2026 data FDA MAUDE openFDA

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 MAUDE casebook

openFDA event book Mesh LIGHT-BOOK · MAUDE

#285 of 1000 · 5,826 reports · 2010–2026

  • BOOK 5,826 reports
  • RANK #285 of 1000
  • DEATH 100 death-typed
  • INJ 5,048 injury-typed
  • MALF 664 malfunction
  • SPAN 2010–2026
  • PEAK 2013: 2,386
  • PHOTO Catheter

Nearest event-volume peer: Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter (6 report gap)

Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling sits #285 of 1000 among tracked device types with 5,826 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 →

Event-type mix vs corpus

Shares of FDA event_type codes on this device type, compared with the mean across 1,000 device types that have ≥100 MAUDE reports. Codes are report labels, not adjudicated causation.

  • DEATH 1.7% corpus 1.5% · near corpus mean (+0.2 pp)
  • INJ 86.6% corpus 30.4% · above corpus mean (+56.2 pp)
  • MALF 11.4% corpus 64.5% · below corpus mean (-53.1 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 36% of coded problems · Lead manufacturer ETHICON INC. accounts for 43% of manufacturer-tagged reports · Top event location I is 48% 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 5,826 MAUDE reports, ranked #285 of 1000.

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

Event Types

Injury 5,048 (86.6%)
Malfunction 664 (11.4%)
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 3,482 (54.2%)
Other 1,152 (17.9%)
646 (10.1%)
R 304 (4.7%)
Hospitalization 205 (3.2%)
S 153 (2.4%)
H 121 (1.9%)
Congenital Anomaly 109 (1.7%)
Death 101 (1.6%)
Disability 81 (1.3%)
O 61 (0.9%)
L 4 (0.1%)
Life Threatening 3 (0.0%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 973
Insufficient Information 502
Break 346
Migration 164
Appropriate Term/Code Not Available 125
Material Erosion 73
Migration or Expulsion of Device 64
Detachment of Device or Device Component 55
Material Protrusion/Extrusion 52
Device Dislodged or Dislocated 49
Extrusion 41
Positioning Failure 41
Material Twisted/Bent 40
Device Appears to Trigger Rejection 36
Patient-Device Incompatibility 33
Material Split, Cut or Torn 29
Positioning Problem 29
Material Fragmentation 28
Device Operates Differently Than Expected 22
Material Deformation 21

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: 61

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

Event Locations

I 2,769 (47.5%)
2,064 (35.4%)
OTHER 621 (10.7%)
HOSPITAL 334 (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 similar MAUDE profiles

Two openFDA-derived peer sets for Mesh, both floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (5,826 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.