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2026 data FDA MAUDE openFDA

Prosthesis, Breast, Inflatable, Internal, Saline

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

#38 of 1000 · 113,497 reports · 1992–2026

  • BOOK 113,497 reports
  • RANK #38 of 1000
  • DEATH 72 death-typed
  • INJ 107,773 injury-typed
  • MALF 2,641 malfunction
  • SPAN 1992–2026
  • PEAK 2019: 15,465
  • PHOTO Pump

Nearest event-volume peer: Pump, Infusion, Implanted, Programmable (591 report gap)

Prosthesis, Breast, Inflatable, Internal, Saline sits #38 of 1000 among tracked device types with 113,497 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 95.0% corpus 30.4% · above corpus mean (+64.5 pp)
  • MALF 2.3% corpus 64.5% · below corpus mean (-62.2 pp)

Lead product-problem code Fluid/Blood Leak is 38% of coded problems · Lead manufacturer ALLERGAN (COSTA RICA) accounts for 59% of manufacturer-tagged reports · Top event location I is 47% 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, Inflatable, Internal, Saline carries 113,497 MAUDE reports, ranked #38 of 1000.

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

Event Types

Injury 107,773 (95.0%)
Malfunction 2,641 (2.3%)
Other 2,626 (2.3%)
385 (0.3%)
Death 72 (0.1%)

Patient Outcomes

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

Required Intervention 89,047 (74.6%)
Other 18,286 (15.3%)
3,956 (3.3%)
R 3,572 (3.0%)
O 1,174 (1.0%)
Hospitalization 958 (0.8%)
S 918 (0.8%)
Disability 542 (0.5%)
Life Threatening 412 (0.3%)
L 285 (0.2%)
H 76 (0.1%)
Congenital Anomaly 76 (0.1%)
Death 66 (0.1%)
Invalid Data 13 (0.0%)
D 6 (0.0%)
Not Applicable 5 (0.0%)
C 3 (0.0%)

Top Product Problems

Fluid/Blood Leak 41,064
Material Rupture 35,178
Adverse Event Without Identified Device or Use Problem 14,562
Device Appears to Trigger Rejection 6,785
Patient-Device Incompatibility 4,534
Deflation Problem 1,410
Migration 971
No Apparent Adverse Event 829
Insufficient Information 446
Appropriate Term/Code Not Available 386
Unintended Deflation 189
Peeled/Delaminated 169
Migration or Expulsion of Device 152
Detachment of Device or Device Component 138
Improper or Incorrect Procedure or Method 130
Malposition of Device 127
Use of Device Problem 125
Connection Problem 121
Device Handling Problem 120
Off-Label Use 115

Yearly Trend

92
1992: 10
93
1993: 62
94
1994: 180
95
1995: 241
96
1996: 384
97
1997: 829
98
1998: 967
99
1999: 1,453
00
2000: 1,455
01
2001: 746
02
2002: 918
03
2003: 769
04
2004: 542
05
2005: 507
06
2006: 383
07
2007: 307
08
2008: 268
09
2009: 123
10
2010: 126
11
2011: 99
12
2012: 142
13
2013: 105
14
2014: 81
15
2015: 110
16
2016: 164
17
2017: 4,487
18
2018: 13,223
19
2019: 15,465
20
2020: 14,022
21
2021: 11,350
22
2022: 13,641
23
2023: 10,640
24
2024: 9,450
25
2025: 8,895
26
2026: 1,353

Related Entities for Prosthesis, Breast, Inflatable, Internal, Saline

Top Manufacturers

ALLERGAN (COSTA RICA) 56,977
MENTOR TEXAS 38,608
UNK 1,569

Event Locations

I 53,314 (47.0%)
51,786 (45.6%)
AMBULATORY SURGICAL FACILITY 2,307 (2.0%)
UNKNOWN 2,279 (2.0%)
HOSPITAL 1,370 (1.2%)
NO INFORMATION 1,268 (1.1%)
INVALID DATA 600 (0.5%)
OTHER 226 (0.2%)
HOME 221 (0.2%)
NOT APPLICABLE 92 (0.1%)
OUTPATIENT DIAGNOSTIC FACILITY 15 (0.0%)
OUTPATIENT TREATMENT FACILITY 12 (0.0%)
AMBULATORY HEALTH CARE FACILITY 5 (0.0%)
AMBULATORY SURGICAL CENTER 2 (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 (113,497 here).

Pump, Infusion, Implanted, Programmable 114,088 Electrosurgical 114,517 Sensor 114,527 System 118,454

Similar death-typed counts

Nearest other device types by death-typed report count (72 here), distinct from the volume row.

Catheter, Hemodialysis, Non-Implanted 72 Catheter, Ultrasound, Intravascular 72 Intestinal Stimulator 72 Ligator, Esophageal 71

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.