GYNECARE TVT 810081LRecalls & reported problems

Summary

The FDA's MAUDE database contains 371 adverse event reports that list this exact device (DI 10705031062306), received between Mar 8, 2013 and Sep 30, 2026 — classified as 349 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Migration” (108 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 371 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Device Appears to Trigger Rejection

  Patient problems: Erosion; Pain

  MAUDE report 50955036 ↗
• InjurySep 17, 2026Material Erosion

  Patient problems: Abscess; Bacterial Infection; Fistula; Fluid Discharge; Hyperthermia; Urinary Incontinence

  MAUDE report 50811743 ↗
• InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Pelvic Pain

  MAUDE report 50796514 ↗
• InjuryMay 13, 2026Migration

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2011 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT SHE CONTINUED TO EXPERIENCE PAIN, DYSURIA, INFECTIONS, DYSPAREUNIA, EROSION OF HER INTERNAL BODILY TISSUE, AND OTHER INJURIES FOLLOWING THE PROCEDURE. IT WAS REPORTED THAT THE PATIENT HAS UNDERGONE MULTIPLE SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION WAS PROVIDED."

  Patient problems: Dysuria; Pain; Pocket Erosion; Unspecified Infection

  MAUDE report 25159874 ↗
• InjuryMay 8, 2026Adverse Event Without Identified Device or Use Problem

  DIR (B)(4) WAS RECEIVED FROM THE THERAPEUTIC GOODS ADMINISTRATION (TGA) CONCERNING THE TVT[?]O TRANSOBTURATOR MIDURETHRAL SLING INDICATED FOR THE TREATMENT OF URINARY INCONTINENCE. THE DEVICE WAS IMPLANTED ON (B)(6) 2009, WITH NO DATE OF EXPLANTATION PROVIDED. THE PATIENT, WITH A KNOWN HISTORY OF TWO MIDURETHRAL SLING IMPLANTS AND A PRIOR RELATED REPORT FOR THE OTHER SLING, WAS REFERRED FOR INVESTIGATION DUE TO RECURRENT URINARY TRACT INFECTIONS. CLINICAL ASSESSMENT, INCLUDING FLEXIBLE CYSTOSCOPY AND FLUOROSCOPIC URODYNAMIC STUDIES, IDENTIFIED VAGINAL MESH EROSION INVOLVING BOTH MIDURETHRAL SLINGS. BASED ON THESE FINDINGS, EXPLANT SURGERY IS BEING PLANNED. NO ADDITIONAL INFORMATION IS AVAILABLE, AS REPORTER DETAILS HAVE NOT BEEN DISCLOSED FOR CONFIDENTIALITY REASONS. .

  Patient problems: Erosion; Urinary Tract Infection

  MAUDE report 25125999 ↗
• InjuryApr 29, 2026Adverse Event Without Identified Device or Use Problem

  A FEMALE PATIENT UNDERWENT IMPLANTATION OF A TRANS-OBTURATOR TAPE (TOT) SLING ON (B)(6) 2017 FOR STRESS URINARY INCONTINENCE. ON (B)(6) 2025, THE PATIENT PRESENTED WITH INTENSE, LOCALIZED VULVO-VAGINAL PAIN ASSOCIATED WITH A FOLD OF THE TOT MESH EXHIBITING PRE-EROSIVE CHANGES OF THE VAGINAL MUCOSA. FOLLOWING CASE REVIEW AND APPROVAL AT A MULTIDISCIPLINARY URO-GYNECOLOGY MEETING, PARTIAL REMOVAL OF THE SUB-VAGINAL PORTION OF THE TOT STRIP WAS RECOMMENDED. THE PATIENT UNDERWENT PARTIAL EXPLANTATION OF THE DEVICE ON (B)(6) 2026.

