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

Device Problem Material Erosion (1214)

Patient Problems Erosion (1750); 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.Citation: journal of gynecologic surgery.2011; 27(2).Doi: 10.1089=gyn.2009.0097.

Event Description

It was reported via journal article: "title: reconstruction of pelvic-organ prolapse using a self-fashioned gynemesh" authors: yu zhu, md; li shan ma, md; zhong ping cheng, md; hong dai, md; li ping hu citation: journal of gynecologic surgery.2011; 27(2).Doi: 10.1089=gyn.2009.0097.This retrospective study was conducted to evaluate the effectiveness of self-fashioned gynemesh for the concomitant treatment of pelvic-organ prolapse (pop) and the factors involved in mesh erosion and disease recurrence.The study population consisted of 81 women (mean age 58.5) with stage 2 or higher pop, according to international continence society pop (ics pop-q) criteria and underwent a procedure for pelvic-reconstructive surgery for pop from feb 2006 to december 2007.During the anterior repair procedure, a self-fashioned mesh was prepared by trimming a gynecare gynemesh ps prolene mesh.The guider was introduced from the incision of the exit points and passed blindly through the obturator foramen against the posterior aspect of the pubic bone.The tip of the guider was advanced into the tunnel and the underlying vaginal mucosa with vicryl 1-0 suture.After sewing the ends of the mesh, the vicryl 1-0 suture was withdrawn from the exit incision.The vicryl 1-0 suture was pulled until the edge of the attached gynemesh passed through the endopelvic fascia, and was then anchored into the arcus tendineus fascia pelvis.The procedure was repeated on the other side.The gynemesh was placed without tension underneath the bladder neck and proximal urethra as well as the supporting part of the anterior vaginal wall as a hammock.During the posterior repair procedure, cymbiform-shaped mesh with two ends was prepared the tip of the guider was advanced into the tunnel and the sacrospinous ligament was transfixed with vicryl 1-0 suture.After sewing the ends of the mesh, the vicryl 1-0 suture was then withdrawn from the exit incision.The posterior mesh was positioned in the ischioanal fossa, inferior to the levator ani muscle, and secured by passage of the straps through the sacrospinous ligament and coccygeus muscles.Reported complications included recurrent prolapse (n-7) and mesh exposure (n-5) which were treated with vaginal estrogen therapy and the eroded mesh exposures were removed by trans-vaginal excision.It was concluded that the modified pelvic-floor reconstruction using self-fashioned gynemesh is a practical procedure for various kinds of pop.However, the long-term effect remains unknown.

• Brand Name: GYNECARE UNKNOWN PRODUCT
• Type of Device: MESH, SURGICAL, POLYMERIC
• 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: 7597220
• MDR Text Key: 111001605
• Report Number: 2210968-2018-73453
• Device Sequence Number: 1
• Product Code: OTO
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K013718
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/24/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention