In its ongoing evaluation of the safety of breast implant medical devices, the FDA convened a public advisory committee meeting of the General and Plastic Surgery Devices Panel at its headquarters on March 25-26, 2019 to discuss a range of topics concerning the benefit-risk profile of breast implants. The committee’s focus included 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

• Best practices for informed consent discussions between patients and clinicians

Less than a week before this hearing, FDA issued two warning letters to implant manufacturers, citing their failure to conduct proper safety studies and warning that certain implants could be pulled off the market if the companies do not fulfill the agency’s requirements for post-approval safety studies.

The panel did not take any votes or issue formal recommendations. The panel’s deliberations will be used by the FDA in the coming weeks and months as the agency considers whether to adopt additional restrictions or regulations on breast implants.

This alert does not purport to be a substitute for advice of counsel on specific matters.

Harris Beach has offices throughout New York State, including Albany, Buffalo, Ithaca, Melville, New York City, Rochester, Saratoga Springs, Syracuse, Uniondale and White Plains, as well as New Haven, Connecticut and Newark, New Jersey.