Mesh, surgical, polymeric: medical device reports filed with FDA

170,304 reports carry this product code, 1992–2026; 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.

170,304
reports with this product code: 0.7% of all MAUDE reports; 3,049
reports, 12 months to August 2026: 4,562 in the 12 months before; 2.5%
classified as malfunction: 62.3% across all reports; 0.5%
classified as death, as reported: 0.9% across all reports

Product code FTL is FDA's classification for "Mesh, surgical, polymeric" (general, Plastic Surgery panel), a class 2 device. 170,304 medical device reports carry this product code, 0.7% of the MAUDE database, from July 1992 to August 2026.

3,049 reports arrived in the 12 months to August 2026, down 33% from 4,562 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 (96.5%), malfunction (2.5%) and death (0.5%). 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
Bard Flat Mesh	8,298	110	0.5%	0.3%
PerFix Plug	8,252	167	0.3%	0.3%
Parietex	6,303	320	1%	1.8%
Ventralight ST Mesh	5,811	106	0.5%	1.8%
Obtryx System	5,367	1	0%	0.7%
Ventralex ST	5,364	101	0.4%	0.8%
Tension Free Vaginal Tape	4,782	0	0.1%	3.9%
Mesh Ventralex	4,661	5	0.4%	0.2%
3DMax	3,971	155	0.1%	2.1%
ProGrip	3,818	412	0.8%	5.9%
Proceed Surg Mesh/Multi Lyr	3,199	29	0%	1.2%
Mesh Sofradim - Parietex Composite Mesh	2,946	16	1.5%	0.2%
Advantage? System	2,872	13	0%	0.3%
Ventrio ST	2,751	51	0.7%	0.7%
Symbotex	2,741	190	1.2%	2.1%
Mesh - Composix Kugel	2,679	42	3.5%	0.4%
Physiomesh	2,607	0	0.1%	0.4%
Unknown Women's Health Product	2,183	0	0%	0%
Mesh Composix Kugel	2,120	1	1.5%	0%
Mesh - Ventralex	2,027	98	0.6%	1.2%
Lynx System	1,914	9	0%	0.6%
SepraMesh IP	1,876	43	0.8%	0.6%
Kugel Patch	1,807	29	0.4%	0.7%
C-Qur V-Patch	1,787	0	0%	0.2%
Ventralex	1,767	0	0.4%	0%
Ventrio Mesh	1,745	30	0.5%	1%
PROLENE POLYPROPYLENE Mesh	1,547	52	0.1%	1.7%
C-Qur Mesh	1,543	0	0.3%	0.2%
Composix Mesh E/X	1,468	0	1.5%	0.1%
Solyx SIS System	1,450	7	0.1%	10.5%

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
Davol Sub C R Bard	54,892	32.2%
Ethicon	29,020	17%
Sofradim Production Sas	19,958	11.7%
Boston Scientific - Marlborough	14,636	8.6%
Davol Sub C R Bard -1213643	10,231	6%
Atrium Medical	6,116	3.6%
American Medical Systems	5,017	2.9%
C R Bard Covington	4,201	2.5%
Sofradim Production	2,465	1.4%
W L Gore & Associates	2,356	1.4%
Coloplast A/S	1,280	0.8%
C R Bard	1,279	0.8%
Bard Shannon	1,246	0.7%
Tissue Science Laboratories	1,222	0.7%
Davol	945	0.6%

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%863

Injury96.5%164,269

Malfunction2.5%4,318

Other0.3%574

Not given0.2%280

Who filed

Manufacturer report97.4%165,877

Voluntary report1.6%2,720

User facility report0%0

Distributor report0.8%1,293

Not given0.2%414

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

Device problems coded

Device problem (FDA code)	Reports	Share
Defective devicethe device was defective	58,403	34.3%
Insufficient device problem information	44,861	26.3%
Patient device interaction problem	32,212	18.9%
Patient-device incompatibilitythe device did not suit the patient	12,280	7.2%
Material erosion	9,256	5.4%
Migration or expulsion of device	6,840	4%
Mechanics altered	5,409	3.2%
Material deformation	3,838	2.3%
Other (for use when an appropriate device code cannot be identified)	3,701	2.2%
Migrationthe device moved from where it was placed	2,735	1.6%
Explanted	2,679	1.6%
Device operates differently than expectedthe device behaved unexpectedly	2,045	1.2%
Device remains implanted	1,423	0.8%
Extrusion	1,341	0.8%
Material split, cut or torn	1,163	0.7%
Material integrity problema problem with the device material	1,023	0.6%
Breakthe device broke	741	0.4%
Detachment of device component	685	0.4%
Loss of or failure to bond	547	0.3%
Entrapment of device	544	0.3%

Questions about mesh, surgical, polymeric reports

What is product code FTL?

FDA's classification code for "Mesh, surgical, polymeric", 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?

170,304 reports through August 2026, 3,049 of them in the latest 12 months.

Which brands appear most often?

Bard Flat Mesh (8,298), PerFix Plug (8,252), Parietex (6,303), Ventralight ST Mesh (5,811) and Obtryx System (5,367). 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.