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2026 data FDA MAUDE openFDA FDA Class III

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

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 §878.3540 (General, Plastic Surgery panel).

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FDA MAUDE casebook

openFDA event book Prosthesis HEAVY-BOOK · MAUDE

#18 of 1000 · 229,178 reports · 1992–2026

  • BOOK 229,178 reports
  • RANK #18 of 1000
  • DEATH 137 death-typed
  • INJ 223,823 injury-typed
  • MALF 3,630 malfunction
  • SPAN 1992–2026
  • PEAK 2025: 31,384
  • PHOTO Drug Eluting Permanen…

Nearest event-volume peer: Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes (1,084 report gap)

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled sits #18 of 1000 among tracked device types with 229,178 MAUDE reports spanning 1992–2026. 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

Prosthesis carries 97.7% INJURY-coded reports, 67.4pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.1% corpus 1.5% · below corpus mean (-1.4 pp)
  • INJ 97.7% corpus 30.3% · above corpus mean (+67.4 pp)
  • MALF 1.6% corpus 64.8% · below corpus mean (-63.2 pp)

Lead product-problem code Material Rupture is 39% of coded problems · Lead manufacturer ALLERGAN (COSTA RICA) accounts for 60% of manufacturer-tagged reports · Top event location is 67% of location-tagged rows .

Prosthesis in the event-volume neighbourhood

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

reports

What this shows Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled carries 229,178 MAUDE reports, ranked #18 of 1000.

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

Event Types

Injury 223,823 (97.7%)
Malfunction 3,630 (1.6%)
1,038 (0.5%)
Other 550 (0.2%)
Death 137 (0.1%)

Patient Outcomes

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

Required Intervention 186,343 (76.8%)
Other 31,525 (13.0%)
R 7,641 (3.2%)
4,788 (2.0%)
O 3,520 (1.5%)
S 2,646 (1.1%)
Hospitalization 2,228 (0.9%)
Disability 1,221 (0.5%)
Life Threatening 942 (0.4%)
L 872 (0.4%)
H 298 (0.1%)
Congenital Anomaly 198 (0.1%)
Death 130 (0.1%)
Invalid Data 64 (0.0%)
Not Applicable 59 (0.0%)
C 14 (0.0%)
D 9 (0.0%)

Top Product Problems

Material Rupture 97,717
Adverse Event Without Identified Device or Use Problem 51,718
Device Appears to Trigger Rejection 49,188
Patient-Device Incompatibility 15,216
Patient Device Interaction Problem 6,065
Migration 5,416
Gel Leak 4,412
Explanted 3,968
Unknown (for use when the device problem is not known) 3,332
Rupture, cause unknown 2,910
No Apparent Adverse Event 1,847
Appropriate Device Problem Term/Code Not Available 1,474
Break 1,233
Malposition of Device 1,179
Replace 1,013
Implant, removal of 915
Leak/Splash 639
Insufficient Device Problem Information 466
Fluid/Blood Leak 458
Migration or Expulsion of Device 382

Yearly Trend

92
1992: 199
93
1993: 398
94
1994: 1,745
95
1995: 1,205
96
1996: 1,205
97
1997: 3,535
98
1998: 3,249
99
1999: 783
00
2000: 720
01
2001: 300
02
2002: 193
03
2003: 173
04
2004: 134
05
2005: 175
06
2006: 127
07
2007: 94
08
2008: 106
09
2009: 53
10
2010: 59
11
2011: 101
12
2012: 102
13
2013: 120
14
2014: 140
15
2015: 204
16
2016: 291
17
2017: 930
18
2018: 2,644
19
2019: 21,411
20
2020: 24,298
21
2021: 23,365
22
2022: 30,817
23
2023: 29,098
24
2024: 30,288
25
2025: 31,384
26
2026: 19,532

Reports in 2025 (31,384) held close to the prior two-year average of 29,693.

Related Entities for Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

Top Manufacturers

ALLERGAN (COSTA RICA) 118,186
MENTOR TEXAS 74,930
UNK 2,414

Event Locations

153,627 (67.0%)
I 60,446 (26.4%)
UNKNOWN 4,069 (1.8%)
NO INFORMATION 2,882 (1.3%)
HOSPITAL 2,611 (1.1%)
INVALID DATA 2,183 (1.0%)
NOT APPLICABLE 1,207 (0.5%)
AMBULATORY SURGICAL FACILITY 996 (0.4%)
OTHER 566 (0.2%)
HOME 494 (0.2%)
OUTPATIENT TREATMENT FACILITY 48 (0.0%)
OUTPATIENT DIAGNOSTIC FACILITY 31 (0.0%)
AMBULATORY SURGICAL CENTER 10 (0.0%)
OPERATING ROOM 4 (0.0%)
NURSING HOME 2 (0.0%)
AMBULATORY HEALTH CARE FACILITY 1 (0.0%)
OUTPATIENT CLINIC/SURGERY 1 (0.0%)

Compare ALLERGAN (COSTA RICA) vs MENTOR TEXAS →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Prosthesis: 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 (229,178 here).

Drug Eluting Permanent Right Ventricular Or… 228,094 Ventilator, Continuous, Facility Use 212,024 Automated External Defibrillators 268,697 Sensor, Glucose, Invasive 281,941

Similar death-typed counts

Nearest other device types by death-typed report count (137 here), distinct from the volume row.

Transcervical Contraceptive Tubal Occlusion… 137 Catheter, Flow Directed 139 Catheter, Subclavian 140 Catheter 141

Read our methodology - how this data is sourced, computed, and verified.

Disclaimer: MAUDE figures for Prosthesis 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 Prosthesis; 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.