GYNECARE TVT ABBREVO TVTOMLRecalls & reported problems

Summary

The FDA's MAUDE database contains 129 adverse event reports that list this exact device (DI 10705031062368), received between Nov 21, 2017 and Mar 30, 2026 — classified as 108 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Migration” (40 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 129 reports, in the reporter's own words as published by the FDA.

• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL SURGICAL PROCEDURE ON (B)(6) 2015 AND TVT-ABBREVO 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 REPORTED.

  Patient problems: Erosion; Pain

  MAUDE report 24715956 ↗
• InjuryJan 26, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Conjunctival Hemorrhage

  MAUDE report 24185768 ↗
• InjuryJan 21, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT EXPERIENCED "MEDICATION REQUIRED; VAGINAL DISCHARGE; INFLAMMATION; TISSUE EROSION ASSOCIATED WITH DEVICE; CHRONIC PAIN; DISCOMFORT" AFTER THE DEVICE WAS IMPLANTED.

  Patient problems: Abnormal Vaginal Discharge; Discomfort; Erosion; Inflammation; Pelvic Pain

  MAUDE report 24136110 ↗
• InjuryOct 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN EMAIL WAS RECEIVED FROM THE ETHICON RISK MANAGER TEAM INDICATING THAT THE PATIENT UNDERWENT HERNIA REPAIR SURGERY ON (B)(6) 2014, DURING WHICH A TVT (TENSION-FREE VAGINAL TAPE) WAS IMPLANTED. THE REPORT NOTED THAT THE PATIENT EXPERIENCED PAIN AND A RECURRENCE OF THE HERNIA. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Hernia; Pain

  MAUDE report 23380405 ↗
• InjuryOct 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA CLINICAL TRIAL PATIENT (B)(6) EXPERIENCE; BACTERIAL VAGINOSIS. RELATIONSHIP TO STUDY DEVICE: POSSIBLE.

  Patient problems: Bacterial Infection

  MAUDE report 23375761 ↗
• InjuryOct 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PLACEMENT OF AN EXACT TVT-TYPE RETROPUBIC STRIP WAS PERFORMED ON (B)(6) 2024. RECENTLY, THERE HAS BEEN AN UNFAVORABLE DEVELOPMENT IN URINARY STATUS, WITH A PROGRESSIVE DETERIORATION IN CONTINENCE. CURRENTLY, THE PATIENT REQUIRES A URINARY PROTECTION DEVICE DURING THE DAY, WHICH IS USUALLY SATURATED BY THE END OF THE DAY, AND THERE IS NO NIGHT PROTECTION IN PLACE. SIGNIFICANT LEAKS OCCUR DURING PHYSICAL EXERTION, ESPECIALLY DURING MOBILIZATION. THE PATIENT ALSO EXPERIENCES DYSURIA AND REQUIRES ABDOMINAL PRESSURE TO INITIATE URINATION. URGENCY IS NOTED AS MARKED (++). THE STRIP WAS SUBSEQUENTLY REMOVED, AND AN AMS 800 ARTIFICIAL URINARY SPHINCTER WAS INSERTED. ON (B)(6) 2025, THE ARTIFICIAL SPHINCTER WAS IMPLANTED.

  Patient problems: Pain; Urinary Incontinence

  MAUDE report 23375600 ↗
• InjuryOct 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT CLINICAL TRIAL PATIENT (B)(6) EXPERIENCED VAGINAL TAPE EROSION, WITH A PROBABLE RELATIONSHIP TO THE STUDY DEVICE.

  Patient problems: Erosion

  MAUDE report 23375387 ↗
• 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 23297601 ↗
• 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 WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN UNKNOWN ADVERSE EVENT. NO ADDITIONAL INFORMATION WAS REPORTED."

