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 9/30/24 Breast Implant Safety Alliance 9/30/24

FDA Approves Establishment Labs Motiva Breast Implants

The FDA has approved Motiva’s SmoothSilk Round and Round Ergonomix Silicone Gel-Filled Breast Implants for breast augmentation in people 22 and older.