Breast Implant Safety Alliance 10/31/24 Breast Implant Safety Alliance 10/31/24

BISA’s Recap of the FDA PEAC Meeting on Patient-Centered Informed Consent

It was encouraging to see the FDA gather expert opinions along with patient advocates and advisors to create improved guidance on more patient-centered informed consent materials for potential participants considering involvement in a clinical study. BISA compiled a few takeaways after the meeting.

Breast Implant Safety Alliance 10/23/24 Breast Implant Safety Alliance 10/23/24

Breast Implant Safety Alliance (BISA) Reflects on FDA Leadership Changes and Potential Impact on Breast Implants

With Dr. Michelle Tarver’s appointment as the new director of CDRH, BISA hopes for stronger patient-focused oversight, contrasting with past controversies.

Breast Implant Safety Alliance 10/16/24 Breast Implant Safety Alliance 10/16/24

FDA Patient Engagement Advisory Committee Meeting on Patient-Centered Informed Consent

The FDA welcomes participation during the October 30, 2024 Patient Engagement Advisory Committee (PEAC) meeting on patient-centered informed consent in clinical study of FDA-regulated medical products.

Breast Implant Safety Alliance 7/12/24 Breast Implant Safety Alliance 7/12/24

BISA Speaks at Session, Meets with FAS to Improve FDA Advisory Committees

BISA worked improve the FDA’s Advisory Committee process by speaking at a recent listening session, along with a post-meeting with the Federation of American Scientists to discuss next steps.