MAUDE Adverse Event Report: ETHICON INC. PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Wound Dehiscence (1154); Fistula (1862); Hemorrhage/Bleeding (1888); Seroma (2069); Hernia (2240); Post Operative Wound Infection (2446)

Event Date 01/08/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4). If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate. Attempts are being made to clarify 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. Does the surgeon believe that any of the ethicon products involved caused and/or contributed to the post-operative complications described in the article? if so, please specify. Does the surgeon believe there was any deficiency with any of the ethicon products used in this procedure? if so, please provide details. Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number. Patient demographics? (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: doi:10. 1111/codi. 14952.

Event Description

Title: further insights into the treatment of perineal hernia based on a the experience of a single tertiary centre. This retrospective study aimed to report on the evolution of a technique for repair of perineal hernia by analysing the experience in a tertiary referral centre and to compare the two consecutive time periods in which biological mesh was replaced by synthetic mesh for transperineal repair of a perineal hernia with regard to success rate and morbidity. Between december 2010 and january 2019, a total of 34 patients were included in the study (18 with biological mesh ; 16 with synthetic mesh). In the biological mesh group, permacoltm was used in four patients (22%) and stratticetm in 14 patients (78%). In the synthetic mesh group, 11 patients (69%) underwent repair using prolene (ethicon), four patients (25%) using parietextm and one patient (6%) using dynamesh. A nonabsorbable polypropylenemesh (prolene) was the standard of care in the absence of bacterial contamination and presence of an omentoplasty that could cover the mesh was used during the second period of the study. The median follow-up duration was 33 months (iqr 14¿68) in the biological mesh group and 17 months (iqr 1¿26) in the synthetic mesh group (p = 0. 019). The overall clinical recurrence rate was determined based on the index hernia repair at the amc (30 primary repairs and four recurrent hernia repairs). The recurrence rate was similar for biological mesh (39%) and synthetic mesh use (31%; p = 0. 642). Reported complications included postoperative perineal wound infection after synthetic mesh repair, recurrence in with polypropylene mesh, failed synthetic mesh repair, perineal seroma after synthetic mesh placement, dehiscence, fistula and bleeding. All perineal wound infections were successfully treated with antibiotics and percutaneous drainage of fluid collections. Of five patients with failed synthetic mesh repair, two underwent re-repair with synthetic mesh and perineal seroma excision was also done. In conclusion, changing the standard surgical technique from biological to synthetic mesh for the repair of perineal hernia did not result in a significant reduction in the rate of recurrence of perineal hernia. Recurrence rates after perineal hernia repair following abdominoperineal excision were high, and did not seem to be related to the type of mesh, but this finding needs confirmation in larger studies.

• Brand Name: PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; 982 road 183 km 8.3; san lorenzo
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 11712101
• MDR Text Key: 262896691
• Report Number: 2210968-2021-03644
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (Y/N): N
• Reporter Country Code: NL
• PMA/PMN Number: K962530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: FOREIGN,HEALTH PROFESSIONAL,L

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 03/24/2021

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 04/22/2021
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: HEALTH PROFESSIONAL
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/30/2021
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Is The Device Single Use?: Yes

Is this a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Initial
• Removal/Correction Number: N/A

Patient TREATMENT DATA

Date Received: 04/22/2021 Patient Sequence Number: 1