FDA warns against risks of lymphoma from breast implantsFebruary 7, 2019
Center for Devices and Radiological Health of US Food and Drug Administration on its continuing efforts to educate patients has warned that there are increased cases of lymphoma from breast implants reported recently. Binita Ashar, director of the Division of Surgical Devices at the Centre said in her recent statement that the agency has received a total of 660 total medical device reports regarding BIA-ALCL cases in the US since 2010. Of the 660 MDRs, our in-depth analysis suggests that there are 457 unique cases of BIA-ALCL, including 9 patient deaths, she added.
“I know there are many choices of breast implants available to patients, including the size, implant fill and surface texture. We want to provide patients with the most up-to-date information about the variety of breast implants available so that patients and providers can have thorough and thoughtful discussions weighing the benefits and risks of different products,” she said in the statement.
We also want to be transparent in sharing the information we regularly gather and analyze in a way that provides important context to help inform these discussions, she added.
The FDA, providing an update regarding the number of cases of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), a type of non-Hodgkin’s lymphoma and a known risk from breast implants, said that it was the first public health agency in the world to communicate about the risks of BIA-ALCL, warning women that the available information at the time indicated that there is a risk for women with breast implants for developing this disease in 2011.
“Since then, we have regularly updated the information available on our website regarding known BIA-ALCL cases, including deaths and known risks,” Ashar stated.
We hope that this information prompts providers and patients to have important, informed conversations about breast implants and the risk of BIA-ALCL. At the same time, we remain committed to working in partnership with all stakeholders to continue to study, understand and provide updates about this important public health issue.
The agency is now providing an updated number of medical device reports (MDRs), also known as adverse event reports. The information presented shows an increase of 246 new MDRs since last year. Given the agency’s continued efforts to communicate with stakeholders about BIA-ALCL risks and our work to encourage patients and providers to file MDRs with the agency, these types of increases in the MDRs are to be expected and may include past cases that were not previously reported to the FDA. “The increased number of MDRs contributes to our evolving understanding of BIA-ALCL and represents a more thorough and comprehensive analysis,” Asher said in her statement issued on February 6, Wednesday.