PROLENE PMXLRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705031049062), received between May 30, 2019 and Dec 14, 2022 — classified as 4 injuries.

The most frequently reported specific device problem is “Migration” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryDec 14, 2022Migration; Migration

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PELVIC ORGAN PROLAPSE WITH TRANSABDOMINAL PROCEDURE ON AN UNKNOWN DATE IN 2008 AND MESH WAS IMPLANTED. THE PATIENT REPORTED THAT THE INFECTED MESH WAS FOUND TO HAVE ERODED INTO THE BOWEL CAUSING A FISTULA AND THE BOWEL TO PERFORATE. FOLLOWING THE PROCEDURE, THE PATIENT REPORTED WAKING UP WITH AN ILEOSTOMY BAG WHICH WAS REPORTED TO BE GIVEN TO HER TO SAVE HER LIFE. THE PATIENT FURTHER REPORTED SPENDING A MONTH IN THE HOSPITAL AFTER THAT SURGERY. ABOUT FOUR DAYS AFTER DISCHARGE, THE PATIENT REPORTED THAT HER BODY REJECTED A COLONIC STENT THAT WAS PUT IN TO HELP WITH WIDENING COLON UNTIL ILEOSTOMY BAG COULD BE REVERSED. THE PATIENT SPENT ANOTHER WEEK IN THE HOSPITAL AFTER THAT. THE PATIENT HAD THE ILEOSTOMY BAG FOR FIVE MONTHS AND REPORTED NON-STOP STOMA BURNS FROM THE WAY THE ILEOSTOMY WAS SITUATED AND ALSO HAD A VERY HIGH OUTPUT BAG. THE PATIENT UNDERWENT REVERSAL OF ILEOSTOMY ON AN UNKNOWN DATE AND SPENT OVER A WEEK AND A HALF IN THE HOSPITAL. THE PATIENT REPORTED BEING ADMITTED AGAIN WITH PAIN AND FOUND OUT THERE WAS A BLOCKAGE AND OTHER UNSPECIFIED CONCERNS. THE BLOCKAGE WAS TREATED IN HOSPITAL AND IT WAS THEN DECIDED TO PERFORM AN OPEN

  Patient problems: Burning Sensation; Distress; Erosion; Fistula; Incontinence; Obstruction/Occlusion; Pain; Perforation; Unspecified Infection

  MAUDE report 15978029 ↗
• InjuryNov 2, 2021Migration; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL SURGICAL PROCEDURE ON (B)(6) 2007 AND TVT PROLENE AND TVT SECUR WERE IMPLANTED. IT WAS REPORTED THAT SHE EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES FOLLOWING THE PROCEDURE. IT WAS REPORTED THAT THE PATIENT HAS UNDERGONE MULTIPLE SURGERIES AND REVISIONARY PROCEDURES.

  Patient problems: Erosion; Pain

  MAUDE report 12741443 ↗
• InjuryNov 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT HERNIA REPAIR SURGERY ON (B)(6) 2020 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT RECURRENT SURGERY ON (B)(6) 2020. IT WAS REPORTED THAT THE PATIENT EXPERIENCED CHRONIC PAIN, INFLAMMATION, SWELLING, BOWEL OBSTRUCTION AND GASTROINTESTINAL MALFUNCTION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Inflammation; Obstruction/Occlusion; Pain; Swelling/ Edema

  MAUDE report 12727562 ↗
• InjuryMay 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL SURGICAL PROCEDURE ON (B)(6) 2010 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT UNDERWENT CONCURRENT SALPINGO-OOPHORECTOMY PROCEDURE. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED SMALL BOWEL OBSTRUCTION. IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2011. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Not Applicable; Obstruction/Occlusion

  MAUDE report 8656355 ↗