  Patient problems: Insufficient Information

  MAUDE report 23297026 ↗
• InjuryMay 19, 2025Migration; Migration

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SLING PROCEDURE ON (B)(6) 2014, AND MESH WAS IMPLANTED. URETHRAL EXTRUSION OF MESH, PREVIOUS ATTEMPTED REMOVAL AT ALTERNATIVE CENTRE- ONGOING MESH FIBRES INTO THE URETHRA REPEAT REMOVAL OF MESH WITH URETHRAL RECON. NO FURTHER INFORMATION WAS REQUESTED DUE TO LACK OF REPORTER CONTACT DETAILS.

  Patient problems: Erosion

  MAUDE report 22045337 ↗
• MalfunctionMar 25, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SLING PROCEDURE IN 2025 AND MESH WAS USED. PRE-OPERATIVELY, IT WAS NOTED THAT THE MATERIAL ARRIVED OPEN. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21691537 ↗
• InjuryDec 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) 2013 AND MESH WAS IMPLANTED. ABOUT ONE YEAR LATER, AGAIN URINARY LEAKAGE, AND URINARY TRACT INFECTIONS FROM (B)(6) 2015. THE PATIENT FURTHER REPORTED THE STRIP NO LONGER HAD ITS EFFECT A YEAR AFTER IT WAS PLACED APPROXIMATELY, AND URINARY TRACT INFECTIONS RETURNED. IN ADDITION TO EXTERNAL LOCAL PAIN AT URINARY MEATUS/CLITORIS LEVEL. TO NOTE, AS SOON AS THE STRIP IS LAID, HORRIBLE PAINS DESCENDING FROM THE LEFT LEG TO THE TOES NOT TO TOLERATE THE WEIGHT OF A SHEET. THE PATIENT HAD FROM THE DAY AFTER THE POSE, CONTACT THE CLINIC. CERTAINLY, DUE TO SPINAL ANESTHESIA, IT WILL LAST A FEW YEARS HAD THE PATIENT BEEN TOLD A NERVE OR THE SPINAL CORD (DOES NOT REMEMBER) MAY HAVE BEEN AFFECTED, DUE TO A REPAIR OF A FEW MM PER YEAR. STOP DOING SPINAL ANESTHESIA. ADDITIONAL DESCRIPTION FOR CONSULTATION ON (B)(6) 2024: FREQUENT URINARY TRACT INFECTIONS WITH BLOOD**** IN URINE. THE PATIENT REPORTED IT TAKES A LONG TIME TO BE ABLE TO URINATE, AND IT IS ALWAYS A FINE SPRAY, RARELY A NORMAL SPRAY. AFTER A WHILE, THE PATIENT GETS UP, WALKS AND GO BACK TO THE TOILET, USUALLY ENDS UP PEEING; IF WAITS FOR MORE THAN 30 MINUTES TO GO TO

  Patient problems: Abnormal Vaginal Discharge; Hematuria; Incontinence; Inflammation; Pain; Unspecified Infection; Urinary Tract Infection

  MAUDE report 20856350 ↗
• InjuryNov 19, 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) 2014 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED FREQUENT URINARY TRACT INFECTIONS, SEPSIS, SCARRING, PELVIC PAIN, VAGINAL PAIN, BULGING, DYSPAREUNIA, DISFIGUREMENT, BLEEDING, VAGINAL DISCHARGE, LOWER BACK PAIN, PAIN IN LEGS, INFECTIONS AND DIFFICULT BOWEL MOVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Abnormal Vaginal Discharge; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Deformity/ Disfigurement; Hemorrhage/Blood Loss/Bleeding; Pain; Scar Tissue; Sepsis; Swelling/ Edema; Unspecified Infection; Urinary Tract Infection

  MAUDE report 20722861 ↗
• InjuryOct 16, 2024Appropriate Device Problem Term/Code Not Available; Migration; Appropriate Device Problem Term/Code Not Available; 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. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Erosion; Incontinence; Pain

