Discussion: Global Adverse Event Reports of Breast Implant–Associated ALCL

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Excerpt

In January of 2016, when the U.S. Food and Drug Administration updated its warning on the association between breast implant–associated anaplastic large-cell lymphoma (ALCL) and implants, the report contained 258 adverse event reports. This was the highest reported number of cases since 2014, when Brody et al. reported breast implant–associated ALCL occurring in 173 cases after reviewing the world literature.1 Other meta-analyses have been conducted to elucidate the incidence and cause of breast implant–associated ALCL, but have been limited by duplicate case reports and a lack of detailed clinical information.2–4 This has ultimately resulted in a large variation in the number of reported cases, making it virtually impossible to answer the question, “How common is breast implant–associated ALCL?”
In “Global Adverse Event Reports of Breast Implant–Associated ALCL: An International Review of 40 Government Authority Databases,” Dr. Clemens et al. searched the U.S. Food and Drug Administration’s Manufacturer and User Facility Device Experience database, which collects adverse events of medical devices, and other equivalent international databases to evaluate the ability of a federally managed database to capture the incidence and treatment of breast implant–associated ALCL.
The findings of this study highlight a number of shortcomings in the reporting of these databases in accurately assessing the true epidemiology of the disease. However, these shortcomings are not those of the database, as any collection of statistics is only as strong as those that are providing the data. Given the results of this study, a number of conclusions as to reporting of breast implant–associated ALCL can be drawn, as follows.
There are inconsistencies among reports from those that fall into the category of “mandatory reporters” and those that are classified as “voluntary reporters,” which result in a high proportion of duplicate entries. In this study, of the 459 entries included in the initial search result of the Manufacturer and User Facility Device Experience database, 190 (41 percent) were duplicates submitted by different sources with different accounts of the events. Although duplicates were omitted in this study, it appears that some of these omissions were caused by a lack of specific details and inconsistencies in data reporting when it comes to revision surgery. Also, details of the clinical history are often omitted or not reported, as is evidenced by the 115 cases (44.6 percent) of the implant surface being reported as unknown or not reported. Therefore, we will benefit from a standardized way of reporting cases of breast implant–associated ALCL, which would include a specific set of criteria by which we can report the event and include pertinent data specific to the individual case itself.
There are also inconsistencies in the diagnosis of breast implant–associated ALCL. In the current study, of the 258 unique cases of breast implant–associated ALCL, 128 cases (49.6 percent) were not confirmed with pathologic markers. These data are not unlike a recent study that queried board-certified U.S. and international plastic surgeons as to the management of a late seroma, in which only 34.6 percent of surgeons send fluid for specialized cytologic analysis to include CD30 and anaplastic lymphoma kinase-1.5
Finally, although there appears to be a consensus that the treatment of breast implant–associated ALCL should include explantation, treatments in this study were described in only 136 cases (52.7 percent). Treatment of breast implant–associated ALCL, beyond explantation and total capsulectomy, seems to remain a large area of dissention among oncologists.
Dr. Clemens should be commended for his continued commitment to elucidating the epidemiology, diagnosis, and treatment of breast implant–associated ALCL. However, it is clear that many plastic surgeons are falling short in all of these areas.
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