FDA Says Implants Responsible for ALCL

posted in: News | 0

NBC News reports that the U.S. Food and Drug Administration is examining 350 reports linking a rare cancer – known as anaplastic large-cell lympoma (ALCL) – to both silicone and saline breast implants. The agency believes the connection may have already resulted in the deaths of nine women.

anaplastic large-cell lympoma - ALCLBreast implants have been in the news many times before, but this is the first truly definitive link to cancer that has been reported by users and studied by the FDA.

Though the cancer is considered “rare” due to the small number of cases identified, the connection is of huge concern, primarily because breast augmentation is the second-most popular cosmetic procedure performed in the U.S., with approximately 300,000 such procedures performed in 2015, the last year for which those figures are available.

“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 a statement.

Thankfully, they added, when caught early, this form of breast cancer is fairly easy to treat and the prognosis is good. Nonetheless, those whose disease is allowed to progress before being treated could be in for a much less cheery scenario.

In many cases, the agency reports, the disease can be treated with the simple removal of the implant and the capsule that surrounds it. Some victims of ALCL have found it necessary to be treated with radiation and chemotherapy to combat their disease, however.

The FDA says suspicions have been progressively growing about the dangers of breast implants, with initial reports hitting the media when many women began reporting implant leakage a few decades ago.

The agency first began to investigate the ALCL connection in 2011 but, at that time, didn’t have enough evidence to ascertain there was indeed a link.

But now, says the NBC report, there are hundreds of complaints and a World Health Organization report pointing to breast implants as a possible cause of the disease, which is a form of non-Hodgkin’s Lymphoma.

“As of February 1, 2017, the FDA has received a total of 359 medical device reports of breast-implant-associated ALCL, including nine deaths,” it said.

This form of cancer can take about a decade to develop. So, those who received the implants 10 years ago could now be candidates for developing the disease.

Usually, the cancer remains near the implant but can grow and spread, experts report. In its early stages, it is generally characterized by pain and swelling. Hence, any breast implant patients experiencing such symptoms should immediately seek medical attention.

Additional research of the disease by The American Society of Plastic Surgeons and the Plastic Surgery Foundation will also strive to identify any potential risk factors and criteria detection, which will help pinpoint which implant users might be most at risk for developing ALCL.