2026 data FDA MAUDE openFDA FDA Class III

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

#133 of 1000 · 22,615 reports · 1993–2026

  • BOOK 22,615 reports
  • RANK #133 of 1000
  • DEATH 14 death-typed
  • INJ 18,890 injury-typed
  • MALF 1,645 malfunction
  • SPAN 1993–2026
  • PEAK 2025: 1,825
  • PHOTO Lens

Nearest event-volume peer: Lens, Intraocular, Phakic (618 report gap)

Implant, Dermal, For Aesthetic Use sits #133 of 1000 among tracked device types with 22,615 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 →

Malfunction reports sit below the device-type norm

Implant, Dermal, For Aesthetic Use carries 7.3% MALFUNCTION-coded reports, 57.6pp below 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 83.5% corpus 30.3% · above corpus mean (+53.2 pp)
  • MALF 7.3% corpus 64.8% · below corpus mean (-57.6 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 56% of coded problems · Lead manufacturer ALLERGAN (PRINGY) accounts for 85% of manufacturer-tagged reports · Top event location is 61% 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 22,615 MAUDE reports, ranked #133 of 1000.

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

Event Types

Injury 18,890 (83.5%)
Malfunction 1,645 (7.3%)
Other 1,079 (4.8%)
987 (4.4%)
Death 14 (0.1%)

Patient Outcomes

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

Required Intervention 13,003 (52.1%)
Other 4,407 (17.7%)
3,362 (13.5%)
R 1,447 (5.8%)
Hospitalization 907 (3.6%)
Disability 599 (2.4%)
S 446 (1.8%)
O 440 (1.8%)
H 180 (0.7%)
Life Threatening 101 (0.4%)
L 45 (0.2%)
Death 17 (0.1%)
Congenital Anomaly 7 (0.0%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 12,983
Insufficient Device Problem Information 2,323
Improper or Incorrect Procedure or Method 1,690
Off-Label Use 942
Reaction 816
Unknown (for use when the device problem is not known) 558
Patient-Device Incompatibility 547
Device remains implanted 524
Detachment of Device or Device Component 441
Detachment Of Device Component 384
Gel Leak 306
Expulsion 239
Leak/Splash 239
Break 211
Crack 211
Use of Device Problem 182
Needle, separation 166
Spillage, accidental 164
Migration or Expulsion of Device 156
No Apparent Adverse Event 121

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: 1,166

Reports in 2025 (1,825) held close to the prior two-year average of 1,436.

Related Entities for Implant, Dermal, For Aesthetic Use

Top Manufacturers

Event Locations

13,747 (60.8%)
I 7,674 (33.9%)
OTHER 467 (2.1%)
INVALID DATA 251 (1.1%)
OUTPATIENT TREATMENT FACILITY 219 (1.0%)
NO INFORMATION 195 (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%)
0 1 (0.0%)
OUTPATIENT DIAGNOSTIC FACILITY 1 (0.0%)

Compare ALLERGAN (PRINGY) vs ALLERGAN →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Implant, Dermal, For Aesthetic Use: 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 (22,615 here).

Similar death-typed counts

Nearest other device types by death-typed report count (14 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.