FDA Approves Establishment Labs Motiva Breast Implants
The FDA has approved Motiva’s SmoothSilk Round and Round Ergonomix Silicone Gel-Filled Breast Implants for breast augmentation in people 22 and older.
According to the FDA Round Up September 27, 2024:
On Thursday, the FDA approved for marketing Motiva USA, LLC’s SmoothSilk Round and Round Ergonomix Silicone Gel-Filled Breast Implants, indicated for breast augmentation for patients of at least 22 years of age. The device approval is supported by an open-label, prospective study of 560 patients followed up to three years at more than 20 U.S. and European study sites. As a condition of the Premarket Approval Application (PMA) approval, the FDA is requiring the manufacturer to conduct post approval studies to continue follow-up of the premarket cohorts for 10 years to assess the long-term clinical performance of the device and provide these data to the FDA on an annual basis, and to conduct a new enrollment multicenter non-randomized prospective study following 2,400 patients for 10 years to assess selected safety and effectiveness issues not addressed during premarket studies, while requiring these data to be provided to FDA every six months. As with all breast implants marketed in the U.S., as a condition of approval of the PMA, Motiva is restricted to selling and distributing its breast implants only to users and user facilities that provide information to patients about the risks and benefits of this device before its use as specified in the approved labeling.
If you think you had a problem with your breast implants or any other medical device, the FDA encourages you to report the problem through the MedWatch Voluntary Reporting Form.
Disclaimer: The Breast Implant Safety Alliance (BISA) provides information to support patient education and informed decision-making regarding breast implants. However, we do not endorse or promote specific brands, products, or manufacturers. Our mission is to advocate for patient safety, transparency, and access to balanced information to help individuals make the choices that are best for their health and well-being. Read What All Women Should Know About Breast Implants.
References & Resources
FDA Round Up September 27, 2024
What All Women Should Know About Breast Implants
FDA: Breast Implants
MedWatch Online Voluntary Reporting Form
FDA Post Approval Database
FDA PreMarket Approval
About Breast Implant Safety Alliance (BISA)
The Breast Implant Safety Alliance (BISA) is the largest organization of board-certified patient advocates and subject matter experts in the world dedicated to patient and consumer safety relating to breast implants. Representing the millions of individuals worldwide that currently have, had, or are considering breast implants, the alliance is a non-industry funded leading authority dedicated to providing balanced, evidence-based information for informed decision making about breast implant surgery and related issues. Founded in 2019 by women, BISA is a grassroots nonprofit organization led by volunteers who do not receive a salary for their work.
Contact: Maria Gmitro, President | maria@bisanonprofit.org