Discussion: U.S. Epidemiology of Breast Implant–Associated Anaplastic Large-Cell Lymphoma

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This article by Doren et al.2 marks a significant step toward understanding breast implant–associated anaplastic large cell lymphoma (ALCL). Since the first case was reported in 1997,3 the efforts to delineate the etiopathogenesis, epidemiology, risk factors and best pathways for diagnosis, clinical treatment, and outcomes have accelerated, and we have come a long way in a relatively short time. This is a testament to global research cooperation, as breast implant–associated ALCL remains a rare disease in the setting of great variation in implant type, surgical technique, craft group training, and geographic location worldwide. It is also clear that our capacity to detect complications following breast implant surgery is still nascent, with no regular surveillance of outcomes and, until recently, no coordination between device registries and regulatory reporting mechanisms.4 It is important that we move steadily and sensibly, backed by good scientific research and by responsible interpretation of these data. Anything to do with breast implants, however, does raise emotion and fear for the simple reason that a large majority of women undergo cosmetic augmentation for purely elective reasons. There are other factors, including the attention of regulators who are charged with protecting the general public, companies that have invested heavily in both technology and marketing these implants, and surgeons whose livelihoods are dependent on the procedure and/or working closely with industry at various levels of engagement.5
These factors, however, are completely subordinated by the imperative to protect the patient from undue risk and harm. History has taught us about what occurs when we ignore this imperative.6 What do we know so far about breast implant–associated ALCL?
This article now adds to the known facts—that textured implants are significantly associated with breast implant–associated ALCL. Even if a handful of pure smooth implant–exposed cases occur, the overwhelming risk with textured implants gives us direction in our research efforts to look at why textured implants pose a greater risk.
The unknowns include the following:
For the numerator, we need an accurate assessment of the number of cases of breast implant–associated ALCL. As no one has systematically collected this information, we have to rely on spontaneous case reports. With these, and analyzing them retrospectively, there is always the uncomfortable feeling that we are not capturing all cases or all the information. For a large country such as the United States, with many implanting practitioners, medical tourism, and large numbers of patients undergoing breast implant surgery, the number of missed and/or incorrect diagnoses, lack of a clear implant history, and duration of exposure impact significantly on the accuracy of the numerator.
Doren et al. chose to include 100 pathologically confirmed cases,2 but how close is this to the real numerator? What of the extra 70+ cases that have been reported but not verified? Even in these 100 cases, the implant type (whether texture or smooth) remained unknown in 49.2
There is also a wider issue of breast implant–associated ALCL diagnosis—do we include seroma-only disease as premalignant or malignant? This debate is ongoing and will certainly impact on the numerator.
As to the denominator, the ideal would be a prospective tracking of all textured implants that are placed in patients. The denominator would be both longitudinal implant-years and women-years at risk, with statistical adjustment for women with one versus two implants (i.e., reconstructive versus cosmetic cases) and women who had their implants removed for whatever indication and/or died as a result of other causes that are unrelated to implant surgery. We currently do not have these data and so we have to rely on sales data to estimate this number.

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