Save the Date: 6th World Consensus Conference on BIA-ALCL in April 2025
Save the date for the 10th International Breast Surgery Workshop (IBSW) and the 6th World Consensus Conference on BIA-ALCL, scheduled for April 11-12, 2025, in Tampa, Florida,
We’re in the News - BISA Quoted in MedTech Dive on Dr. Michelle Tarver’s Appointment as New FDA CDRH Director
BISA’s president Maria Gmitro and BISA’s advisor data advocate Madris Kinard of Device Events were both quoted in MedTech Dive, citing the optimism regarding Dr. Michelle Tarver’s appointment as the new Director of CDRH at FDA.
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.
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.