FDA Links Breast Implants To Rare Form Of Cancer, Confirms 9 Deaths

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Breast implants can be associated with a rare type of cancer that may have led to the death of at least nine, the U.S. Food and Drug Administration (FDA) has warned.

The federal agency pointed to anaplastic large cell lymphoma (ALCL) — a rare kind of non-Hodgkin’s lymphoma — and said it is now checking into over 350 cases linking saline and silicone breast implants with the condition.

The Breast Implant-ALCL Connection

As of Feb. 1, the FDA has received 359 reports of breast implant-associated ALCL, including the nine fatalities. Of these reports, 203 involved textured implants while 28 were smooth implants, and 186 were silicone gel-filled implants while 126 contained saline solution.

“All of the information to date suggests that women with breast implants have a very low but increased risk of developing ALCL compared to women who do not have breast implants,” the FDA said in its announcement.

Breast augmentation surgery remains a leading cosmetic procedure. According to the American Society of Plastic Surgeons (ASPS), there were around 290,000 of these operations done in 2016, an increase of 4 percent from the previous year.

The cancer then remains very rare even with hundreds of cases over 10 years or longer, and it can be treated if detected early on, the FDA added.

In most cases, breast implant-linked ALCL is addressed via the removal of the implant as well as the capsule surrounding it, and chemotherapy or radiation in certain cases.

The FDA first began to look into the link between implants and ALCL back in 2011, at which time it knew of very few cases, making it impossible “to determine what factors increased the risk.”

Now more information has surfaced, including a WHO report and hundreds stepping forward to complain. On average, the disease can take around a decade to develop after the implant first enters the body. The cancer typically stays in the area surrounding the implant but can break out and spread, according to WHO researchers last year.

A diagnosis is usually done once the patient discloses pain and swelling in the breast area.

What To Do If You Have Implants

The FDA, which maintains a website dedicated to breast implants, recommends doing research prior to getting these cosmetic implants. BIA-ALCL, for instance, tends to manifest more often in patients with textured rather than smooth-surfaced implants, so the FDA urges patients to talk to their doctor about the risks and benefits.

The difference in risk relating to the implant surface remains unclear, but the body reacts differently to textured implants versus smooth ones. Plastic surgeon Dr. Alex K. Wong explained to the NYT that tissue grows into microscopic grooves in the textured ones, which lead to a peeling sound when taken out.

“Whereas with a smooth implant, it’s like Jell-O. You can spin it around. It moves really easily,” he said, adding that the cancer appears to be linked to a specific bacterial infection in some cases.

Those with breast implants need not to change their routine care and follow-up, the FDA added, but suggested following the doctor’s instructions on breast implants as well as getting routine mammography.

For those with silicone implants, MRI scans can search for actual leaks.

“The FDA-approved product labeling for silicone gel-filled breast implants states that the first MRI should occur three years after implant surgery and every two years thereafter,” the FDA noted.

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