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2026 data FDA MAUDE openFDA

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.

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FDA MAUDE casebook

openFDA event book Prosthesis HEAVY-BOOK · MAUDE

#18 of 1000 · 214,814 reports · 1992–2026

  • BOOK 214,814 reports
  • RANK #18 of 1000
  • DEATH 135 death-typed
  • INJ 209,684 injury-typed
  • MALF 3,410 malfunction
  • SPAN 1992–2026
  • PEAK 2025: 31,350
  • PHOTO Drug Eluting Permanen…

Nearest event-volume peer: Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes (3,246 report gap)

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled sits #18 of 1000 among tracked device types with 214,814 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 →

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 0.1% corpus 1.5% · below corpus mean (-1.5 pp)
  • INJ 97.6% corpus 30.4% · above corpus mean (+67.2 pp)
  • MALF 1.6% corpus 64.5% · below corpus mean (-62.9 pp)

Lead product-problem code Material Rupture is 41% of coded problems · Lead manufacturer ALLERGAN (COSTA RICA) accounts for 57% of manufacturer-tagged reports · Top event location is 65% 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 214,814 MAUDE reports, ranked #18 of 1000.

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

Event Types

Injury 209,684 (97.6%)
Malfunction 3,410 (1.6%)
1,038 (0.5%)
Other 547 (0.3%)
Death 135 (0.1%)

Patient Outcomes

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

Required Intervention 175,115 (76.5%)
Other 30,006 (13.1%)
R 7,440 (3.3%)
4,479 (2.0%)
O 3,327 (1.5%)
S 2,633 (1.2%)
Hospitalization 2,177 (1.0%)
Disability 1,201 (0.5%)
Life Threatening 900 (0.4%)
L 845 (0.4%)
H 279 (0.1%)
Congenital Anomaly 198 (0.1%)
Death 129 (0.1%)
Invalid Data 64 (0.0%)
Not Applicable 59 (0.0%)
C 13 (0.0%)
D 9 (0.0%)

Top Product Problems

Material Rupture 90,382
Adverse Event Without Identified Device or Use Problem 48,641
Device Appears to Trigger Rejection 44,919
Patient-Device Incompatibility 15,030
Patient Device Interaction Problem 5,643
Migration 4,685
Gel Leak 3,196
No Apparent Adverse Event 1,500
Appropriate Term/Code Not Available 1,387
Break 981
Malposition of Device 639
Fluid/Blood Leak 379
Device Handling Problem 362
Insufficient Information 348
Material Deformation 319
Use of Device Problem 316
Off-Label Use 300
Material Discolored 243
Difficult to Open or Remove Packaging Material 194
Improper or Incorrect Procedure or Method 138

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: 290
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: 30,287
25
2025: 31,350
26
2026: 5,204

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

Top Manufacturers

ALLERGAN (COSTA RICA) 110,900
MENTOR TEXAS 70,172
SIENTRA INC 3,531
SIENTRA INC. 3,278
UNK 2,344
SIENTRA, INC. 2,051
UNKNOWN 1,672

Event Locations

139,244 (64.8%)
I 60,468 (28.1%)
UNKNOWN 4,069 (1.9%)
NO INFORMATION 2,882 (1.3%)
HOSPITAL 2,608 (1.2%)
INVALID DATA 2,183 (1.0%)
NOT APPLICABLE 1,207 (0.6%)
AMBULATORY SURGICAL FACILITY 996 (0.5%)
OTHER 566 (0.3%)
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 similar MAUDE profiles

Two openFDA-derived peer sets for Prosthesis, 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 (214,814 here).

Drug Eluting Permanent Right Ventricular Or… 218,060 Set, Administration, Intravascular 207,687 Ventilator, Continuous, Facility Use 205,183 Mesh, Surgical, Polymeric 168,757

Similar death-typed counts

Nearest other device types by death-typed report count (135 here), distinct from the volume row.

Transcervical Contraceptive Tubal Occlusion… 134 Catheter 138 Catheter, Flow Directed 139 Catheter, Subclavian 140

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.