PROLENE SPMSRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705031050495), received between Aug 30, 2018 and Jul 20, 2023 — classified as 5 injuries.

The most frequently reported specific device problem is “Migration” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJul 20, 2023Adverse 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 EXCISION OF THE CHRONIC SINUS TRACT AND MESH WAS IMPLANTED ON (B)(6) 2020. IT WAS REPORTED THAT THE PATIENT EXPERIENCED CHRONIC DRAINING SINUS AND INFECTED MESH. IT WAS REPORTED THAT THE PATIENT HAD HERNIA REPAIR SURGERY ON (B)(6) 2018, AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT HAD LOCAL WOUND EXPLORATION ON (B)(6) 2019, DUE TO WOUND INFECTION AND ABSCESS. OTHER PROCEDURE WAS CAPTURED IN A SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED ADDED.

  Patient problems: Fluid Discharge; Unspecified Infection

  MAUDE report 17368408 ↗
• InjuryOct 11, 2022Migration; Migration

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL SURGICAL PROCEDURE ON (B)(6) 2005 FOR POSTERIOR COLPORRHAPHY WITH MESH AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED PELVIC PAIN, DYSPAREUNIA AND BLADDER INFECTIONS. IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY ON(B)(6) 2021 FOR EXCISION OF POSTERIOR VAGINAL WALL MESH EXPOSURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Erosion; Pain; Unspecified Infection

  MAUDE report 15577838 ↗
• InjuryNov 15, 2021Migration; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL SURGICAL PROCEDURE ON (B)(6) 2005 AND PROLENE WAS 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. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Erosion; Pain

  MAUDE report 12817863 ↗
• InjuryNov 2, 2021Migration; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL SURGICAL PROCEDURE ON (B)(6) 2008 AND PROLENE WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AND EROSION OF HER INTERNAL BODILY TISSUE. IT WAS REPORTED THAT THE PATIENT HAS UNDERGONE MULTIPLE SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Erosion; Pain

  MAUDE report 12741400 ↗
• InjuryAug 30, 2018Adverse 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 RECURRENT LEFT DIRECT INGUINAL HERNIA REPAIR SURGERY ON (B)(6) 2007 AND MESH WAS IMPLANTED. ADDITIONAL INFORMATION WAS PROVIDED THAT THE PATIENT UNDERWENT SURGERY ON (B)(6) 2017 FOR LEFT INGUINAL HERNIA ¿WITH DEFECT THROUGH THE CENTER OF THE MESH AND SMALL BOWEL RESECTION, EXCISING EIGHT INCHES OF ISCHEMIC SMALL INTESTINE.¿ NO ADDITIONAL INFORMATION IS PROVIDED.

  Patient problems: Hernia; Ischemia

  MAUDE report 7835934 ↗