FDA said it has received reports of 457 unique cancer cases related to breast implants since 2010, including nine patient deaths.
The agency identified those unique cases from a total of 660 adverse event reports in the U.S. from 2010 through September 2018, including 246 new adverse event reports since 2017.
FDA began reporting on 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, in 2011. The new total of reports is larger than the number of unique cases because patients, providers, and manufacturers may all report an incident, resulting in duplicative reports.
The increase in reports may also be due to heightened FDA efforts to communicate BIA-ALCL risks, an increased understanding of this particular type of cancer, and a more thorough analysis of adverse event reports, according to the agency.
“It is crucial to understand that due to under-reporting and missing data, the FDA is unable to confirm whether this dataset reflects the distribution of all BIA-ALCL cases,” FDA said in a prepared statement.
“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,” added Binita Ashar, M.D., of FDA’s Center for Devices and Radiological Health (CDRH), in a separate 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…
“We hope that this information prompts providers and patients to have important, informed conversations about breast implants and the risk of BIA-ALCL,” continued Ashar, who is director of CDRH’sDivision of Surgical Devices. “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.”
Ashar also acknowledged the regulatory actions of FDA counterparts in different countries in response to reports of BIA-ALCL cases. Allergan (NYSE: AGN) removed its textured breast implants from the market in Europe in December, following a request from French regulators. The New York Times reported that the implants were linked to an uncommon form of lymphoma that can arise years after the implant is placed.
“The different devices approved in each country, availability of products, variation in market share, extent of medical device adverse event reporting, and availability of information regarding the total number of implants sold differs from country to country,” Ashar said. “This makes it difficult for the regulatory bodies of different countries to compare data and determine risk rates on a global scale…
“We recognize the limitations of medical device reports, which is why we review other sources of information, including medical literature and the Patient Registry and Outcomes for Breast Implants and Anaplastic Large Cell Lymphoma Etiology and Epidemiology (PROFILE).”
PROFILE collects real-world data regarding patients who have a confirmed diagnosis of BIA-ALCL.
FDA also said it is issuing a letter to healthcare providers to encourage those who regularly treat patients, including primary care physicians and gynecologists, to learn about BIA-ALCL in patients with breast implants. BIA-ALCL will be discussed at a public meeting of the FDA’s General and Plastic Surgery Devices Panel at its headquarters in Silver Spring, Md. on March 25-26.
At DeviceTalks Boston, Tyler Shultz will give attendees an inside look at Theranos and how he was able to sound the alarm after he realized the company was falling apart. Shultz will take attendees behind the story that everyone is talking about: the rise and fall of Elizabeth Holmes and her diagnostic company, Theranos.
Join Shultz and 1,000+ medical device professionals at the 8th annual DeviceTalks Boston.