MAUDE Adverse Event Report: ETHICON INC. TENSION FREE VAGINAL TAPE UNKNOWN PRODUCT; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGICAL

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Adhesion(s) (1695); Erosion (1750); Unspecified Infection (1930); Nerve Damage (1979); Neuropathy (1983); Pain (1994); Injury (2348); Blood Loss (2597); Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

(b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.

Event Description

It was reported that the patient underwent a gynecological procedure in (b)(6) 2003 and mesh was implanted.The patient experienced permanent nerve damage, severe pelvic and vaginal pain and vaginal wall erosion.The patient underwent a procedure on an unknown date and the mesh was cut on one side.The patient reported that a vaginal swab was left during the procedure which caused severe infection.The patient underwent a laparoscopy on an unknown date in which she was told the tape could not be fully removed as it was so deeply embedded.The vaginal portion of the tape was supposedly removed in (b)(6) 2005 with exception of the piece under the urethra.The patient reported that she had attended pain management clinics, but the treatment did not address the severe pain well.The patient reported that her periods became painful and bleeding erratic.The patient underwent a total abdominal hysterectomy and bilateral salpingo-oophorectomy as the surgeon said the pain was coming from the patient¿s uterus.The patient underwent removal of abdominal portion of the tape in (b)(6) 2006.The patient reported that the tape was found to be stuck intensely to the bladder and was removed.Within hours of the surgery, the patient reported that her bladder wall gave way and urine was running into the drain and not the catheter.The patient spent around 3 weeks in hospital with a catheter in situ.The patient¿s micturating cystogram prior to removal of the catheter showed severe bilateral ureteric reflux.The patient reported that the surgery did not help the pelvic pain which became worse and made her so disabled that she had to give up her career and remain disabled with permanent neuropathic pelvic and leg pain.The patient has had several spinal blocks to date.The patient reported that she still remains sore every day and night and is on a lot of medication.The patient underwent a laparoscopy with removal of the right vaginal portion of the tape and the piece of tape under the urethra.The patient has experienced bowel and bladder adhesions.The adhesions were released and the bladder wall was reconstructed.No additional information was provided.

Manufacturer Narrative

Date sent to fda: 9/3/2019.

• Brand Name: TENSION FREE VAGINAL TAPE UNKNOWN PRODUCT
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGICAL
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 7357910
• MDR Text Key: 103140463
• Report Number: 2210968-2018-71574
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• PMA/PMN Number: K974098
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 09/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention