PILLAR AL 48-2212Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 18257200043224), received between Jul 29, 2019 and Nov 14, 2019 — 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.

• InjuryNov 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF SIGNIFICANT STRESS URINARY INCONTINENCE AND HYPER MOBILITY. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED AN UNSPECIFIED ADVERSE OUTCOME.

  Patient problems: Injury

  MAUDE report 9320151 ↗
• InjuryNov 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF SIGNIFICANT STRESS URINARY INCONTINENCE AND HYPER MOBILITY. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED AN UNSPECIFIED ADVERSE OUTCOME.

  Patient problems: Injury

  MAUDE report 9320149 ↗
• InjuryAug 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF MESH EXTRUSION INCONTINENCE, PELVIC PAIN AND RECURRENT UTI'S. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED URGENCY AND PAIN WITH FULL BLADDER, URGE INCONTINENCE AND THE NEED TO CATHETERIZE TWICE DAILY. POST-OPERATIVE PATIENT TREATMENT INCLUDED SURGICAL INTERVENTION.

  Patient problems: Incontinence; Injury; Micturition Urgency; Pain

  MAUDE report 8899859 ↗
• InjuryJul 29, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF SYMPTOMATIC CYSTOCELE AND ENTEROCELE WITH URINARY STRESS INCONTINENCE. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DYSPAREUNIA WITH VAGINAL CUFF GRANULOMA. POST-OPERATIVE PATIENT TREATMENT INCLUDED ADDITIONAL SURGERY THAT FOUND INTACT CERVIX PRESUMED TO BE RETAINED FROM HYSTERECTOMY DESPITE DOCUMENTATION THAT HYSTERECTOMY HAD BEEN TOTAL.

  Patient problems: Granuloma; Injury; No Code Available

  MAUDE report 8838667 ↗