GYNECARE TVT 810041ARecalls & reported problems
Ethicon Sàrl · Abdominal Guides · Class 2 · Implant
All models of GYNECARE TVT (5)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Ethicon Gynecare TVT retropubic mesh is used for stress urinary incontinence. Reports mostly describe mesh migration and erosion, causing pain, incontinence and urinary tract infections. 98 reports name this device identifier, with no deaths and 97 injuries. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 98
- Deaths reported
- 0
- Injuries reported
- 97
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 98 adverse event reports that list this exact device (DI 10705031062283), received between Jan 16, 2013 and Jan 14, 2026 — classified as 97 injuries, 1 malfunction.
The most frequently reported specific device problem is “Migration” (39 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.
Reports received per month
Most reported problems
Device problems
- Migration39
- Appropriate Device Problem Term/Code Not Available29
- Adverse Event Without Identified Device or Use Problem27
- Insufficient Device Problem Information2
- Material Erosion2
- Break1
Patient problems
- Pain56
- Erosion41
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available30
- Incontinence19
- Not Applicable10
- Unspecified Infection9
- Urinary Tract Infection9
- Micturition Urgency6
Recent adverse event reports
The 25 most recent of 98 reports, in the reporter's own words as published by the FDA.
InjuryJan 14, 2026Adverse Event Without Identified Device or Use Problem
DIR (B)(4) (TGA REPORT) CONCERNS AN ETHICON GYNECARE TVT RETROPUBIC SYSTEM (PRODUCT 810041A) IMPLANTED ON (B)(6) 2015. POST-IMPLANTATION, THE PATIENT EXPERIENCED WORSENED URINARY INCONTINENCE, UNRESOLVED STRESS INCONTINENCE, OVERACTIVE BLADDER, CONSTANT URINE LEAKAGE (REQUIRING PADS), NOCTURIA 2¿3 TIMES, SLOW URINARY STREAM, AND VOIDING DIFFICULTIES. URODYNAMICS (B)(6) 2023) SHOWED DETRUSOR OVERACTIVITY WITH POSSIBLE BLADDER OUTLET OBSTRUCTION (BOO). AN EXAMINATION UNDER ANAESTHESIA WITH POP-Q AND CYSTOURETHROSCOPY ON (B)(6) 2025 FOUND A HEALTHY VAGINA/CERVIX, NO MESH EXPOSURE, NORMAL UROTHELIUM, AND CLEAR URETHROSCOPY. THE PATIENT HAS BEEN CONSENTED FOR EXCISION OF THE VAGINAL TVT MESH PORTION + CYSTOSCOPY TO RELIEVE URETHRAL TENSION CAUSING SLOW VOIDS AND OVERFLOW LEAKAGE AND HAS WAITED >12 MONTHS FOR THE PROCEDURE. NO FURTHER PATIENT OUTCOME DETAILS ARE PROVIDED DUE TO CONFIDENTIALITY.
Patient problems: Urinary Incontinence
MAUDE report 24072518 ↗InjuryOct 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT UNDERWENT HERNIA REPAIR SURGERY ON (B)(6) 2009, DURING WHICH A GYNECARE TVT WAS IMPLANTED. FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED INCONTINENCE, INFECTION, AND PAIN. NO FURTHER DETAILS WERE PROVIDED.
Patient problems: Bacterial Infection; Pain; Urinary Incontinence
MAUDE report 23392977 ↗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) 2008 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 23297701 ↗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) 2008 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 23297406 ↗InjuryOct 31, 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 IN (B)(6) 2015 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Pain
MAUDE report 20584832 ↗InjuryJan 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 AN UNKNOWN DATE AND MESH WAS IMPLANTED FOR INCONTINENCE. THE PATIENT REPORTED EXPERIENCING PAINFUL/UNCOMFORTABLE INTERCOURSE, RECURRENT URINARY TRACT INFECTIONS, AND INCONTINENCE. NO FURTHER INFORMATION IS AVAILABLE AS REPORTER DETAILS HAVE NOT BEEN DISCLOSED (CONFIDENTIAL).
