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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Pain (1994); Urinary Retention (2119); Abdominal Distention (2601); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/06/2020

Event Type  Injury  

Event Description

It was reported in a journal article with title: peri- and postoperative outcomes of outpatient vs inpatient laparoscopic apical prolapse repair.The aim of this study was to report our experience and patient outcomes after outpatient laparoscopic apical prolapse repair and to compare the perioperative outcomes of women admitted with those discharged on the day of surgery.A retrospective cohort study was performed including all patients who underwent a laparoscopic sacrocervico- or sacrocolpopexy with or without hysterectomy, along with vaginal prolapse and anti-incontinence procedures as indicated from 2013 to 2017 as a combined procedure between minimally invasive gynecologic surgery (migs) and female pelvic medicine and reconstructive surgery (fpmrs) physicians at brigham & women¿s hospital and brigham & women¿s faulkner hospital.Apical suspension was performed using a either a prepackaged gynecare gynemesh (ethicon, inc., johnson and johnson, somerville, nj).The mesh was secured to the anterior and posterior cervix and/or vagina with 6 interrupted sutures of 2-0 pds (or 2-0 ethibond; ethicon, somerville, nj) anteriorly and 6 sutures posteriorly, tying knots intracorporeally.The mesh was then completely retroperitonealized using 2-0 monocryl suture (ethicon, somerville, nj).Midurethral slings, anterior colporrhaphy, and posterior colpoperineorrhaphy were additionally performed as indicated by the fpmrs team in the usual fashion.Reported complications included clavien-dindo grade 1 or 2 (n=5), urinary retention that required discharge with a catheter.Vaginal bleeding and suture separation in the proximal posterior colporrhaphy repair (n=2), reoperated on and returned to the operating room, and the area was sutured.The other patient underwent the excision of a perineal skin tag with placement of the suture under local anesthesia in the office on postoperative day 6.Abdominal pain and distension noted to have severe urinary retention with a distended bladder (n=2) and was readmitted on postoperative day 5 and was discharged with a foley catheter.In conclusion laparoscopic apical prolapse repair with concomitant vaginal repairs can be performed safely as an outpatient procedure.A unique team approach may foster a shorter, more efficient procedure without compromising short-term outcomes.

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.The single complaint was reported with multiple events.There are no additional details regarding the additional events.Citation cite: https://doi.Org/10.1016/j.Jmig.2020.12.007.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Does the surgeon believe that the ethicon products (gynecare gynemesh, pds ii, ethibond, and monocryl sutures) 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 involved? patient demographics? event related to the pds ii suture reported via mw # 2210968-2021-11309.Event related to the ethibond suture reported via mw # 2210968-2021-11310.Event related to the monocryl suture reported via mw # 2210968-2021-11311.

• Brand Name: GYNECARE MESH UNKNOWN
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; 982 road 183 km 8.3; san lorenzo 00754 ; * 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 12799442
• MDR Text Key: 285546463
• Report Number: 2210968-2021-11308
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Literature,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/12/2021

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: 10/12/2021
• Initial Date FDA Received: 11/11/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female