  MAUDE report 20458714 ↗
• MalfunctionAug 8, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SLING PROCEDURE ON (B)(6) 2024 AND MESH WAS USED. THE SURGEON ATTEMPTED TO INSERT THE PRODUCT CONDUCTION TROCAR THROUGH THE OBTURATOR FORAMEN AND WAS UNSUCCESSFUL. AFTER THE LACK OF SUCCESS, THEY TOOK THE TROCAR OUT AND SAW THAT THE TIP WAS BENT. THEY CONTINUED THE OPERATION WITH ANOTHER PRODUCT. THE STAFF DID NOT KEEP THE PRODUCT PACKAGING AND ITS DETAILS. THE SURGERY WAS DELAYED BY 15 MINUTES, BUT SUCCESSFULLY COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19940313 ↗
• InjuryJul 16, 2024Migration; Migration

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SLING PROCEDURE ON (B)(6) 2022 AND MESH WAS IMPLANTED. MESH EROSION WAS NOTED ON EXAMINATION A FEW MONTHS POST INSERTION. NO FURTHER INFORMATION IS AVAILABLE AS REPORTER DETAILS HAVE NOT BEEN DISCLOSED (CONFIDENTIAL).

  Patient problems: Erosion

  MAUDE report 19751124 ↗
• InjuryMar 24, 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: Abnormal Vaginal Discharge; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Erosion; Hematuria; Hemorrhage/Blood Loss/Bleeding; Pain; Prolapse; Unspecified Infection

  MAUDE report 18966605 ↗
• InjuryMar 7, 2024Migration; Migration

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SLING PROCEDURE ON (B)(6) 2019 AND MESH WAS IMPLANTED. THE PATIENT EXPERIENCED PAIN IN THE INNER SIDE OF THE LEFT THIGH, PAIN UNDER THE BUTTOCK WHEN SITTING AND EXTERNALIZATION OF THE BAND OF MESH INTO THE VAGINA. THE BAND OF MESH WAS PARTIALLY REMOVED. CONTINUOUS PAIN, DIFFICULTY SITTING FOR LONG PERIODS AND DYSPAREUNIA WERE ALSO REPORTED. THIS COMPLAINT HAS BEEN REPORTED BY AN ANONYMOUS PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Erosion; Pain

  MAUDE report 18859616 ↗
• 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) 2012 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEVERE PAIN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Pain

  MAUDE report 18655850 ↗
• MalfunctionNov 30, 2023Unraveled Material; Unraveled Material

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SLING PROCEDURE ON AN UNKNOWN DATE IN 2023 AND MESH WAS USED. DURING THE PROCEDURE, THE DEVICE TORE IN HALF WITHOUT ANY TENSION. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18238869 ↗
• InjuryNov 15, 2023Migration; Migration

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL SURGICAL PROCEDURE ON (B)(6) 2011 AND MESH AND MESH WERE 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 18138984 ↗
• InjuryOct 30, 2023Adverse 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) 2015 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT SHE EXPERIENCED PAIN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Pain

  MAUDE report 18036216 ↗
• InjuryOct 18, 2023Adverse 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 THE SAME DAY AS THE PROCEDURE, THE PATIENT EXPERIENCED MILD URINARY RETENTION. A URINARY CATHETER WAS INSERTED AND THE EVENT WAS RECOVERED/RESOLVED WITHOUT SEQUELAE, ALSO ON (B)(6) 2023. THIS EVENT WAS REPORTED AS HAVING A PROBABLE RELATIONSHIP WITH THE STUDY DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Urinary Retention

  MAUDE report 17961330 ↗
• InjuryJul 18, 2023Adverse 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 CONTINUES TO SUFFER PAIN, DISABILITY AND IMPAIRMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pain

  MAUDE report 17347713 ↗
• MalfunctionJun 21, 2023Fracture; Fracture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SLING PROCEDURE ON (B)(6)2023 AND MESH WAS USED. THE DEVICE COULDN'T BE PLACED DURING THE SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17169989 ↗