BISA Announces Maria Gmitro Appointed as Consumer Representative for the FDA
The Breast Implant Safety Alliance (BISA) is proud to announce that our founder and president, Maria Gmitro, has been appointed as a Special Government Employee (SGE) and serving as a Consumer Representative for the U.S. Food and Drug Administration (FDA) within the Center for Devices and Radiological Health (CDRH) and the General and Plastic Surgery Devices Panel (GPSDP). This prestigious role highlights the importance of consumer advocacy in ensuring the safety and effectiveness of medical devices.
Maria’s appointment ensures that patients and consumers have a voice in evaluating medical device safety and effectiveness. Her extensive experience in patient advocacy and regulatory engagement makes her an ideal candidate for this role.
Maria Gmitro’s Experience Working with the FDA
Maria Gmitro has worked with the FDA in multiple capacities prior to her recent appointment as a Consumer Representative. Her engagement with the agency includes:
Providing public testimony to FDA advisory panel meetings on various topics, including Breast Implant Safety, Medical Device User Fees Amendments, Post Market Surveillance, Medical Device Recall Notification, Optimizing FDA’s Use of and Processes for Advisory Committees, Improving Patient Communication and Informed Consent.
Serving as a Patient and Consumer Stakeholder on Medical Device User Fees Amendments (MDUFA) V Reauthorization
Collaborating with the FDA while serving on patient safety boards and organizations, including Patient Safety Action Network PSAN, USA Patient Network and Patient, Consumer and Public Health Coalition, and Medical Device Innovation Consortium.
Understanding Maria’s Role
What Does a Consumer Representative Do?
A Consumer Representative plays a critical role in regulatory decision-making by providing the consumer perspective on issues before FDA advisory committees. Responsibilities include:
✔ Analyzing scientific data and understanding research design
✔ Discussing benefits and risks of medical devices
✔ Evaluating the safety and efficacy of products under review
✔ Serving as a liaison between advisory committees and consumer organizations
✔ Facilitating dialogue on scientific issues that affect consumers
What Does the CDRH Do?
The FDA’s Center for Devices and Radiological Health (CDRH) oversees medical devices and radiation-emitting products.
Its job is to make sure these products are safe, effective, and high quality before they reach consumers. The CDRH carefully reviews data on medical devices and makes decisions about approval and safety monitoring after they are on the market.
This center also helps develop rules and policies to improve patient safety and protect public health.
What Does the GPSDP Do?
The General and Plastic Surgery Devices Panel (GPSDP) is part of the CDRH. It focuses on evaluating medical devices used in general and plastic surgery.
This panel reviews data to ensure these devices meet safety and effectiveness standards before they are approved for use.
The GPSDP also gives recommendations to the Commissioner of Food and Drugs, providing expert advice on regulatory issues. Their work helps guide the FDA in making decisions about whether a device should be approved, changed, recalled and/or monitored more closely.
Why This Matters for Consumers
Maria’s appointment as an FDA Consumer Representative is a big win for consumer advocacy. This role will help ensure:
✔ More transparency in how medical devices are reviewed.
✔ Better protection for patients and consumers who use these products.
✔ A stronger consumer voice in FDA decision-making.
✔ More accountability for companies to provide honest and accurate safety information.
“I am honored to serve as an FDA Consumer Representative, ensuring that patient and consumer voices are heard in medical device regulation. Transparency, accountability, and patient and consumer safety must always come first. As a former educator turned advocate, I hope to bridge the gap between complex regulatory processes and the real-world experiences of patients and consumers, ensuring that safety remains a top priority.”
Encouraging Consumers to Report to FDA MedWatch
One of the most powerful ways for patients to impact medical device safety is by reporting adverse events and complications directly to the FDA MedWatch program. Maria strongly encourages patients and consumers to use this system to ensure that real-world patient experiences are documented and considered in regulatory decisions.
Reporting to MedWatch helps:
Identify safety concerns that may not be captured in clinical trials.
Hold manufacturers accountable for post-market surveillance.
Support future regulatory actions to improve device safety.
By sharing their experiences through FDA MedWatch, patients contribute valuable data that can influence policies, trigger investigations, and ultimately protect others from potential harm.
FDA: MedWatch Tips and Tools
BISA’s Commitment to Advocacy
At BISA, we believe that patients and consumers must have a seat at the table in regulatory discussions. Maria’s leadership and advocacy have always focused on ensuring transparency, informed consent, and stronger safety measures in medical device regulation. Her appointment as an FDA Consumer Representative is a significant achievement for consumer-driven change in healthcare policies.
We invite our community to celebrate this milestone with us! Maria’s appointment reflects the power of patient advocacy and consumer engagement in shaping regulatory decisions and follow BISA for updates on how her work at the FDA will help drive consumer-focused improvements in medical device safety.
✔ Follow us on social media for updates on Maria’s advocacy work
✔ Share your story—your voice matters in shaping consumer protections
✔ Support BISA in our mission to advocate for patient safety and regulatory accountability
Together, we are making a difference!
References & Resources
FDA: Reporting issues to FDA MedWatch Program
FDA: MedWatch Tips and Tools
FDA: Consumer Representatives on FDA Advisory Committees
FDA: General and Plastic Surgery Devices Panel
FDA: Center for Devices and Radiological Health (CDRH)
BISA: BISA Speaks at Session, Meets with FAS to Improve FDA Advisory Committees
Breast Implant Safety Alliance (BISA) Reflects on FDA Leadership Changes and Potential Impact on Breast Implants
Informed Consent: BISA Submits Comments On FDA Draft Guidance
Coalition Meeting with Commissioner Califf and Key FDA Officials
BISA President Speaks at MDIC Patient Forum in Washington, D.C.
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