We’re in the News - BISA Quoted in The New York Times on Dr. Michelle Tarver’s Appointment as New FDA CDRH Director
Maria Gmitro, president of Breast Implant Safety Alliance (BISA) BISA was quoted in The New York Times regarding the announcement of Dr. Michelle Tarver as the new FDA CDRH Director.
The New York Times reported on October 22, 2024, that Dr. Michelle Tarver was been appointed as the new director of the FDA's Center for Devices and Radiological Health (CDRH). Her appointment comes after the controversial tenure of Dr. Jeffrey Shuren, who faced ethics concerns and criticism for lax approval standards. Dr. Tarver has extensive experience in medical devices, patient safety, and regulatory science. She has previously held leadership roles at the FDA, focusing on patient engagement and advancing health equity. Safety organizations including Breast Implant Safety Alliance (BISA), are hopeful that she will address long-standing concerns about device risks and approval processes.
Maria Gmitro, president of the Breast Implant Safety Alliance, said she had been impressed with Dr. Tarver’s warmth and willingness to listen. Ms. Gmitro said she had raised concerns about whether women were aware that they received recalled breast implants that were associated with rare cases of blood cancer.
Ms. Gmitro said Dr. Tarver helped her group in a practical manner, working to open access to data on age and gender for an analyst examining reports of harm related to breast implants.
“So we are very optimistic with Dr. Tarver being in this position,” Ms. Gmitro said. “I’m hopeful about the progress that can happen.”
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