Discussion: A Prospective Approach to Inform and Treat 1340 Patients at Risk for BIA-ALCL.

W improved awareness among plastic surgeons, creation of the Patient Registry and Outcomes for Breast Implants and Anaplastic Large Cell Lymphoma Etiology and Epidemiology registry with assistance of the Plastic Surgery Foundation, the American Society of Plastic Surgeons, and the U.S. Food and Drug Administration, the incidence of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) continues to rise. As of November 2, 2018, there were 255 identifiable cases in the United States and 615 worldwide, with 16 worldwide deaths, including five in the United States.1,2 The current lifetime risk of BIA-ALCL conveyed from epidemiologic data and implant sales data from several countries ranges from one in 1000 to one in 30,000 patients with textured implants.2 It is important to emphasize that prognosis for these patients remains excellent after removal of implants and surrounding local scar tissue and capsule, that BIA-ALCL is still a rare disease, and there continues to be an ongoing significant investigative effort by various agencies, worldwide task forces, and plastic surgery societies to keep us all continuously apprised. It is in the overshadowing context of our medicolegal environment that the article presented by the authors becomes a potential relevant source of how an institution handled patient education and management decisions about the disease. In this article, Dr. Roberts et al.3 present their comprehensive, medicolegally driven, single-institutional approach undertaken as an internal quality improvement project to educate their patients (about BIA-ALCL) who underwent placement of breast implants (both smooth and textured) at their institution from 1979 to 2017. As stated in the title of their article, their objective was to “inform and treat 1340 patients at risk for BIA-ALCL,” even though no patients who had placement of implants from their institution were identified as having the disease. Their comprehensive protocol was a tour de force involving a multidisciplinary team of nurses, institutional staff, several medical departments, and financial assistance staff. They went to extreme lengths to ensure no stone remained unturned, beginning with early involvement and guidance from risk management. Their approach was as if plaintiff’s attorneys would design the project themselves so that they could not hold the defendant liable in neglecting any aspect of the care of the patient with potential for BIA-ALCL. In contrast to perhaps many plastic surgeons who may follow up with patients routinely during clinic visits knowing that patients are notoriously poorly followed when all is well, the authors are to be commended on taking the “bull by its horns” and proactively approaching patients on an entirely opposite spectrum with the support from risk management, sending out two separate certified letters, one to patients who have had even an exposure to textured implants and another to smooth implant patients. Even according to them, their follow-up of 47 days following letter distribution yielded a low response rate, with only 6.4 percent following up after receipt of their letter, and ultimately resulting in 100 patients being seen, 16 of whom had textured implants, and nine of whom subsequently underwent prophylactic surgery for removal or replacement with a smooth implant. This overall low response and action rate further highlight that, despite this aggressive approach, nothing is foolproof. This indicates that adopting such an approach by other centers may be excessive and it may not apply to all practices and surgeons. Depending on the type of practice, if one is to adopt the authors’ exhaustive approach, the