  Patient problems: Erosion; Pain

  MAUDE report 25032672 ↗
• InjuryApr 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2011 AND TVT-O WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED INCONTINENCE AND DYSPAREUNIA. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Dyspareunia; Pelvic Pain; Urinary Incontinence

  MAUDE report 24876445 ↗
• InjuryApr 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2002 WITH TVT WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED STRESS URINARY INCONTINENCE; CYSTOCELE; RECTOCELE. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Prolapse; Urinary Incontinence

  MAUDE report 24875546 ↗
• InjuryApr 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD CHRONIC PELVIC PAIN + URETHRAL EROSION DUE TO MALPOSITIONED TOT SLING. MANAGED WITH SURGICAL REMOVAL OF SUBURETHRAL + LEFT ARM OF SLING AND URETHRAL RECONSTRUCTION WITH MARTIUS FLAP. POST-OP COURSE COMPLICATED BY PAIN AND STREPTOCOCCUS INFECTION BUT ULTIMATELY FAVORABLE AT DISCHARGE. MULTIPLE CHRONIC PAIN SYNDROMES REMAIN.

  Patient problems: Erosion; Pelvic Pain

  MAUDE report 24867337 ↗
• InjuryFeb 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED LEG, PELVIS, HIP, LOWER BACK, PAINFUL LEFT, BURN VERY COMPLICATED TO PUT FOOT ON THE FLOOR, COMPLICATION FOR WALKING.

  Patient problems: Burning Sensation; Pelvic Pain

  MAUDE report 24236477 ↗
• InjuryFeb 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD VAGINAL PAIN, MARKEDLY INCREASED DURING SEXUAL INTERCOURSE (MAKING INTERCOURSE IMPOSSIBLE), WITH VAGINAL BLEEDING. RETURNED TO THE OPERATING ROOM ON DATE#1 FOR COVERAGE OF THE TOT SLING BY VULVOVAGINOPLASTY."

  Patient problems: Pelvic Pain; Vaginal Mucosa Damage

  MAUDE report 24236214 ↗
• InjuryJan 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA CLINICAL TRIAL PATIENT (B)(6) EXPERIENCE, MESH EROSION. RELATIONSHIP TO STUDY DEVICE: CAUSAL RELATIONSHIP.

  Patient problems: Erosion

  MAUDE report 24185665 ↗
• InjuryJan 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE IN (B)(6) 2012 AND TVT-O WAS IMPLANTED. IT WAS REPORTED THAT PATIENT EXPERIENCED INFECTIONS, INCONTINENCE AND BACK AND LEG PAIN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Pelvic Pain; Urinary Incontinence; Urinary Tract Infection

  MAUDE report 24185615 ↗
• InjuryJan 15, 2026Adverse Event Without Identified Device or Use Problem

  FEMALE PATIENT WITH A 1-YEAR HISTORY OF PELVIC PAIN, GRAVITY SYMPTOMS, AND URINARY LEAKAGE (EMERGENCY-TYPE INCONTINENCE). KNOWN MYXOMATOUS UTERUS AND PROLAPSE (C2H3R2). CLINICAL HISTORY & INTERVENTIONS: PRE-OPERATIVE: MANUAL KINESITHERAPY (10 SESSIONS) WITH MINIMAL IMPROVEMENT. SURGERY 1 (B)(6) 2021): SUBTOTAL HYSTERECTOMY WITH DOUBLE PROMONTOFIXATION (ANTERIOR & POSTERIOR BANDING) AND IMPLANTATION OF A MICROVAL PLATE (LOT MY52910) FOR PROLAPSE. POST-OPERATIVE: MANUAL PHYSIOTHERAPY WAS PROPOSED BUT NOT PERFORMED DUE TO COVID RESTRICTIONS. SURGERY 2 (B)(6) 2022): IMPLANTATION OF AN ETHICON TVT OBTURATOR (TOT) SLING (LOT 3939733) FOR STAGE 2 STRESS URINARY INCONTINENCE AFTER PRENOTIFICATION. ADVERSE EVENTS & SYMPTOMS: RECURRENT URINARY TRACT INFECTIONS (UTIS). MUSCLE PAIN IN LEGS & LOWER BACK, ESPECIALLY AT NIGHT OR WHEN CLIMBING STAIRS. URINARY RETENTION AND PRONOUNCED URGENCY-TYPE INCONTINENCE (NO LONGER STRESS INCONTINENCE). PHYSICAL COMPLAINTS: LEG & ABDOMINAL MUSCLE/JOINT PAIN, FATIGUE, FREQUENT URINATION, URINE RETENTION, STRONG URINE ODOR, NAUSEA, DIZZINESS, AND LOSS OF BALANCE. INCONTINENCE EPISODES EVERY 3¿4 HOURS DUE TO URGENCY, SEVERELY IMPACTING DAILY AND PROFESSIONAL LIF

