GYNECARE TVT 810081Recalls & reported problems

Summary

The FDA's MAUDE database contains 629 adverse event reports that list this exact device (DI 10705031000346), received between Nov 22, 2013 and Sep 23, 2026 — classified as 580 injuries, 49 malfunctions.

The most frequently reported specific device problem is “Migration” (233 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 629 reports, in the reporter's own words as published by the FDA.

• InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Back pain; Constipation; Pain; Urinary Frequency / Polyuria; Urinary Tract Infection

  MAUDE report 50874070 ↗
• InjuryApr 30, 2026Adverse Event Without Identified Device or Use Problem

  DIR 135092 RECEIVED FROM TGA IN RELATION TO ETHICON - PROSTHESIS, INCONTINENCE PRODUCT DETAILS PROVIDED: TVTO - PROSTHESIS, INCONTINENCE CLINICAL EVENT INFORMATION: 17/11/2005 - TVTO, ANT AND POST VAGINAL REPAIR, CYSTOSCOPY - {NAME REDACTED} DISCLAIMER: NO FURTHER INFORMATION AVAILABLE AS REPORTER DETAILS HAVE NOT BEEN DISCLOSED (CONFIDENTIAL)."

  Patient problems: Urinary Incontinence

  MAUDE report 25047701 ↗
• InjuryApr 23, 2026Adverse Event Without Identified Device or Use Problem

  "WCQ RECEIVED AN E-MAIL FROM THE ETHICON RISK MANAGER TEAM STATING THE FOLLOWING: IT WAS REPORTED THAT PATIENT UNDERWENT HERNIA REPAIR SURGERY ON AN UNKNOWN DATE IN 2006 AND AN UNK MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT UNDERWENT PARTIAL REMOVAL SURGERY IN 2010 AND 2016. IT WAS REPORTED THAT PATIENT EXPERIENCED PAIN AND BLEEDING. NO ADDITIONAL INFORMATION WAS REPORTED."

  Patient problems: Genital Bleeding; Pain

  MAUDE report 24970391 ↗
• InjuryApr 11, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE WITH MESH ON (B)(6) 2006 AND TVT BEING IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL OF THE PREVIOUSLY IMPLANTED MESH ON (B)(6) 2012. IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAINFUL INTERCOURSE, EXTRUSION, VAGINAL SCARRING, AND PELVIC PAIN. NO ADDITIONAL INFORMATION WAS REPORTED.".

  Patient problems: Pain; Pelvic Pain; Scar Tissue

  MAUDE report 24851506 ↗
• InjuryApr 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2006 AND TVT-O WAS IMPLANTED. IT WAS REPORTED THAT PATIENT UNDERWENT PARTIAL REMOVAL SURGERY IN 2010 AND 2016. IT WAS REPORTED THAT PATIENT EXPERIENCED PAIN AND BLEEDING. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Genital Bleeding; Pain

  MAUDE report 24767200 ↗
• InjuryFeb 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL SURGERY ON (B)(6) 2006 AND TVT AND GYNO-MESH WERE IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN. NO ADDITIONAL INFORMATION WAS REPORTED."

  Patient problems: Pelvic Pain

  MAUDE report 24284767 ↗
• InjuryFeb 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL SURGERY ON 2005 AND TVT-O WAS IMPLANTED. IT WAS REPORTED THAT PATIENT UNDERWENT PATIENT REMOVAL OF MESH IN 2018. IT WAS REPORTED THAT PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 20121. IT WAS REPORTED THAT THE PATIENT EXPERIENCED MESH EROSION, BURNING SENSATION AND PAIN. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Burning Sensation; Erosion; Pelvic Pain

  MAUDE report 24235839 ↗
• InjuryJan 21, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A COMPLAINT REGARDING TVT-CAL-OBTURATOR: IT WAS REPORTED IN A STUDY, A PROSPECTIVE, RANDOMIZED, CONTROLLED TRIAL CONDUCTED BETWEEN 2007 AND 2009 IN SIX TEACHING HOSPITALS IN BELGIUM AND THE NETHERLANDS, WITH A ONE-YEAR FOLLOW-UP. UTI, MESH EROSION. URINARY URGENCY, "CYSTOTOMY" ARE REPORTED.

