Restorelle 501320Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 05708932483223), received between Nov 26, 2021 and Oct 17, 2024 — classified as 12 injuries.

The most frequently reported specific device problem is “Material Protrusion/Extrusion” (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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryOct 17, 2024Adverse 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 A RESTORABLE MESH/ SLING IMPLANTED IN (B)(6) 2021. REPORTEDLY, POST PROCEDURE THE PATIENT EXPERIENCED THE FOLLOWING: CONTINUED PRESSURE IN PERINEUM [WORSE WITH SITTING], DULL PAIN, URINARY COMPLAINTS UNLIKELY RELATED TO COLOPLAST (PAIN WITH VOIDING, STRESS URINARY INCONTINENCE), VAGINAL BLEEDING, VAGINAL PAIN AFTER INTERCOURSE, TENDERNESS ON PALPATION OF VAGINAL VAULT SUTURES AND MESH EXPOSURE. THE SLING WAS TRIMMED IN AUGUST 2022.

  Patient problems: Erosion; Hemorrhage/Blood Loss/Bleeding; Pain; Pelvic Pain

  MAUDE report 20470819 ↗
• InjuryJan 31, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS REMOVED DUE TO MESH EROSION. PATIENT EXPERIENCED PAIN, VAGINAL BLEEDING, DYSPAREUNIA AND A UTI.

  Patient problems: Abnormal Vaginal Discharge; Dyspareunia; Erosion; Fecal Incontinence; Intermenstrual Bleeding; Pain; Pyogenic Infection; Urinary Incontinence; Urinary Tract Infection

  MAUDE report 18619593 ↗
• InjuryMay 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED, LEGAL REPRESENTATIVE STATED THE PATIENT WITH THIS DEVICE EXPERIENCED VAGINAL PAIN, SPOTTING, BACK AND HIP PAIN ON THE RIGHT, PELVIC PAIN, MYOFASCIAL PAIN, MIXED URINARY INCONTINENCE, FEELING OF A CONTINUAL BLADDER INFECTION, DIFFICULTY EMPTYING BLADDER, AND ANTERIOR DISTAL VAGINAL DEVICE EXPOSURE OF 1 CM.

  Patient problems: Erosion; Genital Bleeding; Pain; Urinary Incontinence

  MAUDE report 16996892 ↗
• InjuryFeb 24, 2023Device Appears to Trigger Rejection; Material Protrusion/Extrusion; Device Appears to Trigger Rejection; Material Protrusion/Extrusion

  ADDITIONAL INFORMATION RECEIVED ON 6/12/2023 INDICATES THE PATIENT WAS EXPERIENCING AN ABNORMAL VAGINAL DISCHARGE.

  Patient problems: Abnormal Vaginal Discharge; Dyspareunia; Erosion; Inflammation; Intermenstrual Bleeding; Micturition Urgency; Pain; Pelvic Pain; Prolapse; Scar Tissue; Unspecified Infection; Urinary Frequency / Polyuria; Urinary Incontinence; Urinary Tract Infection

  MAUDE report 16437028 ↗
• InjurySep 17, 2022Material Protrusion/Extrusion; Material Protrusion/Extrusion

  ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REQUIRES REVISION DUE TO EXPOSURE. THE PHYSICIAN PALPATED A DEVICE EXPOSURE AND WANTS TO BRING THE PATIENT IN FOR A REVISION. THE DEVICE REMAINS IMPLANTED AND THE REVISION HAS NOT YET BEEN COMPLETED. NO OTHER ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 15443090 ↗
• InjuryJun 6, 2022Material Protrusion/Extrusion; Material Protrusion/Extrusion

  ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REQUIRES REVISION DUE TO EXPOSURE. THE REVISION PROCEDURE HAS NOT BEEN SCHEDULED YET AND THE DEVICE REMAINS IMPLANTED. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14605090 ↗
• InjuryMay 6, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REQUIRES EXPLANTATION DUE TO EROSION. IT IS UNKNOWN IF THE DEVICE HAS BEEN REMOVED OR IF IT IS STILL IMPLANTED. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Skin Erosion

  MAUDE report 14310225 ↗
• InjuryMar 25, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED, THE PATIENT WITH THIS DEVICE EXPERIENCED SEVERE ABDOMINAL AND PELVIC PAIN, RECURRENT INCONTINENCE, INFECTION, PROLAPSE, DYSPAREUNIA, AND EMBEDDED DEVICE INTO RECTAL TISSUE. THE PATIENT ALSO HAD A BLADDER RESECTION DUE TO DEVICE EROSION INTO THE BLADDER AND VAGINA. IT WAS NOTED THAT THE DEVICE WAS TRIMMED AND REMAINS PARTIALLY IMPLANTED DUE TO FEARS OF ADDITIONAL TRAUMA TO RECTAL TISSUES.

  Patient problems: Dyspareunia; Pain; Prolapse; Skin Erosion; Unspecified Infection; Urinary Incontinence

  MAUDE report 13901398 ↗
• InjuryJan 26, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED, THE PATIENT WITH THIS DEVICE EXPERIENCED DYSPAREUNIA, PELVIC PAIN, GROIN PAIN, VAGINAL PAIN, AND RECURRENT URINARY INCONTINENCE. ADDITIONALLY EROSION AND EXPOSURE WERE NOTED. THIS DEVICE IS STILL IMPLANTED.

