FDA issues safety warning for cancers linked to breast implants


The U.S. Food and Drug Administration has warned the public about certain cancers, including squamous cell carcinoma and various lymphomas, which have been reported in the scar tissue that forms around breast implants.

of FDA announced Thursday Squamous cell carcinoma and various lymphomas occurring in the capsule around breast implants are considered rare, but not recommended for health care providers, people who have had breast implants, or who are considering breast implants. A person should be aware of these cases and report them or other cancers found. Around the implant to the distributor.

According to the FDA announcement, these various lymphomas are not the same lymphomas previously described as associated with breast implants.

After a preliminary review of the published literature, the FDA said it was aware of fewer than 20 cases of squamous cell carcinoma and fewer than 30 cases of various lymphomas in capsules around breast implants.

As of last week, the FDA has received 10 medical device reports on squamous cell carcinoma associated with breast implants and 12 medical device reports on various lymphomas associated with breast implants, the announcement said. .

According to the FDA, people who have had breast implants do not need to change their usual medical care, but reported signs and symptoms include swelling, pain, lumps, or skin changes. You have to be careful.

The agency said it learned of these reports of squamous cell carcinoma and various lymphomas during an ongoing postmarketing review of breast implant safety in the United States.

“Reports submitted to FDA are only one source of information that FDA uses to monitor the safety of medical devices, and are derived from mandated postmarket studies, published literature, registries and claims databases. “The FDA will continue to collect and review all available data from these sources to assess the incidence of cancer in the capsule surrounding breast implants.” ”

The exact incidence and risk factors for these cancers remain unknown, adding, “This is an emerging problem and our understanding is evolving.”

Links between breast implants and systemic diseases, including autoimmune diseases, have been reported since the 1960s, according to a paper published in the journal this month. Plastic and reconstructive surgery.

In 2011, the FDA approved breast implants and Breast Implant-Associated Anaplastic Large Cell Lymphomaor BIA-ALCL.

In 2019, pharmaceutical company Allergan announced a global recall of Biocell textured breast implants and tissue expanders linked to a rare cancer.The move came after FDA has asked manufacturers to voluntarily recall products, and the FDA maintains a registry where physicians are supposed to report cases Anaplastic large cell lymphoma For those who have undergone breast augmentation surgery.

Since then, efforts have been made to better inform breast implant patients about the potential health risks.

Last year, the FDA made some changes to the regulation of breast implants. This includes new labeling with boxed warnings and patient checklists that let people know that implants are not lifelong medical devices.

The FDA said it has decided to limit the sale of breast implants to healthcare providers who provide a standardized checklist to explain to patients. riskThis change requires physicians to inform patients about these potential health issues and to give patients the opportunity to sign off on a checklist to demonstrate that they have been adequately informed of the risks to their health. I have.

Although most women have breast implants without serious complications, 20% of women who receive implants for breast augmentation have their implants removed within 8-10 years due to complications. Have to. According to FDA.

The older the implant, the higher the health risks, and these risks may require additional surgery.

“Breast implants are not lifetime devices. told CNN in 2019 when the FDA held a meeting Check the safety of breast implants.

He added that he often discusses the benefits and risks with his patients.

“We’re talking about complications. They range from scarring around the implants to pain and discomfort from the implants…over the past seven years, probably a little more, and a specific type of lymphoma associated with breast implants. “What the public should appreciate is that, as doctors and clinicians, we are always looking for what is best and safest for our patients,” he said. We are constantly educating ourselves as well as educating our patients.”

Source: www.cnn.com

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