The FDA Announces General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee Meeting on March 25-26, 2019

The FDA Announces General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee Meeting on March 25-26, 2019

Today, the U.S. Food and Drug Administration (FDA) announced an upcoming meeting of theGeneral and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee to discuss the benefits and risks of breast implants for breast augmentation and reconstruction. The purpose of this meeting is to engage industry stakeholders, health care providers, plastic surgeons, and the public to provide advice and recommendations to the FDA about breast implant regulatory evaluation and issues affecting patients.

This two-day public meeting will include presentations, recommendations, and discussion on the following topics:

• breast implant associated anaplastic large cell lymphoma (BIA-ALCL);
• systemic symptoms reported in patients receiving breast implants;
• the use of registries for breast implant surveillance;
• magnetic resonance imaging (MRI) screening for silent rupture of silicone gel filled breast implants;
• the use of surgical mesh in breast procedures such as breast reconstruction and mastopexy;
• the use of real-world data and patient perspectives in regulatory decision making; and
• best practices for informed consent discussions between patients and clinicians.

The FDA is accepting submissions for data, information, or views on breast implant-related issues to be presented in person or in writing before the committee. For information about how to apply to formally present at the meeting, please see the Federal Register notice.

Additional background materials and the agenda for this meeting will be available on theAdvisory Committee webpage.

For more information about this committee’s purpose and membership, see the Medical Devices Advisory Committee webpage.

Food and Drug Administration

Center for Devices and Radiological Health