Aesthetic society applauds FDA's effort to collect data concerning a rare condition associated with breast implants

January 26, 2011
American Society for Aesthetic Plastic Surgery (ASAPS)

The American Society for Aesthetic Plastic Surgery (ASAPS) announces today its support of a new national registry for breast implants that will be compiled by the American Society of Plastic Surgeons (ASPS) in collaboration with the Food and Drug Administration (FDA). This registry will document reported cases of a very rare condition, Anaplastic Large Cell Lymphoma (ALCL), in the presence of breast implants.

As patient advocates, the members of ASAPS applaud the efforts of the Food and Drug Administration (FDA) to ensure that sound scientific practices are the foundation for information and research, including post market surveillance.

in the presence of breast implants has been noted in sporadic case reports over the past 25 years. To date, ALCL has only been identified in 34 cases out of an estimated 5 to 10 million women with implants worldwide. As opposed to systemic ALCL which can occur anywhere in the body, this condition appears in the scar tissue that forms around the implant. It is encouraging that when this condition occurs in the presence of breast implants the patients have responded to a variety of treatments, including simple removal of the implant and surrounding scar capsule.

ASAPS joins both the FDA and ASPS in its view that breast implants are safe. "Breast implants are the most studied device in medical history. As physicians, our primary commitment is providing safe and effective patient care. We share in the commitment of FDA and ASPS to the continued device evaluation and monitoring," said Felmont Eaves, III, M.D., of Charlotte, NC, and ASAPS President.

ASAPS recommends that 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. Any woman should watch for changes in her breasts such as pain and swelling and contact her physician if she has any questions.