GYNECARE TVT 810041BRecalls & reported problems

Summary

The FDA's MAUDE database contains 362 adverse event reports that list this exact device (DI 10705031000322), received between Jan 6, 2016 and Sep 22, 2026 — classified as 360 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Migration” (129 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 362 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• InjuryMar 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA CLINICAL TRIAL PATIENT (B)(4) EXPERIENCE, NEW DYSPAREUNIA. RELATIONSHIP TO STUDY DEVICE: UNLIKELY. ON (B)(6) 2026, IT WAS REPORTED THAT THE PATIENT NEED MEDICAL INTERVENTION.

  Patient problems: Dyspareunia; Pelvic Pain

  MAUDE report 24630351 ↗
• 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) 2009 AND TVT WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED STRESS URINARY INCONTINENCE AND UTERINE PROLAPSE. NO ADDITIONAL INFORMATION WAS REPORTED."

  Patient problems: Urinary Incontinence

  MAUDE report 23293214 ↗
• InjuryMay 21, 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) 2019 AND A MESH WAS IMPLANTED. IT WAS REPORTED THAT SHE EXPERIENCED UNDISCLOSED INJURIES. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 22058995 ↗
• InjuryMar 5, 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 THE PATIENT UNDERWENT A GYNECOLOGICAL SURGICAL PROCEDURE ON (B)(6) 2008 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT SHE EXPERIENCED PAIN. NO ADDITIONLA INFORMATION WAS PROVIDED.

  Patient problems: Pain

  MAUDE report 21532618 ↗
• InjuryJan 26, 2025Migration; Migration

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL SURGICAL PROCEDURE ON (B)(6)2017 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT SHE EXPERIENCED PAIN, 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.

  Patient problems: Erosion; Pain

  MAUDE report 21238200 ↗
• InjuryNov 1, 2024Adverse 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) 2005 AND MESH WAS IMPLANTED. THE PATIENT EXPERIENCED PELVIC PAIN, VAGINAL PAIN, PERINEAL PAIN IN THE RIGHT AND LEFT GROIN THAT DESCEND INTO THE LEGS, NUMBNESS LEGS, DIFFICULTY WALKING, PAIN PELVIS, LOWER BACK MUSCLE PAIN, JOINT PAIN, FIBROMYALGIC, EMERGENCY, INCONTINENCE, PAIN WHEN URINATING, IMPLANT THAT THE PATIENT FEELS MOVING, WALKING DISABILITY AND INCONTINENCE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Ambulation or Postural Difficulties; Autoimmune Disorder; Incontinence; Micturition Urgency; Numbness; Pain

  MAUDE report 20591640 ↗
• InjurySep 16, 2024Migration; Migration

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL SURGICAL PROCEDURE ON (B)(6) 2020 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT SHE EXPERIENCED PAIN, 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: Erosion; Pain

  MAUDE report 20226389 ↗
• InjuryAug 29, 2024Migration; Migration

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL SURGICAL PROCEDURE ON (B)(6) 2010 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT SHE EXPERIENCED PAIN, 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: Erosion; Pain

  MAUDE report 20095884 ↗
• InjuryAug 28, 2024Adverse 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) 2023 AND MESH WAS IMPLANTED FOR STRESS URINARY INCONTINENCE. ON (B)(6) 2024, MODERATE URINARY TRACT INFECTION WAS NOTED. DRUG THERAPY WAS PROVIDED AND THE EVENT WAS RECOVERED/RESOLVED WITHOUT SEQUELAE AS OF (B)(6) 2024. ON (B)(6) 2024, MODERATE VOIDING DYSFUNCTION WAS NOTED. THE EVENTS OF URINARY TRACT INFECTION AND VOIDING DIFFICULTY WERE REPORTED AS HAVING A CAUSAL RELATIONSHIP WITH THE STUDY DEVICE AND STUDY PROCEDURE. AT AN OFFICE VISIT ON (B)(6) 2024, (APPROXIMATELY 6 MONTHS POST-PROCEDURE), THERE WAS DIFFICULTY INITIATING VOID; SOME BLADDER DISCOMFORT, NO URGENCY, NO LEAKAGE OF URINE. THE URINALYSIS WAS NEGATIVE. THE PATIENT HAD 3 UTIS FOLLOWING SURGERY. FLUID INTAKE WAS DISCUSSED AND THE PATIENT WILL KEEP BLADDER DAIRY WITH NORMAL INTAKE AND THEN REDUCED INTAKE. IF VOIDING DIFFICULTY CONTINUES WITH REDUCED INTAKE, WILL CONSIDER SLING REVISION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Discomfort; Unspecified Kidney or Urinary Problem; Urinary Tract Infection

  MAUDE report 20084865 ↗
• InjuryAug 13, 2024Migration; Migration

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL SURGICAL PROCEDURE ON (B)(6) 2016 AND TVT WAS IMPLANTED. IT WAS REPORTED THAT SHE EXPERIENCED PAIN, 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: Erosion; Pain

  MAUDE report 19971864 ↗
• InjuryJun 7, 2024Migration; Migration

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL SURGICAL PROCEDURE ON (B)(6) 2012 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT SHE EXPERIENCED PAIN, 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: Erosion; Pain

  MAUDE report 19488525 ↗
• InjuryJun 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC-ASSISTED TOTAL LAPAROSCOPIC HYSTERECTOMY AND BILATERAL SALPINGO-OOPHORECTOMY ON (B)(6) 2023 AND MESH WAS IMPLANTED FOR STRESS URINARY INCONTINENCE. ON 01 JAN 2024, A MODERATE URINARY TRACT INFECTION WAS NOTED. MACROBID 100 MG BID X 5 DAYS WAS PROVIDED AND THE EVENT WAS RECOVERED/RESOLVED WITHOUT SEQUELAE AS OF 10 JAN 2024. THIS EVENT WAS REPORTED AS POSSIBLY RELATED TO THE STUDY DEVICE AND STUDY PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Urinary Tract Infection

