MAUDE Adverse Event Report: ETHICON INC. PROLIFT PELVIC FLOOR REPAIR UNKNOWN PRODUCT; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

Device Problem Migration (4003)

Patient Problems Erosion (1750); Fibrosis (3167)

Event Date 03/11/2020

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).(b)(4).Device not returned.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: european journal of obstetrics & gynecology and reproductive biology 248 (2020) 222226.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.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 product (prolift pelvic floor repair) 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 product involved? patient demographics.

Event Description

It was reported in a journal article with title: laparoscopic sacral colpopexy for pelvic organ prolapse recurrence after transvaginal mesh surgery.Pelvic organ prolapse (pop) recurrence in transvaginal mesh surgery patients has become increasingly common, due to widespread mesh use before the fda alert.The aim was to assess feasibility, effectiveness and safety of laparoscopic sacral colpopexy (lscp) in recurrent pop after previous vaginal surgery with polypropylene mesh.From january 2015 to july 2018, a total of 20 patients underwent lscp for pop recurrence from a previous vaginal surgery.The mean age of these patients was 61 years.The previous vaginal surgery used 6 prolift anterior kit (ethicon.Somerville.Nj.Usa), 6 patients who were treated with a prolift anterior kit had pop recurrence which was treated with lscp.1 female patient had an anterior vaginal erosion of the mesh.After verifying cystoscopically the integrity of the bladder mucosa, she underwent transvaginal mesh removal surgery to remove as much mesh as possible and to repair the damaged tissue.After verifying in the 3 months follow-up a complete healing, lscp was performed.Due to excessive fibrosis related to the previous surgery and implanted mesh, we applied some surgical variations during lscp.No postoperative complications were observed for the lscp.Lscp suggests safety, feasible and efficacy in the treatment of recurrent pop after prior transvaginal polypropylene mesh surgery.

• Brand Name: PROLIFT PELVIC FLOOR REPAIR UNKNOWN PRODUCT
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON SARL-NEUCHATEL; puits-godet 20; neuchatel 2000 ; SZ 2000
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 11904898
• MDR Text Key: 263609534
• Report Number: 2210968-2021-05078
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K013718
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/29/2021

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/29/2021
• Initial Date FDA Received: 05/28/2021
• 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