WASHINGTON, D.C. - The Food and Drug Administration announced a possible link between saline and silicone breast implants and a rare type of cancer Wednesday. Data reviewed by the department suggests a link between patients with breast implants and anaplastic large cell lymphoma in the scar capsule adjacent to the implant.
According to the National Cancer Institute, ALCL appears in different parts of the body including the lymph nodes and skin. Each year it is diagnosed in 1 out of every 500,000 women in the U.S. It is located in the breast tissue in three out of every 100 million women nationwide without breast implants. The department is aware of about 60 cases of ALCL in women with breast implants worldwide. The number is difficult to verify due to reporting methods. An estimated 5 to 10 million women worldwide have implants.
The notification is based on a review of scientific literature published between 1997 and 2010.
The incidence of ALCL in women with implants appears to be very rare, however, the FDA is requesting that women with implants monitor their implants and report any report any changes to their doctor. Doctors are asked to report all cases of ALCL in women with breast implants to the department.
The FDA is working with breast implant manufacturers to update their product labeling materials to inform doctors and patients of the possible risk.
"We need more data and are asking that healthcare professionals tell us about any confirmed cases they identify," said Dr. William Maisel, chief scientist and deputy director for science in the FDA's Center of 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."