Breast Implant Illness Awareness Day: Shedding Light on Patient Experiences and Advocacy
Recognized on February 13th, Breast Implant Illness (BII) Awareness Day serves as a critical moment to highlight the struggles faced by individuals experiencing health complications related to breast implants.
FDA Releases New Updates on the Safety and Effectiveness of Breast Implants
On February 6, 2025, the FDA provided updates on the safety and effectiveness of breast implants. BISA provides a brief summary and why this info is crucial for the public.
Page Not Found? BISA Responds to FDA Removing Important Health Information – What It Means for You
The FDA recently removed web pages about diversity in clinical trials, medical device safety, and more. Many experts are worried that this will make it harder for people to find important health information.
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 (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.
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.