FDA Issues Statement on Possible Link between Breast Implants and Rare Cancer

The FDA issued a statement on the possible link between breast implants and a very rare form of lymphoma. This is not breast cancer. It is a rare form of non-Hodgkin lymphoma, a form that is so rare it was not discovered until 1985. It is known as anaplastic large cell lymphoma (ALCL), and it affects immune system cells, not breast tissue cells.

In its statement, the FDA says about 60 confirmed cases of ALCL in women with breast implants have been identified worldwide. The actual number is uncertain because case reports in scientific literature and by doctors sometimes lack identifying information, making it possible that cases were double-counted. In the US, where documentation is better, they have identified 34 unique cases of ALCL in women with breast implants and 17 cases in women without breast implants.

The FDA is not saying that breast implants cause these cases. The number of cases is so small that they cannot make a statement about a causal relationship between breast implants and ALCL. The condition is so rare that they admit they may never be able to identify a causal relationship.

One case study suggests that the relative risk of ALCL for women with breast implants may be up to 20 times greater than for women without breast implants. But the initial risk is so small to begin with (about 3 in 100 million women are diagnosed each year in the US), the absolute risk is still very small. You can read the FDA's analysis of the scientific data for a more detailed review of the studies.

Dr. John Kotis notes that the recommendations say routine care, such as normal follow-ups with your health care provider and breast self exams should be sufficient to identify the cancer in its early stages. The FDA recommends that as always you should pay attention to any changes in your breast implants, especially:

• Pain
• Lumps
• Swelling
• Asymmetry

Symptoms like those above have been associated with every diagnosed case to date. There is no evidence to support having your breast implants removed as a preventative measure.

If you have concerns about your breast implants, we will be happy to talk to you about your concerns and review follow-up care procedures. For more information, please call or email The Center for Cosmetic & Reconstructive Surgery in Chicago, Illinois.