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

Device Problem Migration (4003)

Patient Problems Erosion (1750); Hemorrhage/Bleeding (1888); Incontinence (1928); Unspecified Infection (1930); Pain (1994); Urinary Tract Infection (2120); Unspecified Tissue Injury (4559)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (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: international urogynecology journal.2019; conference: 44th annual meeting of the american urogynecologic society and the international urogynecological association, augs-iuga 2019.Nashville, tn united states.30 (1 supplement): s282.Doi: https://hostedvl106.Quosavl.Com/qb/.  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.  adverse events associated with prolift +m pelvic floor repair device reported via mw #2210968-2021-05021.

Event Description

It was reported in a journal article with title: complications reported to the food and drug administration-a comparison of vaginal mesh products.The aim of this study is to compare vaginal prolapse mesh problems reported to the fda.To compare vaginal mesh device problems, a cross-sectional analysis of mdrs reported to the fda from 1/2004 to 3/2019 was analyzed using the reed tech navigator (lexisnexis, horsum pa), a software that codes medical device reports (mdrs).Chi2 and fisher exact tests with a dunn-sidak correction were used to compare complication proportions.Vaginal mesh products in the maude database were: gynecare prolift and prolift +m combined (ethicon) with n=6334 mdrs, while others from competitors.Reported complications included hematologic complaints (n=?), gynecologic complaints (n=?), pain (n=90.4%), erosion (n=91.2%), infection (n=18.2%), adverse event without identified device problem (n=11.6%), incontinence (n=?), prolapse (n=?), hemorrhage (n=?), urinary tract infection (n=?), unspecified injury (n=?), mesh erosion (n=19.5%), leak/splash (n=?), loose/intermittent connection (n=?), break (n=?), and detachment of device/component (n=?).In conclusion, reports to the fda on transvaginal mesh, a major data source for litigation, describe a wide range of adverse events with unverified biologic plausibility.The quality of data varies widely, and complication proportions may be affected by mesh groupings, market share, duration of time on the market, and trends in surgical placement.Further studies are needed to examine mesh complication profiles.

• Brand Name: PROLIFT +M 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: 11892117
• MDR Text Key: 266637249
• Report Number: 2210968-2021-05022
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071512
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/28/2021
• 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