ALC and Breast Implants

On January 26th, 2011, the FDA reported that it identified a possible association between breast implants and the development of anaplastic large cell lymphoma (ALCL), a rare type of non-Hodgkin's lymphoma. While ALCL is not breast cancer, it is a malignancy that women considering breast implants should be aware of. While the FDA continues to allow the sale and use of approved breast implants, the FDA has stated, "additional data is needed to fully understand the possible relationship between ALCL and breast implants." At the time of this writing, the FDA believes, "women with implants may have a very small, but increased risk of developing anaplastic large cell lymphoma, or ALCL."

What does this mean if I have breast implants or if I am considering breast implants?

The medical community is in the process of gathering more information about breast implant- associated ALCL so that we can better understand this condition and the potential risk breast implants pose. Women considering breast implants should inform themselves about ALCL and weigh the risks, the uncertainty, and the potential benefits of breast implants for themselves. Presently, the FDA is not recommending removal of breast implants for women who presently have them.

What is known so far about breast implants and ALCL?

As of January 26, 2011, approximately 60 cases of breast implant-associated ALCL have been identified by the FDA. This number is based upon 34 case reports in the medical literature and additional cases reported directly to the FDA. Case reports in the medical literature and adverse event reporting to the FDA are know to be unreliable methods of determining the actual incidence of a disease or condition. What this means is that, at the present time, the medical community does not know precisely how many women with breast implants have developed ALCL--the actual number of women who developed breast implant-associated ALCL may, therefore, be much higher.

What Are The Chances of Getting ALCL If I Have A Breast Implant?

The answer is, at the moment, we don't know for certain.

Consider the following:

Without breast implants, the incidence of ALCL (according to information on the FDA website) of the breast is only about 3 in 100,000,000. If, as is reported on the FDA website, there are between 5 and 10 million women worldwide with breast implants and there are between 34 and 60 identified cases of ALCL in these women, the ratio of identified cases of ALCL to women who have had breast implants could, at a minimum, be anywhere between 1.7 women with ALCl per 500,000 women with implants and 6 women with ALCL per 500,000 women with breast implants. These calculations are based upon the "5-10 million women with breast implants worldwide" statistic on the FDA website.

Looking at risk from the standpoint of "how many women with breast implants have developed ALCL" (i.e., ALCL cases per total number of women who have had breast augmentation) does not tell the whole story about a woman's real risk. Because ALCL appears to develop many years after breast implants are placed (the average time between implant placement and diagnosis of ALCL in the reported cases was 8 years) and since many women only recently underwent breast augmentation surgery (296,203 breast augmentations in 2010, 289,328 in 2009 according to the ASPS...), reporting the incidence of ALCL in relation to the total number of women who have had breast implants placed is misleading. This is because hundreds of thousands, or possibly millions, of women who only recently underwent breast augmentation are counted in the statistic, yet they would not be expected to have developed ALCL-they are, so to speak, still in the latency or "incubation" period. In other words, the inclusion of these women who recently underwent breast augmentation in the calculation effectively "dilutes" the ratio and thus dilutes the appear