Restorelle 501450Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 05708932484022), received between Aug 3, 2021 and Mar 18, 2025 — classified as 9 injuries.

The most frequently reported specific device problem is “Migration” (2 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. 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryMar 18, 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 A RESTORELLE IMPLANTED IN (B)(6) 2016 AND A RESTORELLE DIRECT FIX IMPLANTED IN (B)(6) 2018. REPORTEDLY, FROM (B)(6) 2016, THE PATIENT EXPERIENCED: UNCONTROLLED PAIN (PERINEAL, ABDOMINAL, VULVAR AND PELVIC) REQUIRING MEDICATION, HYPERTONICITY, RECTAL ADHESIONS, RECURRENT UTI WITH POSITIVE URINE CULTURE, E. COLI, DYSPAREUNIA, URINARY RETENTION REQUIRING CATHETERIZATION, HEMATURIA, NEED FOR BLADDER IRRIGATION, BLADDER SPASMS, VOIDING DYSFUNCTION, DYSURIA, STRESS URINARY INCONTINENCE, DELAYED SENSATIONS TO VOID, VAGINAL DEFECT, PERSISTENT BLOATING AND UNDERWENT SLING EXCISION [RESTORELLE] UNDER GENERAL ANESTHESIA. FROM (B)(6) 2018, THE PATIENT ALSO EXPERIENCED CONTINUED PAIN, URINARY TRACT INFECTIONS, A SMALL AREA OF DEHISCENCE, SMALL DRAINING HEMATOMA, VAGINAL DISCHARGE WITH ODOR AND VAGINAL PRESSURE, CRAMPING, VAGINAL BLEEDING, URINALYSIS POSITIVE FOR NITRITES, LEFT LEG NUMBNESS THAT SUBSIDED, LEFT LEG SWELLING, BLADDER WALL AND SIGMOID COLON THICKENING, NAUSEA AND VOMITING, POKING SENSATION WITH INTERCOURSE, BLEEDING AFTER INTERCOURSE, ANTERIOR BANDING WITH RECURRENT CYSTOCELE, URINARY FREQUENCY, MESH EXPOSURE, VAGINAL W

  Patient problems: Abnormal Vaginal Discharge; Bladder Wall Thickening; Cramp(s) /Muscle Spasm(s); Discomfort; Dyspareunia; Dysuria; Erosion; Hematoma; Hemorrhage/Blood Loss/Bleeding; Impaired Healing; Intermenstrual Bleeding; Nausea; Numbness; Pain; Pelvic Pain; Prolapse; Scar Tissue; Swelling/ Edema; Urinary Frequency / Polyuria; Urinary Incontinence; Urinary Tract Infection; Vomiting; Wound Dehiscence

  MAUDE report 21631914 ↗
• InjuryFeb 10, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED, THE PATIENT HAD A RESTORELLE Y CONTOUR MESH IMPLANTED IN (B)(6) 2017 AND FROM (B)(6) 2017 EXPERIENCED THE FOLLOWING: PARAVAGINAL DEFECT, MUSCLE WEAKNESS, ABSENCE OF BULBOCAVERNOUS/ ANAL WINK REFLEXES, URINARY TRACT INFECTION, E-COLI, ACUTE ON CHRONIC CYSTITIS, PAIN, FOUL SMELLING URINE, ABNORMAL PUDENDAL NERVE LATENCY AND RECURRENT CYSTOCELE/ VAULT PROLAPSE (FAILED PELVIC ORGAN PROLAPSE REPAIR). IN (B)(6) 2019, A RESTORELLE DIRECTFIX MESH WAS USED FOR CYSTOCELE REPAIR. REPORTEDLY, POST PROCEDURE THE PATIENT EXPERIENCED INCISION SEPARATION WITH CHRONIC DISCHARGE, GRANULATION TISSUE, HEMATURIA, RECURRENT URINARY TRACT INFECTIONS, WORSENING PAIN, SUTURE EXTRUSION, TENDERNESS ON PALPATION, INCREASED RESTING TONE OF PELVIC FLOOR MUSCLES, MESH EXPOSURE, DIFFICULTY WALKING, CONSTIPATION WITH DEFECATORY DYSFUNCTION, ANAL SPASM, RECURRENT GRADE 2 CYSTOCELE, FURTHER EXAMINATION UNDER ANESTHESIA, FLAP EXCISION OF MIDLINE VAGINAL MESH EXPOSURE AND PROLENE SUTURES, EUGENOL ALLERGY (COMPONENT OF POLYPROPYLENE), RECURRENT ENTEROCELE AND ULTIMATE MESH EXCISION AND PLACEMENT OF ALLOGRAFT.