  Patient problems: Dizziness; Nausea; Pelvic Pain; Urinary Incontinence; Urinary Retention; Urinary Tract Infection

  MAUDE report 24083032 ↗
• InjuryJan 14, 2026Adverse Event Without Identified Device or Use Problem

  DIR 129257 RECEIVED FROM TGA IN RELATION TO GYNECARE TVT SYSTEM - TRANSOBTURATOR TAPE (MESH) - PROSTHESIS, INCONTINENCE PRODUCT DETAILS PROVIDED: 810081 PART NUMBER: 810081 LOT NUMBER: 3238455 DATE OF IMPLANTATION: (B)(6) 2009 DATE OF EXPLANATION: (B)(6) 2025 ON THE (B)(6) 2025 PATIENT WENT FOR INSERTION OF TVTO + CYSTOSCOPY + POSTERIOR VAGINAL WALL REPAIR + REFASHIONING OF LEFT MINORA. POST PROCEDURE PATIENT EXPERIENCED SLOW URINE FLOW AND FROM APPROXIMATELY 2021 SHE NOTED THERE WERE FEELINGS OF INCOMPLETE EMPTYING. PATIENT WAS ALSO EXPERIENCING PROGRESSIVE PAIN ON COITUS WITH BLEEDING LEADING TO NO COITUS FOR PAST 2 YEARS. PATIENT ALSO EXPERIENCED SOME GROIN PAIN. PATIENT WAS ALSO SUFFERING WITH RECURRENT UTIS AND REQUIRED CEFALEX PROPHYLAXIS. IN (B)(6) 2024, PATIENT HAD AN EXAMINATION UNDER ANESTHESIA, WHICH DEMONSTRATED A URETHRAL EROSION WITH STONE BUILDING INTO A DIVERTICULUM. THIS RESULTED IN THE PATIENT REQUIRING SURGERY AND ON THE (B)(6) 2025 PATIENT HAD A COMPLETE REMOVAL OF TRANSOBTURATOR SLING, URETHRAL RECONSTRUCTION AND CYSTOSCOPY. POST OPERATIVELY FROM TVTO REMOVAL PATIENT HAD FEVERS LIKELY DUE TO INFECTION/COLONISATION OF TVTO AND LEFT FEMORAL NERVE NEUROPRAXIA SECO

  Patient problems: Erosion; Pelvic Pain; Urinary Retention; Urinary Tract Infection

  MAUDE report 24075539 ↗
• InjuryNov 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE EROSION OF THE URINARY SLING IN THE VAGINA HAS BECOME A CONCERN. AS A RESULT, MY PARTNER CAN FEEL THE STRIP, WHICH NEGATIVELY IMPACTS OUR PERSONAL LIFE AND INCREASES THE RISK OF INFECTIONS. THE STRIP IS INEFFECTIVE, LEADING TO A LOSS OF SELF-CONFIDENCE AND A FEAR OF POTENTIAL INFECTIONS AND PAIN.

