2026 data FDA MAUDE openFDA

Implant, Dermal, For Aesthetic Use

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 MAUDE casebook

openFDA event book Implant, Dermal, For Aesthetic Use MID-BOOK · MAUDE

#131 of 1000 · 21,719 reports · 1993–2026

  • BOOK 21,719 reports
  • RANK #131 of 1000
  • DEATH 12 death-typed
  • INJ 18,000 injury-typed
  • MALF 1,641 malfunction
  • SPAN 1993–2026
  • PEAK 2025: 1,825
  • PHOTO Lens

Nearest event-volume peer: Lens, Intraocular, Phakic (91 report gap)

Implant, Dermal, For Aesthetic Use sits #131 of 1000 among tracked device types with 21,719 MAUDE reports spanning 1993–2026. 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 82.9% corpus 30.4% · above corpus mean (+52.4 pp)
  • MALF 7.6% corpus 64.5% · below corpus mean (-57.0 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 66% of coded problems · Lead manufacturer ALLERGAN (PRINGY) accounts for 85% of manufacturer-tagged reports · Top event location is 59% of location-tagged rows .

Implant, Dermal, For Aesthetic Use in the event-volume neighbourhood

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

reports

What this shows Implant, Dermal, For Aesthetic Use carries 21,719 MAUDE reports, ranked #131 of 1000.

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

Event Types

Injury 18,000 (82.9%)
Malfunction 1,641 (7.6%)
Other 1,079 (5.0%)
987 (4.5%)
Death 12 (0.1%)

Patient Outcomes

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

Required Intervention 12,491 (51.7%)
Other 4,351 (18.0%)
3,264 (13.5%)
R 1,386 (5.7%)
Hospitalization 898 (3.7%)
Disability 584 (2.4%)
S 438 (1.8%)
O 406 (1.7%)
H 171 (0.7%)
Life Threatening 99 (0.4%)
L 44 (0.2%)
Death 15 (0.1%)
Congenital Anomaly 7 (0.0%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 10,237
Improper or Incorrect Procedure or Method 1,465
Off-Label Use 809
Detachment of Device or Device Component 432
Detachment Of Device Component 376
Gel Leak 306
Expulsion 237
Crack 203
Break 197
Patient-Device Incompatibility 196
Leak/Splash 195
Use of Device Problem 143
Insufficient Information 135
No Apparent Adverse Event 112
Burst Container or Vessel 73
Migration or Expulsion of Device 70
Migration 69
Device Appears to Trigger Rejection 51
Difficult or Delayed Positioning 48
Difficult or Delayed Activation 40

Yearly Trend

93
1993: 1
94
1994: 4
95
1995: 1
96
1996: 102
97
1997: 293
98
1998: 291
99
1999: 261
00
2000: 200
01
2001: 154
02
2002: 190
03
2003: 217
04
2004: 163
05
2005: 130
06
2006: 131
07
2007: 175
08
2008: 308
09
2009: 1,217
10
2010: 731
11
2011: 448
12
2012: 402
13
2013: 451
14
2014: 786
15
2015: 885
16
2016: 691
17
2017: 1,509
18
2018: 1,803
19
2019: 1,273
20
2020: 1,156
21
2021: 1,422
22
2022: 1,358
23
2023: 1,478
24
2024: 1,393
25
2025: 1,825
26
2026: 270

Related Entities for Implant, Dermal, For Aesthetic Use

Top Manufacturers

Event Locations

12,890 (59.3%)
I 7,674 (35.3%)
OTHER 454 (2.1%)
INVALID DATA 251 (1.2%)
NO INFORMATION 195 (0.9%)
OUTPATIENT TREATMENT FACILITY 194 (0.9%)
UNKNOWN 31 (0.1%)
AMBULATORY SURGICAL FACILITY 10 (0.0%)
HOME 9 (0.0%)
HOSPITAL 7 (0.0%)
NOT APPLICABLE 3 (0.0%)
OUTPATIENT DIAGNOSTIC FACILITY 1 (0.0%)

Compare ALLERGAN (PRINGY) vs ALLERGAN →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Implant, Dermal, For Aesthetic Use, 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 (21,719 here).

Similar death-typed counts

Nearest other device types by death-typed report count (12 here), distinct from the volume row.

Disclaimer: MAUDE figures for Implant, Dermal, For Aesthetic Use 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 Implant, Dermal, For Aesthetic Use; 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.