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

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Erosion (1750); Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent to the fda: 05/03/2018.(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 believe that ethicon products involved caused and/or contributed to the post-operative complications described in the article? does the surgeon believe there was any deficiency with the ethicon products used in this procedure? citation: chin med j.2016; 129: 1795 9.Doi: 10.4103/0366-6999.186631.[(b)(4)].

Event Description

It was reported via journal article: ¿title: risk factors for mesh exposure after transvaginal mesh surgery.¿ author: ke niu, yong-xian lu, wen-jie shen, ying-hui zhang, wen-ying wang.Citation: chin med j.2016; 129: 1795 9.Doi: 10.4103/0366-6999.186631.The purpose of this retrospective study was to explore the risk factors for polypropylene (pp) mesh exposure after transvaginal mesh (tvm) surgery.This was a retrospective study of 195 patients (average age 63.9 +/- 11.2 years [43.0-89.0 years, mean age 65.0 years]; median duration of menopause 14.8+/-10.7 years [range 0-35 years; average gravidity 3.6+/-1.6 times [range 1-11 times]; average parity 2.6+/-1.5 times [range 1-9 times) with advanced pelvic organ prolapse (pop) who underwent tvm surgery from january 2004 to december 2012 at the first affiliated hospital of chinese pla general hospital.All procedures used gynecare gynemesh ps mesh.The operative methods included prosima anterior leaf fixation, prolift anterior leaf fixation, small mesh fixation, prosima posterior leaf fixation, prolift total pelvic fixation, tension free vaginal tape (tvt), and tvt obturator.Reported complications included recurrence of prolapse (n-2) 3 months after surgery in which no patient was re-operated; and mesh exposure (n-32; age range 43-81 years; most were between 60-70 years).Treatment of mesh exposure included admission for removal of the exposed mesh in (n=8; vaginal mucosa healed completely after mesh resection), regular observation, and local application of estrogen ointment and metronidazole suppositories.Logistic regression analysis of the risk factors for mesh exposure included operative duration (relative risk 1.899) and concomitant procedures (relative risk (0.376).Other factors such as age menopausal status, gravidity, parity, bmi, and blood loss were not related to mesh exposure.It was concluded that the tvm surgery is beneficial for patients with advanced pop.Although exposure may occur after surgery, exposure rate was low and easy to manage.Patients should be cautiously evaluated before mesh surgery.

• 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: 7485543
• MDR Text Key: 107316298
• Report Number: 2210968-2018-72582
• 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: 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