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

Device Problem Migration (4003)

Patient Problems Erosion (1750); Fever (1858); Hematoma (1884); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Pain (1994)

Event Date 01/01/2020

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: journal of gynecologic surgery, volume 36, number 6, 2020; doi: 10.1089/gyn.2020.0072.  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 the ethicon products (ultrapro hernia system and ultrapro hernia plug) 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 involved? adverse events associated with the tension free vaginal tape - obturator device reported via mw #2210968-2021-05064.Adverse events associated with the tension free vaginal tape - secur device reported via mw #2210968-2021-05065.

Event Description

It was reported in a journal article with title: experience with prolift mesh system for correction of uterovaginal prolapse: analysis of 149 cases.The objective of this retrospective chart review was to assess the feasibility, potential complications, safety, and efficacy of the prolift system to correct uterovaginal prolapse.Between september 9, 2005 and march 9, 2009, 149 women who were treated for pelvic organ prolapse (pop) using the gynecare prolift system (ethicon) were included in the study.The mean age was 65.2 +/- 10.9 years and mean body mass index was 29.47 ¿ 5.65 kg/m2.During the procedure,subjects who had uteri required total prolift mesh cut into 2 pieces with the anterior mesh attached to the anterior cervix and the posterior mesh attached to the posterior lip of the cervix, respectively.This anchoring was performed with a permanent prolene suture (ethicon).71 patients had concomitant surgery with tvt-o midurethral sling (ethicon) and 4 had concomitant surgery with tvt-secure midurethral sling (ethicon).Cystourethroscopy was performed in all subjects with anterior or total mesh surgeries or in subjects undergoing concomitant sling procedures.Each subject completed examinations, including the popq and a postoperative pfdi-20 questionnaire, at follow-up visits.Complications included failure at preoperative stage ii (n=2), stage iii (n=14), stage iv (n=7), blood loss >500ml (n=3), blood loss of 1500 ml and massive uterovaginal procidentia (n=1), postoperative infected hematoma with foul odor measuring 7.5x11.6x4.0 cm in the left paravaginal space with bleeding and fever 10 days postoperatively (n=1), not voiding normally (n=18) with patients sent home with an indwelling foley (n=12) and went home self-catheterizing (n=5), mesh exposure into the vagina (n=20) with mesh exposure excised in the office (n=9) and with mesh exposure excised in the operating room (n=6), persistent dyspareunia (n=6), de novo dyspareunia (n=5).Of the subjects who were not voiding normally, a concomitant sling procedure for stress incontinence was performed (n=10) of the subjects discharged with a foley catheter and subjects who were taught self-catheterization (n=5).In conclusion, the prolift mesh reconstruction procedure is safe and effective, with minimal postoperative morbidity.

• 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 SARL-NEUCHATEL; puits-godet 20; neuchatel 2000 ; SZ 2000
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 11899390
• MDR Text Key: 266719917
• Report Number: 2210968-2021-05063
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K013718
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention