FDA identifies more cases of breast implant-associated lymphoma
The number of lymphoma cases linked to breast implants increased approximately 10% in the past year, according to the FDA.
The agency has identified 457 unique cases of breast implant-associated anaplastic large cell lymphoma (ALCL), including nine patient deaths, according to Binita Ashar, MD, director of the division of surgical devices in the agency’s Center for Devices and Radiological Health.
As of March 2018, the agency had identified 414 cases.
Breast implant-associated ALCL is a form of non-Hodgkin lymphoma known to be a risk of breast implants.
“One of the most important roles we have as a public health agency is educating patients and health care providers about both the benefits and risks of medical products, including breast implants,” Ashar said in the statement.
“There are many choices of breast implants available to patients, including the size, implant fill and surface texture,” Ashar added. “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. 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.”
The FDA also announced it is issuing a letter to health care providers — including gynecologists and primary care physicians — to learn about breast implant-associated ALCL.
“We want to ensure that all providers who treat patients with breast implants have information regarding identification, diagnosis and treatment,” Ashar said. “Patients are more likely to seek routine care from primary care physicians, gynecologists and others besides their treating plastic surgeon. By providing information to health care providers, we believe more providers will be empowered with information to assist patients who may have breast implant-associated ALCL.”
In 2011, the FDA became the first public health agency in the world to communicate about the risks for breast implant-associated ALCL. The agency has provided regular updates since then about confirmed cases, deaths and risks.
“We hope that this information prompts providers and patients to have important, informed conversations about breast implants and the risk of BIA-ALCL,” Ashar added. “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.”
Last year, the agency indicated it had received 414 total medical device reports about breast implant-associated ALCL cases in the United States since 2010. The number of reports received since 2010 now stands at 660, Ashar said.
Patients, providers and manufacturers each are allowed to file their own reports. This can lead to duplicate reports and explains why the number of reports exceeds the number of unique cases.
“Given the agency’s continued efforts to communicate with stakeholders about breast implant-associated ALCL risks and our work to encourage patients and providers to file medical device reports with the agency, these types of increases ... are to be expected and may include past cases that were not previously reported to the FDA,” Ashar said. “The increased number of medical device reports contributes to our evolving understanding of breast implant-associated ALCL and represents a more thorough and comprehensive analysis.”
The FDA previously announced it will hold a meeting March 25-26 to explore the risk-benefit profile of breast implants.