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ASPS Collaborates With FDA To Establish Breast Implant Registry

ARLINGTON HEIGHTS, Ill. –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.”


ASPS is the largest organization of board-certified plastic surgeons in the world with more than 7,000 physician members. The Society is recognized as a leading authority and information source on cosmetic and reconstructive plastic surgery. ASPS comprises more than 94 percent of all board certified plastic surgeons in the United States. Founded in 1931, the Society represents physicians certified by The American Board of Plastic Surgery or The Royal College of Physicians and Surgeons of Canada.

Editor’s Note: ASPS President Phillip Haeck, MD, and other ASPS leadership physicians are available for media interviews. Dr. Haeck will be in New York on Wed., Jan. 26 and Thurs., Jan. 27 and is available for in studio appearances.

Contact MediaSource Media Relations: 614-932-9950


 

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ASPS News Release



FDA Medical Device Safety Communication



FDA News Release



FDA White Paper



 

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