MAUDE brand profile

SIENTRA SMOOTH ROUND MODERATE PROFILE BREAST IMPLANTS

MAUDE brand safety profile

Key facts

Brand name SIENTRA SMOOTH ROUND MODERATE PROFILE BREAST IMPLANTS

At a glance

  • 10–99 MAUDE reports
  • 1–9 Injury reports
  • 10–99 Problems coded
  • 10–99 Problems flagged by Orca1 signal analytics
  • Material Deformation, Material Rupture, Chest Tightness/Pressure, Swollen Lymph Nodes, Skin Inflammation, Autoimmune Reaction, Red Eye(s), Gel Leak 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