Restorative Techniques

ALCL and Breast Implants

The FDA has 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. Furthermore, although a conclusive causal relationship has not yet been established, it is presently thought that breast implants may play a role in the development of ALCL—in scientific jargon, there is "biologic plausibility". 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 has stated on its website, “women with implants may have a very small, but increased risk of developing anaplastic large cell lymphoma, or ALCL.”

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.

ALCL and Breast Implants- Are Implants Safe?

Breast Implant-Associated ALCL Statistics

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; there is possibly overlap between the two groups, so the precise number is not known with certainty. Case reports in the medical literature and adverse event reporting to the FDA are know to be unreliable methods of determining the true or actual incidence of a disease or condition. The reasons that these methods of determining the incidence of a disease or condition are notoriously inaccurate include:

• Physicians may not recognize that a particular adverse event (e.g., the development of lymphoma) is linked to a particular drug or medical device, and therefor they do not alert the FDA to this event
• There is no mandatory reporting requirement, and physicians do not necessarily notify the FDA even when they believe that an adverse event has occurred
• Physicians do not always write a medical article for publication when they see an unusual or interesting case
• Not all case reports are accepted by medical journals for publication

What this means is that at this time, there is actually no way for the medical community to know accurately or precisely how many women with breast implants have developed ALCL.

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

Without breast implants, the incidence of ALCL of the breast is only about 3 in 100,000,000 according to the FDA!

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 be:

• 34/5,000,000 = 3.4 in 500,000
• 34/10,000,000 = 1.7 in 500,000
• 60/5,000,000 = 6 in 500,000
• 60/10,000,000 = 3 in 500,000

A Closer Look at the Statistics

It is important to understand that 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 --know as an odds ratio) does not tell the whole story about a woman’s real risk. Since the actual number of women with breast implants is unknown—the FDA reports that there are between 5 and 10 million women with breast implants worldwide—even an odds ratio cannot be accurately determined at this point. Furthermore, since ALCL appears to develop many years after breast implants are placed (the median latency, or time, to development 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 and 289,328 in 2009 according to the American Society of Plastic Surgeons), reporting the incidence of ALCL in relation to the total number of women who have had breast implants placed is potentially misleading. This is because hundreds of thousands, or possibly millions, of women who only relatively recently underwent breast augmentation are counted in the denominator of the odds ratio, yet they would effectively 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 appearance of risk. 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”.

Using patient exposure time to evaluate ALCL associated with breast implants would be akin evaluating the amount of work done by looking at the actual number of “man-hours worked” rather than just looking at the number of people who worked on a given project. Here’s why there is an important distinction between the two calculations: consider a hypothetical assignment for a group of people to work together to build a widget. Group A consists of 5 people, each of whom works together for 10 hours to build the widget. Group B consists of 10 people, each of whom works together for 2 hours to build the widget. Statistically speaking, the ratio of widgets built per people working is:

• 1 widget per 5 people for group A
• 1 widget per 10 people for group B

These statistics do not, however, tell whole story because if you really wanted to understand the amount of work each group did to build its widget, you would need to look at the number of man-hours that each group spent working:

• 1 widget per 50 man-hours for group A
• 1 widget per 20 man-hours for group B

In other words, the same information can appear very different depending on how one looks at it. Similarly if you want to evaluate the risk of ALCL in relation to breast implants, you would probably want to look at exposure to implants over time, not just at how many women have breast implants today.

How is ALCL Diagnosed

On January 26, 2011, the FDA posted new information guidelines on its website of diagnosis and reporting of breast implant-associated ALCL cases. These new guidelines include the recommendation that doctors send tissue (breast capsule and seroma fluid) for special testing if they suspect the possibility of ALCL. The recommended tests are tests that would probably not have been ordered on a regular basis, prior to the January 26, 2011 FDA report, for most women who had surgery for a seroma or capsular contracture after cosmetic breast augmentation. The FDA has requested that health care professionals report all confirmed cases of ALCL in women with breast implants to Medwatch, the FDA’s safety information and adverse event reporting program. Report online or by calling 800-332-1088.

Treatment and Prognosis for Breast Implant-Associated ALCL

Our understanding of the biology of breast implant-associated ALCL is also 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, the medical community has only extremely limited understanding of this disease. For example, 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; 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.”

Information About ALCL for Women with Breast Implants and Women Considering Breast Implants

Information on the FDA website indicates that the Agency will be working with breast implant manufacturers in the coming months to update their product labeling materials for patients and providers. For women who have breast implants, the FDA is currently suggests routine screening mammography and monitoring of your breast implants; contact your health care provider promptly to schedule an appointment if you notice any changes. If a woman is considering breast implant surgery, she should discuss the risks and benefits of the procedure with her doctor. FDA also has some helpful information on its website for consumers. At the time of this writing, the FDA has stated that, "Additional data is needed to fully understand the possible relationship between ALCL and breast implants" and that women with implants may have a very small, but increased risk of developing anaplastic large cell lymphoma, or ALCL.”