Breast implants, both silicone, and saline may be associated with a rare form of cancer called anaplastic large cell lymphoma (ALCL). The U.S. Food & Drug Administration (FDA) announced yesterday that it will be working with breast implant manufacturers in the coming months to update their product labeling to address this cancer risk.
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, the agency said.
An estimated 5 million to 10 million women worldwide have breast implants. In breast implant patients, ALCL has occurred in the scar capsule adjacent to the implant. In total, the FDA is aware of about 60 cases of ALCL in women with breast implants worldwide. The agency said the number is difficult to verify because not all cases were published in the scientific literature and some may be duplicate reports. The FDA is requesting that health care professionals report any confirmed cases of ALCL in women with breast implants.
ALCL is a rare malignant tumor (non-Hodgkin lymphoma) that may appear in several parts of the body including the lymph nodes, skin, bones, soft tissue, lungs, or liver. 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.
Symptoms reported by breast implant patients ultimately diagnosed with ALCL included 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 the 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 said.
According to a report in The Boston Globe, the FDA is requiring the two makers of breast implants, Allergan and Mentor Worldwide, to continue safety studies, including one with more than 40,000 patients. Both medical device makers said yesterday that they supported the FDA’s actions on the issue.
The American Society of Plastic Surgeons announced that it is establishing a national registry for breast implants in collaboration with the FDA to monitor safety issues, the Globe said.
The FDA is recommending that health care professionals and women pay close attention to breast implants. Breast implant recipients should contact their doctor if they notice any changes and women considering breast implants should discuss the risk of ALCL with their doctors.