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Are breast implants safe?

FDA revisits stance on implants

(Photo by Spencer Platt/Getty Images)
(Photo by Spencer Platt/Getty Images) (Getty Images)

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Every year, approximately 400,000 women in the U.S. get breast implants, including 100,000 who undergo reconstruction after a mastectomy to treat or prevent breast cancer. Breast reconstruction has been used for years to help women reclaim their bodies after mastectomy.

News broke in mid-March that the U.S. Food and Drug Administration was investigating the safety of breast implants after reports they may cause breast implant-associated anaplastic large-cell lymphoma (BIA-ALCL). BIA-ALCL is a type of non-Hodgkin’s lymphoma that affects an unknown number of women, with published rates ranging from one in 3,800 to one in 30,000.

Currently, the FDA is aware of 457 confirmed cases of BIA-ALCL out of the estimated 10 million women worldwide who have implants. Because rates are low and implants have the potential to help women’s quality of life after breast cancer treatment, how should doctors balance the benefits and risks?

Ankit Desai, MD, is a plastic and reconstructive surgeon at Baptist MD Anderson Cancer Center whose primary area of focus is reconstructive surgery for breast cancer patients. As new research tries to find what puts some women at risk of BIA-ALCL, he said it’s important for surgeons to inform their patients of all possible risks and benefits of implants.

“BIA-ALCL is a real disease that happens. The actual incidence is probably less than being hit by lightning. It’s rare and related to the use of textured implants, but we’re just starting to understand it,” he said. “Some patients may benefit from the use of textured implants most commonly used in conjunction with shaped/gummy bear implants. I would discuss the benefits and risks with the patients so they can make an informed decision about what they feel is best for their particular needs. But it has to be part of their decision.”

Textured implants were used in nearly all cases of BIA-ALCL. Implants with textured surfaces are sometimes used for patients who have had implants before that wouldn’t stay in place.

“Roughness means there are more areas for bacteria to hide. The theory is that BIA-ALCL is caused by a prolonged inflammatory reaction that can flip a switch and develop a lymphoma. There’s a bacterium that has possibly been linked to creating that inflammation response, which seems most commonly related to patients who have had a textured implant,” said Desai.

“I don’t think we have enough information on it yet, but I do think that patients need to be advised of the relationship to this lymphoma,” said Beth-Ann Lesnikoski, MD, a breast surgical oncologist and director of the Breast Program at Baptist MD Anderson Cancer Center. “It needs to be part of their decision-making process. Women are very capable of making informed choices, and individuals deal with risk numbers very, very differently.”

Most cases of BIA-ALCL began eight to 10 years after implant surgery, and were usually detected because of a common symptom.

“The main thing we look for is delayed onset fluid collection around implants which have otherwise been stable,” said Lesnikoski.

Both experts said the rare condition is highly treatable and hope research will soon answer key questions so they can better serve their patients.

“A better perspective of additional risk factors would be very important,” said Lesnikoski. “For instance, with melanoma, we take into account complexion. What other risk factors exist besides having implants? Family history of autoimmune diseases could be important.”

“Ideally we could identify a true incidence of BIA-ALCL and find out the exact cause, maybe it can be prevented said Dr. Desai. “I want to have an in-depth, informed consent conversation with my patients about the benefits and risks.”

Desai feels women who are interested in breast implants or reconstruction should feel comfortable asking their doctor any questions they may have.

“The breast implant is the most studied medical device in the world, and data suggest it’s reasonably safe with high patient satisfaction,” he said.

Women with breast implants should receive annual screening mammograms (or more often if their doctor recommends) and reach out to their primary care doctor if they have questions about their health. If you don’t have a primary care doctor, please call 904-202-4YOU to find one.

Women with breast implants should receive annual screening mammograms (or more often if their doctor recommends) and reach out to their primary care doctor if they have questions about their health. If you don’t have a primary care doctor, please call 904-202-4YOU to find one.

Source: FDA.gov