New labeling guidelines for breast implants

December 20, 2021

Swedish Health Team

New breast implant labeling guidelines provide more information for patients and doctors.
The FDA has not changed their approval process for breast implants as a medical device.
If you are interested in breast implant surgery, a transparent discussion with your doctor is vital for the best decision suiting you and your lifestyle.

According to the American Society of Plastic Surgeons, there were nearly 138,000 breast reconstruction surgeries performed in the United States in 2020. Breast augmentation topped the list of cosmetic procedures, with a little over 193,000 surgeries performed in the United States the same year. For plastic and reconstructive surgeons, breast implants are essential treatment options for their patients seeking elective or reconstructive breast surgery. Implants are in use worldwide and concepts of breast enlargement have been evolving for decades. Silicone and saline-filled implants have been manufactured since 1962 and 1964, respectively, and have been under constant technological improvement.

The U.S. Food and Drug Administration (FDA) imposes stringent regulations for all medical devices approved for use in the United States; all medical devices that are implanted in the human body are subject to extensive research and scrutiny prior to release, and, after release continue to be reviewed for ongoing assurance. In the late fall, the FDA provided updated informational material for patients interested in breast implants in order to open communication lines between patients and physicians and support informed decisions. Working with implant manufacturers, patients, and plastic surgeons, the FDA has approved new boxed labeling for implants which includes a patient decision checklist and a device description, including a patient device card for record keeping. The new guidelines also update screening recommendations.

To better understand what these new guidelines mean for patients, we spoke with Suzette Miranda, M.D, a surgeon at Swedish Plastics and Aesthetics who specializes in reconstructive surgery at Swedish Cancer Institute.

“The FDA should be applauded for empowering the discussions between patient and physician so that people can continue to make choices that align with their goals,” says Dr. Miranda.

What does this mean for people who want breast implants for reconstructive or gender- affirming surgery?

These recommendations have been implemented to encourage the discussion of risks and benefits between physicians and patients. However, the FDA still believes that devices from all four manufacturers currently supplying implants in the U.S. can be used, and the FDA has not changed their approval or use of implants as medical devices for reconstructive or cosmetic purposes. The FDA has also recommended that the following patients are not candidates for breast implants:

Patients who have an active infection anywhere in the body.
Have existing cancer of the breast tissue that has not been adequately treated.
Are pregnant or nursing.

Are there alternatives to the kind of implants that bear the new boxed labels?

All implants that are used in the United States have been included in this new FDA guidance.

What kind of shell type is preferred for breast implants?

Implants are made with a textured outer shell or a smooth outer shell which is made of silicone (one of the most biologically inert substances on earth). There has been an association of anaplastic large cell lymphoma (ALCL) with textured implants most predominantly linked to a single manufacturer, which voluntarily took these implants off market in 2019 and has not continued to manufacturer these implants. The risk of ALCL is extremely rare, with risk of between one in 3,000 to one in 30,000. We have not seen any cases of ALCL in our practice. Generally speaking, Europe uses more textured implants than smooth, while the United States practice pattern uses a majority of smooth implants. In our practice, we favor using smooth implants rather than textured and have a high degree of safety.

Is there anything else you want to add or think patients should keep in mind?

At Swedish Plastic and Aesthetics, we take pride in offering safe and individualized patient care. We have used informational material much like the FDA recommendations for many years. We are proud that all physicians across the country will be encouraged to have the same communication with their patients as we have in our practice, which is informed by Swedish’s continued philosophy of “health for good.” We encourage any individuals who are interested in breast implants to come in for an evaluation so that we can have a transparent discussion of the risks and benefits and support women and transgender patients to make informed decisions for their lifestyle.

Interested learning more about cosmetic or reconstructive surgery? Contact Swedish Plastics and Aesthetics at 206-215-6221.

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