PROLENE POLYPROPYLENE SUTURE
Report
- Report Number
- 2210968-2026-05021
- Event Type
- Injury
- Date Received
- May 7, 2026
- Date of Event
- January 17, 2026
- Report Date
- May 7, 2026
- Manufacturer
- ETHICON INC.
- Product Code
- GAW
- PMA / PMN Number
- K133356
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- OTHER
Narratives
PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. 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 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. DOES THE SURGEON BELIEVE THAT ANY OF THE ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? WHICH SPECIFIC ETHICON PRODUCTS HAVE BEEN USED DURING THE PROCEDURES (PRODUCT CODE, LOT NUMBER)? 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? 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. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. CITATION: SN COMPREHENSIVE CLINICAL MEDICINE (2026) 8:13 HTTPS://DOI.ORG/10.1007/S42399-026-02251-9.
TITLE: A COMPARATIVE PROSPECTIVE STUDY ON EXTENDED TOTALLY EXTRAPERITONEAL REPAIR VERSUS INTRAPERITONEAL ONLAY MESH REPAIR IN VENTRAL HERNIA WITH EARLY OUTCOMES. THE AIM OF THIS STUDY IS TO COMPARE THE EARLY OUTCOMES OF TWO LAPAROSCOPIC TECHNIQUES FOR VENTRAL HERNIA REPAIR: GROUP A ¿ E-TEP (EXTENDED TOTALLY EXTRAPERITONEAL REPAIR) (N=41) AND GROUP B ¿ IPOM (INTRAPERITONEAL ONLAY MESH REPAIR) (N=41) FROM AUGUST 2022 TO DECEMBER 2023. 2-0 PROLENE SUTURE (ETH) WAS USED TO FIX THE DUAL LAYER MESH IN IPOM WHILE PROLENE MESH WAS USED IN ETEP GROUP. REPORTED COMPLICATIONS: GROUP A - ETEP GROUP (N=41), PROLENE MESH (ETH), RESPIRATORY DISTRESS (N=1), TREATMENT: NOT REPORTED, ABDOMINAL DISTENTION (ILEUS) (N=2), TREATMENT: NOT REPORTED. GROUP B - IPOM GROUP (N=41), 2-0 PROLENE SUTURE (ETH), RESPIRATORY DISTRESS (N=2), TREATMENT: NOT REPORTED, URINARY RETENTION (N=1), TREATMENT: NOT REPORTED, FEVER (N=1), TREATMENT: NOT REPORTED. IN CONCLUSION, THIS PROSPECTIVE COMPARATIVE STUDY DEMON STRATES THAT BOTH E-TEP AND IPOM TECHNIQUES ARE VIABLE OPTIONS FOR LAPAROSCOPIC VENTRAL HERNIA REAPIR. WHILE THE E-TEP APPROACH MAY REDUCE EARLY POSTOPERATIVE PAIN, OPER ATIVE TIME TENDS TO BE LONGER. NO SIGNIFICANT DIFFERENCES WERE OBSERVED IN TERMS OF COMPLICATIONS OR HOSPITAL STAY. FURTHER RESEARCH WITH LARGER COHERTS AND LONG- TERM FOLLOW-UP IS NECESSARY TO FULLY EVALUATE RECURRENCE RATES AND PATIENT- REPORTED OUTCOMES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 268567 | PROLENE POLYPROPYLENE SUTURE | SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE | GAW | ETHICON INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |