Breast implants and rare breast cancer may be linked says FDA
by Aimee Keenan-Greene
The U.S. Food and Drug Administration says there may be a connection between saline and silicone gel-filled breast implants and anaplastic large cell lymphoma (ALCL), a very rare type of cancer.
The FDA just announced they are looking into a link between breast implants and the rare cancer, and they are turning to doctors across the country to report confirmed cases of ALCL in women with breast implants.
“We need more data and are asking that health care professionals tell us about any confirmed cases they identify,” said William Maisel, M.D., M.P.H., chief scientist and deputy director for science in FDA’s Center for Devices and Radiological Health. “We are working with the American Society of Plastic Surgeons and other experts in the field to establish a breast implant patient registry, which should help us better understand the development of ALCL in women with breast implants.”
Data reviewed by the FDA suggest patients with breast implants may have a very small but significant risk of ALCL in the scar capsule adjacent to the implant.
The agency is aware of about 60 cases of ALCL in women with breast implants worldwide. This number is difficult to verify because not all cases were published in the scientific literature and some may be duplicate reports. An estimated 5 million to 10 million women worldwide have breast implants.
The National Cancer Institute says ALCL appears in different parts of the body including the lymph nodes and skin.
Each year ALCL is diagnosed in about 1 out of 500,000 women in the United States. ALCL located in breast tissue is found in only about 3 out of every 100 million women nationwide without breast implants.
The FDA notification is based on a review of scientific literature published between January 1997 and May 2010. The literature review identified 34 unique cases of ALCL in women with both saline and silicone breast implants.
Most cases reviewed by the FDA were diagnosed when patients sought medical treatment for implant-related symptoms such as pain, lumps, swelling, or asymmetry that developed after their initial surgical sites were fully healed. These symptoms were due to collection of fluid (peri-implant seroma), hardening of breast area around the implant (capsular contracture), or masses surrounding the breast implant.
Examination of the fluid and capsule surrounding the breast implant led to the ALCL diagnosis.
The FDA is recommending that health care professionals and women pay close attention to breast implants and contact their doctor if they notice any changes.
Health care professionals should report all confirmed cases of ALCL in women with breast implants to Medwatch, the FDA’s safety information and adverse event reporting program by calling 800-332-1088.
The FDA also plans to provide an update on its review of silicone gel-filled breast implants this spring that will include interim findings from ongoing post-approval studies for silicone gel-filled breast implants currently sold in the United States, adverse event reports submitted to the FDA, and a review of the scientific literature on these products.
FDA will be working with breast implant manufacturers in the coming months to update their product labeling materials for patients and health care professionals.
Breast cancer is the most commonly diagnosed cancer among women. In the U.S., one in 8 women will develop breast cancer sometime in her lifetime.
In Rhode Island, women are even more likely to develop the disease, according to the Cancer Council.
Breast cancer is one of the leading causes of cancer-related deaths among women, second only to lung cancer.
Mammograms are recommended every year for women 40 years and older. Women at increased risk should have mammograms before 40.
Clinical Breast Exams should be done by a health professional every 3 years after age 20 and yearly after age 40.