Breast Implant Safety Alliance 4/21/25 Breast Implant Safety Alliance 4/21/25

Centering Patient Voices in Real-World Evidence: New MDIC Guidance Opens the Door and BISA Highlights the Path Forward

The MDIC released new guidance on using real-world data. As momentum builds around direct patient input, BISA offers practical recommendations to turn this progress into lasting safety, trust, and meaningful partnerships.

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.