  Patient problems: Abnormal Vaginal Discharge; Ambulation or Postural Difficulties; Bacterial Infection; Constipation; Cramp(s) /Muscle Spasm(s); Dyspareunia; Erosion; Hematuria; Hypersensitivity/Allergic reaction; Impaired Healing; Inflammation; Intermenstrual Bleeding; Micturition Urgency; Nervous System Injury; Pain; Prolapse; Scar Tissue; Urinary Frequency / Polyuria; Urinary Tract Infection; Wound Dehiscence

  MAUDE report 21349900 ↗
• InjuryJan 5, 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 16102558 ↗
• InjuryOct 12, 2022Migration; Migration

  AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED, LEGAL REPRESENTATIVE STATED THE PATIENT WAS IMPLANTED WITH A 30X30 CM DEVICE AND A DEVICE FROM ANOTHER MANUFACTURER ON (B)(6) 2016. THE DOCTOR DISSECTED THROUGH THE PATIENT'S VAGINA AT THE LEVEL OF THE MID-URETHRA AND IMPLANTED THE OTHER MANUFACTURERS DEVICE TRANSVAGINALLY USING TROCARS THAT WERE PROVIDED IN THE OTHER MANUFACTURE'S KIT. THE DOCTOR USED THE TROCARS TO FORCE THE OTHER MANUFACTURE'S DEVICE FROM THE VAGINAL INCISIONS INTO THE SUPRAPUBIC INCISIONS. THE TAPE WAS THEN BROUGHT OUT THROUGH THE SKIN INCISIONS DURING CYSTOSCOPY. THE DEVICE WAS TENSIONED, THE PLASTIC SHEATH WAS REMOVED, AND THE DEVICE WAS CUT AT THE LEVEL OF THE SKIN. DURING THE IMPLANT PROCEDURE, THE DOCTOR CUT THE 30X30CM DEVICE INTO A 24X6CM STRIP AND IMPLANTED THE DEVICE THROUGH THE VAGINA FOR CORRECTION OF THE PATIENT'S POSTERIOR PELVIC ORGAN PROLAPSE. THE PROXIMAL PORTION OF THE DEVICE WAS LEFT IN THE RECTOVAGINAL SPACE FOR RETRIEVAL LATER IN THE PROCEDURE. AFTER SUTURING THE DEVICE TRANSVAGINALLY, THE DA VINCI ROBOT VIA ABDOMINAL DISSECTION WAS USED TO ACCESS THE DEVICE LEFT IN THE PATIENT'S POSTERIOR COMPARTMENT DURING THE TRANSVAGINAL PORTION OF THE PROCE

  Patient problems: Abnormal Vaginal Discharge; Burning Sensation; Dyspareunia; Dysuria; Erosion; Intermenstrual Bleeding; Kidney Infection; Nausea; Pain; Prolapse; Scar Tissue; Skin Erosion; Urinary Frequency / Polyuria; Urinary Retention; Vomiting

  MAUDE report 15587200 ↗
• InjuryNov 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED, THE PATIENT EXPERIENCED SEVERE PAIN WITH DAILY ACTIVITIES AND INTERCOURSE, MULTIPLE SEVERE AND PAINFUL INJURES INCLUDING URINARY INCONTINENCE, PHYSICAL DEFORMITY AND THE LOSS OF THE ABILITY TO PERFORM SEXUALLY. THE PATIENT HAD UNDERGONE EXTENSIVE MEDICAL TREATMENT INCLUDING, BUT NOT LIMITED TO, OPERATIONS TO LOCATE AND REMOVE MESH, OPERATIONS TO ATTEMPT TO REPAIR PELVIC ORGANS, TISSUE, AND NERVE DAMAGE, THE USE OF PAIN CONTROL AND OTHER MEDICATIONS, INJECTIONS INTO VARIOUS AREAS OF THE PELVIS, SPINE, AND VAGINA, AND OPERATIONS TO REMOVE PORTIONS OF THE FEMALE GENITALIA. ADDITIONAL INFORMATION RECEIVED REPORTED THAT BETWEEN (B)(6) 2018 AND (B)(6) 2019, THE PATIENT HAD EXPERIENCED OR WAS EXPERIENCING MESH EXTRUSION IN THE UPPER VAGINA, ENTEROCELE, CYSTOCELE, SPOTTING, BLEEDING, DISCHARGE, ODOR, IRRITATION, SWOLLEN LABIA, AND MESH EXPOSED AT CUFF 3X1 CENTIMETER. THE PATIENT UNDERWENT REMOVAL OF THE EXTRUDED MESH AND RE-SUTURING UNDER GENERAL ANESTHESIA. VAGINALLY ERODED MESH AND POSTMENOPAUSAL BLEEDING WERE NOTED.

