Reply: Global Adverse Event Reports of Breast Implant-Associated ALCL
The search criteria for the article was to include adverse event reports from government authorities. Although not part of our study, we are aware from the ASPS ALCL Global Network of 460 unique confirmed cases reported to us that include cases in Argentina, Brazil, Chile, Colombia, and Mexico, as well as 16 disease related deaths worldwide. Confirmed cases of this disease are now reported in 24 countries. This discrepancy between government adverse event reports versus confirmed cases we are aware of was both concerning and a call to action. The Scientific Committee on Health Environmental and Emerging Risks (SCHEER) recently reviewed this disease and mirrored our findings, stressing the critical need for reporting to prospective registries.6 The U.S. Food and Drug Administration describes the shortcomings of its own MAUDE adverse event database as potentially “incomplete, inaccurate, untimely, unverified, and/or biased data.” Because of this, the U.S. Food and Drug Administration collaborates with the American Society of Plastic Surgeons Patient Registry and Outcomes for Breast Implants and ALCL Etiology and Epidemiology (PROFILE) registry (www.thepsf.org/PROFILE) since 2012 and currently reports 184 unique U.S. cases. Discrepancy between adverse event reports and confirmed cases demonstrates the vital need for physician reporting to PROFILE, a much more reliable and detailed patient registry. Several countries have created model registries by establishing close working relationships between plastic surgery societies and government authorities, creating a nearly identical number of known cases and government reporting. This is seen in Australia, France, Italy, The Netherlands, Sweden, and the United Kingdom. It is no coincidence that these countries also have the highest numbers of known cases, demonstrating the consequences of well-organized registries, inclusive collaborations with frequent communication, and recognized local academic centers focused on the study of this disease.
Dr. Palafox is right to ask why Latin American cases are not proportionally reported. Consider that Brazil and Mexico represent the second and third largest textured breast implant markets in the world, respectively, but have so few reported cases compared to countries with less implant sales. I am optimistic and confident that Latin American countries are currently at an inflection point in the study of ALCL. Many plastic surgery and mastology societies have recently placed a priority on physician education, as evidenced by ALCL discussion panels at national society meetings in Argentina, Mexico, Brazil, Venezuela, Colombia, and Chile. Consensus recommendations were established at the recent Mexican Association of Plastic, Reconstructive and Aesthetic Surgeons meeting in Cancun between Mexico and South American plastic surgery societies. This meeting led to informational resources on seroma screening and pathologic investigation that is now available to all society members at cirugiaplastica.mx.
This past year American Society of Plastic Surgeons created an ALCL global network of 27 countries (and growing), with members chosen by national societies to facilitate cross-country data exchange and disbursement of disease updates.