Wednesday, January 26, 2011 (Last Updated: 01/27/2011)
WEDNESDAY, Jan. 26 (HealthDay News) -- Saline or silicone gel-filled breast implants may be associated with anaplastic large cell lymphoma (ALCL), the U.S. Food and Drug Administration announced today. The agency requested that health care professionals report any confirmed cases of the disease in women with implants.
The announcement is based on the FDA's review of scientific literature published between 1997 and 2010 and information from other international regulators, scientists, and breast implant manufacturers.
The literature review identified 34 incidents of ALCL in women with saline and silicone breast implants. The FDA is aware of about 60 cases worldwide of ALCL in women with implants, but this number is difficult to confirm. ALCL appears in different parts of the body, including skin and lymph nodes. It is rarely found in breast tissue in women who do not have breast implants.
"We need more data and are asking that health care professionals tell us about any confirmed cases they identify," William Maisel, M.D., M.P.H., chief scientist and deputy director for science in the FDA's Center for Devices and Radiological Health, said in a statement. "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."
Hematology & Oncology
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