GYNECARE TVT EXACT TVTRLRecalls & reported problems

Summary

The FDA's MAUDE database contains 457 adverse event reports that list this exact device (DI 10705031062375), received between Sep 27, 2016 and Sep 17, 2026 — classified as 443 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Migration” (174 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 457 reports, in the reporter's own words as published by the FDA.

• InjurySep 17, 2026Material Erosion

  Patient problems: Bladder Dysfunction; Discomfort; Erosion; Foreign Body In Patient; Urinary Incontinence

  MAUDE report 50808859 ↗
• InjurySep 14, 2026Material Erosion

  Patient problems: Erosion; Pain

  MAUDE report 50765882 ↗
• InjuryMay 14, 2026Adverse Event Without Identified Device or Use Problem

  SEVERE POSTOPERATIVE PAIN TO THE RIGHT OF UROLOGIC SURGERY: TVT IMPLANTATION. INCIDENT REQUIRING HOSPITALIZATION AND A CT SCAN THAT DOES NOT FIND A WOUND IN THE ADJACENT ORGANS AND VISUALIZES A MINIMAL EFFUSION. RECOMMENDATION TO RETURN HOME WITH PRESCRIPTION FOR PAIN MANAGEMENT. EROSION OF THE TVT STRIP AT THE HIGH RIGHT SIDE. COMMENTS PAIN PRESENT IN THE RIGHT LEG FATIGUE AND CHRONIC PAIN NOCTURNAL AWAKENING FOR URGENTRY TENESME EDC SICK STOP CURRENT PATIENT STATUS: NECESSITY OF TWO SURGICAL INTERVENTIONS A FEW WEEKS LATER, TAKING INTO ACCOUNT AN RECURRENCE OF ENDOVESICAL TUMOR LESION, TO AVOID THE RISK OF SPINNING ENDOPERITONEAL UROTHELIAL CELLS. CONVALESCENT PATIENT WITH NEXT POSTOPERATIVE APPOINTMENT IN (B)(6) 2026.

  Patient problems: Erosion; Pain

  MAUDE report 25174648 ↗
• InjuryMay 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA CLINICAL TRIAL PATIENT ESC_2020_03: (B)(6) EXPERIENCE, RIGHT INGUINAL PAIN. RELATIONSHIP TO STUDY DEVICE: POSSIBLE.

  Patient problems: Pain

  MAUDE report 25163059 ↗
• InjuryMay 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA CLINICAL TRIAL PATIENT (B)(6) EXPERIENCE, PAIN IN GROIN AFTER SURGERY. RELATIONSHIP TO STUDY DEVICE: UNLIKELY.

  Patient problems: Pain

  MAUDE report 25116572 ↗
• InjuryApr 30, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT LAPAROSCOPIC PROMONTOFIXATION FOR GRADE 3/4 CYSTOCELE ON (B)(6) 2025 WITH THT BIOSCIENCE PRO SWING PS4 MONOFILAMENT POLYPROPYLENE MESH, REF (B)(4), LOT 24070428. POST-OP RECOVERY WAS UNEVENTFUL WITH NORMAL VOIDING AT DISCHARGE 04/FEB/2025. FOLLOWING SURGERY, PATIENT DEVELOPED UNMASKED STRESS URINARY INCONTINENCE. ON 21/MAR/2025 SHE UNDERWENT RETROPUBIC TVT PROCEDURE WITH GYNECARE TVT EXACT SLING, ETHICON TVTRL, LOT 3944960. INTRA-OPERATIVE CYSTOSCOPY CONFIRMED CORRECT PLACEMENT; PATIENT DISCHARGED (B)(6) 2025 WITH NORMAL VOIDING AND NO POST-VOID RESIDUAL. FOLLOW-UP (B)(6) 2025: URO-SCANNER NORMAL. PATIENT REPORTED PERSISTENT MIXED CONSTIPATION AND RIGHT ILIO-INGUINAL NEUROPATHIC PAIN TREATED WITH LUMBAR TENS. (B)(6) 2026 UROLOGY NOTE: CONTINUED PAIN, CONSTIPATION, AND SIGNIFICANT QUALITY-OF-LIFE IMPACT. PATIENT STATES SHE "NO LONGER GOES OUT" AND IS "SUFFERING AND DEPRESSED FOLLOWING TREATMENT FOR PAIN." NO DEVICE EXPOSURE, EROSION, OR MALFUNCTION DOCUMENTED TO DATE. PATIENT REPORTS ONGOING CHRONIC PAIN AND DEPRESSION FOLLOWING THE TWO IMPLANT PROCEDURES.

  Patient problems: Constipation; Pain

  MAUDE report 25048494 ↗
• InjuryApr 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA CLINICAL TRIAL PATIENT ESC_2020_03: (B)(6) EXPERIENCE, POST OPERATIVE URINARY RETENTION. RELATIONSHIP TO STUDY DEVICE: UNLIKELY.SURGOCAL INTERVENTION PERFORMED ON (B)(6) 2026.

  Patient problems: Urinary Retention

  MAUDE report 25000859 ↗
• InjuryApr 21, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA CLINICAL TRIAL PATIENT (B)(6) THAT PATIENT (B)(6) EXPERIENCED POST-OPERATIVE URINARY RETENTION. THE RELATIONSHIP TO THE STUDY DEVICE IS CONSIDERED UNLIKELY. ON APRIL 21, 2026, IT WAS NOTED THAT A SURGICAL INTERVENTION WAS PERFORMED ON (B)(6) 2026.

  Patient problems: Urinary Retention

  MAUDE report 24942299 ↗
• InjuryApr 13, 2026Adverse Event Without Identified Device or Use Problem

  T WAS REPORTED VIA CLINICAL TRIAL PATIENT ESC (B)(6) EXPERIENCE, URINARY TRACT INFECTION. RELATIONSHIP TO STUDY DEVICE: POSSIBLE.

  Patient problems: Urinary Tract Infection

  MAUDE report 24867459 ↗
• InjuryMar 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA CLINICAL TRIAL PATIENT (B)(6): 01315-061 EXPERIENCE, RESIDUAL URINE. RELATIONSHIP TO STUDY DEVICE: NOT RELATED.

  Patient problems: Urinary Retention

  MAUDE report 24700039 ↗
• InjuryMar 24, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED IN CLINICAL TRIAL ESC_2020_03 THAT PATIENT (B)(6) EXPERIENCED A HEMATOMA, ESTABLISHING A CAUSAL RELATIONSHIP WITH THE STUDY DEVICE.

  Patient problems: Hematoma

  MAUDE report 24675242 ↗
• InjuryMar 4, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA CLINICAL TRIAL PATIENT (B)(6) EXPERIENCE, ER VISIT FOR UTI SYMPTOMS. RELATIONSHIP TO STUDY DEVICE: UNLIKELY.

  Patient problems: Urinary Tract Infection

  MAUDE report 24507051 ↗
• InjuryMar 3, 2026Adverse Event Without Identified Device or Use Problem

  "IT WAS REPORTED VIA CLINICAL TRIAL PATIENT (B)(6) EXPERIENCE, OCCASIONALLY LOSS OF URINE. RELATIONSHIP TO STUDY DEVICE: NOT RELATED." .

  Patient problems: Urinary Retention

  MAUDE report 24501348 ↗
• InjuryMar 3, 2026Material Protrusion/Extrusion; Adverse Event Without Identified Device or Use Problem

  AFTER THE SURGERY, THE PATIENT DEVELOPED A 0.5 CM VAGINAL MESH EXTRUSION UPON EXAMINATION AND EXPERIENCED VAGINAL BLEEDING AND A UTI.

  Patient problems: Intermenstrual Bleeding; Urinary Tract Infection; Vaginal Mucosa Damage

  MAUDE report 24501149 ↗
• InjuryFeb 26, 2026Adverse Event Without Identified Device or Use Problem

  CALDERA MEDICAL RECEIVED AN EMAIL: THIS INCIDENT CONCERNS A 68 YEARS OLD PATIENT WHO UNDERWENT IMPLANTATION OF THIS DEVICE ON (B)(6) 2023. A URETHRAL EROSION OF THE SLING WAS DIAGNOSED REQUIRING SURGICAL REMOVAL ON (B)(6) 2026.

