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.
What Happened?
📌 The FDA took down pages that helped companies include different types of people in medical studies.
📌 A new rule now requires government health agencies to get White House approval before sharing health news.
📌 The FDA also removed a guide that told companies to study how medical devices affect different groups of people.
The FDA recently removed key webpages on women’s health, clinical trials, and medical device safety—critical resources that helped people understand health risks and research diversity. A new MedTech Dive article covers these changes, featuring insights from BISA Advisor and Healthcare IT expert Madris Kinard.
The FDA also pulled draft guidance that encouraged including diverse populations in clinical trials. This follows an executive order rolling back diversity, equity, and inclusion policies in federal agencies. Additionally, a new policy now requires federal health agencies to get White House approval before releasing public health information, raising concerns about delays in critical updates.
Why Does This Matter?
🚨 Doctors and researchers need diverse medical studies to make sure medicines and devices work safely for everyone.
🚨 If health agencies can’t share information quickly, it could delay warnings about unsafe medical products.
🚨 Without public access to FDA safety updates, patients may not know about risks from medical devices like breast implants.
Maria Gmitro, President of BISA, responded to the FDA’s webpage removals, stating:
"Women’s health should be protected. The removal of these pages raises a serious concern about access to health information and patient safety. We hope this 'short pause' leads to better communication and transparency, but right now, I agree with other experts; it feels like we are moving backward. These changes could affect public health, but BISA will continue sharing critical information to keep people safe.”
What You Can Do
💡 Stay informed by following independent health organizations.
💡 Support transparency—everyone deserves clear, honest health information.
💡 Subscribe to BISA—sign up for email updates from BISA about breast implant safety.
About BISA
The Breast Implant Safety Alliance (BISA) is the largest organization of board-certified patient advocates and subject matter experts in the world dedicated to patient and consumer safety relating to breast implants. Representing the millions of individuals worldwide that currently have, had, or are considering breast implants, the alliance is a non-industry funded leading authority dedicated to providing balanced, evidence-based information for informed decision making about breast implant surgery and related issues. Founded in 2019 by women, BISA is a grassroots nonprofit organization led by volunteers who do not receive a salary for their work.
References & Resources
BISA: Breast Implant Safety Updates
MedTech Dive: FDA webpages on clinical trial diversity removed after Trump orders
Reuters: US FDA drops web pages on improving clinical trial diversity
Time: Trump Appointees Must Temporarily Approve Federal Health Communications
New York Times: FDA Names a New Chief of Medical Devices
MassDevice: DA CDRH Director Jeff Shuren announces retirement
New York Times: Regulated Medical Devices His Wife Represented Their Makers
New York Times: Lawmakers Seek Inquiry of F.D.A. Device Chief’s Potential Conflicts
BioPharmaDive: Lawmakers call for investigation of former FDA device director
A Discussion of Conflicts of Interest in Plastic Surgery and Possible Remedies
How Conflict Of Interest Harms Patients: The Case Of FDA’s Dr. Jeffrey E. Shuren
MassDevice: FDA’s Shuren faces ethics questions in NYT report
New York Times: Breast Implants Linked to Rare Cancer Are Recalled
MedTechDive: FDA defends Shuren’s tenure after report raises ethics concerns
Fortune: Why are breast implants still putting millions of women at risk?
Fortune: Women with breast implants deserve to know more about what’s in their bodies
Public Citizen: Outrage of the Month: a Senior FDA Official Regulated Medical Devices While His Wife’s Law Firm Represented Their Manufacturers
Public Citizen: Letter to the Inspector General of the Department of Health and Human Services requesting an Investigation of Conflict of Interest Allegations Against a Senior FDA Official
STAT News: Jeff Shuren stabilized the FDA’s medical devices center, winning over industry but not all patients
Shuren Faces Calls for Investigation on Conflict of Interest Claims
New York Times: Head of F.D.A. Division, Under Scrutiny, Resigns
Wall Street Journal: FDA Medical-Device Regulator Resigns
MassDevice: FDA device chief Schultz to step down
Reuters: FDA devices chief steps down
MDDI Online: The Year Turmoil Erupted at CDRH
MedTech Dive: 6 ways the FDA can improve medical device recalls
MedTechDive: Tarver, acting CDRH director, sets tone for future of the device center
BISA Speaks at Session, Meets with FAS to Improve FDA Advisory Committees
FDA: Advisory Committees Give FDA Critical Advice and the Public a Voice
FDA: Learn About FDA Advisory Committees
The Future Of FDA Advisory Committees: Protecting Public Health And Preserving Public Trust
About Breast Implant Safety Alliance (BISA)
The Breast Implant Safety Alliance (BISA) is the largest organization of board-certified patient advocates and subject matter experts in the world dedicated to patient and consumer safety relating to breast implants. Representing the millions of individuals worldwide that currently have, had, or are considering breast implants, the alliance is a non-industry funded leading authority dedicated to providing balanced, evidence-based information for informed decision making about breast implant surgery and related issues. Founded in 2019 by women, BISA is a grassroots nonprofit organization led by volunteers who do not receive a salary for their work.
Contact: Maria Gmitro, President | maria@bisanonprofit.org