Restorelle 501460Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 05708932484084), received between Nov 27, 2019 and Sep 5, 2025 — classified as 7 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjurySep 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED: THE PATIENT HAD AN UNKNOWN TVT [TRANSVAGINAL TAPE] IMPLANTED IN 2013 AND A RESTORELLE DIRECT FIX IMPLANTED IN 2015. REPORTEDLY FROM 2019, THE PATIENT EXPERIENCED RIGHT FLANK PAIN, ABDOMINAL PAIN, MICROHEMATURIA, FREQUENCY, INCONTINENCE, PELVIC PAIN, URGENCY, HYPERTONICITY OF BLADDER, VAGINITIS, INFLAMMATION, POSTCOITAL BLEEDING, ABNORMAL VAGINAL BLEEDING, DETRUSOR HYPERREFLEXIA OF BLADDER, PAIN DURING SEX, OVERACTIVE BLADDER, BROWN VAGINAL DISCHARGE, BACTERIAL VAGINOSIS, ODOR, ATYPICAL GLANDULAR CELLS, BACTERIA MORPHOLOGICAL CONSISTENT WITH ACTINOMYCES SPECIES INFECTION, STRESS URINARY INCONTINENCE, EXPOSURE OF VAGINAL MESH THROUGH VAGINAL WALL, RECURRENT RECTOCELE AND SCARRING. THE PATIENT UNDERWENT EXCISION OF EXPOSED VAGINAL MESH AND POSTERIOR COLPORRHAPHY VIA GENERAL ANESTHESIA. PATHOLOGY SHOWED SURGICAL MESH WITH ATTACHED INFLAMMATORY DEBRIS AND BACTERIAL COLONIES. POST EXCISION, THE PATIENT REPORTEDLY EXPERIENCED SPOTTING, MILD BLEEDING FROM PROLONGED STANDING, RECURRENT MESH EXPOSURE, PARTNER DYSPAREUNIA AND OVERACTIVE SYMPTOMS.

  Patient problems: Abdominal Pain; Abnormal Vaginal Discharge; Abnormal scarring; Bacterial Infection; Cramp(s) /Muscle Spasm(s); Dyspareunia; Erosion; Hematuria; Inflammation; Intermenstrual Bleeding; Micturition Urgency; Pain; Pelvic Pain; Prolapse; Urinary Frequency / Polyuria; Urinary Incontinence

  MAUDE report 22984454 ↗
• InjuryApr 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED, THE PATIENT REPORTEDLY HAD AN ALTIS AND RESTORELLE DIRECTFIX IMPLANTED. THE PATIENT REPORTEDLY EXPERIENCED BLADDER SLING EROSION COMING FROM THE RIGHT VAGINAL WALL WITH A FOUL SMELL COMING FROM THE ERODED SLING, MESH EROSION, AND SEVERE GROIN PAIN RADIATING DOWN THE LEGS. EXCISION OF THE ALTIS SLING WAS PERFORMED UNDER GENERAL ANESTHESIA.

  Patient problems: Erosion; Pain; Wound Odor

  MAUDE report 21767713 ↗
• InjuryJan 6, 2023Migration; Migration

  AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED, LEGAL REPRESENTATIVE STATED THE PATIENT WITH THIS DEVICE EXPERIENCED WORSENING PELVIC PAIN, DIFFICULTY WITH VOIDING, RECURRENT URINARY TRACT INFECTIONS AND URGE INCONTINENCE. PATIENT HAD EXPLANTATION AND REVISION OF THE DEVICE, VAGINAL PARAVAGINAL REPAIR WITH XENOGRAFT, POSTERIOR REPAIR AND PERINEORRHAPHY, CYSTOURETHROSCOPY, AND EXCISION OF LABIAL CYST UNDER GENERAL ANESTHESIA. INTRAOPERATIVE FINDINGS NOTED A GRADE 2-3 CYSTOCELE, BILATERAL PARAVAGINAL DEFECTS AND WEAKENED PELVIC TISSUE. PATIENT WAS NOTED TO HAVE A STAGE II RECTOCELE AFTER PORTIONS OF THE DEVICE WERE EXPLANTED. ON EXAM, A 5 MM LINEAR DEVICE EXPOSURE ON THE POSTERIOR APICAL WALL WAS NOTED.

  Patient problems: Cyst(s); Erosion; Micturition Urgency; Muscle Weakness/Atrophy; Pain; Prolapse; Urinary Retention; Urinary Tract Infection

  MAUDE report 16112103 ↗
• InjuryOct 20, 2022Migration or Expulsion of Device; Migration or Expulsion of Device

  AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED, LEGAL REPRESENTATIVE STATED THE PATIENT WITH THIS DEVICE EXPERIENCED SEVERE PELVIC PAIN AND EXTRUSION OF THE DEVICE. THE PATIENT HAD REVISION OF THE DEVICE DUE TO EROSION INTO THE VAGINAL CANAL AND TO PREVENT FURTHER DAMAGE.

  Patient problems: Erosion; Micturition Urgency; Pain

  MAUDE report 15638059 ↗
• InjuryAug 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED AS FOLLOWS: PINK VAGINAL DISCHARGE, CHILLS, URINARY TRACT INFECTION (+) MIXED FLORA (MULTIPLE SPECIES PRESENT), HEMATURIA, DYSURIA, CONSTIPATION, HEMATOCHEZIA, NAUSEA/VOMITING. WEIGHT LOSS (DOWN TO 104 LBS) DUE TO INABILITY TO EAT DUE TO PAIN. LUMBAR DISCOGENIC PAIN, MYALGIA, MYOSITIS, RADICULOPATHY. PUDENDAL NEURALGIA, DYSPAREUNIA, PAIN AT THE END OF URINATION.

  Patient problems: Abdominal Pain; Abnormal Vaginal Discharge; Chills; Constipation; Decreased Appetite; Dyspareunia; Dysuria; Hematuria; Incontinence; Muscle Weakness/Atrophy; Myalgia; Nausea; Pain; Prolapse; Urinary Tract Infection; Weight Changes

  MAUDE report 12380924 ↗
• InjuryJul 20, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE PATIENT WITH THIS DEVICE EXPERIENCED INTER ALIA, SEVERE PAIN WITH DAILY ACTIVITIES, AND INTERCOURSE. THE PATIENT SUFFERED SEVERE EMOTIONAL PAIN AND INJURY INCLUSIVE OF URINARY INCONTINENCE, PHYSICAL DEFORMITY, AND THE LOSS OF ABILITY TO PERFORM SEXUALLY.

  Patient problems: Adhesion(s); Deformity/ Disfigurement; Dyspareunia; Emotional Changes; Pain; Prolapse; Urinary Incontinence

  MAUDE report 12196743 ↗
• InjuryNov 27, 2019Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AS REPORTED TO COLOPLAST THOUGH NOT VERIFIED, PATIENT'S LEGAL REPRESENTATIVE STATED PLAINTIFF SUFFERED SERIOUS BODILY INJURIES, INCLUDING, BUT NOT LIMITED TO, FOREIGN BODY REACTION, MESH PROTRUSION, MESH EROSION, PELVIC PAIN, BOWEL PROBLEMS, URINARY PROBLEMS AND OTHER INJURIES.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Erosion; Foreign Body Reaction; Injury; No Information; Pain; Prolapse

  MAUDE report 9386481 ↗