The Study of the Safety and Effectiveness of Motiva SmoothSilk Silicone Gel-filled Breast Implants in Patients Undergoing Primary and Revisional Breast Augmentation: 5-Year Clinical Data

Background The FDA requires implant manufacturers to continue collecting safety and efficacy data annually through year ten. Investigators are encouraged to follow their enrolled subjects in person to obtain the most accurate and complete data. Objectives The authors reviewed the 5-year data on the safety and effectiveness of Motiva SmoothSilk® silicone gel filled breast implants submitted to the FDA. The reported data includes both the Primary and Revision Breast Augmentation cohorts. Methods The five-year clinical data from the breast augmentation cohorts of the Motiva IDE, 10-year pivotal study was submitted to the FDA in 2024. Data was collected from on adverse events, reoperation, patient and physician satisfaction, connective tissue and rheumatologic diseases, and quality of life instruments. MRIs were obtained at years 1, 2, 3, and 5 for patients enrolled in the MRI sub-study. Results There were 451 primary augmentation patients and 109 revision augmentation patients enrolled in the pivotal study. Follow-up rates were 87% of expected patients at both years 4 and 5. Of the 218 patients enrolled in the MRI cohort, 152 underwent MRI screening at year 5, an overall compliance of 79.2% of expected screenings. The reported re-operation rates for any reason were 8.8% in the Primary Augmentation Cohort and 36.0% in the Revision Augmentation Cohort. Conclusions The five-year data from the Primary and Revision Breast Augmentation cohorts reveal low rates of device rupture. Size change and malposition were the most common causes of reoperation in the Primary Augmentation Cohort, while capsular contracture and size change were the leading drivers of reoperation in the Revision Augmentation Cohort.