Mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobturator: medical device reports filed with FDA

38,649 reports carry this product code, 2006–2026; 30 brands with a page.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use." And: "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."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

38,649
reports with this product code: 0.2% of all MAUDE reports; 343
reports, 12 months to August 2026: 435 in the 12 months before; 1.6%
classified as malfunction: 62.3% across all reports; 1%
classified as death, as reported: 0.9% across all reports

Product code OTN is FDA's classification for "Mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobturator" (general, Plastic Surgery panel), a class 2 device. 38,649 medical device reports carry this product code, 0.2% of the MAUDE database, from November 2006 to August 2026.

343 reports arrived in the 12 months to August 2026, down 21% from 435 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 (97.4%), malfunction (1.6%) and death (1%). 30 brand names with a page on this site carry this code; the brands table is 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."

Brands with this product code

Brand	Reports	Latest 12 months	Classified as death	Classified as malfunction
Gynecare Tvt Retropubic System	5,294	0	0%	0.3%
Gynecare Tvt Obturator System	4,330	0	0%	0.6%
Tension Free Vaginal Tape	3,904	0	0.1%	3.9%
Gynecare Mesh Unknown	2,974	3	0.1%	0%
Gynecare Tvt Oburator System	1,571	0	0.1%	0%
Tension Free Vaginal Tape Unknown Product	1,161	24	0%	0.1%
Gynecare Tvt-Aa Abdominal	904	0	0%	0%
Advantage Fit System	897	10	0.1%	4.2%
Gynecare Tvt Obturator	862	15	0%	6.5%
Uretex Support Pp Kit X1	766	0	0.1%	0.7%
Gynecare Tvt Exact Continence System	682	0	0%	3.5%
Tension Free Vaginal Tape - Obturator Unknown Prod	676	5	0%	0%
Advantage? System	665	13	0%	0.3%
Obtryx System	664	1	0%	0.7%
Gynecare TVT	657	3	0%	1.3%
Obtape Transobturator Sling	584	0	0%	0%
Desara	571	0	0%	0.2%
Tvt Exact Retropubic System	547	49	0%	6.9%
Gynecare Tvt Device	443	0	0%	0%
Gynecare Tvt Obturator W Lasr	430	14	0%	5.3%
Lynx System	409	9	0%	0.6%
Uretex Support Pp Transobtur2 Kit X1	375	0	0%	0.2%
Gynecare Tvt Abrevo Continence System	324	0	0%	4.3%
T-Sling	316	0	0%	0.5%
Ams Monarc Sling System	300	0	58%	1.3%
Aris Transobturator Kit	240	0	0%	1.7%
Obtryx? System - Halo	228	9	0%	7.2%
Align To Urethral Support System	216	0	0%	0%
Tension Free Vaginal Tape - Exact Unknown Product	202	28	0%	0%
Ams Sparc Sling System	197	0	68%	1.5%

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."

Manufacturers named

Manufacturer (as written on reports)	Reports	Share
Ethicon	24,943	64.5%
Sofradim Production	1,951	5%
Ethicon Sarl	1,487	3.8%
Boston Scientific - Marlborough	995	2.6%
C R Bard Covington -1018233	668	1.7%
Bard Shannon	613	1.6%
Coloplast A/S	595	1.5%
Mentor Worldwide	555	1.4%
American Medical Systems	442	1.1%
Caldera Medical	432	1.1%
C R Bard Covington	385	1%
American Medical Systems Mn	293	0.8%
Sofradim Production Sas	232	0.6%
C R Bard	87	0.2%
Mentor	30	0.1%

Reports by month, five years

FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.

Event type and report source

Event type

Death1%376

Injury97.4%37,631

Malfunction1.6%607

Other0%9

Not given0.1%26

Who filed

Manufacturer report97.8%37,815

Voluntary report0.7%261

User facility report0%0

Distributor report1.2%479

Not given0.2%94

Grey bar: all 26,136,888 MAUDE reports.

Device problems coded

Device problem (FDA code)	Reports	Share
Material erosion	17,174	44.4%
Insufficient device problem information	3,231	8.4%
Migration or expulsion of device	1,999	5.2%
Migrationthe device moved from where it was placed	1,787	4.6%
Other (for use when an appropriate device code cannot be identified)	857	2.2%
Device operates differently than expectedthe device behaved unexpectedly	444	1.1%
Extrusion	295	0.8%
Breakthe device broke	130	0.3%
Positioning problem	87	0.2%
Patient-device incompatibilitythe device did not suit the patient	79	0.2%
Material integrity problema problem with the device material	70	0.2%
Material protrusion/extrusion	57	0.1%
Detachment of device or device componentpart of the device came off	56	0.1%
Defective devicethe device was defective	48	0.1%
Material twisted/bent	47	0.1%
Material split, cut or torn	42	0.1%
Difficult to advance	37	0.1%
Manufacturing, packaging or shipping problem	37	0.1%
Detachment of device component	31	0.1%
Device appears to trigger rejection	28	0.1%

Questions about mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobturator reports

What is product code OTN?

FDA's classification code for "Mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobturator", class 2, reviewed by the general, Plastic Surgery panel. Every device report carries the product code of the device involved.

How many reports carry this code?

38,649 reports through August 2026, 343 of them in the latest 12 months.

Which brands appear most often?

Gynecare Tvt Retropubic System (5,294), Gynecare Tvt Obturator System (4,330), Tension Free Vaginal Tape (3,904), Gynecare Mesh Unknown (2,974) and Gynecare Tvt Oburator System (1,571). Widely used products collect more reports because more people use them.

Can the brands table be used to rank the devices?

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." Brands differ in how many are in use, how long they have been sold and how reports are collected.

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. 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.