MAUDE brand profile
STYLE 15 SILICONE GEL FILLED BREAST IMPLANT
MAUDE brand safety profile
Key facts
| Brand name | STYLE 15 SILICONE GEL FILLED BREAST IMPLANT |
|---|
At a glance
- 1,000+ MAUDE reports
- 10–99 Death reports
- 1,000+ Injury reports
- 1–9 Malfunction reports
- 10–99 Problems coded
- 10–99 Problems flagged by Orca1 signal analytics
- Material Rupture, Failure of Implant, Capsular Contracture, Device Appears to Trigger Rejection, Patient-Device Incompatibility, Adverse Event Without Identified Device or Use Problem, No Apparent Adverse Event, No Clinical Signs, Symptoms or Conditions Most reported problems
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About MAUDE brand safety profiles
Brand profiles aggregate every MAUDE report that names the brand, so you can compare report volumes and problem patterns across devices. Reports are unverified and do not by themselves establish causation.
Source: U.S. Food and Drug Administration (FDA), MAUDE database; aggregation by Orca1