Mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, female, mini-sling: medical device reports filed with FDA

5,985 reports carry this product code, 2010–2026; 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.

5,985
reports with this product code: 0% of all MAUDE reports; 295
reports, 12 months to August 2026: 270 in the 12 months before; 13%
classified as malfunction: 62.3% across all reports; 1.7%
classified as death, as reported: 0.9% across all reports

Product code PAH is FDA's classification for "Mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, female, mini-sling" (general, Plastic Surgery panel), a class 2 device. 5,985 medical device reports carry this product code, 0% of the MAUDE database, from February 2010 to August 2026.

295 reports arrived in the 12 months to August 2026, close to the 270 of 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 (85.1%), malfunction (13%) and death (1.7%). 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 Tvt Secur System	1,729	0	0%	0%
Altis single incision sling system	973	250	0%	56%
Tension Free Vaginal Tape	616	0	0.1%	3.9%
Solyx SIS System	577	7	0.1%	10.5%
T-Sling	461	0	0%	0.5%
Altis Kit	367	0	0%	1.9%
AJUST Adjustable Single-Incision Sling	175	0	0%	1.1%
Obtape Transobturator Sling	119	0	0%	0%
Ajust Adjustable Single Incision Sling	114	0	0%	18.5%
Miniarc Single-Incision Sling	35	0	0%	0.3%
Desara	10	0	0%	0.2%
Miniarc Sling System	9	0	0.5%	0%
Advantage Fit System	1	10	0.1%	4.2%
Apogee	1	3	0.4%	0.8%
Aris Trans-Obturator Kit	1	0	0%	1.4%
Avaulta Plus Biosynthetic Support System - Anterior	1	0	0%	0%
Gynecare Tvt Oburator System	1	0	0.1%	0%
Titan	1	0	0%	23.8%
Unk Women's Health Product	1	0	0%	0%
Uphold Lite	1	0	0%	40.5%
Upsylon	1	10	0%	9.1%

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	2,239	37.4%
Coloplast A/S	1,325	22.1%
Boston Scientific - Marlborough	144	2.4%
American Medical Systems	133	2.2%
Bard Shannon	114	1.9%
Ethicon Sarl	92	1.5%
American Medical Systems Mn	90	1.5%
C R Bard Covington	51	0.9%
C R Bard Covington -1018233	45	0.8%
Caldera Medical	44	0.7%
C R Bard	8	0.1%
Tissue Science Laboratories	2	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

Death1.7%100

Injury85.1%5,091

Malfunction13%780

Other0%1

Not given0.2%13

Who filed

Manufacturer report97.3%5,823

Voluntary report0.9%54

User facility report0%0

Distributor report1.2%71

Not given0.6%37

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

Device problems coded

Device problem (FDA code)	Reports	Share
Material erosion	2,370	39.6%
Insufficient device problem information	673	11.2%
Breakthe device broke	471	7.9%
Migrationthe device moved from where it was placed	171	2.9%
Migration or expulsion of device	87	1.5%
Device operates differently than expectedthe device behaved unexpectedly	85	1.4%
Extrusion	77	1.3%
Detachment of device or device componentpart of the device came off	57	1%
Device dislodged or dislocated	51	0.9%
Material protrusion/extrusion	50	0.8%
Device appears to trigger rejection	44	0.7%
Material fragmentation	44	0.7%
Positioning failure	43	0.7%
Material twisted/bent	42	0.7%
Patient-device incompatibilitythe device did not suit the patient	38	0.6%
Material split, cut or torn	29	0.5%
Other (for use when an appropriate device code cannot be identified)	29	0.5%
Positioning problem	29	0.5%
Material deformation	23	0.4%
Detachment of device component	20	0.3%

Questions about mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, female, mini-sling reports

What is product code PAH?

FDA's classification code for "Mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, female, mini-sling", 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?

5,985 reports through August 2026, 295 of them in the latest 12 months.

Which brands appear most often?

Gynecare Tvt Secur System (1,729), Altis single incision sling system (973), Tension Free Vaginal Tape (616), Solyx SIS System (577) and T-Sling (461). 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.