FDA, Breast Implants and ALCL It’s all over the news and you have probably heard it: the FDA is concerned that there may be a link between breast implants and a very rare form of cancer called anaplastic large cell lymphoma (ALCL). According to the FDA, they are aware of 60 cases worldwide and 34 cases in the United States where woman who have breast implants also have ALCL. The FDA points out that they do not know if breast implants actually cause ALCL. The following quotation comes directly from the FDA’s white paper on breast implants and ALCL:
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 10 years. Even then, causality may not be conclusively established. (FDA, “Anaplastic Large Cell Lymphoma (ALCL) In Women with Breast Implants: Preliminary FDA Findings and Analyses, January 2011)
If you would like to read the whole FDA white paper, you may do so by clicking the following link: FDA White Paper on Breast Implants and ALCL. You may also download a PDF version here.
Approximately 10 million women worldwide have breast implants yet the FDA is aware of only 60 cases of ALCL that could possibly be related to breast implants. Both Dr. Philip Haeck, President of the American Society of Plastic Surgeons, and Dr. Richard Besser, ABC News Chief Health and Medical Editor, state that your chances of getting struck by lightning are greater than your chances of getting ALCL from breast implants. The first thing is, do not panic! 60 cases out of 10 million breast implant patients is a tiny, tiny percentage - 0.0006%. If you feel good, you don’t need to do anything. The FDA says, “There is no need for women with breast implants to change 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.”Most cases reviewed by the FDA were diagnosed when patients sought medical treatment for breast implant-related symptoms such as pain, lumps, swelling, or asymmetry that developed after their initial surgical sites were fully healed. If you have any of these symptoms, go see your plastic surgeon and have him examine your breasts and ascertain the condition of your breast implants.
In some ways, this media outburst harkens back to the Silicone Gel outburst years ago. The FDA pulled Silicone Breast Implants from the market, then allowed them back on the market after a 15 year ban. It turned out that they were safe all along and the outcry had no basis. Silicone gel breast implants were never pulled from the market in Europe because the science didn’t back up the ban. Perhaps our FDA has leaned its lesson. In its news release on January 26, 2011, the FDA states, “...the existing data support the continued marketing and use of breast implants.”While it is still early in the examination of ALCL, let’s hope that the FDA continues to proceed rationally and doesn’t simply jump to conclusions the way they did in 1991. After all, women should have the right to choose the way they look and feel.
It is worth re-reading this insightful editorial on the silicone gel breast implant ban by Steve Chapman. This was originally printed in the Chicago Tribune in 2006, but has direct applicability to today’s breast implant and ALCL issue. Recovering, Finally, From the Breast Implant Panic
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