Keep Anaplastic Large Cell Lymphoma Breast Implant Risk in Perspective

Michael Bogdan, MD


February 24, 2011

Anaplastic Large Cell Lymphoma (ALCL) in Women With Breast Implants: Preliminary FDA Findings and Analysis

Center for Devices and Radiological Health, US Food and Drug Administration
January 2011

White Paper Summary

Anaplastic large cell lymphoma (ALCL) is an extremely rare form of lymphoma, with an incidence of 1/500,000 per year on the basis of Surveillance, Epidemiology and End Results (SEER) data from the National Cancer Institute.[1] Diagnosing ALCL in the breast is even more rare, with a yearly incidence of 3 in 100 million women. This US Food and Drug Administration (FDA) white paper[2] covered a 13-year period, finding at most 60 cases of ALCL of the breast (34 definitely unique, and some of the 60 could be duplicate cases) in women with breast implants. The number of women with breast implants worldwide is estimated to be between 5 and 10 million. Calculating for the worst-case scenario, assuming that all 60 cases were unique and that only 5 million women have implants worldwide, the expected yearly incidence of ALCL of the breast would be 4.6 cases per year for the 5 million women who have breast implants. With these current data, the incidence of ALCL of the breast is less than 1 case per 1 million women with breast implants per year. Although this is less than the expected incidence of ALCL for all body sites (2 per 1 million women per year), it is much higher than the expected incidence of ALCL of the breast (3 per 100 million women per year).


By now I expect that every surgeon who uses breast implant devices for either reconstruction or aesthetic enhancement has already had a number of patients calling in asking "if they should be concerned" about the FDA's findings of an association between breast implants and ALCL. The media has been quick to latch onto this hot topic with inflammatory terms to describe the findings, such as "alarming," and calling patients "victims."[3] Breast implants are, and will likely continue to be, the most scrutinized medical devices that have ever been used. Under such intense observation, it is not surprising that rare associations would eventually be identified, but it is crucial to keep findings in perspective to avoid inappropriate amplification in the media. It is important to educate patients on potential risks associated with any medical intervention, and it is just as important to relate the statistical chances of those risks to avoid unnecessary anxiety.

Because of the volatile history of breast implants, a balanced reference point should be provided to allow patients to understand the new information and avoid the tendency for panic. With respect to the new findings about breast implants and ALCL, it is reasonable to say that in a 1-year period, for every 1 million women who already have breast implants, 1 woman will be diagnosed with ALCL (according to current FDA statistics) and 2 other women in the group will be struck by lightning (according to current National Oceanic and Atmospheric Administration statistics[4]). Most women are not afraid of lightning strikes, and should view these new findings about breast implants in a similar light.

Although ALCL is not breast cancer, patients may rightfully wonder why they would consider an intervention that might increase their risk for any form of cancer. To place this in perspective, it is worth reviewing the association between alcoholic beverages and breast cancer. On the basis of the SEER data,[5] approximately 1 in 8 women will be diagnosed with breast cancer in her lifetime. With an average life expectancy of 80.8 years (US Census Bureau data[6]), the average yearly risk for a woman to develop breast cancer is estimated to be 1 in 650 (an incidence of 1539 cases per 1 million women per year). Multiple studies have shown that even moderate consumption of alcohol significantly increases the chance of developing breast cancer. In a meta-analysis of 38 epidemiologic studies, Boyle and Boffetta[7] found a pooled relative risk of 1.1 for the development of breast cancer in women who drank an average of 1 alcoholic drink per day. This means that approximately 154 new cases of breast cancer per 1 million women who drink alcohol are attributable to the lifestyle choice of drinking, much higher than the 1 case of ALCL per 1 million women who choose to have breast implants.

Now that surgeons are aware of the possibility of ALCL in peri-implant capsules, I expect that more cases will be identified. Surgeons will have a higher index of suspicion for ALCL, and will follow the FDA recommendations for sending peri-implant seroma for histology in addition to sending the capsules for pathology in cases of capsular contracture or late-onset, persistent peri-implant seroma. The American Society of Plastic Surgeons is collaborating with the FDA to establish a national registry for breast implants to track these types of data. As more data arise, it will be important to relay information to patients in a meaningful format to avoid the possibility of creating psychological unrest and social panic.


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