Anaplastic Large Cell Lymphoma (ALCL) and Silicone Breast Implants

FDA Report of January 2011

In January 2011, the US-American FDA issued an alert concerning Anaplastic Large Cell Lymphoma (ALCL) and breast implants. It has been an observation for many years that some women have pain and swelling in their breast with silicone breast implants. A study was performed to collect case studies and subsequent clinical examples of this phenomenon. A review of the literature since 1997 has found approximately 60 cases of ALCL in women with breast implants worldwide in a population of 5–10,000,000 women. It is estimated that the incidence of ALCL in women is 1 in 500,000 in the U.S.A.

With only 60 cases reported to date, it is extremely difficult to draw any conclusions and the FDA is asking for more information from the community to determine more about this phenomenon. Women should not be unduly alarmed and it is not suggested that women should have their implants removed. There are a few things known though:

  1. Anaplastic Large Cell Lymphoma(ALCL) is NOT breast cancer. It is a non-Hodgkins lymphoma.
  2. There is no demonstrated causal effect between breast implants and ALCL. There is a possible link at this moment which is what the FDA is trying to determine.
  3. It is not possible to identify any specific type of implant with a lower or higher risk of ALCL.
  4. Because of the rare nature of ALCL, it is not possible to determine the true cause of ALCL.
  5. Women should not have their implants prophylactically removed.
  6. If one thinks that they have ALCL, then they should contact their health care provider the implant manufacturer and/or the FDA.

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