  Patient problems: Abnormal Vaginal Discharge; Deformity/ Disfigurement; Dyspareunia; Erosion; Genital Bleeding; Nerve Damage; Pain; Prolapse; Sexual Dysfunction; Skin Inflammation/ Irritation; Swelling/ Edema; Urinary Incontinence

  MAUDE report 12832587 ↗
• InjuryOct 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED, PATIENT'S LEGAL REPRESENTATIVE REPORTED PAIN, CHRONIC UTI, VAGINAL BLEEDING, URINARY INCONTINENCE, VAGINAL DISCHARGE, MESH EROSION. ADDITIONAL INFORMATION RECEIVED ON 04/09/2021. PALPABLE MESH, OVERACTIVE BLADDER, CYSTOCELE. (B)(6) 2016 - CHRONIC UTI AFTER ANTERIOR REPAIR. (B)(6) 2016 - ERODED MESH. CYSTOURETHROSCOPY WITH SOUNDING, PELVIC EXAM, EXCISION OF ERODED VAGINAL MESH. SMALL EXPOSED MESH VS SUTURE, VAGINAL BURNING/PAIN. (B)(6) 2016 - CYSTOURETHROSCOPY WITH SOUND PELVIC, MESH EXCISION. (B)(6) 2016 - EROSION. LASER ABLATION OF ERODED MESH AND EXCISION WITH CLOSURE OF THE VAGINAL MUCOSA WITH VAGINOSCOPY AND CYSTOSCOPY. ABDOMINAL PAIN, FEVER, VAGINAL DISCHARGE, POSITIVE BLOOD CULTURES. EXPOSURE, GRADE 1 RECTOCELE AND CYSTOCELE, GRANULATION TISSUE, TENDER RIGHT PROXIMAL LIMB. (B)(6) 2016 - CHRONIC INFLAMMATION AND NECROTIC TISSUE WITH MESH GRAFT EXPOSURE IN THE LEFT ANTERIOR VAGINAL WALL AND PAINFUL RIGHT PROXIMAL GRAFT LIMB WITH PALPABLE ANCHOR. EXCISION OF NECROTIC VAGINAL WALL TISSUE AND MESH GRAFT MATERIAL. PATCH GRAFT WITH A-CELL GRAFT AND EXCISION OF BONE ANCHOR. INFECTED MESH. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Abnormal Vaginal Discharge; Erosion; Genital Bleeding; Pain; Urinary Tract Infection

  MAUDE report 12612104 ↗
• InjurySep 24, 2021Adverse 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

  ADDITIONAL INFORMATION RECEIVED ON 1/29/2023 AS FOLLOWS: THE RESTORELLE DIRECTFIX WAS IMPLANTED ON 9/2/2015. BEGINNING (B)(6) 2015 EXTENDING THROUGH (B)(6) 2019 THE PATIENT AT SOME TIME EXPERIENCED THE FOLLOWING SYMPTOMS, OCCASIONAL PINK DISCHARGE, CRAMPING, VAGINAL DISCHARGE/BLEEDING. A PHYSICAL EXAM FOUND A 3X4 MM MESH EXPOSURE OF ANTERIOR VAGINAL WALL AND A SECOND AREA OF EXPOSURE 1X3 MM MIDLINE, 2CM FROM CUFF. RECURRENT URINARY TRACT INFECTIONS AND GRADE 1 RECTOCELE WERE OBSERVED. AN MRI OF THE PELVIS SUGGESTS EROSION ALONG THE MESH ARM. ON (B)(6) 2018 VAGINAL MESH EXCISION OF THE RESTORELLE DIRECTFIX WAS PERFORMED. BLADDER NECK POLYPS WERE NOTED UNDER GENERAL ANESTHESIA WITH EVIDENCE OF MESH IN THE BLADDER AND TRANSVAGINAL MESH EXPOSURE WAS OBSERVED ALONG WITH ACUTE AND CHRONIC INFLAMMATION AND A FOREIGN BODY REACTION TO REFRACTILE MATERIAL AND ADHERENT MESH. ADDITIONAL SYMPTOMS OBSERVED WERE PURULENT DISCHARGE AND POSSIBLE MESH INFECTION WITH TRACKING OF THE INFECTION ALONG THE MESH ARM TO THE PERINEAL BODY. CT OF THE PELVIS REVEALED COMPLEX FLUID COLLECTION IN THE PELVIS, CONCERNING FOR ABSCESS. PELVIC ABSCESS FOUND ON CT TREATED WITH MEDICATION. TRANSVAGINAL REMOVAL OF ADDI

