After a review, the U.S. Food and Drug Administration suggests patients with breast implants may have a very small but significant risk of anaplastic large cell lymphoma in the scar capsule adjacent to the implant, but more data is needed.
"We need more data and are asking that healthcare professionals tell us about any confirmed cases they identify," Dr. William Maisel, chief scientist and deputy director for science in FDA's Center for Devices and Radiological Health, says 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."
The FDA says it is aware of about 60 cases of ALCL in women with breast implants worldwide, but this may not be accurate 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, Maisel says.
Healthcare professionals are asked to report all confirmed cases of ALCL in women with breast implants to Medwatch, the FDA's safety information and adverse event reporting program, at 800-332-1088.
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