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); Granuloma (1876); Incontinence (1928)

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 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.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: european journal of obstetrics & gynecology and reproductive biology, 169 (2013), 108¿112, http://dx.Doi.Org/10.1016/j.Ejogrb.2013.03.018.(b)(4).

Event Description

It was reported via journal article: title: "self-perceived quality of life after pelvic organ prolapse reconstructive mesh surgery: prospective study." authors: aleksandra bartuzi, konrad futyma, beata kulik-rechberger and tomasz rechberger.Citation: european journal of obstetrics & gynecology and reproductive biology, 169 (2013), 108¿112, http://dx.Doi.Org/10.1016/j.Ejogrb.2013.03.018.The aim of this current study was to assess the self-perceived quality of life in women with advanced pelvic organ prolapse before and after mesh surgery.Between january 2009 and january 2010, a total of 119 patients who signed informed consent and fulfilled the inclusion criteria.The mean age of patients was 57.7 years (range 33¿79 years), and 92 of them (77.3%) were post-menopausal.Forty-one women suffered from coexisting stress urinary incontinence (sui).Sixteen patients (13.4%) had previously undergone hysterectomy.Prolapse severity before the operation was evaluated by means of pelvic organ prolapse quantification (pop-q).All patients were operated due to pelvic organ prolapse (pop) for the first time.During the surgery, synthetic polypropylene mesh (the gynecare prolift1 pelvic floor repair system; ethicon, johnson & johnson, (b)(4) usa) was used.In 32 patients (26.9%) mesh repair was supplemented by surgical restoration of the perineal body using absorbable vicryl no.1 sutures.De novo sui occurred in 10 patients (8.8%), whereas recurrent sui was observed in 3 cases (2.7%).Three women (2.7%) reported overactive bladder (oab) symptoms after surgery.Erosions were observed in 7 patients (6.2%) and in one case (0.9%) a vaginal wall granuloma was found.All these complications relating to sui or oab were managed either surgically or with anticholinergics for oab treatment.In conclusion, the results of this study indicate that pop negatively affected qol, whereas reconstructive mesh surgery significantly improved various qol dimensions.Patients should expect a significant improvement in their quality of life after this type of operation.These findings will help counsel patients suffering from genital prolapse before an operation, and will help predict the influence of this surgery on their quality of life.

• 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: 7877567
• MDR Text Key: 120306950
• Report Number: 2210968-2018-75840
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• Reporter Country Code: PL
• 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: 08/30/2018

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: 08/30/2018
• Initial Date FDA Received: 09/14/2018
• 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