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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Erosion (1750); Hematoma (1884); Unspecified Infection (1930); Pain (1994)

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.If further details are received at the 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: south med j.2015; 108(12): 715¿721.Doi:10.14423/smj.0000000000000377.(b)(4).

Event Description

It was reported via journal article title : pain scores and exposure rates after polypropylene mesh for pelvic organ prolapse.Author: jana illston, md, jeffrey garris, md, ms, holly richter, md, phd, and thomas wheeler ii, md, msph.Citation: south med j.2015; 108(12): 715¿721.Doi:10.14423/smj.0000000000000377.The objectives of the study was to characterize pain and exposure after prolift placement and identify risk factors.A total of 183 patients (age: 57.9 ± 11.5; bmi: 29.2 ± 5.6) with pelvic organ prolapse (pop) who underwent placement of prolift vaginal mesh (ethicon) were surveyed and were included in the study.Patients who received the prolift vaginal mesh grafts in the institution were identified by a billing database query.Reported complications included post-operative pain (1.35), graft exposure (n-23), post-operative hematoma associated with mesh exposure (<0.01), post-operative change in hemoglobin associated with mesh exposure (0.36), and post-operative infection or wound breakdown associated with mesh exposure (0.82).It was reported that hematoma formation was associated with significantly increased odds of mesh exposure and change in hemoglobin has previously been shown to be associated with mesh exposure and perhaps this decrease in hemoglobin was related to hematoma formation.It is possible that increased post-operative pain may be related to larger permanent mesh load suggesting a potential for increases in contracture and scar formation.

• 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: 7902211
• MDR Text Key: 121562153
• Report Number: 2210968-2018-75941
• 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: 08/29/2018

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: 08/29/2018
• Initial Date FDA Received: 09/24/2018
• 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