GYNECARE TVTRecalls & reported problems across all models

We found 5 models of GYNECARE TVT by Ethicon Sàrl in the FDA's device registry (GUDID). Together they are named in 1,481 adverse event reports in the FDA's MAUDE database, received between Jan 16, 2013 and Sep 30, 2026 — classified as 1,406 injuries, 75 malfunctions.

The most frequently reported specific device problem is “Migration” (512 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported GYNECARE TVT problems

GYNECARE TVT models

5 models, most reported first. Each model has its own page with its reports, recalls and device details.

• GYNECARE TVT 810081

  mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobturator
  629 reports
• GYNECARE TVT 810081L

  mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobturator
  371 reports
• GYNECARE TVT 810041B

  mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobturator
  362 reports
• GYNECARE TVT 810041A

  mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobturator
  98 reports
• GYNECARE TVT 810041BL

  mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobturator
  21 reports

Recent GYNECARE TVT adverse event reports

The 15 most recent reports across all models, 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 23, 2026Adverse Event Without Identified Device or Use Problem

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

  MAUDE report 50874070 ↗
• InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient underwent a Gynecare TVT implant procedure and had a favorable outcome of spontaneous urination without difficulty or recurrence of incontinence. However, for a few months, the patient experienced the reappearance of a more marked emergency, associated with malodorous vaginal discharge. Endoscopic exploration was therefore programmed to eliminate erosion of the strip. In (b)(6) 2022, the patient had a clinical examination and the presence of anterior vaginal erosion, facing the urethra measuring approximately 1 cm wide by 4 mm high, with a strip that was visible. In (b)(6) 2025, the patient had a cystoscopy and vaginoscopy. It was found that the patient had an absence of involvement of urethra and bladder and an absence of other areas of erosion or associated abnormality. It was decided to proceed to an excision of the exposed strip fragment, associated with vaginal covering. The patient was informed of the risk of recurrence of urinary incontinence following this procedure. It was also noted that the patient has multiple sclerosis and is currently taking Ocrevus. In addition, the patient is autonomous in walking, has a known neuro-bladder, and mixe

  Patient problems: Abnormal Vaginal Discharge; Erosion; Urinary Incontinence

  MAUDE report 50855761 ↗
• InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Erosion; Pain

  MAUDE report 50855267 ↗
• 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 14, 2026Adverse Event Without Identified Device or Use Problem

  (B)(6) RECEIVED AN E-MAIL FROM THE ETHICON RISK MANAGER TEAM STATING THE FOLLOWING: IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2012 AND TVT-O WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED PELVIC PAIN, HIP PAIN, BACK PAIN, ABDOMEN PAIN, FREQUENT URINARY TRACT INFECTIONS, URINARY INCONTINENCE, AND BOWEL INCONTINENCE, VAGINAL PROLAPSE AND PAIN DURING INTERCOURSE. NO ADDITIONAL INFORMATION WAS REPORTED.

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

  MAUDE report 25173907 ↗
• InjuryMay 14, 2026Adverse Event Without Identified Device or Use Problem

  A 55-YEAR-OLD FEMALE PATIENT BEING TREATED FOR MULTIPLE SCLEROSIS COMPLICATED BY NEUROGENIC BLADDER, PRESENTING WITH MIXED URINARY INCONTINENCE - PREDOMINANTLY STRESS INCONTINENCE[?]ASSOCIATED WITH URGE INCONTINENCE. IN THIS CONTEXT, A TVT-TYPE SUBURETHRAL SLING WAS IMPLANTED IN APRIL 2022. THE COURSE OF THE CONDITION WAS MARKED IN 2025 BY THE DEVELOPMENT OF SLING EROSION AT THE LEVEL OF THE ANTERIOR VAGINAL WALL. SURGICAL MANAGEMENT WAS PERFORMED ON (B)(6) 2025, CONSISTING OF PARTIAL REMOVAL OF THE SLING VIA THE VAGINAL ROUTE WITH EXCISION OF 12 MM OF SUBURETHRAL MATERIAL. SUBSEQUENTLY, ON (B)(6) 2026, A RECURRENCE WAS OBSERVED WITH BILATERAL EROSION OF THE SLING ON EITHER SIDE OF THE URETHRA, ASSOCIATED WITH PROTRUSION OF A FEW MILLIMETERS OF SLING INTO THE VAGINA ON EACH SIDE. IN LIGHT OF THIS PERSISTENT COMPLICATION, THE DECISION WAS MADE TO PROCEED WITH COMPLETE REMOVAL OF THE DEVICE. A ROBOT-ASSISTED LAPAROSCOPIC PROCEDURE TO REMOVE BOTH ARMS OF THE SLING WAS PERFORMED ON (B)(6) 2026. THE DEVICE IS AVAILABLE AT THE HOSPITAL PITIÉ-SALPETRIÈRE AND IN WAITING TO BE RETURNED.

