American Society of Plastic Surgeons, FDA & The Breast Implant Registry
ASPS and FDA Collaborate to help establish a new 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. There are an estimated 10 million breast implants worldwide and there have been only 34 cases of ALCL identified over the last twenty-two years. Lymphomas can appear anywhere in the body. However, this lymphoma subset appears to arise 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.
According to the FDA report:
“Based on available information, it is not possible to confirm with statistical certainty that breast implants cause ALCL. At this time, data appear to indicate that the incidence of ALCL is very low, even in breast implant patients. Currently it is not possible to identify a type of implant (silicone versus saline) or a reason for implant (reconstruction versus aesthetic augmentation) associated with a smaller or greater risk.”
According to Phillip Haeck, MD, ASPS President, “the 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. 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. A woman with breast implants has about the same chance of being hit by lightning as she does coming down with this condition,” he added”
Recommendations for all patients with breast implants have not changed. 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. As I have always recommended to my patients, anyone who notes new changes in their breasts or around their breast implants (i.e. pain, swelling, hardening) should contact our offices at 310-777-5400.
The American Society of Plastic Surgeons is the largest organization of board-certified plastic surgeons in the world. They have more than 7,000 physician members. The ASPS is the leading authority and information source on cosmetic and reconstructive plastic surgery. My commitment as a member of ASPS is to relay important findings and updates from the ASPS to my patients.
FDA medical device safety advisory
FDA ALCL preliminary findings