January 26, 2011
The U.S. Food and Drug Administration (FDA) announced today that women with saline and silicone breast implants might have a “very small but significant” risk of developing a rare cancer.
An estimated 5 million to 10 million women worldwide have breast implants.
Investigating reports of anaplastic large cell lymphoma (ALCL) in women with breast implants, the FDA reviewed scientific literature published between January 1997 and May 2010 and information from other international regulators, scientists and breast implant manufacturers. The review found about 60 cases of ALCL worldwide. However, the FDA warns that these numbers may not be accurate because the scientific literature does not contain all the ALCL cases and some cases may be duplicates.
The FDA requests that health care professionals report any confirmed cases of ALCL in women with breast implants to the agency. The agency will conduct an ongoing review.
Anaplastic large cell lymphoma is an aggressive T-cell lymphoma, a cancer involving cells of the immune system, which can occur anywhere in the body. The cases of ALCL related to breast implants are not a cancer of the breast tissue, but a cancer in the fibrous scar tissue that develops around the breast implant after surgery, the FDA’s page of Questions and Answers about Anaplastic Large Cell Lymphoma (ALCL) clarifies.
Doctors diagnosed most cases of breast implant associated ALCL when the women sought medical treatment for pain, lumps, swelling or asymmetry of their breasts. Doctors generally found the ALCL adjacent to the implant itself and contained within the fibrous scar tissue.
“We need more data and are asking that health care professionals tell us about any confirmed cases they identify,” said William Maisel, M.D., M.P.H., chief scientist and deputy director for science in FDA’s Center for Devices and Radiological Health. “We are working with the American Society of Plastic Surgeons and other experts in the field to establish a breast implant patient registry, which should help us better understand the development of ALCL in women with breast implants.”
The FDA posted its review entitled “Anaplastic Large Cell Lymphoma (ALCL) in Women with Breast Implants” on the website.
While the FDA says the risk of women with breast implants developing ALCL is small, the agency is requiring that breast implant manufacturers update their product labeling materials to inform patients and health care professionals of the risk. The FDA has no plans to remove these medical devices off the market.
FDA is recommending that women:
- Continue their routine medical care and follow-up. ALCL is very rare; it has occurred in only a very small number of the millions of women who have breast implants.
- Monitor their breast implants and contact their doctors promptly if they notice pain, swelling or any changes in or around their breast implants. There is no reason to contact their doctors if they have no symptoms.
- Women who are considering breast implant surgery should discuss the risks and benefits of the procedure with their doctors.
The FDA has released a consumer update entitled FDA Advises Women with Breast Implants.
In response to the FDA’s report, the American Society of Plastic Surgeons (ASPS) is collaborating with the FDA to establish a national breast implant registry.
“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 in a statement. “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.”