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2026 data FDA MAUDE openFDA FDA Class III

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.

FDA Class III (highest risk, premarket approval required), regulated under 21 CFR §878.3530 (General, Plastic Surgery panel).

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FDA MAUDE casebook

openFDA event book Prosthesis HEAVY-BOOK · MAUDE

#36 of 1000 · 117,618 reports · 1992–2026

  • BOOK 117,618 reports
  • RANK #36 of 1000
  • DEATH 75 death-typed
  • INJ 111,856 injury-typed
  • MALF 2,676 malfunction
  • SPAN 1992–2026
  • PEAK 2019: 15,465
  • PHOTO Electrosurgical

Nearest event-volume peer: Electrosurgical, Cutting & Coagulation & Accessories (79 report gap)

Prosthesis, Breast, Inflatable, Internal, Saline sits #36 of 1000 among tracked device types with 117,618 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 95.1% INJURY-coded reports, 64.8pp 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 95.1% corpus 30.3% · above corpus mean (+64.8 pp)
  • MALF 2.3% corpus 64.8% · below corpus mean (-62.6 pp)

Lead product-problem code Fluid/Blood Leak is 33% of coded problems · Lead manufacturer ALLERGAN (COSTA RICA) accounts for 59% of manufacturer-tagged reports · Top event location is 48% 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 117,618 MAUDE reports, ranked #36 of 1000.

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

Event Types

Injury 111,856 (95.1%)
Malfunction 2,676 (2.3%)
Other 2,626 (2.2%)
385 (0.3%)
Death 75 (0.1%)

Patient Outcomes

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

Required Intervention 92,287 (74.9%)
Other 18,628 (15.1%)
3,992 (3.2%)
R 3,622 (2.9%)
O 1,219 (1.0%)
Hospitalization 961 (0.8%)
S 919 (0.7%)
Disability 542 (0.4%)
Life Threatening 426 (0.3%)
L 296 (0.2%)
H 77 (0.1%)
Congenital Anomaly 76 (0.1%)
Death 67 (0.1%)
Invalid Data 13 (0.0%)
D 7 (0.0%)
Not Applicable 5 (0.0%)
C 3 (0.0%)

Top Product Problems

Fluid/Blood Leak 43,165
Material Rupture 36,819
Adverse Event Without Identified Device or Use Problem 15,038
Device Appears to Trigger Rejection 7,448
Explanted 6,758
Deflation, cause unknown 4,707
Patient-Device Incompatibility 4,612
Replace 2,887
Deflation Problem 1,550
Migration 1,172
No Apparent Adverse Event 1,031
Rupture, cause unknown 910
Implant, removal of 789
Unknown (for use when the device problem is not known) 615
Insufficient Device Problem Information 596
Leak/Splash 480
Appropriate Device Problem Term/Code Not Available 425
Malposition of Device 334
Device Issue 262
Unintended Deflation 223

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: 165
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: 9,449
25
2025: 8,861
26
2026: 5,508

Reports in 2025 (8,861) held close to the prior two-year average of 10,045.

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

Top Manufacturers

ALLERGAN (COSTA RICA) 59,621
MENTOR TEXAS 39,762
UNK 1,569

Event Locations

55,922 (47.5%)
I 53,299 (45.3%)
AMBULATORY SURGICAL FACILITY 2,307 (2.0%)
UNKNOWN 2,279 (1.9%)
HOSPITAL 1,371 (1.2%)
NO INFORMATION 1,268 (1.1%)
INVALID DATA 599 (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 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 (117,618 here).

Electrosurgical 117,697 Sensor 117,148 Pump, Infusion, Implanted, Programmable 116,799 Device, Hemostasis, Vascular 123,919

Similar death-typed counts

Nearest other device types by death-typed report count (75 here), distinct from the volume row.

Lift, Patient, Ac-Powered 75 Negative Pressure Wound Therapy Powered Suc… 75 Screw, Fixation, Bone 75 Intestinal Stimulator 74

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.