Stronger Warnings from FDA for Breast Implants

Why the FDA is Ordering Stronger Warnings for Breast Implants

by Julia Ries on November 2, 2021

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• The FDA will require breast implant devices to include a boxed warning, in which the potential risks are listed on the product's packaging.
• Risks linked to breast implants include infection, rupture, scarring around the implant, breast implant illness, and, in rare cases, lymphoma.
• Plastic surgeons encourage everyone who's thinking about having breast implants to have a thorough conversation with their healthcare professional about the risks, benefits, and alternative options.

The Food and Drug Administration (FDA) issued a new warning Trusted Source last week for breast implants requiring healthcare professionals to communicate the risks and safety concerns associated with implants thoroughly.

The FDA will also require breast implant devices to include a boxed warning, in which the potential risks are listed on the product's packaging.

The manufacturers can only sell breast implants to healthcare professionals who review the potential health risks and side effects with patients before surgery.

Patients must also complete a decision checklist Trusted Source to demonstrate that professionals have clearly communicated the risks, benefits, and alternatives for breast implants.

"The stronger warning is appropriate for patients as many practitioners and patients were not aware of the earlier warnings or did not take them seriously," said Dr. Constance M. Chen, a board-certified plastic surgeon and breast reconstruction specialist.

What are the health risks of breast implants?

Risks linked to breast implants include infection, rupture, capsular contracture (when the body forms scar tissue around the implant), breast implant illness, and, in rare cases, breast implant-associated anaplastic large cell lymphoma, according to Chen.

Anaplastic large cell lymphoma occurs in approximately 1 in 450 women with textured breast implants, Chen says.

Breast implant illness is much more common and can lead to chronic fatigue, joint pain, and cognitive difficulties.

But breast implant illness is not formally accepted by everyone in the medical community, Chen says.

"Other risks such as capsular contracture (51.7%), infection (35.4%), rupture (31.2%), or need for reoperation (59.7%) are also relatively common according to statistics maintained by the implant manufacturers," Chen said.

The longer a person has implants, the greater the likelihood they'll experience complications.

Dr. Andy Wongworawat, a board-certified plastic surgeon and owner of Advanced Institute for Plastic Surgery, said it's crucial for patients to understand that breast augmentation is surgery.

"All surgeries, regardless of how common they seem, come with risks," Wongworawat said.

What do plastic surgeons think of the new warning?

Dr. Alexander Zuriarrain, a double board-certified plastic surgeon with Zuri Plastic Surgery in Miami, says the guidelines were designed to improve patient education and quality of care.

"All patients should understand the risks of breast implants to include additional surgeries, capsular contracture, implant rupture, and possible infection," Zuriarrain said.

There are risks with any type of implantable device, Zuriarrain says, but breast implants are generally safe.

Wongworawat says all of the plastic surgeons in his network already spend time thoroughly discussing the potential risks with people interested in breast implants.

He isn't surprised to see a stronger warning issued.

"For the longest time, our plastic surgery society has been promoting improved education so that patients can make the most informed decisions," Wongworawat said.

Previously, there weren't many restrictions on which kind of professionals could provide breast augmentation procedures, which has led to a wide range of practice routines, Wongworawat added.

"These stronger warnings will help these less vigilant practices to step up their processes and start doing what reputable plastic surgeons have been doing for a long time," Wongworawat said.

Anyone thinking about getting breast implants should talk with their doctor about the risks, benefits, and alternative options.

"It is important that all patients discuss breast augmentation with a board-certified plastic surgeon who has extensive training in this field," Zuriarrain said.

The bottom line

The FDA issued a new warning for breast implants requiring healthcare professionals to communicate the risks and safety concerns associated with implants thoroughly.

The warning also requires manufacturers to include a boxed warning and only sell the products to certified healthcare professionals who agree to review safety materials with patients.

Plastic surgeons encourage everyone thinking about having breast implants to have a thorough conversation with their healthcare professionals about the risks, benefits, and alternative options.