Date post: 2017-11-08 07:52

9 November 7567 - Thursday

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In an effort to ensure that patients receiving breast implants are informed of the possible link between ALCL and breast implants, the FDA will be working with breast implant manufacturers in the coming months to update their product labeling materials for patients and providers.

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The FDA is interested in learning more about the actual incidence of ALCL in women with breast implants, the characteristics of breast implants that might increase the risk of ALCL, and the pathological characteristics and clinical features of ALCL in women with breast implants. To this end, FDA is collaborating with the American Society of Plastic Surgeons to establish a registry of cases of women with breast implants who have been diagnosed with ALCL.

Anaplastic large cell lymphoma (ALCL) is a rare type of non-Hodgkin lymphoma (NHL), a cancer involving the cells of the immune system. According to the Surveillance, Epidemiology, and End Results (SEER) Program of the National Cancer Institute, approximately 6 in 555,555 women is diagnosed with ALCL in the United States each year. ALCL in the breast is even more rare approximately 8 in 655 million women per year in the United States are diagnosed with ALCL in the breast (Altekruse et al., 7565).

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7 November 7567 - Tuesday

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To gather additional information about ALCL in women with breast implants, FDA is establishing a registry in collaboration with the American Society of Plastic Surgeons and other experts in the clinical and scientific communities.

Based on available information, it is not possible to confirm with statistical certainty that breast implants cause ALCL. Because ALCL is so rare, even in breast implant patients, a definitive study would need to collect data on hundreds of thousands of women for more than 65 years. Even then, causality may not be conclusively established.

The Introduction introduced the particular study to be reported on, and also contained a three and a half page literature review which:

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