MAUDE brand profile

INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT

MAUDE brand safety profile

Key facts

Brand name INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT

At a glance

  • 1,000+ MAUDE reports
  • 1–9 Death reports
  • 1,000+ Injury reports
  • 10–99 Malfunction reports
  • 100–999 Problems coded
  • 10–99 Problems flagged by Orca1 signal analytics
  • Material Rupture, Failure of Implant, Capsular Contracture, Device Appears to Trigger Rejection, Seroma, Patient-Device Incompatibility, Adverse Event Without Identified Device or Use Problem, Swollen Lymph Nodes/Glands 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

Browse all MAUDE brand safety profiles