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.

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.

Important news for women facing breast cancer! Support for including flat closure as a breast cancer reconstruction option was published by the Society of Surgical Oncology (SSO) in a new position statement.

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.

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.

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.

With Dr. Michelle Tarver’s appointment as the new director of CDRH, BISA hopes for stronger patient-focused oversight, contrasting with past controversies.

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.

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

BISA submitted public comments on the FDA’s recent draft guidance on improving the informed consent process.