2026 data FDA MAUDE openFDA FDA Class II

Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed

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

#328 of 1000 · 4,774 reports · 2006–2026

  • BOOK 4,774 reports
  • RANK #328 of 1000
  • DEATH 24 death-typed
  • INJ 4,679 injury-typed
  • MALF 67 malfunction
  • SPAN 2006–2026
  • PEAK 2013: 2,272
  • PHOTO Ventilator

Nearest event-volume peer: Ventilator, Emergency, Powered (Resuscitator) (25 report gap)

Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed sits #328 of 1000 among tracked device types with 4,774 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 98.0% INJURY-coded reports, 67.7pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.5% corpus 1.5% · below corpus mean (-1.0 pp)
  • INJ 98.0% corpus 30.3% · above corpus mean (+67.7 pp)
  • MALF 1.4% corpus 64.8% · below corpus mean (-63.4 pp)

Lead product-problem code Material Erosion is 50% of coded problems · Lead manufacturer ETHICON INC. accounts for 60% of manufacturer-tagged reports · Top event location I is 44% 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 Apical Vaginal And Uterine Prolapse, Transabdominally Placed carries 4,774 MAUDE reports, ranked #328 of 1000.

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

Event Types

Injury 4,679 (98.0%)
Malfunction 67 (1.4%)
Death 24 (0.5%)
3 (0.1%)
Other 1 (0.0%)

Patient Outcomes

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

Required Intervention 3,842 (76.4%)
Other 577 (11.5%)
169 (3.4%)
R 136 (2.7%)
Hospitalization 128 (2.5%)
O 63 (1.3%)
S 44 (0.9%)
Disability 29 (0.6%)
Death 25 (0.5%)
H 10 (0.2%)
L 9 (0.2%)

Top Product Problems

Material Erosion 2,447
Adverse Event Without Identified Device or Use Problem 1,139
Insufficient Device Problem Information 240
Other (for use when an appropriate device code cannot be identified) 213
Migration 206
Migration or Expulsion of Device 199
Appropriate Device Problem Term/Code Not Available 174
Material Protrusion/Extrusion 31
Device Appears to Trigger Rejection 27
Patient-Device Incompatibility 26
Break 24
Device Operates Differently Than Expected 22
Material Split, Cut or Torn 22
Torn Material 21
Extrusion 20
Defective Device 12
Missing Information 12
Material Twisted/Bent 7
Patient Device Interaction Problem 7
Degraded 6

Yearly Trend

06
2006: 1
11
2011: 7
12
2012: 160
13
2013: 2,272
14
2014: 267
15
2015: 448
16
2016: 156
17
2017: 75
18
2018: 145
19
2019: 347
20
2020: 153
21
2021: 292
22
2022: 112
23
2023: 101
24
2024: 113
25
2025: 81
26
2026: 44

Reports in 2025 (81) held close to the prior two-year average of 107.

Related Entities for Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed

Event Locations

I 2,086 (43.7%)
1,849 (38.7%)
OTHER 598 (12.5%)
HOSPITAL 207 (4.3%)
NO INFORMATION 34 (0.7%)

Compare ETHICON INC. vs ETHICON, INC. →

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 (4,774 here).

Similar death-typed counts

Nearest other device types by death-typed report count (24 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.