Breaking Down the FDA’s New Stronger Set of Breast Implant Requirements

Breaking Down the FDA’s New Stronger Set of Breast Implant Requirements featured image
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The US Food and Drug administration announced new changes to breast implant regulations this week which will give patients more information about any risks associated with the medical devices and require added transparency between patients, surgeons and implant manufacturers.

The new implant safety measures come after a period of more than two years of gathering information on anaplastic large cell lymphoma (BIA-ALCL)—a rare type of cancer that is said to be caused by certain textured implants—and breast implant illness, which includes symptoms like hair loss, joint pain, fatigue, rashes, muscle pain and more which some patients say are brought on by their implants. 

Among the new guidelines are manufacturer box warnings on the devices and a checklist of risks associated with implants that surgeons have to share with their patients.

The Biggest Takeaways

Tucson, AZ plastic surgeon Raman Mahabir, MD, who helped Arizona pass a bill that requires its own breast implant patient checklist, says the news reflects a move to require all surgeons to have clear communication with their patients about implants before they’re put in their bodies. “Now the FDA has made a clear stance on what exactly surgeons need to review with regards to implants in addition to the normal risks and benefits of surgery,” he says.

“I was part of the FDA panel on implants back in March of 2019, testifying before the board as they reviewed the safety of silicone and saline implants,” says  Louisville, KY plastic surgeon M. Bradley Calobrace, MD. “The new guidelines require each implant manufacturer to provide a ‘patient decision checklist that the physician will review with each patient prior to a breast augmentation as well as a boxed warning describing some of the risks of implants, including BIA-ALCL, a rare lymphoma associated with textured implants, and systemic illnesses that may be associated with implants.”  

Also required now are updated silicone gel-filled breast implant rupture screening recommendations and a patient device card to help patient’s keep track of which implant is in their bodies.

Greater Transparency

“The sale and distribution of breast implants will now be restricted only to health care providers and facilities that utilize a ‘Patient Decision Checklist,” explains Washington D.C. plastic surgeon Troy Pittman, MD. “This checklist will include the risks associated with implants. Each patient will sign the checklist and the surgeon will countersign.”

Dr. Pittman notes that most board-certified plastic surgeons have already been discussing these risks in the routine pre-operative informed consent. “The real issue is that breast augmentation is being performed by others who are not board-certified plastic surgeons,” he says. “The new FDA guidance is hopefully a way to urge the ‘others’ to speak with patients about the risks.”

“Many plastic surgeons currently include information about the safety and risks of breast implants; however, this recent decision by the FDA will help formalize the process and provide patients with more comfort that they are fully educated about their decision to proceed with breast augmentation,” adds Newport Beach, CA plastic surgeon Sanjay Grover, MD

While the new guidelines do not specifically address Breast Implant Illness, as it’s currently not recognized as a diagnosable medical condition, one of the new checklist items states that patients have reported “systemic symptoms” after having implants placed. “When this information is given to women in advance of surgery, it gives them the opportunity to act on it,” adds Dr. Mahabir. “When this happens, knowledge then becomes power.”

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