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.
FDA Safety Alert: Do Not Use BioZorb Marker Implantable Radiographic Marker Devices
Federal health regulators are alerting doctors to stop using BioZorb Markers due to reports of serious health problems among women who had these implants placed in their breast tissue for targeted cancer treatment.
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.
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.
Informed Consent: BISA Submits Comments On FDA Draft Guidance
BISA submitted public comments on the FDA’s recent draft guidance on improving the informed consent process.