Inamed silicone breast implant core study results at 6 years.

BACKGROUND Silicone gel-filled breast implants were developed in 1962 but did not fall under the auspices of the U.S. Food and Drug Administration until 1976 and were not classified as class III devices until 1988. This set the stage for a series of Food and Drug Administration advisory panel meetings and a moratorium on the sale of these implants from 1992 until 2006, when sufficient clinical data were presented to demonstrate their safety. METHODS This study was conducted under the rigorous framework of a Food and Drug Administration-approved investigational device exemption to document the safety and effectiveness of Inamed silicone-filled breast implants through 10 years. Of 940 female subjects, approximately half were augmentation subjects, one-quarter were reconstruction subjects, and one-quarter were revision subjects. Follow-up visits were conducted at 0 to 4 weeks, 6 months, 1 year, and annually thereafter. Approximately one-third of subjects also underwent biennial magnetic resonance imaging evaluation to detect silent rupture. Primary statistical analyses used the Kaplan-Meier product limit method. RESULTS Data through 6 years are currently available from the 10-year study, with patient follow-up rates for that visit ranging from 78 to 92 percent per cohort. As expected, the most common local complication in all cohorts was capsular contracture, occurring in 15 to 20 percent of subjects. The by-implant rupture rate was 3.5 percent overall at 6 years. Satisfaction with implants was uniformly high throughout the study period, with 6-year rates of 95 percent for augmentation subjects and 94 percent for reconstruction subjects. CONCLUSION Study results demonstrate the safety and effectiveness of Inamed silicone-filled breast implants through 6 years, including a low rupture rate and high satisfaction rate.