2026 data FDA MAUDE openFDA FDA Class II

Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling

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 LIGHT-BOOK · MAUDE

#287 of 1000 · 5,966 reports · 2010–2026

  • BOOK 5,966 reports
  • RANK #287 of 1000
  • DEATH 100 death-typed
  • INJ 5,081 injury-typed
  • MALF 771 malfunction
  • SPAN 2010–2026
  • PEAK 2013: 2,386
  • PHOTO Catheter

Nearest event-volume peer: Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter (20 report gap)

Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling sits #287 of 1000 among tracked device types with 5,966 MAUDE reports spanning 2010–2026. 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 85.2% INJURY-coded reports, 54.9pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 1.7% corpus 1.5% · near corpus mean (+0.2 pp)
  • INJ 85.2% corpus 30.3% · above corpus mean (+54.9 pp)
  • MALF 12.9% corpus 64.8% · below corpus mean (-51.9 pp)

Lead product-problem code Material Erosion is 40% of coded problems · Lead manufacturer ETHICON INC. accounts for 42% of manufacturer-tagged reports · Top event location I is 46% 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, Female, Mini-Sling carries 5,966 MAUDE reports, ranked #287 of 1000.

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

Event Types

Injury 5,081 (85.2%)
Malfunction 771 (12.9%)
Death 100 (1.7%)
13 (0.2%)
Other 1 (0.0%)

Patient Outcomes

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

Required Intervention 3,503 (53.0%)
Other 1,171 (17.7%)
780 (11.8%)
R 310 (4.7%)
Hospitalization 205 (3.1%)
S 154 (2.3%)
H 121 (1.8%)
Congenital Anomaly 109 (1.6%)
Death 101 (1.5%)
Disability 87 (1.3%)
O 62 (0.9%)
L 4 (0.1%)
Life Threatening 3 (0.0%)

Top Product Problems

Material Erosion 2,371
Adverse Event Without Identified Device or Use Problem 1,411
Insufficient Device Problem Information 675
Break 461
Migration 171
Appropriate Device Problem Term/Code Not Available 133
Migration or Expulsion of Device 90
Device Operates Differently Than Expected 85
Extrusion 78
Detachment of Device or Device Component 58
Material Protrusion/Extrusion 54
Device Dislodged or Dislocated 53
Material Fragmentation 46
Device Appears to Trigger Rejection 45
Positioning Failure 45
Material Twisted/Bent 42
Patient-Device Incompatibility 41
Positioning Problem 32
Material Split, Cut or Torn 31
Other (for use when an appropriate device code cannot be identified) 29

Yearly Trend

10
2010: 1
11
2011: 7
12
2012: 129
13
2013: 2,386
14
2014: 338
15
2015: 275
16
2016: 697
17
2017: 127
18
2018: 174
19
2019: 298
20
2020: 171
21
2021: 318
22
2022: 159
23
2023: 154
24
2024: 287
25
2025: 244
26
2026: 201

Reports in 2025 (244) held close to the prior two-year average of 221.

Related Entities for Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling

Event Locations

I 2,769 (46.4%)
2,199 (36.9%)
OTHER 621 (10.4%)
HOSPITAL 339 (5.7%)
NO INFORMATION 36 (0.6%)
AMBULATORY SURGICAL FACILITY 1 (0.0%)
OPERATING ROOM 1 (0.0%)

Compare ETHICON INC. vs COLOPLAST A/S →

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 (5,966 here).

Similar death-typed counts

Nearest other device types by death-typed report count (100 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.