In light of concerns that breast implants may be linked to a range of serious side effects, the U.S. Food and Drug Administration (FDA) has asked manufacturers to include a boxed warning about implants’ possible health risks, according to the New York Times.

Because most patients never see breast implants’ packaging, doctors will have to share with patients the possible risks and warnings, as well as advise them of the signs and symptoms of breast implant illness. Manufacturers will also reportedly be required to provide a checklist for doctors to share with patients considering breast implants, outlining possible health risks.

These new recommendations are just that — recommendations. The FDA is not requiring any action on the part of manufacturers. Additionally, the agency is accepting input about the issue from those in the breast implant industry, and from the general public.

The move was made after recent studies suggest numerous signs and symptoms of breast implant illness. The conditions under scrutiny are autoimmune diseases, cancer, chronic pain, arthritis, fibromyalgia, and others.

Some breast implants have been recalled over particular concerns that they may be harmful to patients. The FDA requested that Allergen recall its textured breast implants due to a possible link to cancer.

The FDA has previously stated that textured breast implants are more likely to be linked to breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). The FDA says that when breast implants are inserted in the body, they are placed behind the breast tissue or under the chest muscle, and over time, a fibrous scar called a capsule forms around the implant. This scar tissue separates the implant from the rest of the breast. 

In July, ABC News reported that there have been 572 cases of BIA-ALCL reported worldwide, and 33 deaths connected to the disease. 

Health agencies around the world have banned certain textured breast implants upon learning more about the signs and symptoms of breast implant illness. The FDA has not banned textured breast implants and has only recalled certain products. However, the FDA is further investigating the health effects associated with them.

According to the Times, breast implants may also have a role in other connective tissue diseases, such as rheumatoid arthritis and lupus. 

The newspaper notes that the FDA’s request to have breast implant manufacturers place a boxed warning was based, at least in part, on patient concern. More than 70,000 women signed a petition asking the agency to require manufacturers to include the checklist of risks for doctors to share with patients.

Additionally, according to the Times, many patients complain that they were never warned about risks when they considered having, or have had, breast implant surgery.

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This article is not legal advice. It is presented
for informational purposes only.