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

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

Patient Problems Erosion (1750); Hematoma (1884); Pain (1994)

Event Date 10/17/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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.Does the surgeon believe that any of the ethicon products involved caused and/or contributed to the post-operative complications described in the article? which specific ethicon products have been used during the procedures (product code, lot number)? does the surgeon believe there was any deficiency with any of the ethicon products used in this procedure? if so, please provide details.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Patient demographics? 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.(b)(4).The single complaint was reported with multiple events.There are no additional details regarding the additional events.Citation: https://doi (b)(4).

Event Description

Title: long-term outcomes after pelvic organ prolapse repair in young women this retrospective study aims to describe the long-term outcomes of pop repair in women under 40 years old.Between january 1997 and december 2015, 74 patients less than or equal to 40 years old underwent a pop repair.Among these, 31 patients were excluded: 2 patients suffered from a rectal prolapse, and 29 patients had missing data (lost to followup).Forty-three patients age may be anywhere in the range from 35 to 4 (28¿40).Constituted the study population.The study population was separated into three groups: a sacrohysteropexy group (n=28 patients), a vaginal native tissue repair (ntr) group ((n=7 patients) consisting mainly of posterior sacrospinofixations according to richter or richardson¿s procedures, and a transvaginal mesh surgery (vms) group (n=8 patients).In this case, the mesh used was made of polypropylene (prolift®, pelvic floor repair system; ethiconwomen¿s health and urology, somerville, nj, usa).The transvaginal mesh repair technique was standardized.An anterior and/or a posterior mesh was applied according to the prolapse type (anterior pop, posterior pop, or the complete floor).The anterior mesh was inserted between the bladder and the vagina and fixed laterally by four arms passing through the obturator foramen, near the tendinous arch of the pelvic fascia.The posterior mesh was placed between the rectum and the vagina with an arm passing through the ischiorectal fossa and fixed in the sacrospinous ligament.The mesh was made of non-absorbable monofilament polypropylene (prolift pelvic floor repair system; ethicon women¿s health and urology, somerville, nj, usa).The mean followup may be anywhere in the range from 89 to 53 months.Reported complications included: vms group: grade i and ii : (n=1) vaginal hematoma, was not reoperated.(n=1) dyspareunia ,could be due to a mesh retraction.(n=2) non-reoperated pop recurrence.(n=1) mesh exposure.Grade iii: (n=6) global reoperation, whatever the type of pop surgery.(n=5) pop recurrence reoperation.(n=1) mesh related reoperation.Among patients with mesh exposure, only one underwent a surgical removal of the vaginal prosthetic mesh.It was concluded , that despite the risk of recurrence, pelvis organ prolapse (pop) repair should be proposed to young women in order to restore their quality of life.Vaginal native tissue repair or sacrohysteropexy can be performed after explaining to women the advantages and disadvantages of each procedure.

• 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 ; 9083863534
• MDR Report Key: 15977290
• MDR Text Key: 305494570
• Report Number: 2210968-2022-10241
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K013718
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial

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: 12/07/2022
• Initial Date FDA Received: 12/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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