  Patient problems: Erosion; Urinary Incontinence; Urinary Tract Infection

  MAUDE report 24140790 ↗
• InjuryJan 21, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AN ISSUE CONCERNING THE TRANS OBTURATOR TENSION-FREE VAGINAL TAPE (TVT-O). THE PURPOSE OF THE REPORT WAS TO DEMONSTRATE THAT THE OVERALL SUCCESS RATE OF THE TREATMENT EXCEEDED 75% AMONG WOMEN UNDERGOING TVT-O SURGERY FOR STRESS URINARY INCONTINENCE (SUI). HOWEVER, 5.3% OF PATIENTS EXPERIENCED PAIN, 1% DEVELOPED MESH EROSION, 2.3% EXPERIENCED VOIDING DYSFUNCTION, AND 7% REPORTED ABNORMAL VOIDING AT DISCHARGE.

  Patient problems: Erosion; Pelvic Pain; Urinary Incontinence

  MAUDE report 24139951 ↗
• InjuryJan 21, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT EXPERIENCED URINARY INCONTINENCE SINCE 1992, AND THE TVTO SLING FAILED WITHIN 6 MONTHS OF IMPLANTATION. BY 2019, INCONTINENCE SIGNIFICANTLY WORSENED, REQUIRING FREQUENT NIGHT VOIDING, WHICH NEEDED SURGICAL INTERVENTION

  Patient problems: Genital Bleeding; Stroke/CVA; Urinary Retention; Urinary Tract Infection

  MAUDE report 24135766 ↗
• InjuryOct 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AFTER THE SURGERY, THE PATIENT REMOVED TENSION FREE VAGINAL TAPE - OBTURATOR.

  Patient problems: Erosion; Urinary Incontinence

  MAUDE report 23443451 ↗
• InjuryOct 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AFTER THE SURGERY, THE PATIENT DEVELOPED REPEATED URINARY TRACT INFECTIONS, WHICH REQUIRED TAKING ANTIBIOTICS ALMOST PERMANENTLY AND CAUSED THE PATIENT INTESTINAL PROBLEMS - PAIN IN THE BLADDER, URINE RETENTION, SEVERE FATIGUE, AND A DEPRESSIVE STATE.

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

  MAUDE report 23442643 ↗
• InjuryOct 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A COMPLAINT WAS RECEIVED FROM A DUTCH WOMAN REGARDING THE TVT-O SLING MESH AND TWO PROLENE POLYPROPYLENE MESHES. THIS COMPLAINT PERTAINS TO THE TVT-O DEVICE FROM CALDER MEDICAL, WHILE THE OTHER DEVICE IS DOCUMENTED IN THE ETHICON COMPLAINT SYSTEM UNDER REFERENCE NUMBER (B)(4). THE PATIENT HAD THE TVT-O SLING MESH (LOT NUMBER UNKNOWN) IMPLANTED ON (B)(6) 2014. SHE EXPERIENCED SEVERAL SYMPTOMS, INCLUDING VAGINAL PAIN, PELVIC PAIN, PAIN DURING INTERCOURSE, GROIN PAIN, LEG PAIN, ARM PAIN, VARIABLY ELEVATED CREATINE KINASE (CK) LEVELS, AND FATIGUE. DUE TO THESE ONGOING ISSUES, THE SURGEON REMOVED THE TVT-O VAGINAL SLING AND THE REMNANTS OF THE POSTERIOR RECTOPEXY MESH ON (B)(6) 2025.

