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

Device Problems Material Erosion (1214); Material Protrusion/Extrusion (2979); Positioning Problem (3009)

Patient Problems Erosion (1750); Incontinence (1928); Inflammation (1932); Scar Tissue (2060)

Event Type  Injury  

Manufacturer Narrative

(b)(4).This report is related to a journal article, therefore no product will be returned for analysis and the batch history records cannot be reviewed as the lot number has not been provided.No specific patient information regarding events has been provided.Attempts are being made to obtain the following information.If further details are received at the later date a supplemental medwatch will be sent.Does the surgeon(s) believe that the ethicon products involved caused and/or contributed to the post-operative complications described in the study? were these events previously reported to ethicon? if so, can you provide complaint numbers.Does the surgeon believe there is any deficiency in the mesh? citation: arch gynecol obstet (2015) 291:79¿84; doi 10.1007/s00404-014-3374-6.(b)(4).

Event Description

It was reported via journal article: "title: minimally invasive cystocele repair technique using a polypropylene mesh introduced with the transobturator route" author(s): hazem samour, amgad abougamra, haitam a.M.Sabaa citation: arch gynecol obstet (2015) 291:79¿84; doi 10.1007/s00404-014-3374-6.This observational follow-up retrospective study aimed to describe a new procedure for treatment of cystocele, which involves passage of the corkscrew needle through transobturator space and across the vagina for fixation of anterior wall polypropylene mesh.Between 2007 and 2010, 152 female patients (mean age of 52 years; average bmi of 30.1) with symptomatic cystocele stage 2 or more with or without stress urinary incontinence underwent surgical repair involving introduction of gynecare gynemesh ps prolene mesh via the transobturator route.Gynemesh served as a hammock below bladder, and possessed two anterior corners that were brought through the obturator foramen and similar was done on the other side.Early postoperative complications included mesh erosion (n=2), with protrusion from the vaginal suture line and beginning inflammation, at third and fourth day postoperatively which required re-transfer to the operating theater.The mesh was readjusted in position with re-suturing, and cephalosporin was administered.Both patients stayed in the hospital for 10 days until no evidence of infection or erosion was observed.The explanation for this early mesh erosion could be overly stretched vagina over the mesh making the sutures undertension and so easily disrupted.Another explanation of early mesh erosion was most probably due to displacement of the mesh resulting in bunching up in the middle and not to true graft rejection per se.In the follow-up on the over the first 3-4 months post-surgery, (b)(6)% of sexually active patients had variable degrees of dyspareunia mostly caused by the scar and fibrosis induced by the mesh, which decreased by the sixth month.Only (b)(6)% of these patients had persistent dyspareunia that impaired their sexual life.This mostly caused by the scar and fibrosis induced by the mesh.Furthermore, four patients had mesh erosion at 12, 15, 18 or 24 months post-surgery which required intervention.In two cases, the only symptom of was the protrusion of mesh with evidence of infection and healing defect.After the protruding parts of the mesh found in the midline were cut, the vaginal edges were trimmed and sutured in the presence of antibiotics.No recurrence of prolapse was observed in the follow up of these four patients.There were 11 patients who did not suffer from stress urinary incontinence preoperatively who developed de novo urge between 6 and 8 months postoperatively and required medical treatment.This incidence is similar to the rate of 6.5% reported in a previous study for this condition which was mostly due to irritation to the detrusor muscles by the mesh.The transobturator mesh placement can be considered a minimally invasive, effective method for the correction of cystocele and sui based on the low rate of complications, the high rate of success, and the low incidence of recurrence.

• 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.; road 183, km. 8.3; san lorenzo
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7485606
• MDR Text Key: 107315531
• Report Number: 2210968-2018-72586
• Device Sequence Number: 1
• Product Code: OTO
• Combination Product (y/n): N
• Reporter Country Code: EG
• PMA/PMN Number: K013718
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/06/2018

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: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/06/2018
• Initial Date FDA Received: 05/03/2018
• 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