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); Hemorrhage/Bleeding (1888); Incontinence (1928); Pain (1994); Urinary Retention (2119); Urinary Tract Infection (2120); Unspecified Tissue Injury (4559)

Event Date 10/11/2021

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.Org/10.1186/s12905-021-01505-z.Related events captured via 2210968-2022-10239 and 2210968-2022-10240.

Event Description

Title: long-term outcomes of transvaginal mesh surgery for pelvic organ prolapse: a retrospective cohort study the objective of this study was to evaluate the overall outcomes and complications of transvaginal mesh (tvm) placement for the management of pelvic organ prolapse (pop) with different meshes with a greater than 10-years of follow-up.Between january 2005 and december 2010, 134 patients with pelvic organ prolapse who underwent transvaginal mesh (tvm) placement were included in the study.There were 52 patients (mean age 62.1 years, mean bmi 24.59kg/m2) implanted with prolift mesh (ethicon) and 82 patients (mean age 61.4 years, mean bmi 24.38 kg/m2) implanted with gynemesh (ethicon).Most of the patients underwent total repair.In total, 3 of 52 patients underwent anterior repair with the prolift kit, and 8 of 82 patients underwent anterior repair with gynemesh.No patients underwent posterior repair.The mean number of years follow-up was 11.8 (± 1.32), with a median of 12 years (range 10¿15).The reported complications included mesh vaginal extrusion (n=23), vaginal bleeding (n=11), pelvic pain or dyspareunia (n=16), urinary incontinence (n=32), urinary tract infection (n=21), urinary retention (n=1), bladder injury during operation (n=3), and recurrence of prolapse (n=9).In conclusion, treatment of pop by tvm surgery exhibited long-term effectiveness with acceptable morbidity.The outcomes of the mesh kit were the same as those for self-cutmesh.

• 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 INC. - NEUCHATEL; puits godet 20; neuchatel 2000 ; SZ 2000
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 15977283
• MDR Text Key: 305491625
• Report Number: 2210968-2022-10239
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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

• Date FDA Received: 12/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/07/2022
• 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
• Patient Sex: Female