Patient problems: Incontinence; Pain; Urinary Tract Infection
MAUDE report 18601600 ↗InjuryJan 22, 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 EXPERIENCED FEELING OF URGENCY, INCOMPLETE EMPTYING, SLOW STREAM, DAILY PERIOD LIKE PAIN AND HIP/GROIN PAIN. THE PATIENT TAKES NAPROSYN DAILY. NO FURTHER INFORMATION IS AVAILABLE AS THE REPORTER DETAILS ARE CONFIDENTIAL.
Patient problems: Micturition Urgency; Pain; Urinary Retention
MAUDE report 18552324 ↗InjuryDec 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY AN ATTORNEY THAT THAT THE PATIENT UNDERWENT A GYNECOLOGICAL SURGICAL PROCEDURE ON (B)(6) 2005 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Pain
MAUDE report 18271836 ↗InjuryNov 10, 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) 2005 AND MESH WAS IMPLANTED, CONCURRENTLY WITH DILATION AND CURETTAGE, ENDOMETRIAL ABLATION, AND CYSTOSCOPY. IT WAS REPORTED THAT SHE EXPERIENCED PAIN FOLLOWING THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Pain
MAUDE report 18108349 ↗InjurySep 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 COMBINED ANTEROPOSTERIOR COLPORRHAPHY SLING OPERATION FOR STRESS INCONTINENCE ON (B)(6) 2023 AND MESH WAS IMPLANTED. IN (B)(6) 2023, THE PATIENT EXPERIENCED MILD URINARY RETENTION. ON (B)(6) 2023, 4 WEEKS POST-PROCEDURE, ELEVATED PVR WAS NOTED IN THE OFFICE. THE PATIENT WAS CATHED FOR 125ML. ON (B)(6) 2023, THE PATIENT PRESENTED NORMAL PVR WHICH WAS VERIFIED VIA CATH FOR ONLY 60ML. AS OF (B)(6) 2023, THE PATIENT IS DOING WELL POSTOPERATIVELY, HEALING NORMALLY AND HAS NORMAL PVR, NO URINARY RETENTION. THIS EVENT WAS REPORTED AS HAVING A PROBABLE RELATIONSHIP WITH THE STUDY DEVICE AND A CAUSAL RELATIONSHIP WITH THE STUDY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Urinary Retention
MAUDE report 17765297 ↗InjuryMay 31, 2023Migration; Migration
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, 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 17028577 ↗InjuryMay 15, 2023Migration; Migration
IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL SURGICAL PROCEDURE ON (B)(6) 2013 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT SHE EXPERIENCED PAIN AND EROSION OF HER INTERNAL BODILY TISSUE. IT WAS REPORTED THAT THE PATIENT HAS UNDERGONE MULTIPLE SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Erosion; Pain
MAUDE report 16928642 ↗InjuryFeb 1, 2023Migration; Migration
IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL SURGICAL PROCEDURE ON (B)(6) 2010 AND TWO MESH PRODUCTS 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 16281208 ↗InjuryOct 13, 2022Migration; Migration
IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL SURGICAL PROCEDURE ON (B)(6) 2006 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 15602361 ↗InjuryAug 24, 2022Adverse 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 DUE TO BLADDER SUSPENSION AND SUI. IT WAS REPORTED THAT THE PATIENT EXPERIENCED PELVIC PAIN, BLEEDING AND DYSPAREUNIA, TUMOR-LIKE MASS/COMPLEX URETHRAL LESION WHICH CAUSED URETHRAL NARROWING, STENOSIS AND STRICTURE. IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH EXCISION SURGERY AND URETHRAL/BLADDER NECK MASS, URETHRAL RECONSTRUCTION, AND AUTOLOGOUS FASCIAL SLING ON (B)(6) 2020. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hemorrhage/Blood Loss/Bleeding; Pain; Urethral Stenosis/Stricture
MAUDE report 15280705 ↗InjuryJul 26, 2022Migration; Migration
IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL SURGICAL PROCEDURE ON (B)(6) 019 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED PELVIC PAIN, VAGINAL PAIN, URINARY ISSUES, AND MESH EROSION FOLLOWING THE PROCEDURE. IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2021. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Erosion; Pain
MAUDE report 15108907 ↗InjuryMay 18, 2022Migration; Migration
IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL SURGICAL PROCEDURE ON (B)(6) 2009 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 14432768 ↗InjuryApr 25, 2022Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration
IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL SURGICAL PROCEDURE ON (B)(6) 2007 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2021. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN UNDISCLOSED ADVERSE EVENT. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Erosion; Urethral Stenosis/Stricture
MAUDE report 14191451 ↗InjuryMar 20, 2022Migration; Migration
IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL SURGICAL PROCEDURE ON (B)(6) 2019 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: Discomfort; Erosion; Pain; Urinary Tract Infection
MAUDE report 13835645 ↗InjuryNov 24, 2021Appropriate 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 ABDOMINAL PAIN, UTI, URGENCY, FREQUENCY AND INCONTINENCE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Abdominal Pain; Incontinence; Urinary Frequency / Polyuria; Urinary Tract Infection
MAUDE report 12872898 ↗InjuryNov 24, 2021Adverse 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) 2007 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY ON AN UNKNOWN DATE. IT WAS REPORTED THAT THE PATIENT EXPERIENCED PELVIC PAIN, URINARY PAIN, DYSPAREUNIA, PELVIC ORGAN PROLAPSE, URINARY RETENTION, URINARY INCONTINENCE, VAGINAL SHORTENING, VAGINAL TIGHTENING, DISTENDED BOWEL, AND REDUNDANT SIGMOID. IT WAS REPORTED THAT SHE UNDERWENT SURGERY TO EXCISE THE MESH ON (B)(6) 2016. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Incontinence; Pain; Urinary Retention
MAUDE report 12868439 ↗InjuryNov 24, 2021Adverse 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) 2006 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT FOLLOWING THE PROCEDURE THE PATIENT EXPERIENCED URINARY TRACT INFECTION. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Urinary Tract Infection
MAUDE report 12867393 ↗InjuryNov 23, 2021Appropriate 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) 2002 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT SHE EXPERIENCED UNDISCLOSED INJURIES. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 12866761 ↗InjuryNov 22, 2021Migration; Migration
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 SHE EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE, CYSTOCELE AND VAGINAL VAULT PROLAPSE FOLLOWING THE PROCEDURE. IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2015. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Erosion; Pain; Prolapse
MAUDE report 12850567 ↗InjuryNov 19, 2021Migration; Migration
(B)(6) 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 AND PROLIFT WERE IMPLANTED INTO THE PATIENT. IT IS REPORTED THAT THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL TISSUES, AND SHE HAS UNDERGONE ADDITIONAL SURGERIES AND REVISIONARY PROCEDURES. ADDITIONAL INFORMATION ALSO REPORTED THAT THE PATIENT EXPERIENCED RECURRENT LEAKAGE, BLADDER INFECTIONS, PELVIC PAIN, AND DYSPAREUNIA.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pain; Unspecified Infection
MAUDE report 12842446 ↗
Other mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobturator devices
- GYNECARE TVT 810081Ethicon Sàrl · mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobturator629 reports
- GYNECARE TVT EXACT TVTRLEthicon Sàrl · mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobturator457 reports
- Advantage Fit™ System M0068502110Boston Scientific Corporation · mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobturator451 reports
- GYNECARE TVT 810081LEthicon Sàrl · mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobturator371 reports
- GYNECARE TVT 810041BEthicon Sàrl · mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobturator362 reports
- Obtryx™ System - Halo M0068505000Boston Scientific Corporation · mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobturator288 reports
- Aris 93-4400Coloplast A/S · mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobturator215 reports
- Align® TO Trans-Obturator Urethral Support System - Halo BRD500HLC. R. Bard, Inc. · mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobturator213 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page