NEW! BISA Reviews Article Concerning Breast Implant Safety and Reputation of the FDA
Are breast implants as safe as we think and why do we still question the safety? Members of Breast Implant Safety Alliance (BISA) reviewed a new article examining the reputation of the FDA concerning the safety of breast implants.
BISA’s Medical Advisor, Siham Azahaf, MD, PhD Candidate and board members, Laura Willging and Heidi Rolfs who hold degrees in the nursing profession and are Board Certified Patient Advocates, were reviewers for the new prospective article. Titled, Conflicting interpretations and FDA reputation: the case of post-market surveillance of breast implants, the article was published in Frontiers in Medicine of November 2024.
Is the FDA in their Reputation Era?
Generally speaking, the opinion article discusses how the FDA faces challenges in protecting its reputation. After breast implants are sold, the FDA tries to collect safety data through a process called Post Market Surveillance, but this data can often be low quality. This means doctors, patients, and the FDA may disagree about how safe implants are. Since the FDA doesn’t get steady money from the government, it relies partly on money from companies that make these devices. This makes it harder for the FDA to strictly monitor problems with implants. The article suggests that if the FDA got steady government funding, it could better protect people and its own reputation.
What Does Post-Market Surveillance Mean?
Post-market surveillance is how the FDA checks that medical devices, medicines, and other products are still safe after they’re sold to the public. Even though products are tested before they go on the market or are similar to previously FDA- approved products, some problems might only show up when lots of people start using them. The FDA collects information from doctors, hospitals, and even people using the products to find any new risks or side effects. If problems are found, the FDA can warn people, update safety labels, or even recall the product to keep everyone safe.
The data can be low quality because not everyone reports problems, especially if people don’t know they should report them. Sometimes, reports don’t have enough details, so it’s hard to understand what went wrong. Since this data comes from people using the products in real life, it can be less clear than lab tests. Not all doctors have to report problems to the FDA.
Why is this important?
This is important because the FDA’s ability to protect public health relies on how well it can monitor the safety of products like breast implants after they’re sold. If the FDA is unable to gather reliable safety data, people may not get clear or accurate information about potential risks, which could lead to health issues going unreported or unresolved. This is one of the main reasons why BISA exists and why we will continue to monitor the FDA for safety alerts.
If you have had issues with your health or problems with your breast implants, you can file a report directly to the FDA through the MedWatch Program. Problems are referred to as “adverse events.” Anyone can submit a report, and long-term data is needed. Read more about how to report a problem.
“Conflicting opinions surrounding breast implants can create confusion, making it hard for women to understand their options. ”
RESOURCES & RECOMMENDED READING
BISA: What All Women Should Know About Breast Implants
MedWatch: The FDA Safety Information and Adverse Event Reporting Program
Reporting Problems to the FDA
Frontiers in Medicine: Conflicting interpretations and FDA reputation: the case of post-market surveillance of breast implants
Breast Implant Iatrogenics: Challenging the Safety Narrative
BISA: Breast Implant Safety Updates
Breast Implant Safety Alliance (BISA) Reflects on FDA Leadership Changes and Potential Impact on Breast Implants
Is the FDA Failing Women?
New York Times: FDA Names a New Chief of Medical Devices
A Discussion of Conflicts of Interest in Plastic Surgery and Possible Remedies
MedTech Dive: 6 ways the FDA can improve medical device recalls
FDA: What to Know About Breast Implants
FDA: Medical Device Reports for Systemic Symptoms in Women with Breast Implants
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