2020 the patient was experiencing chronic pelvic pain, cystocele/recurrent, and dyspareunia.In october 2020, the patient underwent laparoscopic total abdominal colectomy with ileorectal anastomosis.Surgical findings included multiple adhesions of the omentum to the right colon, colon socked down along prior cervix/mesh location and colon adherent to pelvic side wall, ileorectal anastomosis, hepatic flexure was fixed to the gb and liver.On (b)(6) 2021, cystocele and lateral defect were noted.Four corner bladder suspension and cystoscopy under general anesthesia for chronic pelvic pain, recurrent urinary tract infection, vaginal pain, neuropathy/myofascial pain, pelvic pressure, and dyspareunia.Additional information received on 8/17/2021.3/1/2018: new onset fecal incontinence, has pure diarrhea due to stimulant medications for severe chronic idiopathic constipation.No mesh extrusion, very well supported, anal sphincter is perfect, rectocele might have helped hold onto stool.(b)(6) 2018: chronic pelvic pain due to pop, insomnia due to chronic pain and depressive symptoms.(b)(6) 2019: new patient office visit.Fecal incontinence of liquid stool, dyspareunia, and aggravation of chronic pelvic pain that started after urogynecology surgery on (b)(6) 2018, fecal incontinence x 3/day, wears 3-4 pads/day.Vaginal walls are soft and md states he does not want to remove the mesh.(b)(6) 2019: chronic idiopathic constipation, infrequent bowel movements, straining excessively with defecation.Colonic manometry - consistent with colonic inertia.(b)(6) 2019: pelvic floor dysfunction.Anorectal manometry - suggestive of dyssynergia, needs further workup.(b)(6) 2019:new patient office visit.States most bothered by her colon not working for ~8 years (2011), takes 14 bisacodyl qd, mestinon, trulance, due to taking such large quantities of laxatives she has constant liquid stools and fecal incontinence, 8-12 bowel movements/day.Constipation, colonic inertia.7/1/2019: urgent care visit - urinary frequency/urgency/dysuria, difficult urination, states had intercourse and didn't urinate afterward, states abdomen is always tender to palpation due to mesh.Acute cystitis with hematuria.(b)(6) 2019: qualified medical examiner (qme) further review of work related pelvic injury ((b)(6) 2015) - last day of work was 08/2017 due to full fecal incontinence, has to wear diapers, during sleep has to get up 3+ times to clean herself from fecal incontinence, constant vaginal/incisional/suprapubic burning pain, states she is always in pain, develops a different type of pain with intercourse, ui, states whole body feels sick, has lost 15 lbs since (b)(6) 2019 surgery, rarely able to do household chores, still with chronic neck/back pain from another prior injury/worker's compensation claim.Determination: vaginal laxity, vaginal prolapse, rectocele, cystocele, enterocele, ui (assigned 65% of these conditions to the work related injury on (b)(6) 2014 and 35% to pre-existing conditions/factors) fecal incontinence (assigned 100% of this condition to the work related injury on (b)(6) 2015 - although the injury itself did not cause this condition, the condition was caused by the surgery done by (b)(6), md, urogynecology on (b)(6) 2018).Vaginal pain - will need to re-evaluate in 4-6 months for determination of causation (b)(6) 2020: qualified medical examiner (qme) further review of work related pelvic injury ((b)(6) 2015) - fecal incontinence (unchanged since last visit), vaginal pain (increased, constant, takes norco), ui (increased, occurs with or without activity, cough worsens ui), feeling sick (has seen immunology and has been told these conditions are not immunologically related), cystocele (makes walking difficult), sexual dysfunction (has stopped having intercourse due to dyspareunia, she is no longer in a relationship due to the inability to have intercourse), uses estrogen patch and vaginal estrogen.Recommended future worker's compensation coverage for evaluation, medications, diapers, diagnostic testing, procedures when indicated.Urinary incontinence (causation determination percentage not assigned to the work related injury on (b)(6) 2015).(b)(6) 2020: new patient office visit states she has chronic pain syndrome due to complication from work related injuries, significant vaginal/lower abdominal/rectal nerve damage, states significant nerve damage was due to removal of mesh 'like taking rebar out of concrete' and then resulted in full fecal incontinence, now needs help with housework/shopping/laundry/cooking, now with moderate depression and low anxiety due to medical condition(s).Determination: claimant did not have clinical levels of depression/anxiety prior to worker's compensation injury, claimant's mood/anxiety/chronic pain/social impairments/occupation functioning were precipitated by back injury and complications from pelvic prolapse surgery, claimant's current medical condition has been predominately caused (>50%) by work related events.