  Patient problems: Abdominal Cramps; Dyspareunia; Erosion; Foreign Body Reaction; Inflammation; Kidney Infection; Pain; Prolapse; Purulent Discharge; Urinary Incontinence

  MAUDE report 12528155 ↗
• InjurySep 2, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED, ADD'L INFO REC'D 4/23/2021: ON (B)(6) 2018 PELVIC PAIN, UTERINE PROLAPSE. EXAMINATION UNDER ANESTHESIA, TOTAL HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY, EXTENSIVE LYSIS OF ADHESIONS. INTRAOPERATIVE FINDINGS: PALPABLE SUPRIS WITH GOOD SUPPORT, EXTENSIVE BLADDER ADHESIONS FROM PRIOR SUPRIS/ RESTORELLE/ACELL SURGERY, EXTENSIVE PELVIC ADHESIONS, TOTAL UTERINE PROLAPSE WITH CERVIX AND PORTION OF LOWER UTERINE SEGMENT EXTENDING PAST INTROITUS. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Deformity/ Disfigurement; Pain; Sexual Dysfunction; Urinary Incontinence

  MAUDE report 12419025 ↗
• InjuryAug 3, 2021Adverse 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

  ADDITIONAL INFORMATION RECEIVED FURTHER REPORTED THAT ON THE FOLLOWING DATES, THE PATIENT HAD EXPERIENCED OR WAS EXPERIENCING THE FOLLOWING: (B)(6) 2019: VAGINAL GREEN DISCHARGE. FOUND TO HAVE VAGINAL EROSION DUE TO GRANULATION TISSUE, CAUTERIZED WITH SILVER NITRATE. (B)(6) 2019: 2 X 1 CENTIMETER MESH EXPOSURE AT THE ANTERIOR WALL NEAR THE APEX. CAUTERIZED WITH SILVER NITRITE. CONSORTIUM COMPLAINT OF POKING SENSATION DURING INTERCOURSE. (B)(6) 2019: CONTINUED CONSORTIUM COMPLAINT; ANTERIOR VAGINAL WALL EXPOSURE OF THE MESH WITH A PROLENE STITCH AT THE VAGINAL APEX; 1.5 CM X 1.5 CM IN DIMENSION. EXCISED IN THE OFFICE. (B)(6) 2019: SMALL 2 MM PROLENE SUTURE CAN AT THE VAGINAL APEX; 1 MM WIDE AND 4 MM VAGINAL WALL MESH EXPOSURE ON THE ANTERIOR VAGINAL WALL. EXCISED IN THE OFFICE. (B)(6) 2019: UNSPECIFIED BILATERAL LEG PAIN FROM THIGHS TO BOTTOM OF FEET WORSENING OVER 2 WEEKS, WITH INCREASING LOWER BACK PAIN. (B)(6) 2019: CLAIMANT CAN STILL FEEL THE MESH WHEN SHE PUTS HER FINGER IN THE VAGINA. COMPLAINTS OF URINARY INCONTINENCE WITH BOTH STRESS AND URGE. SMALL 2 MM PROLENE SUTURE AT THE VAGINAL APEX. SLIGHT 2 MM WIDE AND 2 MM LONG ANTERIOR VAGINAL WALL MESH EXPOSURE. (B)(6) 2019: EXCIS

  Patient problems: Abnormal Vaginal Discharge; Discomfort; Erosion; Foreign Body Reaction; Genital Bleeding; Micturition Urgency; Pain; Urinary Incontinence; Urinary Tract Infection

  MAUDE report 12269423 ↗