Mesh, surgical, synthetic, urogynecologic, for pelvic organ prolapse, transvaginally placed: medical device reports filed with FDA

11,655 reports carry this product code, 2007–2026; 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.

11,655
reports with this product code: 0% of all MAUDE reports; 9
reports, 12 months to August 2026: 33 in the 12 months before; 4.1%
classified as malfunction: 62.3% across all reports; 2.2%
classified as death, as reported: 0.9% across all reports

Product code OTP is FDA's classification for "Mesh, surgical, synthetic, urogynecologic, for pelvic organ prolapse, transvaginally placed" (obstetrics/Gynecology panel), a class 3 device. 11,655 medical device reports carry this product code, 0% of the MAUDE database, from December 2007 to August 2026.

9 reports arrived in the 12 months to August 2026, down 73% from 33 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 (93.6%), malfunction (4.1%) and death (2.2%). 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 Prolift Total Pelvic Floor Repair System	1,186	0	0.1%	0%
Prolift Pelvic Floor Repair	1,142	0	0.1%	0.1%
Uphold Lite	869	0	0%	40.5%
Pinnacle Pelvic Floor Repair Kits	835	0	0.1%	5.2%
Uphold Vaginal Support System	708	0	0.1%	16.5%
Unknown Women's Health Mesh Product	704	0	0%	0%
Gynecare Prolift Anterior Pelvic Floor Repair System	638	0	0%	0%
Gynecare Prolift Posterior Pelvic Floor Repair System	370	0	0%	0%
Gynecare Prolift Pelvic Floor Repair System	312	0	0%	0%
Gynecare Prosima Pelvic Floor Repair System	308	0	0%	0%
Gynecare Prolift +m Total Pelvic Floor Repair System	292	0	0%	0%
Prolift Pelvic Floor Repair Unknown Product	292	0	0%	0%
Prolift +m Pelvic Floor Repair	261	0	0.4%	0%
Ams Elevate Anterior Prolapse Repair System With Intepro Lite	202	0	18.3%	1%
Gynecare Prolift +m Anterior Pelvic Floor Repair System	169	0	0%	0%
Prosima Pelvic Floor Repair Kit	155	0	0%	0%
Parietex Ugytex Pp Anterior Kit X1	154	0	0%	1.2%
Unk Women's Health Mesh Product	151	0	0%	0%
Parietex Ugytex Pp Posterior Kit X1	105	0	0%	1.3%
Avaulta Solo Synthetic Support System - Anterior	98	0	0%	0%
Avaulta Plus Biosynthetic Support System - Anterior	95	0	0%	0%
Avaulta Plus Biosynthetic Support System - Posterior	71	0	0%	0%
Gynecare Mesh Unknown	68	3	0.1%	0%
Pfr Kit Uphold Lite Vaginal Support System	68	0	0%	28.7%
Polyform Synthetic Mesh	56	0	0.2%	0.5%
Perigee System	41	0	0%	0%
Apogee System	30	0	0%	0%
Elevate Prolapse Repair System	23	0	0.5%	0%
Avaulta Plus Biosynthetic Support System	15	0	0%	0.6%
Elevate Anterior Prolapse Repair System	15	0	0.5%	1%

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	5,320	45.6%
Boston Scientific - Marlborough	1,819	15.6%
C R Bard Covington	1,153	9.9%
Sofradim Production	341	2.9%
American Medical Systems Mn	321	2.8%
American Medical Systems	306	2.6%
Bard Shannon	220	1.9%
Ethicon Sarl	153	1.3%
C R Bard	129	1.1%
C R Bard Covington -1018233	108	0.9%
Boston Scientific - Spencer	39	0.3%
Sofradim Production Sas	38	0.3%
Boston Scientific	24	0.2%
Coloplast A/S	12	0.1%
Cook Biotech	12	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

Death2.2%256

Injury93.6%10,907

Malfunction4.1%483

Other0%4

Not given0%5

Who filed

Manufacturer report99.3%11,569

Voluntary report0.5%54

User facility report0%0

Distributor report0%3

Not given0.2%29

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

Device problems coded

Device problem (FDA code)	Reports	Share
Material erosion	5,195	44.6%
Insufficient device problem information	604	5.2%
Detachment of device component	435	3.7%
Migrationthe device moved from where it was placed	295	2.5%
Device operates differently than expectedthe device behaved unexpectedly	172	1.5%
Breakthe device broke	164	1.4%
Detachment of device or device componentpart of the device came off	159	1.4%
Migration or expulsion of device	149	1.3%
Extrusion	140	1.2%
Other (for use when an appropriate device code cannot be identified)	102	0.9%
Retraction problem	43	0.4%
Patient-device incompatibilitythe device did not suit the patient	31	0.3%
Defective devicethe device was defective	23	0.2%
Material protrusion/extrusion	23	0.2%
Patient device interaction problem	14	0.1%
Torn material	10	0.1%
Malposition of device	9	0.1%
Material separation	8	0.1%
Entrapment of device	7	0.1%
Material split, cut or torn	7	0.1%

Questions about mesh, surgical, synthetic, urogynecologic, for pelvic organ prolapse, transvaginally placed reports

What is product code OTP?

FDA's classification code for "Mesh, surgical, synthetic, urogynecologic, for pelvic organ prolapse, transvaginally placed", class 3, reviewed by the obstetrics/Gynecology panel. Every device report carries the product code of the device involved.

How many reports carry this code?

11,655 reports through August 2026, 9 of them in the latest 12 months.

Which brands appear most often?

Gynecare Prolift Total Pelvic Floor Repair System (1,186), Prolift Pelvic Floor Repair (1,142), Uphold Lite (869), Pinnacle Pelvic Floor Repair Kits (835) and Uphold Vaginal Support System (708). 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.