  Patient problems: Erosion

  MAUDE report 25166880 ↗
• 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 ↗
• InjuryMay 7, 2026Adverse Event Without Identified Device or Use Problem

  A PATIENT REPORTED: THE IMPLANT WAS PERFORMED ON (B)(6) 2023, AND IMMEDIATELY UPON AWAKENING FROM THE PROCEDURE I EXPERIENCED SEVERE PAIN IN THE RIGHT GROIN, ALONG WITH DIFFICULTY STANDING AND EMPTYING MY BLADDER. THIS PAIN HAS NEVER RESOLVED AND HAS PROGRESSIVELY SPREAD INTO MY HIP, DOWN MY THIGH, AND BELOW THE KNEE. DESPITE NUMEROUS TREATMENTS ATTEMPTED FOR PAIN RELIEF, NONE HAVE BEEN EFFECTIVE, AND I AM CURRENTLY ON MORPHINE. MY FUNCTIONAL CAPACITY IS SEVERELY LIMITED: I CAN STAND FOR NO MORE THAN 15 MINUTES AND WALK FOR ONLY 5 MINUTES, WHILE SITTING OR LYING DOWN IS EXTREMELY PAINFUL AND CAUSES SEVERE INSOMNIA. AT NIGHT, I AM FORCED TO CHANGE POSITION EVERY TWO HOURS BECAUSE I CANNOT TOLERATE MAINTAINING ANY POSTURE. FOR OUTDOOR MOBILITY, I MUST USE A MANUAL WHEELCHAIR. I ALSO SUFFER FROM UNBEARABLE PAIN AND SIGNIFICANT DIFFICULTY WITH URINATION. SUBSEQUENT MEDICAL EXAMINATIONS REVEALED A LARGE LONGITUDINAL EROSION OF THE URETER, AND A BLUE STRIP IS VISIBLE BY TRANSPARENCY THROUGH THE VAGINAL WALL. SINCE THIS INTERVENTION, WHICH WAS PRESENTED AS SAFE AND QUICK, MY QUALITY OF LIFE HAS BEEN DEVASTATINGLY ALTERED, AND MY LIFE AS A WIFE AND MOTHER OF FOUR CHILDREN HAS BEEN PROFOUND

  Patient problems: Erosion; Pain; Urinary Retention

  MAUDE report 25115503 ↗
• 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 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 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 20, 2026Malposition of Device

  A PATIENT REPORTED: FOR 1 YEAR FOLLOWING IMPLANTATION OF THE SECOND STRIPS OF TVT, THE PATIENT EXPERIENCED RECURRENT URINARY INFECTIONS, INCLUDING 4 EPISODES OF PYELONEPHRITIS, AFTER HER 2ND DELIVERY; THERE WAS FOLLOW-UP WITH NUMEROUS EXAMINATIONS AND ANTIBIOTIC TREATMENTS FROM 2010 TO 2013, FOLLOWED BY A PERIOD OF CALM. RIGHT INGUINAL FOSSA PAIN AND DYSPAREUNIA HAVE BEEN PRESENT SINCE 2016, ALONG WITH DISCOMFORT WITH WALKING AND SPORTS SINCE 2016. THE PATIENT REPORTS RECURRENT INFECTIONS, WITH 15 EPISODES IN 9 MONTHS. EVALUATION IS CURRENTLY IN PROGRESS AND HAS VISUALIZED ONE STRIP IN THE URETHRAL MUCOSA, WHILE THE OTHER IS CONSIDERED INEFFECTIVE DUE TO MISORIENTATION.

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

  MAUDE report 24927282 ↗

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