  MAUDE report 19480161 ↗
• InjuryJun 5, 2024Adverse 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) 2023 AND MESH WAS IMPLANTED. ON (B)(6) 2023, THE PATIENT EXPERIENCED MILD POST-OPERATIVE PAIN. STANDARD POST-OP CARE WAS PROVIDED AND NO ADDITIONAL PAIN MEDICATION WAS PRESCRIBED. ON (B)(6) 2024, MODERATE BACK PAIN WAS NOTED. UNSPECIFIED DRUG THERAPY WAS PROVIDED AND MRI WAS PERFORMED. AS OF (B)(6) 2023, NO ADDITIONAL CALLS/COMPLAINTS WERE RECEIVED. THE PATIENT IS SCHEDULED FOR A FOLLOW-UP VISIT ON (B)(6) 2023. THIS EVENT WAS REPORTED AS UNLIKELY RELATED TO THE STUDY DEVICE, BUT POSSIBLY RELATED TO THE STUDY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Pain

  MAUDE report 19472420 ↗
• InjuryMay 8, 2024Adverse 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) 2023 AND MESH WAS IMPLANTED FOR STRESS URINARY INCONTINENCE. ON (B)(6) 2024, MODERATE URINARY TRACT INFECTION WAS NOTED. THE PATIENT WAS TREATED WITH MACROBID AND THE EVENT HAS BEEN RECOVERED/RESOLVED WITHOUT SEQUELAE AS OF (B)(6) 2024. THIS EVENT WAS REPORTED AS POSSIBLY RELATED TO THE STUDY DEVICE AND NOT RELATED TO THE STUDY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Urinary Tract Infection

  MAUDE report 19270877 ↗
• InjuryApr 22, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL SURGICAL PROCEDURE ON (B)(6) 2004 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY IN 2006. IT WAS REPORTED THAT THE PATIENT EXPERIENCED INCONTINENCE, URINARY TRACT INFECTIONS, PAINFUL INTERCOURSE AND DYSURIA. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 19153805 ↗
• InjuryMar 28, 2024Migration; Migration

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL SURGICAL PROCEDURE ON (B)(6) 2012 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT SHE EXPERIENCED PAIN, 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: Erosion; Pain

  MAUDE report 18996168 ↗
• InjuryMar 14, 2024Migration; Migration

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SLING PROCEDURE ON AN UNKNOWN DATE AND MESH WAS IMPLANTED. THE PATIENT EXPERIENCED EXCRUCIATING PAIN, EXTRUSION, MESH EROSION AND IRRITABLE BLADDER. NO FURTHER INFORMATION IS AVAILABLE AS REPORTER DETAILS HAVE NOT BEEN DISCLOSED (CONFIDENTIAL).

  Patient problems: Erosion; Pain; Unspecified Kidney or Urinary Problem

  MAUDE report 18904263 ↗
• InjuryFeb 29, 2024Adverse 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) 2023 AND MESH WAS IMPLANTED. ON (B)(6) 2023, MODERATE URINARY TRACT INFECTION WAS NOTED. UNSPECIFIED DRUG THERAPY WAS PROVIDED AND THE EVENT HAS BEEN RESOLVED AS OF (B)(6) 2023. THIS EVENT WAS REPORTED AS POSSIBLY RELATED TO THE STUDY DEVICE AND STUDY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Urinary Tract Infection

  MAUDE report 18812624 ↗
• InjuryFeb 20, 2024Adverse 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 AN UNKNOWN DATE AND MESH WAS IMPLANTED. THE PATIENT REPORTED EXPERIENCING RECURRENT UTIS, HEMATOMA, DARK URINE DESPITE DRINKING A LOT OF WATER, PAIN DURING INTERCOURSE, DRYNESS, NERVE PAIN IN LEGS AND BACK, LOW IMMUNE SYSTEM, CHRONIC FATIGUE AND BLADDER FULL 4.5L BEFORE SENSATION TO EMPTY URINARY RETENTION. NO FURTHER INFORMATION IS AVAILABLE AS REPORTER DETAILS HAVE NOT BEEN DISCLOSED (CONFIDENTIAL).

  Patient problems: Fatigue; Hematoma; Pain; Unspecified Kidney or Urinary Problem; Urinary Retention; Urinary Tract Infection

  MAUDE report 18739897 ↗
• InjuryFeb 6, 2024Adverse 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) 2018 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Pain

  MAUDE report 18655825 ↗
• InjuryFeb 6, 2024Adverse 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 AN UNKNOWN DATE AND MESH WAS IMPLANTED. THE PATIENT REPORTED HAVING ONLY STOPPED USING VAGINAL ESTROGEN THIS YEAR, 10+ YR HX, EXCRUCIATING LABOR PAINS DURING INTERCOURSE PARTICULARLY DURING AN ORGASM AND BOWEL MOVEMENTS, PELVIC PAIN ONGOING AND UNRELATED CHRONIC BACK PAIN. NO FURTHER INFORMATION IS AVAILABLE AS THE REPORTER DETAILS HAVE NOT BEEN DISCLOSED (CONFIDENTIAL).

  Patient problems: Pain

  MAUDE report 18653179 ↗
• InjuryFeb 5, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL SURGICAL PROCEDURE ON (B)(6) 2010 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Pain

  MAUDE report 18647788 ↗