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); Cellulitis (1768); Hemorrhage/Bleeding (1888); Incontinence (1928); Unspecified Infection (1930); Pain (1994); Urinary Tract Infection (2120)

Event Date 01/01/2012

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 and pelvic floor dysfunction.2012 sep.23 (2 suppl.1): s203-s204.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Event related to prolift device reported via mw # 2210968-2021-02936.Event related to gynecare mesh reported via mw # 2210968-2021-02937.Event related to prollene suture reported via mw # 2210968-2021-02938.

Event Description

It was reported in a journal article with title: transvaginal mesh for pelvic organ prolapse: 10-year experience with 627 procedures.The objective of this retrospective cohort study was to evaluate and compare the outcomes of three different transvaginal mesh (tvm) procedures for pelvic organ prolapse.Between january 2002 and april 2012, a total of 672 (average age=61.2 years, age range=31 ¿ 87 years) tvm procedures were performed.The patients were divided into three groups: 76 with gynemesh, 299 with prolift, and 248 with elevate.During the procedure, an anterior and/or posterior vaginal repair with a surgeon fashioned inlay of gynemesh (ethicon, inc., a knitted, large-pore, monofilament polypropylene mesh of 41g/m2 density), with or without concurrent ssf using 0-prolene suture (ethicon) (referred to as the 'gynemesh' group hereafter); an anterior, posterior or total prolift, (ethicon, inc., a kit utilizing gynemesh in a trocar-based delivery system, with 4 exits anteriorly and 2 exits posteriorly, providing apical support via bilateral sacrospinous ligament fixation (ssf) with the posterior and total systems, the 'prolift' group); or an anterior and/or posterior elevate (american medical systems, inc., a kit using intepro litetm mesh, a polypropylene mesh of 25 g/m2 density, in a trocar-less, no exit system, designed with self-fixating tips, allowing bilateral ssf with both the anterior as well as the posterior systems, the 'elevate' group).Reported complications in prolift group included longer time (mean difference 15 mins, p<0.001) and had greater number of intraoperative bleeding complications (defined as an estimated blood loss of >=500 cc, a hemoglobin drop of >=30 g/l, or the need for blood transfusion, 15.3% vs 7.4%, p=0.009) compared to the other groups (n=?); cystotomies (n=4); urinary tract infection and transient voiding dysfunction resulted in 5.1% (n=?); suffered more febrile episodes (5.4% vs 1.2%, p=0.014) (n=?); exit-site cellulitis (3.0%) (n=?); mesh complications, such as erosion, contraction causing stenosis, and prominence (n=?); de novo stress urinary incontinence, urge incontinence, and dyspareunia (n=?).Reported complications in gynemesh group included intraoperative bleeding complications (defined as an estimated blood loss of >=500 cc, a hemoglobin drop of >=30 g/l, or the need for blood transfusion, 15.3% vs 7.4%, p=0.009) (n=?); infection (n=?) requiring surgical debridement and removal of the mesh implant; mesh complications, such as erosion, contraction causing stenosis, and prominence (n=?); de novo stress urinary incontinence, urge incontinence, and dyspareunia (n=?).In conclusion, the study suggest that while elevate and prolift tvm kits are associated with improved anatomical cure rates over the surgeon-fashioned gynemesh inlay, - the trocar ¿ based system, which requires greater dissection and has exit sites, is associated with greater operative morbidity, and complications such as mesh erosion and contraction appear to be related to the specific mesh used, indicating that differences in mesh properties, such as density, could account for differences in these complication rates.

• 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
• Manufacturer (Section G): ETHICON SARL-NEUCHATEL; puits-godet 20; neuchatel 2000 ; SZ 2000
• Manufacturer Contact: elba bello ; p.o. box 151, route 22 west; somerville, NJ 08876 ; 9082182213
• MDR Report Key: 11602575
• MDR Text Key: 243637271
• Report Number: 2210968-2021-02936
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K013718
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/02/2021

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: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/02/2021
• Initial Date FDA Received: 04/01/2021
• 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