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

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Wound Dehiscence (1154); Erosion (1750); Not Applicable (3189)

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.If further details are received at the later date a supplemental medwatch will be sent.Citation: korean journal of urology, volume 49:616-621), issue 7, 2008.Reference attached journal article.

Event Description

Title: a comparison of traditional anterior colporrhaphy and cystocele repair with monofilament polypropylene mesh repair (gynemesh pstm).The aim of this retrospective comparative study was to compare the surgical results of anterior colporrhaphy which uses existing tissue in cystocele patients who have central defect and cystocele repair that uses monofilament polypropylene mesh (gynemesh ps, gynecare, ethicon) to externally reinforce support tissue.From january 2003 to june 2006, medical records were retrospectively analyzed for 71 patients who could be followed-up for at least more than 1 year among patients that received cystocele repair or monofilament polypropylene mesh (gynemesh ps, gynecare, ethicon) through central defect cystocele.These patients were divided into 2 groups: anterior colporrhaphy (n=38; age: 61.7±9.1 years; bmi 24.2+/-2.1) and anterior repair with propylene mesh (n=33; age: 59.1±10.9 years; bm 24.3+/-3.1).During the procedure of anterior colporrhaphy, the vaginal mucosa was dissected from the pubocervical fascia and separated from the bladder neck, and plication was performed on the loose pubocervial fascia through discontinuous suturing using vicryl 2-0 and the remaining vaginal mucosa was simply sutured after resection.For cystocele repair using polypropylene mesh, the polypropylene mesh (gynemesh ps, gynecare, ethicon) was cut into a double wing-shaped size of 15 cm, and the central area was induced between the pubocervial fascia and the vaginal wall.Two cases of wound disruption existed in anterior colporrhaphy and 1 case of wound disruption was present in cystocele repair using mesh within 1 month after surgery, but these disappeared after the second round of sutures.Vaginal erosion the size of a coin occurred in patients who underwent cystocele repair with mesh for the 12th month during the follow-up period.Improvement was seen after application of vaginal estrogen cream following removal of the exposed mesh.Among 38 patients who underwent anterior colporrhaphy in follow-ups that were more than 12 months after surgery, there were 8 patients who had recurrences, 3 patients saw recurrence 3 months after surgery and 5 patients experienced recurrence 1 year after surgery.Stage iii patients at the time of recurrence complained of prolapse, and stage ii patients did not show prolapse related symptoms.Among 33 patients who underwent cystocelne repair with mesh, 1 examined stage iv patient before surgery experienced stage ii recurrence 6 months after surgery and showed no prolapse symptoms.In conclusion, in cystocelene patients with anterior defect, cystocele repair with monofilament polypropylene mesh (gynemesh pstm) showed a higher cure rate (84.9% vs.63.2%) and success rate (97.0% vs.79.0%) compared to anterior colporrhaphy, but complications such as vagina erosion requires close monitoring through long-term follow-up.

• 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.-SAN LORENZO PR
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7500086
• MDR Text Key: 107776710
• Report Number: 2210968-2018-72690
• Device Sequence Number: 1
• Product Code: OTO
• Combination Product (y/n): N
• 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: 04/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2018
• 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: 04/11/2018
• 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