ALCL 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. ALCL is not breast cancer, however,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.” The FDA has stated, “women with implants may have a very small, but increased risk of developing anaplastic large cell lymphoma, or ALCL.”
If I have breast implants or if I am considering breast implants, what is currently recommended by the FDA?
The medical community is in the continuing to gathering information about breast implant- associated ALCL so that we can better understand this condition and the potential risk breast implants may 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.
Breast implants and ALCL-what do we know so far?
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. Because case reports in the medical literature and adverse event reporting to the FDA are know to be unreliable methods of determining the true number of people with a disease or condition, the actual number may ultimately turn out to be higher. In other words, 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 be higher.
What are the chances of a woman developing ALCL if she has 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. Unfortunately, trying to asses the chances that a women who has breast implants would get ALCL by looking at “how many women with breast implants have developed ALCL” is deceiving. 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), the inclusion of recently "implanted women" effectively skews the perceived risk. This is because counting the hundreds of thousands of women who only recently had implants placed in statistics like, "1 in 500,000 women with breast implants may develop ALCL" means the statistics are "diluted"; women who only recently underwent breast implant placement would not be expected to have developed ALCL—they are, so to speak, still in the latency or “incubation” period. A more accurate way to represent the incidence of a condition with a long latency period would be to express the number of cases in terms of “patient exposure time”.
What is the prognosis for breast implant-associated ALCL and how is it treated?
Our understanding of the biology and prognosis of breast implant-associated ALCL is presently limited. While there is the suggestion that the type of ALCL that has been reported in association with breast implants is less aggressive than other types of ALCL, it is not yet clear. In the medical literature, only 19 of the 34 reported cases include information about ALCL recurrence or the development of systemic lymphoma. Of these, 14 patients remained free of ALCL during the follow-up period, but the average reported follow-up period was only 12 months. The FDA presently recommends that if a woman develops breast implant-associated ALCL, her doctors should “develop an individualized treatment plan in coordination with the patient’s multi-disciplinary care team. Because of the small number of cases worldwide and variety of available treatment options, there is no single defined consensus treatment regimen.” Reported cases of ALCL have been treated with one or more of the following: surgery, radiation and chemotherapy. According to published information on the FDA website, “Because of the small number of cases and the short median duration of follow-up, the FDA believes it is premature to draw conclusions regarding the prognosis of ALCL in women with breast implants.”
What is the FDA saying?
Information on the FDA website indicates that the in the coming months breast implant labeling materials for patients and providers will be updated with information about the anaplastic large cell lymphoma. For women who have breast implants, the FDA is currently suggests routine screening mammography and monitoring your breast implants; contact your health care provider promptly to schedule an appointment if you notice any changes. At present, the FDA is not suggesting that women with breast implants have them removed because of this newly reported association with ALCL. FDA also has some helpful information on its website for consumers. 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.” If a woman is considering breast implant surgery, she should discuss the risks and benefits of the procedure with her doctor.