MAUDE Adverse Event Report: ETHICON INC. PROLENE MESH 2X12; MESH, SURGICAL, POLYMERIC

Model Number PROLENE MESH

Device Problem Device Appears to Trigger Rejection (1524)

Patient Problems Erosion (1750); Emotional Changes (1831); Fistula (1862); Failure of Implant (1924); Unspecified Infection (1930); Pain (1994); Burning Sensation (2146); Obstruction/Occlusion (2422); Bowel Perforation (2668); Urinary Incontinence (4572)

Event Date 11/25/2021

Event Type  Injury  

Event Description

Infected mesh was found to have eroded into bowel causing bowel perforation and fistula from pop with transabdominal surgery performed in 2008.Unbeknownst to me i woke up from surgery with an ileostomy bag (i was told they had to give me one to save my life) i also spent a month in hospital after that surgery, then about 4 days after discharge my body rejected a colonic stent they had put in to help with widening colon until ileostomy bag could be reversed.I spent another week in hospital after that.I had ileostomy bag for 5 months and it was absolutely terrible experience with non-stop stoma burns from the way the ileostomy was situated and also had a very high output bag.I then had reversal of ileostomy in (b)(6) of 2022 (spent over a week and a half in hospital) was then admitted again on (b)(6) 2022 with pain and found out i had a blockage and other concerns.They treated the blockage in hospital and then decided on (b)(6) 2022 to perform an open low anterior resection with a portion of rectum removal for a contained rectal perforation and pelvic pain.I was in hospital again for a month.I am now still in pain and am taking gabapentin 900 mg x 3 and also experiencing bladder incontinence.I also had a bladder lift sling implanted in 2011.So to this date i am still not better and am scheduled for a sigmoidoscopy in (b)(6) of 2022 to see why i'm having issues voiding my bowels.I am totally mentally and physically drained from this experience and am also on a waiting list for a psychiatrist from all the trauma i have experienced.My husband and family have also been affected by this experience and my daughter had to move in with us from (b)(6) 2022 (she lives in vancouver) to help with day-to-day living and for emotional support.Fda safety report id # (b)(4).

• Brand Name: PROLENE MESH 2X12
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.
• MDR Report Key: 15800271
• MDR Text Key: 303837067
• Report Number: MW5113272
• Device Sequence Number: 1
• Product Code: MQR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 11/10/2022
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PROLENE MESH
• Device Lot Number: XL B855
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/14/2022
• Patient Sequence Number: 1
• Treatment: BLADDER SLING; LEVOTHYROXINE SODIUM 50MCG, VORTIOXETINE 29 MG, RABAPRAZOLE SODIUM 20 MG, LORAZEPAM 2MG AT BEDTIME OR AS NEEDED, ESTROGEL 0.06% I PUMP AT BEDTIME, GABAPENTIN 600 MG X 3, MIRABEGRON 50 MG, SOLIFENACIN SUCCINATE 5 MG. BLADDER LIFT SLING.; VITAMIN B12 1000 MCG, VITAMIN D3&K2 1000IU & K2 120MCG (2 CAPSULE'S DAILY), MAGNESIUM GLYCINATE 200MG.
• Patient Outcome(s): Disability; Life Threatening; Hospitalization
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Weight: 68 KG
• Patient Race: White