Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

What the Data Shows About Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

The FDA MAUDE database aggregates 214,814 adverse-event reports for Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled spanning the period from 1992 through 2026. Of these, 135 are classified as death reports, 209,684 as injury reports, and 3,410 as malfunction reports under FDA adverse-event categorization rules. Report counts do not by themselves indicate a device is unsafe — widely used devices and longer market histories naturally generate larger raw counts, so proportional and comparative reads are more informative than totals alone.

The adverse-event profile breaks down across 5 distinct event types and 17 reported patient-outcome categories, giving a multi-dimensional view that goes beyond a single headline number. A total of 20 distinct product-problem codes appear in the reports, with Material Rupture topping the list at 90,382 reports. Reports are associated with 10 different manufacturers in the MAUDE record, reflecting both OEMs and repackagers of this device category.

Annual reporting volume is tracked across 35 years of MAUDE data, with the peak single-year volume reaching 31,350 reports — trend shape often reflects changes in device adoption, reporting rules, or FDA enforcement focus rather than underlying device behavior alone. Events are documented across 17 reported care-setting categories (hospital, home, ambulatory surgery center, etc.). All figures reflect the openFDA MAUDE snapshot last refreshed on 2026-05-15. This page is informational and is not medical advice — discuss device-safety questions with your healthcare provider.