BISA Announces Maria Gmitro Appointed as Consumer Representative for the FDA
The FDA plays a major role in deciding which medical devices are safe, but who ensures that patient voices are heard in those decisions? BISA’s own Maria Gmitro has been appointed as a Consumer Representative for the FDA, bringing real-world patient perspectives to the table. Read on to find out why this is a major win for patient advocacy!
Breast Implant Illness Awareness Day: Shedding Light on Patient Experiences and Advocacy
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.
FDA Releases New Updates on the Safety and Effectiveness of 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.
Breaking News: Society of Surgical Oncology Says Surgeons Should Offer Aesthetic Flat Closure (AFC)
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.
Page Not Found? BISA Responds to FDA Removing Important Health Information – What It Means for You
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.
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.