ASPS, FDA collaborate to establish national breast implant registry

The American Society of Plastic Surgeons (ASPS) is establishing a national registry for breast implants in collaboration with the Food and Drug Administration (FDA). The registry is being developed in response to reports of a rare lymphoma--Anaplastic Large Cell Lymphoma (ALCL)—in a very small number of women with breast implants.

The ASPS and the FDA agree this extremely rare form of lymphoma is not breast cancer. Of the estimated 10 million implants worldwide, only 34 cases of ALCL have been identified since 1989.

While lymphomas can appear anywhere in the body, this condition appears in the scar tissue that forms around the breast implants. At this time both the FDA and ASPS remain confident that breast implants are safe and effective.

"ASPS shares the FDA's commitment to patient safety, but we also want to make certain this information does not raise false alarms with our patients," Phillip Haeck, MD, ASPS President, said. "We've been down this path before. For nearly 20 years American women were denied access to their choice of breast implants because of false claims and unfounded science. We are determined this shouldn't happen again."

ASPS recommends that women with breast implants should continue their normal routine in medical care and follow-up, specifically regular self examination and mammography when appropriate. Women with breast implants should watch for changes in their breasts such as pain and swelling and contact their plastic surgeon if they have questions.

"Women who are considering breast implant surgery," Dr. Haeck said, "should do their homework to see if it is right for them. ASPS is committed to helping women make informed choices about their health care and our website www.plasticsurgery.org is an excellent resource."