Mesh, surgical, synthetic, urogynecologic, for apical vaginal and uterine prolapse, transabdominally placed: medical device reports filed with FDA

4,779 reports carry this product code, 2006–2026; 21 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.

4,779
reports with this product code: 0% of all MAUDE reports; 64
reports, 12 months to August 2026: 128 in the 12 months before; 1.4%
classified as malfunction: 62.3% across all reports; 0.5%
classified as death, as reported: 0.9% across all reports

Product code OTO is FDA's classification for "Mesh, surgical, synthetic, urogynecologic, for apical vaginal and uterine prolapse, transabdominally placed" (general, Plastic Surgery panel), a class 2 device. 4,779 medical device reports carry this product code, 0% of the MAUDE database, from November 2006 to August 2026.

64 reports arrived in the 12 months to August 2026, down 50% from 128 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%), malfunction (1.4%) and death (0.5%). 21 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 Gynemesh Ps	1,989	0	0.1%	0%
Alyte Y-Mesh Graft	248	3	0.4%	2%
Gynecare Mesh Unknown	227	3	0.1%	0%
Upsylon	214	10	0%	9.1%
Gynecare Unknown Product	192	1	0%	0%
Polyform Synthetic Mesh	170	0	0.2%	0.5%
Gynecare Gynemsh Ps 4inx6in	160	0	0%	0%
Gynecare Gynemesh	115	0	0%	0.5%
Parietex Ugytex Pp Posterior Kit X1	27	0	0%	1.3%
PROLENE POLYPROPYLENE Mesh	8	52	0.1%	1.7%
Parietex Ugytex Pp Anterior Kit X1	7	0	0%	1.2%
Gynecare Tvt Oburator System	3	0	0.1%	0%
Unknown Women's Health Product	3	0	0%	0%
Boston Scientific	2	5	3.3%	55%
Phasix Mesh	2	57	0.7%	4%
Prosima Pelvic Floor Repair Kit	2	0	0%	0%
Align Urethral Support System Retropubic	1	0	0%	0%
ETHIBOND Extra & Excel Polyester Suture	1	34	0%	24.9%
Gynecare Prolift Total Pelvic Floor Repair System	1	0	0.1%	0%
Gynecare TVT	1	3	0%	1.3%
Mesh	1	2	0.4%	2.6%

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	2,691	56.3%
Coloplast A/S	439	9.2%
Boston Scientific - Marlborough	175	3.7%
Sofradim Production	91	1.9%
Bard Shannon	45	0.9%
C R Bard Covington -1018233	25	0.5%
American Medical Systems	23	0.5%
Caldera Medical	19	0.4%
C R Bard Covington	14	0.3%
American Medical Systems Mn	4	0.1%
Cook Biotech	1	0%
Ethicon Sarl	1	0%
Sofradim Production Sas	1	0%

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

Death0.5%24

Injury98%4,683

Malfunction1.4%67

Other0%2

Not given0.1%3

Who filed

Manufacturer report98.7%4,717

Voluntary report1%49

User facility report0%0

Distributor report0%0

Not given0.3%13

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

Device problems coded

Device problem (FDA code)	Reports	Share
Material erosion	2,447	51.2%
Insufficient device problem information	240	5%
Other (for use when an appropriate device code cannot be identified)	213	4.5%
Migrationthe device moved from where it was placed	206	4.3%
Migration or expulsion of device	199	4.2%
Material protrusion/extrusion	30	0.6%
Device appears to trigger rejection	29	0.6%
Patient-device incompatibilitythe device did not suit the patient	26	0.5%
Breakthe device broke	24	0.5%
Device operates differently than expectedthe device behaved unexpectedly	22	0.5%
Material split, cut or torn	22	0.5%
Torn material	21	0.4%
Extrusion	20	0.4%
Defective devicethe device was defective	12	0.3%
Missing information	12	0.3%
Patient device interaction problem	7	0.1%
Degraded	6	0.1%
Malposition of device	6	0.1%
Material deformation	6	0.1%
Material twisted/bent	6	0.1%

Questions about mesh, surgical, synthetic, urogynecologic, for apical vaginal and uterine prolapse, transabdominally placed reports

What is product code OTO?

FDA's classification code for "Mesh, surgical, synthetic, urogynecologic, for apical vaginal and uterine prolapse, transabdominally placed", 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?

4,779 reports through August 2026, 64 of them in the latest 12 months.

Which brands appear most often?

Gynecare Gynemesh Ps (1,989), Alyte Y-Mesh Graft (248), Gynecare Mesh Unknown (227), Upsylon (214) and Gynecare Unknown Product (192). 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.