FDA recalls: What happens when there is a recall, and what should you do?

You've undergone plastic surgery, obtained the desired result and are living your best life. Everything seems perfect. Yet, what happens when you discover that an implant or other medical device is not as safe as you or your plastic surgeon were led to believe?

The 2024 U.S. Food and Drug Administration (FDA) medical device recall list is extensive, with some estimates suggesting that recalls may have increased by as much as 13.8 percent during the first quarter of 2024. What is an FDA recall, how does it impact you and what should you do if your medical device is on a recall list? Kelly Killeen, MD, helps break down what you should know and the actions you can take.

What is the FDA?

The FDA is a government agency, a part of the Department of Health and Human Services (HHS), that helps promote and protect public safety. Its mission is to ensure the safety and efficacy of our food, the drugs we take and the medical devices we use daily. Pharmaceuticals, biological products and medical devices must undergo an extensive FDA-approval process, proving they are safe and effective before they hit the consumer marketplace.

Sometimes, even with FDA approval, additional studies or large-scale implementation of a drug or product show it is not safe for the public. The FDA then oversees recalls, safety alerts and market withdrawals, alerting physicians and consumers about safety concerns.

What is a recall?

There are typically two forms of recall: voluntary and an FDA recall. A voluntary recall occurs when a company or manufacturer finds an issue with a product or bows to public or private pressure and initiates a recall on its own.

When a manufacturer or company fails to issue a voluntary recall, and there is reason to believe that public safety is at risk, the FDA can issue a recall. An FDA recall is one way to remove hazardous products from the marketplace and initiate correction procedures for medical devices or other products violating U.S. laws administered by the FDA.

Recalls fall into one of three classifications:

• Class I: There is a reasonable probability that exposure or use of a medical device or product will cause serious adverse health consequences or potentially death.
• Class II: This occurs when the use or exposure to a device or product can cause temporary or medically reversible adverse consequences or when the probability of serious health consequences is remote.
• Class III: The lowest level of FDA recall, this recall means that the use or exposure to a device or product will not likely cause significant health consequences.

What happens when there is a recall, and what should you do?

From breast implants to CPAP machines for sleep apnea and joint replacement devices, medical device recalls can impact every area of the medical field, from plastic surgeons to orthopedists. What should you do if you discover a medical device has been recalled, and what does the notification process look like? Dr. Killeen helps patients understand what to expect in this Q&A session.

ASPS: Does the FDA notify your office when there is a recall?

Dr. Killeen: So, usually, it is the device manufacturer that notifies us of the recall. They usually make a public announcement and notify facilities that purchased the product. If the device is registered to the patient, they should notify the patient of what they need to do if anything comes up. For the Allergan implant recall, which was something not typical (it was due to a newly found cancer risk and not the typical sterility or manufacturing concern), the company notified all of us surgeons who work with them.

ASPS: How do patients find out about a recall?

Dr. Killeen: Our office sent out letters to all patients who had received the recalled device and explained what the recall was for and what they can do.

ASPS: What options do patients have if they have a medical device subject to recall?

Dr. Killeen: What the patient should do really depends on what the recall is for. For the Allergan recall several years ago, there was nothing to do – it was to just remove unused products off the shelves. We sent info educating patients on why the recall was done and what their options were moving forward for monitoring or implant exchange. Recalls for medical devices rarely lead to a removal recommendation. The important thing as a patient is to make sure that if you have a medical device, your doctor's office always has your current contact information so they can find you if something ever pops up! It's never a reason to panic. If you think you may have the device that a recall notice is for, call your surgeon who placed the device for guidance!

Patients can also find updated recalls and product safety information on the FDA website. The best thing you can do if you find out about a recall or if you have safety concerns about a medical device is to contact your plastic surgeon for further advice. They can guide you through the next steps and evaluate whether further action is needed.

To find a qualified plastic surgeon for any cosmetic or reconstructive procedure, consult a member of the American Society of Plastic Surgeons. All ASPS members are board certified by the American Board of Plastic Surgery, have completed an accredited plastic surgery training program, practice in accredited facilities and follow strict standards of safety and ethics. Find an ASPS member in your area.