  Patient problems: Pain; Pelvic Pain

  MAUDE report 23427479 ↗
• InjuryOct 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT HERNIA REPAIR SURGERY ON (B)(6) 2005, AND GYNECARE TVT-E WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AND PROTRUSION, RECTOCELE, CYSTOCELE, EROSION, AND EXTRUSION. IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2006 AND ANOTHER REMOVAL SURGERY OF MESH ON (B)(6) 2012. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Erosion; Pain; Prolapse

  MAUDE report 23407545 ↗
• InjuryOct 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT HERNIA REPAIR SURGERY ON (B)(6) 2009, DURING WHICH A GYNECARE TVT WAS IMPLANTED. THE PATIENT HAS SINCE EXPERIENCED STRESS INCONTINENCE, PROLAPSE, INFECTION, AND PAIN. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Bacterial Infection; Pain; Prolapse; Urinary Incontinence

  MAUDE report 23393851 ↗
• InjuryOct 23, 2025Adverse 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

  IT WAS REPORTED THAT PATIENT UNDERWENT HERNIA REPAIR SURGERY ON AN UNKNOWN DATE IN 2006 AND AND A MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT UNDERWENT PARTIAL REMOVAL SURGERY IN 2010 AND 2016. IT WAS REPORTED THAT PATIENT EXPERIENCED PAIN AND BLEEDING. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pain

  MAUDE report 23368707 ↗
• InjuryOct 23, 2025Adverse 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

  IT WAS REPORTED BY AN ATTORNEY THAT PATIENT UNDERWENT HERNIA REPAIR SURGERY ON AN UNKNOWN DATE IN 2006 AND A MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT UNDERWENT PARTIAL REMOVAL SURGERY IN 2010 AND 2016. IT WAS REPORTED THAT PATIENT EXPERIENCED PAIN AND BLEEDING. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pain

  MAUDE report 23368705 ↗
• InjuryOct 15, 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) 2011 AND TVT WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN UNKNOWN ADVERSE EVENT. NO ADDITIONAL INFORMATION WAS REPORTED."

  Patient problems: Insufficient Information

  MAUDE report 23296770 ↗
• InjuryOct 15, 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) 2010 AND TVT OBTURATOR WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED STRESS URINARY INCONTINENCE, PAINFUL INTERCOURSE, RECTAL PROLAPSE, INFECTION, URINARY AND BOWEL ISSUES, EROSION, UTERINE PROLAPSE, CYSTOCELE, RECTOCELE, ABDOMINAL PAIN, BLEEDING, BURNING, DISCHARGE, FOUL SMELL AND DISCOMFORT. NO ADDITIONAL INFORMATION WAS REPORTED.".

  Patient problems: Erosion; Pelvic Pain; Urinary Incontinence

  MAUDE report 23292865 ↗
• InjurySep 12, 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) 2011 AND TVT-O WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED CHRONIC PELVIC AND GROIN PAIN, BLADDER DYSFUNCTION, RECURRENT URINARY TRACT INFECTIONS, VAGINAL DISCHARGE, AND SEXUAL DYSFUNCTION. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Pelvic Pain

  MAUDE report 23039879 ↗
• InjurySep 12, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  "PAIN AT THE ROOTS OF THE THIGHS AND VAGINAL PROSTHETIC EXPOSURE OF THE TVT-O TRANSORETHRAL SLING. WALKING WITH CANE. REOPERATION FOR EXPLANTATION OF PROSTHETIC MATERIAL."

  Patient problems: Erosion; Pelvic Pain

  MAUDE report 23039483 ↗
• InjurySep 8, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  "PATIENT IN PERPETUAL SUFFERING CHRONIC CYSTALGIA AND URINARY INFECTIONS VERY PAINFUL: SINCE THE PLACEMENT OF THIS STRIP REPEATED URINARY INFECTIONS, AT LEAST ONE PER MONTH. AND MORE AND MORE CHRONIC CYSTALGIA."

  Patient problems: Incontinence

  MAUDE report 22997148 ↗
• MalfunctionJul 3, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SLING PROCEDURE ON (B)(6) 2025 AND MESH WAS USED. THE MESH WAS USED DURING THE SURGERY, AND THE SURGEON REPORTED THAT IT BROKE WHEN PULLED, MAKING IT IMPOSSIBLE TO USE AND HANG. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22396215 ↗
• InjuryMay 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL SURGICAL PROCEDURE ON (B)(6) 2014 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN UNKNOWN INJURIES. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 22071404 ↗
• InjuryMay 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL SURGICAL PROCEDURE ON (B)(6) 2005 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT SHE EXPERIENCED UNDISCLOSED INJURIES. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 22071172 ↗