  Patient problems: Dyspareunia; Erosion; Pain; Urinary Tract Infection

  MAUDE report 23482835 ↗
• InjuryOct 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DIR 109707 WAS RECEIVED FROM TGA REGARDING THE ETHICON PROSTHESIS FOR INCONTINENCE. PRODUCT DETAILS: PRODUCT: TVTO STRESS URINARY INCONTINENCE MESH. DATE OF IMPLANTATION: ON (B)(6) 2011. DATE OF EXPLANATION: ON (B)(6) 2025. CLINICAL EVENT INFORMATION: THE PATIENT UNDERWENT A TVT-O PROCEDURE FOR STRESS INCONTINENCE, WHICH INVOLVES THE INSERTION OF A MID-URETHRAL SLING MESH. THE PATIENT HAS A HISTORY OF CHRONIC CLASSICAL HODGKIN LYMPHOMA (NODULAR SCLEROSIS) AND RECEIVED TREATMENT CONSISTING OF AVD (ADRIAMYCIN, VINBLASTINE, DACTINOMYCIN) CHEMOTHERAPY FOR FOUR CYCLES FOLLOWED BY INTERSTITIAL FIELD RADIATION THERAPY (IF XRT) WITH THE CONDITION RESOLVED. NO FURTHER UNRESOLVED PROBLEMS WERE DOCUMENTED.

  Patient problems: Urinary Incontinence

  MAUDE report 23379737 ↗
• InjurySep 18, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  "PATIENT UNDERWENT 3 OPERATIONS FOR HYSTERECTOMY, CYSTOCELE AND STRIP DATE#1 BY A GYNECOLOGIST WHO GAVE ME NO INFORMATION, NO CONTRAINDICATIONS, NO BOOKLET OR EXPLANATION! HE DECIDED TO PUT THIS STRIP ON ME WITHOUT ME NEEDING IT. CURRENT CONDITION OF THE PATIENT: MUTILATED, WITH SEVERE POSTOPERATIVE COMPLICATIONS, MULTIPLE SURGERIES, MONTHS OF HOSPITALIZATION, AND REHABILITATION AT A SPECIALIZED CENTER. TO DATE, I AM OFFICIALLY RECOGNIZED AS DISABLED BY MDPH AND CPAM. I SUFFER FROM DYSURIA, BLADDER HYPERACTIVITY, AND CAN NO LONGER URINATE SEATED (IT DOES NOT COME OUT); I HAVE TO URINATE STANDING. I CAN NO LONGER WALK, AND I EXPERIENCE DAILY PAIN. I HAVE A PRIORITY CARD AND A PARKING CARD. I CAN NO LONGER WORK EXCEPT REMOTELY. I AM CURRENTLY LOSING MY JOB BECAUSE IT IS IMPOSSIBLE TO WORK FULL-TIME REMOTELY."

  Patient problems: Bladder Dysfunction; Erosion; Pelvic Pain

  MAUDE report 23092529 ↗
• InjurySep 10, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  "PAIN ++ INSIDE LEFT THIGH WITH ALMOST IMPOSSIBLE TO WALK AFTER SURGERY. AT THE ECHO THE STRIP PASSES INTO THE ADDUCTOR. 1 TH SURGICAL RESUMPTION FOR PARTIAL REMOVAL DATE 1. PAIN IN THE BUTTOCKS INDICATING CONFLICT WITH OBTURATORS. 2TH RESUMED FOR NEW PARTIAL WITHDRAWAL ON DATE 2. ALWAYS PAINS ESPECIALLY LEFT BUTTOCK AT PROLONGED SITTING BUT ALSO AT THE LEVEL OF THE INSIDE OF THE LEFT THIGH AND AT WALKING SIMPLE MODERATE PAINS INSIDE THE LEFT THIGH RISING UP IN THE GROIN AND ACCENTUATED IN DESCENT OR UPHILL. VERY DISABLING PAIN. 4 MONTHS OF COMPLETE WORK STOPPAGE AND SINCE MID-JUNE RESUMPTION OF MY PROFESSIONAL ACTIVITY IN THERAPEUTIC HALF-TIME."

