FDA notice: Breast implants need updated warnings

From left: Breast examinations. Getty Images Patients undergoing breast reconstruction should be informed of the risks associated with certain implants, according to the US Food and Drug Administration. In a notice from the agency…

FDA notice: Breast implants need updated warnings

From left: Breast examinations.

Getty Images

Patients undergoing breast reconstruction should be informed of the risks associated with certain implants, according to the US Food and Drug Administration.

In a notice from the agency on Monday, it said that implant risks identified in two different studies were likely due to implant materials that can be toxic or otherwise risky in terms of inflammation, scarring, or rupture.

According to the FDA notice, the risks arise from “vibrio vulnificus, which can cause the soft tissue surrounding the breast to become inflamed, resulting in lacerations.”

That’s a concern because such infections can also cause severe gastrointestinal bleeding, and can lead to death.

Moreover, another risk cited by the FDA comes from a toxic chemical called acetone, which can be released from certain medical devices to a surrounding tissue, causing irritation. But there are non-toxic alternatives to acetone – available now in many types of disposable plastic products.

The FDA noted that additional devices that could be affected include surgical guides and other instruments used to make breast reconstruction work, and “breast removal devices.”

That possibility is a big concern for many patients, as menopause typically brings breast pain and eventually nipple pain.

An editorial published in the journal Breast Cancer Research and Treatment noted that these breast implants were given widespread coverage “despite not being particularly effective.” Indeed, a low percentage of women who have received them suffer complications.

“The risk associated with breast implanting is relatively low; however, current patient awareness and access to information regarding the risk of these artificial breasts is lacking,” the editorial writers noted.

The authors suggested that women should be told that if they have experienced problems – even if they are not immediately obvious to them – they should check in with their surgeons about the latest developments in breast implant safety and risks.

In other news related to plastic surgery, the FDA last week put out a recall on certain products sold by Cheri L. Waxman and her company. The products were linked to infections in patients, and many of those cases were fatal.

The FDA said in a statement that patients of concern should bring their information with them to the Hospital for Special Surgery, where they have been treated.

Some patients also may be able to seek treatment through a community health provider.

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