NCI Cancer Bulletin for February 8, 2011 - National Cancer Institute: FDA Investigates Breast Implants and a Rare Lymphoma

FDA Investigates Breast Implants and a Rare Lymphoma

The FDA is investigating a possible association between breast implants and a very rare form of cancer called anaplastic large cell lymphoma, or ALCL. Based on a review of the scientific literature and discussions with experts, the agency said that women with breast implants may have a very low but increased risk of developing ALCL compared with women who do not have breast implants. The announcement came in a January 26 news release.

At this time, there is not enough information available to determine whether the implants might be a cause of ALCL, and the FDA is not recommending breast implant removal in patients without symptoms or other abnormalities. Nevertheless, the FDA said it would work with breast implant manufacturers to update their product labeling materials for patients and health care professionals in the coming months.

To date, FDA scientists have learned of approximately 60 cases of ALCL in women with breast implants worldwide, though they said the actual number of cases could be difficult to determine. (An estimated 5 to 10 million women have breast implants.) The agency is working with the American Society of Plastic Surgeons and other experts to establish a registry of breast implant patients, which researchers could use to study the possible association.

“We need more data and are asking that health care professionals tell us about any confirmed cases they identify,” said Dr. William Maisel, chief scientist and deputy director for science in FDA’s Center for Devices and Radiological Health, in a statement.

ALCL is diagnosed in about 1 out of 500,000 women in the United States each year and appears in different parts of the body, including the lymph nodes and skin. ALCL located in breast tissue is found in only about 3 out of every 100 million women nationwide without breast implants.

“Health care providers should be aware ALCL in women with breast implants is a very rare condition,” said the authors of an FDA white paper on the subject. 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, the authors added.

Some researchers have suggested that breast implant-associated ALCL may represent a new clinical entity with less-aggressive (indolent) behavior. However, in view of the small number of cases and the short median duration of follow-up, the FDA said it is premature to draw conclusions regarding the prognosis of ALCL in women with breast implants.

For more information see the FDA’s Questions and Answers about Anaplastic Large Cell Lymphoma (ALCL) [Breast Implants > Questions and Answers about Anaplastic Large Cell Lymphoma (ALCL)] and a Consumer Update [Consumer Updates > FDA Advises Women with Breast Implants].

The NCI Fact Sheet on breast implants is here: National Cancer Institute Breast Implant Study - National Cancer Institute.


NCI Cancer Bulletin for February 8, 2011 - National Cancer Institute