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U.S. Department of Health and Human Services

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

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ETHICON INC. PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Hernia (2240); Numbness (2415); Post Operative Wound Infection (2446); Foreign Body In Patient (2687); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 03/10/2020
Event Type  Injury  
Manufacturer Narrative

(b)(4). Attempts are bei if further details are received at a later date a supplemental medwatch will be sent. Ng made to clarify the following information. To date no response has been provided. 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: surgical endoscopy (2020) 34:5338¿5345, https://doi. Org/10. 1007/s00464-019-07324-6.

 
Event Description

Title: propensity score analysis of outcomes between the transabdominal preperitoneal and open lichtenstein repair techniques for inguinal hernia repair: a single-center experience. The aim of the present study was to investigate the risk factors of chronic pain after transabdominal preperitoneal (tapp) repair and open lichtenstein repair (olr) in a single institution. Between 2008 and 2018, 824 patients who underwent either tapp or olr hernia repair were included in the study. Tapp was performed in 400 patients and olr was performed in 424 patients. The two groups were balanced in 400 pairs for further statistical analysis. In the tapp group, there were 345 males and 55 females with a mean age of 47 years and mean bmi of 25. 3 (kg/m2). In the orl group, there were 349 males and 51 females with a mean age of 57 years and a mean bmi of 26. 3(kg/m2). A total of 403 patients were implanted with a 6x6 cm light prolene mesh (ethicon) in which 227 patients were from tapp group and 176 were from orl group. The rest of the patients were implanted with a competitor's synthetic polyester mesh. All patients underwent a multidisciplinary team (mdt) assessment that included surgeons and radiologists to avoid the possibility of occult hernia. Complications in the tapp group include: foreign body sensation within 3 months (n=62), scrotal invasion (n=114), wound edema (n=22), wound infection (n=19), numbness (n=29), persistent sensation loss (n=54), pain interfere with sports (n=63), recurrence after 1 year (n=3), recurrence after 5 years (n=1), postoperative vas of 3. 0 at 1 year, postoperative vas of 1. 0 at 4 years and postoperative vas of 1 at 5 years. Complications in the orl group include: foreign body sensation within 3 months (n=103), scrotal invasion (n=91), wound edema (n=35), wound infection (n=51), numbness (n=61), persistent sensation loss (n=88), pain interfere with sports (n=89), recurrence after 1 year (n=3), recurrence after 5 years (n=2), postoperative vas of 2. 5 at 3 months, postoperative vas of 3. 0 at 1 year, postoperative vas of 1. 0 at 2 years, postoperative vas of 4. 0 at 3 years, postoperative vas of 5. 0 at 4 years, and postoperative vas of 4. 0 at 5 years. In conclusion, the tapp repair technique demonstrated better performance in terms of decreased postoperative chronic pain development than did the olr technique. However, more prospective clinical studies with a large number of patients are needed to determine the surgeon choice in the development of postoperative pain.

 
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Brand NamePROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT
Type of DeviceMESH, 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 Key11709141
MDR Text Key247900294
Report Number2210968-2021-03656
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeCH
PMA/PMN NumberK962530
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,L
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/25/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/22/2021
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 Received04/27/2021
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 NumberN/A

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