Devices › Mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobturator
Device brand name · Mesh surgical synthetic urogynecological
Gynecare TVT: medical device reports filed with FDA
679 reports name it, 2008–2026. Manufacturer given most often on reports: Ethicon. Product code OTN.
- 679
- device reports naming the brand
- 0% of all MAUDE reports · about 37 a year
- 3
- reports, 12 months to August 2026
- 0 in the 12 months before
- 1.3%
- classified as malfunction
- 1.6% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
679 medical device reports received by FDA name the brand "Gynecare TVT" (mesh surgical synthetic urogynecological); the manufacturer given most often on reports is Ethicon; received from May 2008 to July 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
3 reports arrived in the 12 months to August 2026, with none in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are injury (98.1%), malfunction (1.3%) and other (0.3%); across all mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobturator reports (product code OTN) death is recorded in 1% and malfunction in 1.6%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are material erosion (52.6%), migration or expulsion of device (22.4%) and other (for use when an appropriate device code cannot be identified) (10.6%). The patient problems coded most often are erosion, pain and surgical procedure. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Reports by month, five years
Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 38,649 reports carrying product code OTN. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share | Share across product code |
|---|---|---|---|
| Material erosion | 357 | 52.6% | 44.4% |
| Migration or expulsion of device | 152 | 22.4% | 5.2% |
| Other (for use when an appropriate device code cannot be identified) | 72 | 10.6% | 2.2% |
| Insufficient device problem information | 5 | 0.7% | 8.4% |
| Implant extrusion | 3 | 0.4% | 0% |
| Material perforation | 2 | 0.3% | 0% |
| Device inoperablethe device could not be used | 1 | 0.1% | 0% |
| Device operates differently than expectedthe device behaved unexpectedly | 1 | 0.1% | 1.1% |
| Difficult to removethe device was hard to remove | 1 | 0.1% | 0% |
| Entrapment of device | 1 | 0.1% | 0% |
| Material frayed | 1 | 0.1% | 0% |
| Material puncture/hole | 1 | 0.1% | 0% |
FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.
Patient problems coded
| Patient problem (FDA code) | Reports | Share |
|---|---|---|
| Erosion | 512 | 75.4% |
| Painpain, site not specified | 478 | 70.4% |
| Surgical procedure | 373 | 54.9% |
| Other (for use when an appropriate patient code cannot be identified) | 167 | 24.6% |
| Incontinence | 86 | 12.7% |
| Urinary tract infectionbladder or urinary infection | 46 | 6.8% |
| Bleeding | 41 | 6% |
| Scar tissue | 33 | 4.9% |
| Urinary retentionbeing unable to empty the bladder | 32 | 4.7% |
| Urinary frequency / polyuria | 27 | 4% |
| Micturition urgency | 23 | 3.4% |
| Treatment with medication(s) | 20 | 2.9% |
| Blood loss | 19 | 2.8% |
| Not applicable | 18 | 2.7% |
| Neurological deficit/dysfunction | 15 | 2.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Gynecare TVT | Product code OTN | All MAUDE reports |
|---|---|---|---|
| Reports | 679 | 38,649 | 26,136,888 |
| Share of that pool | — | 1.8% | 0% |
| Classified as death, per 1,000 reports | 0 | 10 | 9 |
| Classified as injury | 98.1% | 97.4% | 36.2% |
| Classified as malfunction | 1.3% | 1.6% | 62.3% |
| Filed by the manufacturer | 95.7% | 97.8% | 94.9% |
Shares are of reports, not of devices in use. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Other brands with product code OTN
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Gynecare Tvt Retropubic System | 5,752 | 0 | 0% |
| Gynecare Tvt Obturator System | 4,330 | 0 | 0% |
| Tension Free Vaginal Tape | 9,355 | 0 | 0.1% |
| Gynecare Mesh Unknown | 5,830 | 3 | 0.1% |
| Gynecare Tvt Oburator System | 1,578 | 0 | 0.1% |
| Tension Free Vaginal Tape Unknown Product | 1,161 | 24 | 0% |
| Gynecare Tvt-Aa Abdominal | 905 | 0 | 0% |
| Advantage Fit System | 1,496 | 10 | 0.1% |
| Gynecare Tvt Obturator | 868 | 15 | 0% |
| Uretex Support Pp Kit X1 | 999 | 0 | 0.1% |
| Gynecare Tvt Exact Continence System | 682 | 0 | 0% |
| Tension Free Vaginal Tape - Obturator Unknown Prod | 676 | 5 | 0% |
| Advantage? System | 3,537 | 13 | 0% |
| Obtryx System | 6,031 | 1 | 0% |
| Obtape Transobturator Sling | 1,304 | 0 | 0% |
Ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."
Questions about Gynecare TVT reports
How many FDA reports name Gynecare TVT?
679 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 3 in the latest 12 months.
What kinds of events are reported?
injury (98.1%), malfunction (1.3%) and other (0.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
material erosion (52.6%), migration or expulsion of device (22.4%), other (for use when an appropriate device code cannot be identified) (10.6%), insufficient device problem information (0.7%) and implant extrusion (0.4%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (95.7%) and voluntary reports (2.9%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Gynecare TVT was at fault?
No. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."
How do I report a problem with a medical device?
Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.