GHN News – FDA – The
U.S. Food and Drug Administration has announced that research has observed apossible
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 FDA is requesting that health care professionals report any confirmed cases of ALCL in women with breast implants.
an effort to ensure that patients receiving breast implants are
informed of the possible risk, FDA will be working with breast implant
manufacturers in the coming months to update their product labeling
materials for patients and health care professionals.
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.”
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.
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 FDA is recommending that health care professionals and women pay close attention to breast implants and do the following: