2026 data FDA MAUDE openFDA FDA Class II

Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator

Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.

OpenFDA device adverse-event casebook.

FDA Class II (moderate risk, special controls required), regulated under 21 CFR §878.3300 (General, Plastic Surgery panel).

FDA MAUDE casebook

openFDA event book Mesh MID-BOOK · MAUDE

#88 of 1000 · 38,646 reports · 2006–2026

  • BOOK 38,646 reports
  • RANK #88 of 1000
  • DEATH 376 death-typed
  • INJ 37,629 injury-typed
  • MALF 607 malfunction
  • SPAN 2006–2026
  • PEAK 2013: 19,083
  • PHOTO Plate, Fixation, Bone

Nearest event-volume peer: Plate, Fixation, Bone (172 report gap)

Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator sits #88 of 1000 among tracked device types with 38,646 MAUDE reports spanning 2006–2026. Rank counts report volume, not confirmed device fault. Event_type Death / Injury / Malfunction are one code per report — not the same population as patient-outcome rows ( methodology). Read with this device → · Lead manufacturer → · Similar-volume device →

Injury-coded reports run above the device-type norm

Mesh carries 97.4% INJURY-coded reports, 67.1pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 1.0% corpus 1.5% · below corpus mean (-0.5 pp)
  • INJ 97.4% corpus 30.3% · above corpus mean (+67.1 pp)
  • MALF 1.6% corpus 64.8% · below corpus mean (-63.3 pp)

Lead product-problem code Material Erosion is 44% of coded problems · Lead manufacturer ETHICON INC. accounts for 65% of manufacturer-tagged reports · Top event location I is 49% of location-tagged rows .

Mesh in the event-volume neighbourhood

FDA MAUDE report totals among this device type and nearest nationwide peers

reports

What this shows Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator carries 38,646 MAUDE reports, ranked #88 of 1000.

Source FDA MAUDE via openFDA, aggregated by PlainHospital As of August 2026

Event Types

Injury 37,629 (97.4%)
Malfunction 607 (1.6%)
Death 376 (1.0%)
25 (0.1%)
Other 8 (0.0%)
No answer provided 1 (0.0%)

Patient Outcomes

FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.

Required Intervention 29,791 (74.5%)
Other 6,168 (15.4%)
1,434 (3.6%)
R 825 (2.1%)
Hospitalization 569 (1.4%)
Death 377 (0.9%)
Disability 285 (0.7%)
O 239 (0.6%)
S 238 (0.6%)
H 35 (0.1%)
L 32 (0.1%)
Life Threatening 8 (0.0%)
Congenital Anomaly 3 (0.0%)

Top Product Problems

Material Erosion 17,174
Adverse Event Without Identified Device or Use Problem 10,027
Insufficient Device Problem Information 3,232
Appropriate Device Problem Term/Code Not Available 2,579
Migration or Expulsion of Device 1,999
Migration 1,787
Other (for use when an appropriate device code cannot be identified) 857
Device Operates Differently Than Expected 444
Extrusion 295
Break 132
Positioning Problem 89
Patient-Device Incompatibility 81
Material Integrity Problem 71
Material Protrusion/Extrusion 60
Detachment of Device or Device Component 59
Defective Device 50
Material Twisted/Bent 47
Material Split, Cut or Torn 42
Difficult to Advance 39
Manufacturing, Packaging or Shipping Problem 38

Yearly Trend

06
2006: 1
10
2010: 1
11
2011: 25
12
2012: 874
13
2013: 19,083
14
2014: 2,063
15
2015: 3,904
16
2016: 1,901
17
2017: 676
18
2018: 737
19
2019: 2,457
20
2020: 1,003
21
2021: 2,606
22
2022: 809
23
2023: 1,076
24
2024: 822
25
2025: 464
26
2026: 144

Reports fell to 464 in 2025, down from an average of 949 in the two years before.

Related Entities for Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator

Event Locations

I 18,917 (48.9%)
13,313 (34.4%)
OTHER 3,948 (10.2%)
HOSPITAL 1,812 (4.7%)
NO INFORMATION 647 (1.7%)
AMBULATORY SURGICAL FACILITY 3 (0.0%)
HOME 3 (0.0%)
OUTPATIENT DIAGNOSTIC FACILITY 2 (0.0%)
OUTPATIENT TREATMENT FACILITY 1 (0.0%)

Compare ETHICON INC. vs BOSTON SCIENTIFIC CORPORATION →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Mesh: nearest by total report volume and nearest by death-typed count, each floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (38,646 here).

Similar death-typed counts

Nearest other device types by death-typed report count (376 here), distinct from the volume row.

Disclaimer: MAUDE figures for Mesh are informational only and are not clinical advice. Report codes do not prove device causation. Consult a qualified clinician before acting on this data.

Every figure on PlainHospital is rendered directly from federal source data, no number is typed in by an editor. Event-type mix on this page is computed from FDA MAUDE codes for Mesh; corpus means use device types with ≥100 reports. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of August 2026.