FDA reports possible association between breast implants, ALCL

The U.S. Food and Drug Administration reported on January 26 that "a possible association between saline and silicone gel-filled breast implants and anaplastic large cell lymphoma (ALCL), a very rare type of cancer. Data reviewed by the FDA suggests that patients with breast implants may have a very small, but significant risk, of ALCL in the scar capsule adjacent to the implant. According to the National Cancer Institute, ALCL appears in different parts of the body including the lymph nodes and skin. Each year ALCL is diagnosed in about 1 out of 500,000 women in the United States. ALCL located in breast tissue is found in only about 3 out of every 100 million women nationwide without breast implants. In total, the agency is aware of about 60 cases of ALCL in women with breast implants worldwide. This number is difficult to verify because not all cases were published in the scientific literature and some may be duplicate reports. An estimated 5 million to 10 million women worldwide have breast implants."

Due to the extremely low incidence and some conflicting evidence, the FDA is recommending routine medical care and follow-up for women with breast implants.  The American Academy of Cosmetic Surgery agrees with the FDA recommendations and hopes that this report does not produce undue panic from the millions of women who have breast implants. Many ongoing studies will eventually find a more definitive conclusion and the AACS will help spread the word to improve patient safety.  The AACS has recently established a new taskforce on safety in cosmetic surgery and will continue to update our safety guidelines for cosmetic breast surgery as well as other cosmetic procedures.

Our Academy is also implementing a new database reporting system for our members, which will benefit the public in these matters by adding valuable data on cancer incidence or complications related to breast implants.  Many studies to date reported by organizations such as Allergan (a major breast implant producer) have not shown evidence of increased risk of breast cancer and implants (see below). 

"The potential association of breast implants and lymphoma has been evaluated in several studies with long-term follow-up, and the published epidemiological evidence does not support an increased risk of non-Hodgkin's lymphoma in patients with breast implants."

• An epidemiological study reviewed evidence from five long-term studies of 43,000 women with breast implants and followed for up to 37 years and noted no difference in the incidence ratio of non-Hodgkin's lymphoma in implant patients (Lipworth, March 2009).
• A Scandinavian cancer incidence study evaluated 6,222 women with breast implants including 3,336 women with 15 or more years of follow-up and 827 with 25 or more years of follow-up and found no excess of lymphoma in subjects with implants (Lipworth, Jan 2009).
• A large, controlled Canadian cancer study followed 24,558 breast augmentation patients and 15,893 women who received other cosmetic surgeries and found a similar incidence of non-Hodgkin's lymphoma after over 600,000 person years of follow-up (Brisson, 2006).

The incidence of primary ALCL in the breast of U.S. females is approximately 1.2 per year. The FDA is doing its due diligence to define any possible relationship it has with breast implants or possible scar tissue around implants.  Due to the low numbers of total cases in the world at this time, it is difficult to make any definitive correlations.  However, awareness of breast cancer in general hopefully will increase women's desire for routine care and follow-up.  This alone may be a good thing if it promotes early recognition and patient's awareness of any type of breast cancer regardless if women have implants or not.  The AACS recommends that women perform routine breast self-examinations whether they have implants or not as an important diagnostic tool.  This, along with routine physician exams and appropriate imaging such as ultrasound, mammogram or MRI when indicated, will promote early recognition of any type of breast cancer. The AACS will do our part to keep surgeons and the public up to date with new developments on the ALCL issue or other safety issues regarding cosmetic surgery.