2026 data FDA MAUDE openFDA FDA Class III

Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally 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 III (highest risk, premarket approval required), regulated under 21 CFR §884.5980 (Obstetrics/Gynecology panel).

FDA MAUDE casebook

openFDA event book Mesh MID-BOOK · MAUDE

#198 of 1000 · 11,654 reports · 2007–2026

  • BOOK 11,654 reports
  • RANK #198 of 1000
  • DEATH 256 death-typed
  • INJ 10,906 injury-typed
  • MALF 483 malfunction
  • SPAN 2007–2026
  • PEAK 2013: 7,150
  • PHOTO Mesh, Surgical

Nearest event-volume peer: Mesh, Surgical (59 report gap)

Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed sits #198 of 1000 among tracked device types with 11,654 MAUDE reports spanning 2007–2026. 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 93.6% INJURY-coded reports, 63.3pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 2.2% corpus 1.5% · above corpus mean (+0.7 pp)
  • INJ 93.6% corpus 30.3% · above corpus mean (+63.3 pp)
  • MALF 4.1% corpus 64.8% · below corpus mean (-60.7 pp)

Lead product-problem code Material Erosion is 44% of coded problems · Lead manufacturer ETHICON INC. accounts for 42% of manufacturer-tagged reports · Top event location I is 37% 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 Pelvic Organ Prolapse, Transvaginally Placed carries 11,654 MAUDE reports, ranked #198 of 1000.

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

Event Types

Injury 10,906 (93.6%)
Malfunction 483 (4.1%)
Death 256 (2.2%)
5 (0.0%)
Other 4 (0.0%)

Patient Outcomes

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

Required Intervention 8,586 (66.7%)
Other 1,786 (13.9%)
S 913 (7.1%)
612 (4.8%)
R 260 (2.0%)
Death 256 (2.0%)
Hospitalization 210 (1.6%)
Disability 193 (1.5%)
O 39 (0.3%)
L 6 (0.0%)
H 5 (0.0%)
Life Threatening 3 (0.0%)
D 2 (0.0%)
Congenital Anomaly 2 (0.0%)

Top Product Problems

Material Erosion 5,195
Adverse Event Without Identified Device or Use Problem 4,028
Insufficient Device Problem Information 604
Detachment Of Device Component 435
Migration 295
Appropriate Device Problem Term/Code Not Available 174
Device Operates Differently Than Expected 172
Break 164
Detachment of Device or Device Component 159
Migration or Expulsion of Device 149
Extrusion 141
Other (for use when an appropriate device code cannot be identified) 102
Retraction Problem 43
Patient-Device Incompatibility 32
Material Protrusion/Extrusion 26
Defective Device 24
Use of Device Problem 17
Patient Device Interaction Problem 15
Material Separation 11
Torn Material 11

Yearly Trend

07
2007: 1
09
2009: 3
10
2010: 3
11
2011: 32
12
2012: 494
13
2013: 7,150
14
2014: 778
15
2015: 684
16
2016: 416
17
2017: 270
18
2018: 392
19
2019: 368
20
2020: 175
21
2021: 647
22
2022: 114
23
2023: 59
24
2024: 35
25
2025: 28
26
2026: 5

Reports fell to 28 in 2025, down from an average of 47 in the two years before.

Related Entities for Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed

Event Locations

I 4,329 (37.1%)
4,083 (35.0%)
OTHER 1,618 (13.9%)
HOSPITAL 1,594 (13.7%)
NO INFORMATION 26 (0.2%)
OPERATING ROOM 1 (0.0%)
OUTPATIENT DIAGNOSTIC FACILITY 1 (0.0%)
OUTPATIENT TREATMENT FACILITY 1 (0.0%)
UNKNOWN 1 (0.0%)

Compare ETHICON INC. vs BOSTON SCIENTIFIC - MARLBOROUGH →

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 (11,654 here).

Similar death-typed counts

Nearest other device types by death-typed report count (256 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.