(b)(6) 2020: psychology visit regarding chronic pain syndrome/fecal incontinence/ depression/anxiety as a result of work-related injuries and post operative complications.(b)(6) 2020: unintentional weight loss, fatigue due to inability to sleep due to fecal incontinence.(b)(6) 2020: continued persistent moderate to severe pelvic pain, severe muscle spasms.(b)(6) 2020: psychology visit regarding chronic pain syndrome/fecal incontinence/ depression/anxiety as a result of work-related injuries and post operative complications, states she recently had psychiatric qme evaluation - states she is worried about being able to afford to live comfortable on worker's compensation settlement and state retirement, has also had significant unintentional weight loss recently.(b)(6) 2021: psychology visit regarding chronic pain syndrome/fecal incontinence/ depression/anxiety as a result of work-related injuries and post operative complications, states regular household tasks continue to be very difficult for her.(b)(6) 2020: psychology visit regarding chronic pain syndrome/fecal incontinence/ depression/anxiety as a result of work-related injuries and post operative complications, states she does not feel comfortable being in a relationship due to fecal incontinence and inability to be intimate.(b)(6) 2021: psychology visit regarding chronic pain syndrome/fecal incontinence/ depression/anxiety as a result of work-related injuries and post operative complications, states she had debilitating pain s/p pain injection and couldn't walk for 2 days.(b)(6) 2021: urgent care visit - urinary frequency/urgency/dysuria/hematuria x 2 days acute cystitis with hematuria.(b)(6) 2021: urgent care visit - urinary frequency/urgency/dysuria x 1 day acute cystitis with hematuria.(b)(6) 2021: psychology visit regarding chronic pain syndrome/fecal incontinence/ depression/anxiety as a result of work-related injuries and post operative complications, states she was ill for a few days following first bsp session.(b)(6) 2021: psychology visit regarding chronic pain syndrome/fecal incontinence/ depression/anxiety as a result of work-related injuries and post operative complications, states fecal incontinence is what makes her life hard, states she can never have a job or a relationship, states she still needs to fast the day prior to a planned event to limit the amount of stool and gi stimulus.(b)(6) 2021: chronic pain syndrome, fecal incontinence.Recommend diapers (10/day, 300/month), chucks (3/day, 90/month), claimant is currently on wait list for iv ketamine treatment, will order unskilled home health services (1 day/week for 3 hours) due to permanent lifting restrictions.(b)(6) 2021: qualified medical examiner (qme) definition of work restrictions related pelvic injury ((b)(6) 2015) - fecal incontinence (unchanged, has to change/clean multiple times day/night, skin breakdown due to incontinence, frequently wakes from sleep to wash/clean herself from incontinence), vaginal pain (unchanged, constant, increased with walking > 1 block), urinary incontinence (unchanged, continues wearing diapers), sexual dysfunction (no activity at this time, had 1 unsuccessful attempt since last evaluation, has multiple problems/issues with sexual activity and so chooses to be abstinent), pain (abdominal pain increases with sitting, vaginal pain with standing, occasional back pain with walking).There appear to be no changes since last evaluation ((b)(6) 2020).Additional information received on (b)(6) 2021.Between (b)(6) 2018: chronic idiopathic constipation, lower abdominal pain, acute cystitis with hematuria, abdominal pain, non-intractable vomiting with nausea, and uterine prolapse.Additional information received on (b)(6) 2021.Between (b)(6) 2020 - (b)(6) 2021: chronic pelvic pain, sympathetically maintained pain, neuropathic pain, chronic post-operative pain, chronic pain syndrome, muscle spasm, and incontinence.(b)(6) 2021 laparoscopic total abdominal colectomy with ileorectal anastomosis.Surgical findings: multiple adhesions of the omentum to right colon, colon socked down along prior cervix/mesh location and colon adherent to pelvic side wall, ileorectal anastomosis, hepatic flexure was fixed to the gb and liver.High risk medication use.(b)(6) 2021: cystocele, lateral defect - 4 corner bladder suspension and cystoscopy under general anesthesia for chronic pelvic pain, recurrent uti, vaginal pain, neuropathy/myofascial pain, pelvic pressure, dyspareunia.

