FDA Warns That Rare Form Of Cancer Has Direct Link To Breast Implants


On Tuesday, the Food and Drug Administration said that Breast implants can cause a rare form of cancer that may have killed at least nine people.

Rare form of cancer:

The FDA is checking into more than 350 reports linking the cancer, which is called anaplastic large cell lymphoma (ALCL), and both silicone and saline breast implants.

In a statement, the FDA said: “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.”

After liposuction, breast augmentation is the second most popular cosmetic procedure among women. In 2015, more than 300,000 procedures were performed which makes cancer extremely rare with 300 cases over 10 years or longer.

The FDA has added that it can be easily treated if caught early enough. It said “Most cases of breast implant-associated ALCL are treated by removal of the implant and the capsule surrounding the implant and some cases have been treated by chemotherapy and radiation.”

The FDA first started looking into the possibility that implants might cause ALCL, which is a type of non-Hodgkin’s lymphoma, in 2011. The agency said “At that time, the FDA knew of so few cases of this disease that it was not possible to determine what factors increased the risk.”

Hundreds of complaints and a World Health Organization report pointing to breast implants as a possible cause meant the agency has more information, it said: “As of February 1, 2017, the FDA has received a total of 359 medical device reports of breast-implant-associated ALCL, including nine deaths. Breast implants approved in the U.S. can be filled with either saline or with silicone gel. They come in different sizes and shapes and have either smooth or textured surfaces (shells).”

“There are 231 reports that included information on the implant surface. Of these, 203 were reported to be textured implants and 28 reported to be smooth implants,” the FDA added.

Last year WHO researchers reported in the journal Blood that the cancer can take about 10 years to develop on average after the implant first goes in and usually stays in the area right around the implant, but it can break out and spread. The diagnosis usually occurs after a patient reports pain and swelling.

Staying healthy with breast implants:

Patients should do some research before getting breast implants, according to the FDA recommendation. “Although it is rare, breast-implant-associated ALCL appears to develop more frequently in women with textured implants than in women with smooth-surfaced implants. Before getting breast implants, make sure to talk to your health care provider about the benefits and risks of textured-surface vs. smooth-surfaced implants.”

For more details, the FDA has a website dedicated to breast implants.

The agency noted that ALCL is rare and added: “If you have breast implants, there is no need to change your routine medical care and follow-up. Follow your doctor’s instructions on how to monitor your breast implants. If you notice any changes, contact your health care provider promptly to schedule an appointment. Get routine mammography screening and ask for a technologist specifically trained in performing mammograms on patients with breast implants.”

Magnetic resonance imaging (MRI) scans should be performed on people with silicone gel implants to look for leaks.

A list of implant patients who develop ALCL is being prepared by the American Society of Plastic Surgeons and the Plastic Surgery Foundation. The groups said on a website devoted to the matter: “The research will also focus on identifying potential risk factors and criteria detection and management of this disease.”

The FDA reported in 2011, that one in five women who had silicone breast implants for cosmetic purposes, as well as half of those who got implants after a mastectomy, needed surgery to remove the implants within a decade.