We’re in the News - BISA Quoted in MedTech Dive about FDA Layoffs and Delay in Safety Communications
When the FDA communicates clearly and consistently, patients benefit. Recent mass layoffs at the agency have eliminated many of the staff responsible for crafting safety alerts, public recall notices, and plain-language updates about high-risk medical devices. This slowdown threatens the timely delivery of information patients and healthcare providers rely on to make informed decisions.
In the article by Senior Reporter, Elise Reuter in MedTech Dive published on May 6, 2025, BISA expressed concern that these staffing cuts could jeopardize public safety. Communication gaps can delay action during device recalls, confuse patients about their risks, and undermine trust in the regulatory system. BISA’s president Maria Gmitro and BISA’s advisor data advocate Madris Kinard of Device Events were both quoted.
For years, BISA has advocated for better communication around breast implant safety. Thousands of women still do not know if they were affected by the 2019 Allergan Biocell implant recall. Many never received notices or were told what kind of devices they have. These are not isolated failures. They are part of a larger pattern where transparency has too often come second to industry convenience.
Now, with fewer people inside the FDA to manage safety alerts and respond to public concerns, the risk of delayed or unclear messaging grows. BISA urges the FDA to restore its full capacity to deliver timely, accurate, and understandable safety communications.
We recommend the following immediate actions:
Re-establish a dedicated communications team within CDRH focused on plain-language safety updates
Resume public meetings to engage with patients and stakeholders
Prioritize transparency and patient outreach as critical components of device oversight
Clear communication saves lives. It is not an optional part of medical device regulation. It is essential.
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