Polyform™ M0068402580Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729839224), received between Dec 30, 2019 and Dec 22, 2025 — classified as 4 injuries.

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 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A POLYFORM SYNTHETIC MESH WAS IMPLANTED TO THE PATIENT ON (B)(6) 2022. FOLLOWING THE IMPLANTATION, THE PATIENT SUSTAINED SEVERE, PAINFUL, AND IRREVERSIBLE COMPLICATIONS RELATED TO THE MESH ERODING INTO THE BLADDER AND VAGINA. A 1.3 CM CALCIFIED VESICOVAGINAL FISTULA WAS FIRST IDENTIFIED DURING CYSTOSCOPY ON (B)(6) 2024. ON (B)(6) 2024, A PARTIAL MESH EXCISION WAS MADE BUT DID NOT RESOLVE THE INJURY. A SECOND SURGERY ON (B)(6) 2025, REMOVED A LARGE MASS OF CALCIFIED MESH; HOWEVER, THE FISTULA PERSISTED. ON (B)(6) 2025, THE PATIENT EXPERIENCED A LIFE-THREATENING EPISODE OF URINARY SEPSIS. A THIRD SURGERY ON (B)(6) 2025, ATTEMPTED TO REPAIR THE DAMAGE BUT WAS UNSUCCESSFUL DUE TO EXTENSIVE TISSUE DAMAGE CAUSED BY THE MESH. ON (B)(6) 2025, THE PATIENT WAS HOSPITALIZED FOR FIVE DAYS FOLLOWING ANOTHER EPISODE OF SEPSIS. THE PATIENT WAS SUBSEQUENTLY REFERRED TO A SPECIALIST IN URINARY DIVERSION SURGERY. THE PROCEDURE WAS INITIALLY SCHEDULED FOR (B)(6) 2025 BUT WAS POSTPONED DUE TO A FOUR-DAY SEPSIS EPISODE. ON (B)(6) 2025, URINARY DIVERSION SURGERY WAS PERFORMED, INVOLVING REMOVAL OF THE BLADDER AND URETHRA AND CREATION OF AN INDIANA POUCH. THIS PROCEDURE UTILIZED A SE

  Patient problems: Calcium Deposits/Calcification; Dyspareunia; Erosion; Fistula; Micturition Urgency; Pain; Sepsis; Unspecified Mental, Emotional or Behavioral Problem; Unspecified Tissue Injury; Urinary Tract Infection

  MAUDE report 23865606 ↗
• InjurySep 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A POLYFORM GRAFT IMPLANTED DURING A PROCEDURE AND HAS SINCE EXPERIENCED COMPLICATIONS INCLUDING MESH EXPOSURE, CLOSED-LOOP OBSTRUCTION OF THE SMALL BOWEL, NAUSEA, VOMITING, SEVERE PAIN INCLUDING ABDOMINAL AND BACK PAIN, AND LOSS OF ENJOYMENT OF LIFE. ADDITIONALLY, THE PATIENT CLAIMS THAT SHE HAS SUFFERED, OR MAY IN THE FUTURE SUFFER, DAMAGES SUCH AS PHYSICAL PAIN, MENTAL ANGUISH, PHYSICAL IMPAIRMENT, AND MEDICAL EXPENSES DUE TO THE IMPLANTATION OF THE DEVICE.

  Patient problems: Abdominal Pain; Constipation; Erosion; Fecal Incontinence; Hemorrhage/Blood Loss/Bleeding; Hernia; Insufficient Information; Ischemia; Nausea; Obstruction/Occlusion; Pain; Swelling/ Edema; Unspecified Kidney or Urinary Problem; Unspecified Mental, Emotional or Behavioral Problem; Urinary Incontinence; Vomiting

  MAUDE report 20190717 ↗
• InjuryMar 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THE PATIENT WAS DIAGNOSED WITH VAGINAL PROLAPSE, CYSTOCELE, RECTOCELE, AND STRESS URINARY INCONTINENCE (SUI). SHE WAS IMPLANTED WITH A POLYFORM DEVICE FOR PROLAPSE REPAIR (WITH CONCOMITANT IMPLANT OF ADVANTAGE FIT SLING) ON (B)(6) 2016. AS REPORTED BY THE PATIENT'S ATTORNEY, THE PATIENT UNDERWENT A PROCEDURE FOR REVISION OF THE POLYFORM MESH ON (B)(6) 2017 DUE TO CHRONIC ABDOMINAL PELVIC PAIN. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE.

  Patient problems: No Code Available; Pain

  MAUDE report 9849264 ↗
• InjuryDec 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NOTE: THIS MANUFACTURER REPORT PERTAINS TO THE SECOND OF TWO DEVICES IMPLANTED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANTAGE FIT AND A POLYFORM MESH WERE IMPLANTED ON (B)(6) 2016. AS REPORTED BY THE PATIENT'S ATTORNEY, THE PATIENT EXPERIENCED THE FOLLOWING INJURIES: PAIN, NERVE ENTRAPMENT, EROSION, INFECTION AND MESH REMOVAL. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE.

  Patient problems: Erosion; Nerve Damage; No Code Available; Pain; Unspecified Infection

  MAUDE report 9533730 ↗