Manufacturer Narrative

This complaint was investigated to the extent information was provided to coloplast.Due to the legal nature of this complaint, the device not being returned for evaluation and the implanted device lot number not being provided, a thorough investigation could not be executed.Should additional information become available, this file will be re-evaluated and updated according to current procedures.Complaints of this nature are monitored and captured within the product risk documentation.No further action or corrective action is required at this time.Coloplast has not been provided any corroborating evidence to verify the information contained in this report.

Event Description

Additional information received reported on (b)(6) 2019, the patient was experiencing dyspareunia, there were signs of nerve damage and stunting from restorelle.The surgical revision in (b)(6) 2019 involved excision/revision of anterior and posterior, excision of vaginal wall.Chronic inflammation was also noted.The intervention in (b)(6)2019 included partial excision.It was further reported that between (b)(6) 2018 and (b)(6)2018, the patient experienced stabbing suprapubic pain with sitting, squatting, and leaning over, constant dull pain inside the vagina, pelvic pain, dyspareunia, feels her vagina is too short now, difficulty with penetration due to partner's large size, tender to palpitation over r>l levators, right obturator, and anterior vaginal wall.On (b)(6) 2018, the patient underwent a cystoscopy for frequent urinary tract infections and pelvic floor dysfunction, with fecal incontinence and deep pain.On (b)(6) 2019, the patient was still experiencing fecal incontinence.In addition, she experienced vaginal heaviness and deep constant burning.Fluoroscopic defecogram was noted.Recurrent cystocele was noted on (b)(6) 2019.Additional information received further reported that between (b)(6) 2019 and (b)(6) 2020 the patient experienced sensation of vaginal bulge and heaviness, causing additional pain and deep constant burning.The patient felt her bladder bulge out of the vaginal opening with pushing, felt burning in the vaginal area which was described as nerve damage from previous surgery.The patient also experienced pelvic pressure, myofascial pain, vaginal pain, full incontinence of feces, chronic pelvic pain, neuropathy, and grade two cystocele/recurrent.Additional information further reported that in (b)(6) 2020 the patient was experiencing chronic pelvic pain, cystocele/recurrent, and dyspareunia.In (b)(6) 2020, the patient underwent laparoscopic total abdominal colectomy with ileorectal anastomosis.Surgical findings included multiple adhesions of the omentum to the right colon, colon socked down along prior cervix/mesh location and colon adherent to pelvic side wall, ileorectal anastomosis, hepatic flexure was fixed to the gb and liver.On (b)(6) 2021, cystocele and lateral defect were noted.Four corner bladder suspension and cystoscopy under general anesthesia for chronic pelvic pain, recurrent urinary tract infection, vaginal pain, neuropathy/myofascial pain, pelvic pressure, and dyspareunia.

• Brand Name: RESTORELLE - UNKNOWN
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humblebaek, 3050, 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST MANUFACTURING US, LLC; 1601 west river road north; minneapolis MN 55411
• Manufacturer Contact: brian schmidt ; 1601 west river road north; minneapolis, MN 55411 ; 6128651177
• MDR Report Key: 9942967
• MDR Text Key: 187037716
• Report Number: 2125050-2020-00322
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/22/2022

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: 5014401400
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/09/2020
• Initial Date FDA Received: 04/09/2020
• Supplement Dates Manufacturer Received: 05/07/2022; 05/07/2022
• Supplement Dates FDA Received: 08/22/2022; 08/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Other
• Patient Age: 45 YR
• Patient Sex: Female