Breast implants linked to rare form of cancer, but FDA declines to ban

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Breast implants tied to rare cancer to remain on US market

A type of breast implant linked to a rare form of cancer will remain on the market, according to U.S. health authorities. Due to a recently confirmed link to a rare cancer and thousands of unconfirmed complaints of other health problems women are attributing to the implants, the FDA has struggled with how to handle the matter. However, the FDA's director for medical devices said the agency wasn't ready to ban the implants just yet.

WARNING: GRAPHIC IMAGE BELOW

Anecdotes of a breast implant and cancer connection have sent several foreign governments into a tailspin and raised alarm bells for some recipients, but as it stands the U.S. is refusing to halt the questionable implant type.

Recent medical studies have found that anaplastic large cell lymphoma (BIA-ALCL), which is a rare type of non-Hodgkin lymphoma, is notably higher in patients who have textured implants, compared to other types. The majority of women in the U.S. get “smooth surface” implants rather than textured, and to-date there has been no connection found between smooth and the BIA-ALCL.

“It is not a massive pandemic, but it is real,” Dr. Kaveh Alizadeh, chief plastic and reconstructive surgeon at Westchester Health Network and associate professor at the New York Medical College, told Fox News. “Most women in the U.S. get smooth implants and no one has seen this cancer from that, but around 10 percent get textured and that is what is being studied further.”

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BIA-ALCL is a scarce immune system cancer which starts in the fluid and scar tissue surrounding the breast implants, and there is an average of 700 known diagnoses globally each year.

Textured implant in place (Dr. Kaveh Alizadeh)

Testimony from an almost 40-person panel of surgeons with the American Society of Plastic Surgeons in late March was amplified by a number of women who shared their stories of suffering. The panel, according to the Health Care and Life Sciences Practice Group, recommended stronger informed consent practices and disclosure of information regarding the signs and symptoms related to BIA-ALCL.

Meanwhile, Health Canada recently banned textured implants – a move embraced by breast cancer survivors who expressed stress and concern about ever having to go through such an ordeal again and voiced a desire to have the device removed. Late last year, a French regulatory body issued a recall, citing the anomalous but serious cancer connection.

And in Australia, at least four women are alleged to have died as a result of BIA-ALCL, associated with their textured implants. According to Sydney-based Professor Anand Dava, who led a comprehensive study on the matter, some 29 patients in just the past year have been identified as acquiring the rare form of cancer seemingly connected to their implants.

“The incidence of BIA-ALCL is very rare, between one in 3,800 and one in 30,000. Still, the concern is great enough with textured implants for France, Australia, and New Zealand to ban their use. Unfortunately, the link between cancer and the textured breast implant is still unclear and further studies need to be done to find a definitive answer,” noted Dr. Gabriel Chiu of the Beverly Hills Plastic Surgery. “Doctors and scientists are focusing on implant texture, bacterial contamination, and geographical location.”

Dr. Elliot Hirsch, chief of plastic surgery at Providence Cedars-Sinai Tarzana, concurred that while rare, the current thought is that it may be related to a chronic prolonged immune system response to the textured implant and “possibly the presence of a certain bacteria.”

For American women who have had textured implants, the sentiment is something of a mixed bag.

“I get my mammogram and sonogram every year, along with a physical. I eat organic and I run every day in the park,” one 42-year-old New York-based professional, who preferred to remain anonymous, said, after having textured implants taken out in April after just a few years of having them. “I’m not too concerned.”

However, Lauren Clement, a 50-year-old New York-based physician educator said she got implants in 1998 and didn’t know that they were textured until she had them removed years later.

Lauren Clement, 50, says she still lives in fear having had textured implants for many years (Lauren Clement)

“During the time that I had these implants, I went through skin conditions consisting of eczema allergic reactions that had no allergies related, menopause and other female issues. Menopause was at 40 years old with no hereditary explanation,” Clement lamented. “My fear is that I had the textured implants for a long period of time and they have done permanent damage. Currently, my only health issue is residual pain in my right hip where the golf ball size lump was.”

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In a statement issued to Fox News, the U.S. Food and Drug Administration (FDA) said that while a few of their international counterparts have started to initiate actions to ban or restrict sales of some textured breast implants based on the cancer concerns, there is no scientific data to support such an association.

“The type of macro-textured implants targeted by some of our international counterparts represents less than 5 percent of breast implants sold here. At this time, the FDA does not believe that, on the basis of all available data and information, the device meets the banning standard set forth in the Federal Food, Drug and Cosmetic Act,” the representative said. “The FDA believes regulatory action must be based on scientific data. While the majority of women who develop BIA-ALCL have had textured implants, there are known cases in women with smooth-surface breast implants and many reports do not include the surface texture of the implant at the time of diagnosis.”

The agency acknowledged that they are focused on strengthening the evidence generated to help inform future regulatory actions and to assure that women and providers are adequately informed of the risk of BIA-ALCL, including that the risk is higher with the use of textured implants, albeit still low.

“We are still investigating the cause of the association and we will continue to monitor, assess and report our findings as we continue to strengthen our evidence collected so that women and providers can be better informed about BIA-ALCL as they consider breast implants,” the FDA added.

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Alizadeh affirmed that there was no need for patients with textured implants to get scared and make any rash removal decisions.

Dr. Kaveh Alizadeh, chief plastic and reconstructive surgeon at Westchester Health Network and associate professor at the New York Medical College (Dr. Kaveh Alizadeh)

“Don’t act out of fear, act of knowledge. The U.S. did the right thing in bringing attention to the issue. And while it is being studied, there is no need for anyone to get a textured implant until we know more,” he added. “And even if one does decide to get it removed, know that it can be completely removed and there are other options now like fat grafting, so women don’t have to feel as though they are putting anything to foreign into their bodies. These are your own cells.”