The FDA today announced a possible association between saline and silicone gel-filled breast implants and anaplastic large cell lymphoma (ALCL), a very rare type of cancer. Data reviewed by the FDA suggest that patients with breast implants may have a very small but significant risk of ALCL in the scar capsule adjacent to the implant.
The FDA is requesting that health care professionals report any confirmed cases of ALCL in women with breast implants.
In an effort to ensure that patients receiving breast implants are informed of the possible risk, the FDA will be working with breast implant manufacturers in the coming months to update their product labeling materials for patients and health care professionals.
“We need more data and are asking that health care professionals tell us about any confirmed cases they identify,” says William Maisel, MD, MPH, 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.”
According to the National Cancer Institute, 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.
In total, 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 FDA notification is based on a review of scientific literature published between January 1997 and May 2010 and information from other international regulators, scientists, and breast implant manufacturers. 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.