Risk of ALCL in women with breast implants--2011 FDA report.


The FDA report of January 26, 2011 states that ALCL can occur anywhere in the body. According to the SEER (Surveillance, Epidemiology, and End Results) Program of the National Cancer Institute, an estimated 1 in 500,000 women per year in the US is diagnosed with ALCL. ALCL of the breast is even more rare; approximately 3 in 100 million women per year in the US are diagnosed with ALCL of the breast. The scientific literature from January 1997 through May 2010 showed 34 unique cases (case lists showing a higher number were a result of some cases being double-reported in more than one study or report) of ALCL in women with breast implants, in up to an estimated 10 million women with breast implants, which equates to 1 case per 294,118 women (over 13.3 years), or 0.00033%.

Data from the CDC regarding lightning-related deaths show an average annual of 107 deaths over the period from 1968 and 1985, for a rate of 6.1 per 10 million, equal to 1 death in 1.6 million, or 0.00006%.
Although the risk of developing ALCL in women with breast implants is actually 5.5 times greater than the likelihood of dying from a lightning strike, both are EXCEEDINGLY RARE!

ALCL is lymphoma, NOT breast cancer, and some researchers have suggested that breast implant-associated ALCL may represent a new clinical entity with less aggressive behavior (Li, 2010; Miranda et al, 2009; Thompson et al, 2010). Because of the extremely small number of cases and short median duration of follow-up, the FDA states that it is premature to draw conclusions regarding prognosis of ALCL in women with breast implants. The FDA also states that because the risk of ALCL appears very small, the totality of evidence continues to support a reasonable assurance that FDA-approved breast implants are safe and effective when used as labeled.
The FDA further states that "There is no need for women with breast implants to change their routine medical care and follow-up."
Article by
Minneapolis Plastic Surgeon