The Study of the Safety and Effectiveness of Motiva SmoothSilk Silicone Gel-Filled Breast Implants in Patients Undergoing Primary and Revisional Breast Augmentation: Three-Year Clinical Data.

Abstract

Silicone breast implant design has evolved over the last 50 years. Regulatory bodies including the FDA require data to support the modifications designed to improve the safety, efficacy, longevity, and biocompatibility of breast implants. The authors reviewed the 3-year data on the safety and effectiveness of Motiva (Establishment Labs Holdings, Inc., Alajuela, Costa Rica) SmoothSilk silicone gel-filled breast implants submitted to the FDA. The current submitted data include the primary breast augmentation and revisional augmentation cohorts. The Motiva IDE is a prospective, single-arm, multicenter, 10-year pivotal study in which data are collected on breast augmentation, reconstruction, and revisional surgery. Three-year data were submitted to the FDA on adverse events, reoperations, patient and physician satisfaction, connective tissue diseases, and quality of life validated instruments. A subset of the patients underwent annual magnetic resonance imaging (MRI) at years 1, 2, and 3 to screen for implant rupture. A total of 451 patients were implanted in the primary augmentation cohort and 109 patients in the revisional augmentation cohort. There were 218 patients enrolled in the MRI cohort. Reported rates for reoperation for any reason were 6.1% in the primary augmentation cohort (92.4% follow-up) and 25.8% in the revisional augmentation cohort (88.7% follow-up). Motiva implants were first introduced in 2010. The 3-year Motiva data suggests that the leading cause of revisional surgery has shifted from capsular contracture and rupture to more subjective indications for reoperation such as malposition and size change. Three-year data from the primary augmentation and revisional augmentation cohorts submitted to the FDA demonstrate the safety and efficacy of the Motiva implants. There were low complication rates for implant-related complications and high surgeon and patient satisfaction.