The FDA, Breast Implants and Anaplastic Large Cell Lymphoma
On January 26, 2011 the FDA released a White Paper and Advisory Statement on Anaplastic Large Cell Lymphoma (ALCL) in women with breast implants.
ALCL is an incredibly rare tumor… only 34 cases worldwide have been reported over the last 25 years despite an estimated number of at least 5 to 10 million women with breast implants. Moreover, the type of ALCL that has been reported is very different from other ALCL’s. As opposed to systemic ALCL, which can occur anywhere in the body, this condition is localized to the scar tissue that forms around the breast implant. Most importantly, in the very rare cases where this condition has occurred in the presence of breast implants, patients have responded well to a variety of treatments, including simple removal of the implant and surrounding scar tissue. It is important to understand that this is NOT breast cancer.
The FDA has not changed the status or availability of breast implants. The FDA, in conjunction with the American Society of Plastic Surgeons (ASPS) and the American Society of Aesthetic Plastic Surgeons (ASAPS), maintain that breast implants, one of the most studied devices in medical history, are safe.
Of course, all women including those with breast implants should follow their normal routine in medical care and follow-up, specifically regular self examination and mammography when appropriate.