Serious Side Effect
A rise in the number of cases of a rare type of lymphoma linked to breast implants has been witnessed by the US Food and Drug Agency (FDA), according to an article by Conor Hale in Fierce Biotech. The FDA attributes the spike to the agency’s efforts to educate people about the risks of breast implants, in addition to its attempts to encourage both patients and providers to file reports.
The FDA says that the cases are related to breast implant-associated anaplastic large cell lymphoma, which is a form of non-Hodgkin’s lymphoma that can occur in the scar tissue that surrounds an implant. The FDA, which initially alerted the public to the risks of the disease in 2011, has been tracking known cases of BIA-ALCL, deaths and risk factors ever since then.
The agency has gotten 660 adverse event reports about cases in the U.S., linked to 457 unique cases of the lymphoma and nine patient deaths, as of September 2018, the FDA says. As compared to the year before, the total represents an increase of 246 new reports. Based on the FDA’s education efforts on encouraging reporting procedures, an FDA official believes that these types of growth “are to be expected and may include past cases that were not previously reported to the FDA.”
Binita Ashar, M.D., director of CDRH’s Division of Surgical Devices, adds, “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.”
Although the FDA’s medical device reporting system enables patients, providers and manufacturers to individually file reports about issues, even if it is about the same case, not every report captures thorough information. There could be additional details about such issues as the type of breast implant, reasons for use and characteristics such as surface texture. Thus it can be “more difficult to know if any particular breast implant characteristic is associated with BIA-ALCL or if higher reports of BIA-ALCL are simply due to higher implantation rate of a particular manufacturer,” Ashar explains.
To achieve transparency, the FDA offers a breakdown of the raw data it has collected on its website. Additionally, the agency reviews medical literature and registry data from confirmed patients in order to achieve a bigger picture of the risks involved. The FDA also issued a letter to providers, including primary care physicians and gynecologists, encouraging these doctors to learn more about BIA-ALCL and its risks.
Ashar summarized, “We want to ensure that all providers who treat patients with breast implants have information regarding identification, diagnosis and treatment. Patients are more likely to seek routine care from primary care physicians, gynecologists and others besides their treating plastic surgeon.”