  Patient problems: Dyspareunia; Erosion; Pain; Urinary Incontinence

  MAUDE report 13361024 ↗
• InjuryJan 12, 2022Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED THE PATIENT WITH THIS DEVICE EXPERIENCED CHRONIC PAIN AND A FIBROTIC REACTION. IT WAS REPORTED THAT THEY ALSO EXPERIENCED EROSION, RECURRENT INCONTINENCE, CONSTIPATION, AND RECURRENCE OF PELVIC ORGAN PROLAPSE. THE PATIENT HAD MANY REVISION SURGERIES AND HAD THE MESH FULLY REMOVED.

  Patient problems: Abnormal Vaginal Discharge; Abscess; Adhesion(s); Bacterial Infection; Burning Sensation; Constipation; Cramp(s) /Muscle Spasm(s); Dizziness; Erythema; Fibrosis; Genital Bleeding; Inflammation; Itching Sensation; Malaise; Pain; Prolapse; Skin Erosion; Urinary Incontinence; Wound Dehiscence

  MAUDE report 13237147 ↗
• InjuryDec 10, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED, BETWEEN (B)(6)2017-(B)(6)2020: POSTERIOR VAGINAL WALL AND RECTUM TENDERNESS, SPASM OF PELVIC MUSCLES AROUND VAGINA, VAGINAL PAIN, WORST WHEN SHE FIRST URINATES, SPASM OF PELVIC MUSCLES AROUND VAGINA, PELVIC PAIN AND A FEELING THAT HER REPAIR IS SLIPPING, TENDER BLADDER, UTI. PELVIC PAIN, CONSTIPATION (CHRONIC), BLADDER TENDER, TIGHT PELVIC FLOOR MUSCULATURE, TENDER THROUGHOUT PELVIC EXAM. PHYSICAL THERAPY: PELVIC FLOOR MUSCLE HYPERTONUS, PELVIC PAIN, DYSPAREUNIA, INCONTINENCE, MUSCLE SPASMS, PFM PAIN, CONSTIPATION. SEVERE PELVIC PAIN, PELVIC FLOOR SPASM AND BLADDER PAIN. PELVIC FLOOR SPASM AND PAIN. PELVIC PAIN FROM LEVATOR SPASM. VAGINAL PROLAPSE (NO PROLAPSE FELT ON EXAM) REFERRED TO OB-GYN. RECURRENT VAGINAL PROLAPSE (RECTOCELE OR ENTEROCELE) AFTER CAR ACCIDENT, POSTERIOR WALL TENDERNESS NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Bacterial Infection; Dyspareunia; Pain

  MAUDE report 12980791 ↗
• InjuryNov 26, 2021Material Deformation; Adverse Event Without Identified Device or Use Problem; Positioning Problem; Material Deformation; Adverse Event Without Identified Device or Use Problem; Positioning Problem

  ADDITIONAL INFORMATION RECEIVED FURTHER REPORTED THAT BETWEEN (B)(6) 2015 AND (B)(6) 2016 THE PATIENT EXPERIENCED: PELVIC PAIN, BACK PAIN, PAIN AND ADHESIONS FROM THE SLING AND MESH, PAIN IF SITTING OR STANDING TOO LONG, PAINFUL TRANSITION FROM A SITTING OR STANDING POSITION. DAILY PAIN LIMITS THE PATIENT¿S ABILITY TO STAND AND SIT AND WALK. SEVERE BULGE, DYSPAREUNIA, ATROPHY, CHRONIC PELVIC PAIN, PERINEAL PAIN WITH STANDING, TUGGING IN RECTAL AREA. RECTAL PAIN WITH DEFECATION, DIFFICULTY EVACUATING, RECTAL PAIN DURING BOWEL MOVEMENTS, VAGINAL INTERCOURSE, OR LONG PERIODS OF SITTING, TENDERNESS UPON PALPATION OF HYPERTONIC PUBORECTALIS MUSCLE, INTRA-ANAL INTUSSUSCEPTION, DYSSYNERGIA AND LEVATOR SPASM. GENERAL CONSENSUS THE MESH IS MISPLACED AND PULLING ON THE RECTUM. URETHRAL DISCOMFORT WITH SITTING, PERINEAL PAIN WITH STANDING, TUGGING IN THE RECTAL AREA, VAGINAL BULGE: PAIN/TUGGING, DYSPAREUNIA: TIGHT INTROITUS, DECREASED SENSATION, MESH PROMINENT ON DIGITAL RECTAL EXAMINATION, EROSION OF MESH INTO GASTROINTESTINAL TRACT. MRI: SCARRING FROM POSTERIOR VAGINAL FORNIX TO RECTOSIGMOID COLON. PELVIC PAIN, DYSPAREUNIA, RECTAL PAIN, PULLING SENSATION, FEELING OF A BALL IN HER PERINEUM,

  Patient problems: Adhesion(s); Anxiety; Burning Sensation; Cramp(s) /Muscle Spasm(s); Diarrhea; Discomfort; Dyspareunia; Erosion; Fecal Incontinence; Flatus; Intermenstrual Bleeding; Obstruction/Occlusion; Pain; Scar Tissue; Swelling/ Edema; Urinary Incontinence; Urinary Retention

  MAUDE report 12878174 ↗