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

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Adhesion(s) (1695); Erosion (1750); Granuloma (1876); Hematoma (1884); Incontinence (1928); Pain (1994); Urinary Retention (2119); Urinary Tract Infection (2120); Blood Loss (2597); 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.No specific patient information regarding events has been provided.If further details are received at the later date a supplemental medwatch will be sent.(b)(4).

Event Description

Title: vaginal prolapse repair using the prolifttm kit: a registry of 100 successive cases the purpose of this single-center, observational study was to assess the anatomical and functional outcomes in prolapse repair using the prolift¿ system and define the complications inherent to the use of this type of prosthesis.From oct2006 to mar2009, 100 female patients (mean age of 66.7±10.4 years; bmi of 27.7±3.5) with pelvic organ prolapse underwent tension-free vaginal mesh procedure with vaginal implantation of prolift kit and were divided into three groups based on the site of repair: anterior prolapse repairs (n=32), posterior prolapse repair (n=14) and total prolapse repair (n=54).With respect to peri-operative complications, 3 patients experienced bleeding (>/=300ml) without needing transfusion.Immediately postoperatively, the following complications were observed: hematoma in the retropubic space (n=1; required reoperation to remove both clot and prosthesis); urinary tract infection (n=4), acute urine retention (n=2; resolved after 3 weeks of intermittent self-catheterization).In patients who underwent anterior prolapse repair, recurrence was observed at 2 months (n=1), at 6 months (n=1) and at 12 months (n=4).In patients who underwent posterior prolapse repair, recurrence was observed at 12 months (n=1).In patients who underwent total prolapse repair, recurrence was observed at 2 months (n=2), at 6 months (n=2) and at 12 months (n=4).New-onset stress urinary incontinence (sui) was reported in 17% (n=8; 2 months), 16.3% (n=7; 6 months), and 7.7% (n=3; 12 months).Exacerbation/recurrence of sui occurred in 2 patients at 12 months.New-onset urinary incontinence with urgency occurred at 2 months (n=3; 3.5%) and 12 months (n=2; n=2.7%).Grade 1a healing defect (exposure of the prosthesis) occurred at 2 months (n=2; resolved by local oestrogen administration [n=1] and excision of the exposed tissue [n=1]), 6 months (n=1), and 12 months (n=1).Grade 1b healing defect (granuloma, adhesions) occurred at 2 months (n=2) and 6 months (n=2).At 2 months, mesh retraction grade 2 (n=20) and grade 3 (n=1) were observed.At 6 months, mesh retraction were at grade 2 for 25 patients and grade 3 for 6 patients.At 12 months, grade 2 mesh retraction were evident in 25 patients, but 7 patients had grade 3 major or symptomatic retraction.New-onset dyspareunia was reported by 11.1% of the patients.The use of the prolift kit in vaginal repair of pelvic organ prolapse appears to be a viable option, with advantages in terms of feasibility, the incidence of per- and post-operative complications, and anatomical and functional outcomes.

• 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
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7495581
• MDR Text Key: 107688046
• Report Number: 2210968-2018-72657
• 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: Other
• Type of Report: Initial
• Report Date: 04/10/2018

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
• Initial Date Manufacturer Received: 04/10/2018
• Initial Date FDA Received: 05/08/2018
• 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