Polyform™ M0068402590Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729845256), received between Mar 5, 2021 and Jun 13, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Material Twisted/Bent” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLYFORM GRAFT DEVICE WAS IMPLANTED INTO THE PATIENT DURING A REDO MESH AUGMENTED RECTOCELE REPAIR + REDO ROBOTIC ASSISTED LAPAROSCOPIC SACRAL COLPOPEXY PROCEDURE PERFORMED ON (B)(6) 2022, DUE TO RECURRENT RECTOCELE WITH POSTERIOR APICAL VAGINAL PROLAPSE AND HISTORY OF PRIOR ROBOTIC ABDOMINAL SACRO COLPOPEXY WITH MESH, CYSTOCELE REPAIR AND MESH RECTOCELE REPAIR. THE PATIENT TOLERATED THE PROCEDURE WELL WITHOUT ANY COMPLICATIONS AND WAS TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION. AS REPORTED BY THE PATIENT'S ATTORNEY, THE PATIENT EXPERIENCED AN UNKNOWN INJURY.

  Patient problems: Abdominal Pain; Dyspareunia; Hemorrhage/Blood Loss/Bleeding; Insufficient Information; Pain; Scar Tissue; Unspecified Mental, Emotional or Behavioral Problem; Urinary Tract Infection

  MAUDE report 17122455 ↗
• InjuryMar 5, 2021Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem; Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THE PATIENT WAS DIAGNOSED WITH UTERINE PROLAPSE STAGE 3. ON (B)(6) 2019, PATIENT WAS IMPLANTED WITH A POLYFORM MESH DURING A DAVINCI SACROCOLPOHYSTEROPEXY, POSTERIOR REPAIR AND CYSTOSCOPY PROCEDURE. ON (B)(6) 2019, THE PATIENT UNDERWENT REMOVAL OF ABDOMINAL POLYFORM, ABDOMINAL HYSTERECTOMY, BILATERAL SALPINGECTOMY, REMOVAL OF POSTERIOR POLYFORM MESH, POSTERIOR COLPORRHAPHY AND COLPOPERINEORRHAPHY PROCEDURE DUE TO MESH IN THE ABDOMEN FROM THE PREVIOUS ABDOMINAL HYSTEROPEXY, VAGINAL MESH CORDING IN THE POSTERIOR CUL-DE-SAC FROM THE HYSTEROPEXY AND EXTENSION TO THE PERINEUM ALONG THE ENTIRE POSTERIOR SEGMENT OVER THE RECTUM. PATIENT WAS ALSO PRESENTED WITH VAGINAL PAIN, PAIN WITH INTERCOURSE AND FOREIGN MATERIAL IN THE VAGINA. DURING THE PROCEDURE, IT WAS FOUND THAT THERE WAS SOME SCAR TISSUE FROM THE MESH AS WELL AS ADHESIONS OF THE MESH TO THE BLADDER, AROUND AND THROUGH THE RIGHT AND LEFT BROAD LIGAMENTS. THERE WERE ALSO BOWEL ADHESIONS TO THE MESH AS WELL AS "BUNCHED" FOLDED MESH IN THE CUL-DE-SAC AND POSTERIOR VAGINAL WALLS. THE MESH WAS REMOVED WITHOUT INJURY TO THE BOWEL OR BLADDER. PROCEDURE WAS COMPLETED WITH AN ESTIMATED

  Patient problems: Adhesion(s); Dyspareunia; Erosion; Pain; Scar Tissue

  MAUDE report 11419106 ↗