  Patient problems: Dysuria; Erosion; Urinary Incontinence

  MAUDE report 24460842 ↗
• InjuryFeb 24, 2026Adverse Event Without Identified Device or Use Problem

  A PATIENT UNDERWENT A GYNECOLOGICAL SURGICAL PROCEDURE ON (B)(6) 2016, DURING WHICH A TVT EXACT IMPLANT WAS USED. THE PATIENT SUBSEQUENTLY EXPERIENCED A URINARY TRACT INFECTION, LEAKING, AND A BURNING SENSATION. REVISIONAL SURGERY WAS PERFORMED ON (B)(6) 2022, DUE TO MESH EROSION. ON (B)(6) 2023, THE PATIENT UNDERWENT A LEFT-SIDE SLING MESH REMOVAL DUE TO PROTRUSION. A FINAL REMOVAL SURGERY OCCURRED ON (B)(6) 2025, DUE TO INTENSE, STABBING PAIN. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Erosion; Urinary Tract Infection

  MAUDE report 24436584 ↗
• InjuryFeb 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA CLINICAL TRIAL PATIENT (B)(6): 00087-173 EXPERIENCE, URINARY TRACT INFECTION AND POST-OP HEMATOMA. RELATIONSHIP TO STUDY DEVICE: PROBABLE.

  Patient problems: Hematoma; Urinary Tract Infection

  MAUDE report 24416272 ↗
• MalfunctionFeb 17, 2026

  NOT USED POWDER IN THE IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24363999 ↗
• InjuryFeb 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA CLINICAL TRIAL PATIENT (B)(6): (B)(6) EXPERIENCE, POST OPERATIVE URINARY RETENTION. RELATIONSHIP TO STUDY DEVICE: UNLIKELY.

  Patient problems: Urinary Retention

  MAUDE report 24293653 ↗
• MalfunctionJan 28, 2026Manufacturing, Packaging or Shipping Problem

  ETHICON COMPLAINT HANDLING TEAM REPORTED THAT A TVTRL CAME IN THE ORIGINAL PACKAGE WITHOUT TAPE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24202479 ↗
• InjuryJan 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL SURGERY ON (B)(6) 2015 AND TVT-E WAS IMPLANTED. IT WAS REPORTED THAT PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2021. IT WAS REPORTED THE PATIENT EXPERIENCED PROLAPSE AND RECURRENT UTI. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Prolapse; Urinary Tract Infection

  MAUDE report 24190712 ↗
• InjuryJan 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA CLINICAL TRIAL PATIENT (B)(6): EXPERIENCE, VOIDING DYSFUNCTION AND UTI. RELATIONSHIP TO STUDY DEVICE: POSSIBLE.

  Patient problems: Urinary Incontinence; Urinary Tract Infection

  MAUDE report 24185291 ↗
• InjuryJan 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA CLINICAL TRIAL PATIENT (B)(6) EXPERIENCE, RESIDUAL URINE. RELATIONSHIP TO STUDY DEVICE: NOT RELATED.

  Patient problems: Urinary Retention

  MAUDE report 24185097 ↗
• InjuryJan 21, 2026Adverse Event Without Identified Device or Use Problem

  THE 2004 STUDY BY WARD KL AND HILTON P AIMED TO COMPARE THE EFFECTIVENESS OF TVT (USING THE GYNECARE TVT DEVICE) AND COLPOSUSPENSION IN A RANDOMIZED, MULTICENTER TRIAL WITH A 2-YEAR FOLLOW-UP. CYSTOCELE, CERVICAL PROLAPSE, RECTOCELES, URODYNAMIC STRESS INCONTINENCE, SUPRAPUBIC EXTRUATION, UTI ARE REPORTED.

  Patient problems: Cervical Changes; Urinary Incontinence; Urinary Tract Infection

  MAUDE report 24140328 ↗
• InjuryJan 21, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT EXPERIENCED MESH EROSION AFTER USING TVTRL, WHICH REQUIRED INTERVENTION.

  Patient problems: Erosion; Urinary Tract Infection

  MAUDE report 24136714 ↗