Mesh, surgical: medical device reports filed with FDA

11,623 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.

11,623
reports with this product code: 0% of all MAUDE reports; 192
reports, 12 months to August 2026: 266 in the 12 months before; 5.2%
classified as malfunction: 62.3% across all reports; 0.4%
classified as death, as reported: 0.9% across all reports

Product code FTM is FDA's classification for "Mesh, surgical" (general, Plastic Surgery panel), a class 2 device. 11,623 medical device reports carry this product code, 0% of the MAUDE database, from April 1992 to August 2026.

192 reports arrived in the 12 months to August 2026, down 28% from 266 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 (87.1%), other (7.1%) and malfunction (5.2%). 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
Unspecified By Complainant	1,812	0	0%	0%
Gynecare Mesh Unknown	1,133	3	0.1%	0%
Pelvisoft Acellular Collagen Biomesh	953	0	0%	0.7%
Xenform	761	0	0%	0.1%
Strattice	303	0	1.9%	33.8%
Unknown Strattice	295	47	0.7%	0%
Mesh Tsl - Permacol	289	4	2.6%	1%
XenMatrix	272	8	0.7%	3.6%
Permacol	260	1	0.5%	2.1%
Unk - Unspecified By The Complainant	200	0	0%	0%
Orthadapt Bioimplant	191	0	0%	0.5%
Biodesign 4-Layer Tissue Graft	185	0	0%	0%
Unknown - Unspecified By The Complainant	177	0	0%	0%
Veritas Collagen Matrix	176	0	0.5%	1.9%
Uphold Vaginal Support System	103	0	0.1%	16.5%
Unspecified By The Complainant	100	0	0%	0%
Unknown Mesh Product	89	8	0.4%	5.7%
Desara	55	0	0%	0.2%
Ethicon Mesh Unknown	32	9	1.3%	2%
Mesh	31	2	0.4%	2.6%
T-Sling	18	0	0%	0.5%
Pelvicol Acellular Collagen Matrix	12	0	0%	0%
Pinnacle Pelvic Floor Repair Kits	11	0	0.1%	5.2%
Perigee	8	0	0%	0.5%
Unknown Mesh Product Ewhu	6	0	0.3%	0%
Ivs Tunneller	5	0	0%	9.2%
Unknown_Fro_Product	5	7	0%	36.5%
Xenform Soft Tissue Repair Matrix	4	0	0.1%	0.3%
Apogee	3	3	0.4%	0.8%
Elevate Anterior Prolapse Repair System	3	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
Cook Biotech	2,951	25.4%
Tissue Science Laboratories	1,190	10.2%
Lifecell	1,008	8.7%
Ethicon	875	7.5%
Synovis Surgical Innovations	355	3.1%
Davol Sub C R Bard	255	2.2%
Sofradim Production Sas	155	1.3%
Baxter Healthcare	100	0.9%
Davol	95	0.8%
Covidien Formerly US Surgical A Divison	86	0.7%
W L Gore & Associates	71	0.6%
Davol Sub C R Bard -1213643	63	0.5%
American Medical Systems	58	0.5%
Lemaitre Vascular	51	0.4%
C R Bard Covington -1018233	41	0.4%

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

Death0.4%48

Injury87.1%10,120

Malfunction5.2%606

Other7.1%821

Not given0.2%28

Who filed

Manufacturer report96.2%11,177

Voluntary report1.9%220

User facility report0%0

Distributor report1.3%152

Not given0.6%74

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

Device problems coded

Device problem (FDA code)	Reports	Share
Insufficient device problem information	4,222	36.3%
Migration or expulsion of device	308	2.6%
Patient-device incompatibilitythe device did not suit the patient	260	2.2%
Patient device interaction problem	219	1.9%
Other (for use when an appropriate device code cannot be identified)	217	1.9%
Device operates differently than expectedthe device behaved unexpectedly	201	1.7%
Needle, separation	158	1.4%
Defective devicethe device was defective	132	1.1%
Explanted	132	1.1%
Breakthe device broke	115	1%
Material disintegration	103	0.9%
Unexpected therapeutic results	102	0.9%
Torn material	98	0.8%
Detachment of device component	94	0.8%
Material erosion	85	0.7%
Migrationthe device moved from where it was placed	66	0.6%
Degraded	64	0.6%
Material deformation	62	0.5%
Device remains implanted	60	0.5%
Extrusion	59	0.5%

Questions about mesh, surgical reports

What is product code FTM?

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

11,623 reports through August 2026, 192 of them in the latest 12 months.

Which brands appear most often?

Unspecified By Complainant (1,812), Gynecare Mesh Unknown (1,133), Pelvisoft Acellular Collagen Biomesh (953), Xenform (761) and Strattice (303). 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.