Washington — A Food and Drug Administration review has uncovered a possible link between breast implants and a rare form of non-Hodgkin’s lymphoma, MedPage Today reports.
The review identified 34 cases of anaplastic large-cell lymphoma (ALCL) in women with breast implants. Twenty-seven cases involved silicone-filled devices.
A statement posted on the FDA website notes that agency officials are aware of another two dozen or so cases of ALCL among implant users worldwide.
It says that although the possible link requires confirmation, “The FDA believes that women with breast implants may have a very small but increased risk of ALCL. Because the risk of ALCL appears very small, FDA believes that the totality of evidence continues to support a reasonable assurance that FDA-approved breast implants are safe and effective when used as labeled.”
MedPage Today reports that in a press briefing, William Maisel, M.D., of the FDA’s Center for Devices and Radiological Health, said, “We need more data and are asking that healthcare professionals tell us about any confirmed cases they identify. 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 agency also will work with implant manufacturers to update product labeling information.
Other review results discussed during the press briefing:
• Most of the ALCL cases were diagnosed after silicone implants returned to the market in 2006.
• The diagnoses tended to occur a median of eight years after implantation
• Most lesions arose in the fibrous capsule that formed around the implant.
• A majority of cases involved implants for breast augmentation as opposed to reconstruction following breast cancer surgery.