The U.S Food and Drug Administration (FDA) recently announced that it has begun investigating a possible link between breast implants and an increased risk of a rare form of cancer known as anaplastic large cell lymphoma (ALCL).
The announcement is based on a review of information from international regulatory agencies, scientific experts, and implant manufacturers that account for the sixty cases that have been identified among the 5 to 10 million women with breast implants worldwide. Of these cases, about 34 have been diagnosed in the U.S. alone.
Although the number of cases of ALCL associated with breast implants remains very low, these numbers are very different from the three known cases of ALCL among the 100 million women worldwide who do not have implants.
However, none of the 60 cases of ALCL identified have proven fatal. ALCL cases associated with breast implants tend to remain confined to the capsule surrounding the implant, and sometimes the immediately adjacent tissue. The majority of the cases have been successfully treated with surgery and local therapy.
The agency has been commended on being forthright regarding an issue that left un-addressed could spark widespread concern among women having breast implants.
However, not all responses to the FDA announcement have been positive. Michael Harbut, MD, a Detroit environmental medicine specialist of the Karmanos Cancer Institute, pointed out that the issue could have been address a decade ago, at which time he petitioned the FDA to investigate potential health risks associated with chemicals used in the manufacture of breast implants.
He stated, “I warned them that breast implants contained toxins and that there could be health problems, and they ignored me.”
Harbut sent his 70-page petition to the FDA back in October of 2000 as an appeal for government officials to warn the public about medical devices containing silicone.
These devices are manufactured with hexachloroplatinate, a chemical catalyst known to cause immunologic reactions that lead to a variety of harmful health effects.
The American Society of Plastic Surgeons (ASPS) will work with the FDA to establish a breast implant registry for documentation of adverse effects and additional cases of ALCL.
With the FDA’s involvement in the research, far more information can be gathered due to the ability to circumvent the need to follow the HIPAA (Health Insurance Portability and Accountability Act) privacy rules.
The FDA will also request the update of product labeling to include information about ALCL by Allergan of Irvine and Mentor Worldwide Santa Barbara, the two U.S. manufacturers of breast implants.
The FDA is advising women not to make changes to their routine medical care, but to seek medical advice if they experience swelling or pain, or notice lumps around implants after post-surgical healing.
According to William Maisel, chief scientist and a deputy director of the FDA’s medical device office, “Women who are not showing any symptoms or problems require only routine follow-up.... FDA is not recommending the routine removal of breast implants.”
He explained that ALCL is a treatable cancer of the immune system, and that its occurrence in the breast does not equate to breast cancer.
According to the ASPS, approximately 355,000 women received implants in 2009. Of those, about 290,000 received them for cosmetic purposes, while 65,000 received them for reconstructive purposes.
Most experts agree that such a low number of ALCL cases are not a reason for deep or widespread concern.
In fact, the FDA pointed out that ALCL associated with breast implants is extremely rare, citing data from the National Cancer Institute that the incidence of ALCL is only about one case per 500,000 among women in general, with the rate among women having breast implants numbering approximately three cases per 100 million.
Meanwhile, doing what you can to keep your immune system healthy may be a good preventive move against ALCL, as well as many other diseases and disorders. Try giving your immune system a boost with some healthy diet staples, and vitality food sources.
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