FDA requires insurance to warn about life-threatening cancer risk with breast implants

Patients needing breast implants should be given information about the risk of developing tumors or developing conditions that can prove lethal, according to the U.S. Food and Drug Administration. On Thursday, the agency published…

FDA requires insurance to warn about life-threatening cancer risk with breast implants

Patients needing breast implants should be given information about the risk of developing tumors or developing conditions that can prove lethal, according to the U.S. Food and Drug Administration.

On Thursday, the agency published a final rule that requires health plans to provide these warnings to new patients and to current patients who have had implants for a year or more.

Patients enrolled in high-deductible health plans and those who buy individual health insurance policies may find out about these warnings when they receive their renewal notices or financial aid documents, the agency said. Plans are not required to include the information before people are given coverage, however.

“Today, nearly every insurance policy requires new patients to disclose risk of death from disease associated with surgery,” FDA Commissioner Scott Gottlieb said in a statement. “These updated rules will require plans to also provide that information to people who received implants more than one year ago.”

The FDA has determined that silicone gel-filled breast implants can, in rare cases, lead to a rare and deadly condition called “allergic rhinitis,” according to the agency. The rare condition is characterized by runny or blocked nasal passages, conjunctivitis or a dry nose that may linger for a month or more. It can cause infections, congestion, wheezing, headaches, and, in rare cases, eye infections and skin problems.

Silicone gel-filled breast implants are a mainstay of the cosmetic surgery industry, with some hospitals and clinic in the U.S. offering them for cosmetic reasons, according to the FDA.

The agency considers there are nearly 300,000 breast implants in the U.S. each year. There has never been a case of breast cancer or a life-threatening cancer associated with one of these implants, according to the FDA. But according to a 2017 FDA report on implants, more than 2,200 women in the U.S. had at least one implant that made their breasts not only tight and prominent, but potentially more susceptible to cancer.

In addition to the risk of cancers of the breast and the genitalia, researchers found that 17 women had at least one documented case of serious bacterial infection during the last 30 years, including a reported case of necrotizing fasciitis and one case of sepsis. According to the FDA, these infections were suspected to be caused by leaking breast implants.

At this point, the FDA recommends that all women considering implants discuss these risks with their doctors.

Currently, there are different types of implants.

The FDA advises women considering an implant to check with their own doctors first to learn about the pros and cons of each implant.

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