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); Unspecified Infection (1930); Pain (1994); Urinary Tract Infection (2120); Therapeutic Response, Decreased (2271); Injury (2348); Not Applicable (3189)

Event Type  Injury  

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.Attempts were 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 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: can urol assoc j.2014; 8 (9-10): e605-9.Doi: http://dx.Doi.Org/10.5489/cuaj.2022.(b)(4).

Event Description

It was reported via journal article: "title : morbidity and functional mid-term outcomes using prolift pelvic floor repair systems." authors: sébastien kozal, md; thomas ripert, md; younes bayoud, md; johan menard, md; ioannis nicolacopoulos, md; laurence bednarzyck, md; frederic staerman, md; stéphane larré, md.Citation: can urol assoc j.2014; 8 (9-10): e605-9.Doi: http://dx.Doi.Org/10.5489/cuaj.2022.The authors assess midterm morbidity and functional outcomes using the gynecare prolift mesh system (ethicon) and identify potential related risk factors.The prolift mesh system was used to treat genital prolapse and was introduced in 2005.Over a 7-year period, the authors retrospectively analyzed a cohort of 112 consecutive patients (age range: 40 to 86 years old; bmi: 15 to 41.5) who underwent the prolift procedure since 2006.All women presenting with pelvic organ prolapse (pop) and treated with the prolift mesh system were included.Reported complications included bladder perforation (n-3) which were immediately repaired transvaginally with favorable outcomes, urinary tract infection (n-2), infection (n-2), chronic pain syndrome (n-2), mesh exposure (n-5) which required surgical resection (n-4) and ablation after a secondary retraction at 45 months post-operatively (n-1), mesh retraction (n-2), pop recurrence (n-9), de novo dyspareunia (n-9), failure of treatment (n-9), and de novo prolapse (n-13).Despite market withdrawal, the prolift mesh system was associated with good midterm anatomic outcomes and few severe complications.The main limit was the impact on sexuality and the occurrence of de novo pop.Based on the results, better outcomes were observed in elderly non-obese women with stage 3 or more pop.

• Brand Name: PROLIFT PELVIC FLOOR REPAIR UNKNOWN PRODUCT
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON SARL-NEUCHATEL; puits-godet 20; neuchatel ; SZ
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7897585
• MDR Text Key: 120989914
• Report Number: 2210968-2018-75916
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/28/2018

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/28/2018
• Initial Date FDA Received: 09/21/2018
• 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