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Follow-Up Health Update for Breast Implant Patients

Last week, I informed you of breaking news about breast implants and ALCL (Anaplastic Large Cell Lymphoma). The FDA recently issued an update, which was reported this week in Cosmetic Surgery Times and summarized below:

A Food and Drug Administration review has uncovered a possible link between breast implants and a rare form of non-Hodgkin’s lymphoma called anaplastic large cell lymphoma. Of the estimated 10 million breast implants worldwide, the review identified 34 cases of ALCL since 1989 in women with breast implants. Twenty-seven of those cases involved silicone gel-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 breast implant patients 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 (the chance of being struck by lightening is greater), the 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.”

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.

If you have any questions, the FDA has made a consumer information brochure available on their website at http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm240985.htm  or go to the combined specialty  ASPS/ASAPS websited http://www.breastimplantsafety.org/  or ask your plastic surgeon, or feel free to contact me.