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 10. Investigators are encouraged to follow their enrolled patients 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 include both the primary and revisional breast augmentation cohorts.

[METHODS] The 5-year clinical data from the breast augmentation cohorts of the Motiva IDE 10-year pivotal study were submitted to the FDA in 2024. Data were collected 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 substudy.

[RESULTS] There were 451 primary augmentation patients and 109 revisional 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 reoperation rates for any reason were 8.8% in the primary augmentation cohort and 36.0% in the revisional augmentation cohort.

[CONCLUSIONS] The 5-year data from the primary and revisional 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, and capsular contracture and size change were the leading drivers of reoperation in the revisional augmentation cohort.

[LEVEL OF EVIDENCE] : 2 (Therapeutic).