The agency went on to say it has been tracking the safety of breast implants since 1988, and was satisfied with the results from 6 postapproval studies following its brief moratorium on silicone implants in 2006.
Although the authors of the Annals study acknowledged that patient self-reporting can be sometimes be flawed, these reports could represent the proportion of patients who will seek further evaluation, which, they wrote, was more reflective of “what practically occurs.” In addition, they noted that another limitation of their analysis was that differences in the reporting protocols between Allergan and Mentor, the manufacturers at the heart of the study, made it impossible to compare the manufacturers (or the type of implant used — saline vs silicone) in a head-to-head manner.
FDA Press Officer Stephanie Caccomo wrote in an email to Cancer Therapy Advisor that the “Coroneos report highlights the need for better postmarket evidence generation, including active surveillance capabilities. This is why FDA has helped develop breast implant registries and is working with other partners to establish the National Evaluation System for Health Technology. In addition, for breast implants specifically, we have coordinated with the American Society of Plastic Surgeons and the Plastic Surgeons Foundation to develop the Patient Registry and Outcomes for Breast Implants and Anaplastic Large Cell Lymphoma (ALCL) Etiology and Epidemiology (PROFILE), which collects real world data regarding patients who have a confirmed diagnosis of BIA-ALCL.”
She added that the agency is also helping facilitate the development of the National Breast Implant Registry to provide a platform for evaluating real-world data on the safety and performance of breast implants.
“In light of the growing science regarding the benefits and risks of breast implants since our last advisory committee meeting in 2011, we intend to hold a public meeting of our Medical Devices Advisory Committee in 2019 to ensure that patients and healthcare providers continue to have accurate, scientific information about breast implant safety and effectiveness and to promote public dialogue on the currently available information,” Caccomo wrote.
- Coroneos CJ, Selber JC, Offodile AC, Buler CE, Clemens MW. US FDA breast implant postapproval studies: long-term outcomes in 99,993 patients [published online September 14, 2018]. Ann Surg. doi: 10.1097/SLA.0000000000002990
- US Food and Drug Administrstion. Statement from Binita Ashar, MD, of the FDA’s Center for Devices and Radiological Health on agency’s commitment to studying breast implant safety. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm620589.htm. Issued September 14, 2018. Accessed September 19, 2018.
- Balk EM, Earley A, Avendano EA, et al. Long-term health outcomes in women with silicone gel breast implants: a systematic review. Ann Intern Med. 2016;164:164-175.
- Ashar B. Assessing the risks of breast implants and FDA’s vision for the national breast registry [published September 13, 2018]. Ann Surg. doi: 10.1097/SLA.0000000000003052