  Patient problems: Erosion; Pelvic Pain

  MAUDE report 23022449 ↗
• InjuryAug 26, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  "WCQ RECEIVED AN E-MAIL FROM THE ETHICON RISK MANAGER TEAM STATING THE FOLLOWING: IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL SURGICAL PROCEDURE ON (B)(6) 2009 AND TVT-O WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN UNKNOWN ADVERSE EVENT. NO ADDITIONAL INFORMATION WAS REPORTED."

  Patient problems: Insufficient Information

  MAUDE report 22900335 ↗
• InjuryAug 26, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  DESCRIPTION OF THE INCIDENT: SERIOUS PELVIC PAIN, DIFFICULT TO WALK, REPEATED TENDONITIS, CHRONIC FATIGUE.

  Patient problems: Pelvic Pain

  MAUDE report 22898568 ↗
• InjuryAug 18, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  UPON AWAKENING OF VERY STRONG PAIN IN THE ELDEST RIGHT LEG, IMPOSSIBILITY OF WALKING, LIFTING THE FOOT, DRESSING. DATE#1 AFTER TOT STRIP APPLICATION EXTREMELY SEVERE PAIN OF CRURALGAE/SCIALGIA TYPE. SCANNER, MRI. PERSISTENT SEVERE DISABLING PAIN. REMOVAL OF THE TOT STRIP ON DATE#2 BY DR. (B)(6).

  Patient problems: Pelvic Pain

  MAUDE report 22835370 ↗
• InjuryJul 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SLING PROCEDURE ON (B)(6) 2010 AND MESH WAS IMPLANTED. STRIP TOO TIGHT, REPEATED URINARY INFECTION AND PAIN PELVIS, RIGHT LEG WERE REPORTED. NO FURTHER INFORMATION IS AVAILABLE OR COULD BE OBTAINED AS REPORTER DETAILS HAVE NOT BEEN DISCLOSED (CONFIDENTIAL).

  Patient problems: Pain; Urinary Tract Infection

  MAUDE report 22396756 ↗
• InjuryJun 18, 2025Migration; Migration

  IT WAS REPORTED THAT A PATIENT WITH A HISTORY OF PELVIC STATIC DISORDERS, FIRST OPERATED ON WITH A TOT (TENSION-FREE VAGINAL TAPE) IN 2009 DUE TO STRESS URINARY INCONTINENCE. COMPLETION OF A PROMONTO-FIXATION VIA LAPAROSCOPY WITH MESH FOR PROLAPSE REPAIR, ALONG WITH THE PLACEMENT OF A NEW SUBURETHRAL SLING VIA TOT ON (B)(6) 2023. THE PATIENT QUICKLY EXPERIENCED A NEW DETERIORATION IN URGENCY LEAKS, AS WELL AS THE EMERGENCE OF URINARY INFECTIONS. ON (B)(6) 2024, RE-OPERATED TO REMOVE THE TWO STRIPS (TOT AND TVT) VIA THE VAGINAL ROUTE DUE TO EROSION. ON (B)(6) 2025, PARTIAL REMOVAL OF THE PROMONTO-FIXATION STRIP PLACED IN 2023 AND PLACEMENT OF A URINARY SPHINCTER. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Erosion; Incontinence; Urinary Tract Infection

  MAUDE report 22287419 ↗
• InjuryMay 29, 2025Migration; Migration

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SLING PROCEDURE ON (B)(6) 2013 AND MESH WAS IMPLANTED. VAGINAL EXPOSURE OF MESH WAS NOTED, REQUIRING EXPLANTATION OF DEVICE. NO FURTHER INFORMATION IS AVAILABLE OR COULD BE OBTAINED AS REPORTER DETAILS HAVE NOT BEEN DISCLOSED (CONFIDENTIAL).

  Patient problems: Erosion

  MAUDE report 22110302 ↗