MAUDE Adverse Event Report: ETHICON INC. GYNECARE MESH UNKNOWN MESH, SURGICAL

Device Problem Migration (4003)

Patient Problems Erosion (1750); Fatigue (1849); Hemorrhage/Bleeding (1888); Incontinence (1928); Pain (1994); Swelling (2091); Burning Sensation (2146); Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

(b)(4). This medwatch report is in response to receipt of maude event report mw5079609. To date the device has not been returned. If the device or further details are received at the later date a supplemental medwatch will be sent.

Event Description

It was reported that the patient underwent a gynecological procedure on (b)(6) 2006 and the mesh was implanted for bladder suspension. The patient hemorrhaged immediately following this surgery and had to be taken back to operating room. The doctor opined that the surgery failed. Later that year the patient had a cadaver iv fascia lata sling put in, but it was too tight and caused urinary retention and was taken down several months later. In 2008, ams devices were implanted such as a mini arc mid ureteral sling and elevate mesh for enterocele and posterior repair. Soon after this surgery, the patient experienced erosion of mesh. The patient also experienced auto immune symptoms, pain in joints, swelling of joints, pain and burning of skin, urge and stress incontinence, hashimotos, severe fatigue, rheumatoid arthritis and lyme disease. It was also reported that eventually this mesh eroded through vaginal wall, causing pain and inability to have intercourse. On (b)(6) 2016, the patient underwent a full removal. The doctor opined that it was one of the most complicated cases, with mesh erosions in multiple locations. It was also reported that it was 4 hours removal, extremely complicated with pain. The patient is still experiencing severe incontinence, and an incisional hernia which allowed bowels to lay on the bladder. In 2017 the patient underwent repairs, which were unsuccessful. It was reported that the patient is still experiencing severe incontinence as well as a myriad of auto immune issue, fatigue and emotional distress. No further information is available.

• Brand Name: GYNECARE MESH UNKNOWN
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7945719
• MDR Text Key: 123062756
• Report Number: 2210968-2018-76395
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other,user facility
• Type of Report: Initial
• Report Date: 09/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Was Device Available for Evaluation?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/25/2018
• 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?

• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 10/08/2018 Patient Sequence Number: 1