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Medical Device Recruiters

FDA details spike in reports of breast implant-associated lymphomas

The FDA has seen a jump in the number of cases of a rare type of lymphoma linked to breast implants, which the agency says results from its efforts to educate stakeholders of the risks, as well as its work to encourage patients and providers to file reports.

The cases are related to breast implant-associated anaplastic large cell lymphoma, a type of non-Hodgkin’s lymphoma that can develop in the scar tissue surrounding an implant. The agency first alerted the public to the risks of the disease in 2011, and has been tracking known cases of BIA-ALCL, deaths and risk factors.

As of September 2018, the FDA has received 660 adverse event reports regarding cases in the U.S., linked to 457 unique cases of the disease and nine patient deaths, the agency said. The total represents an increase of 246 new reports compared to the year before.

Based on the agency’s education efforts, an agency official said these types of growth “are to be expected and may include past cases that were not previously reported to the FDA.”

“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,” Binita Ashar, M.D., director of CDRH’s Division of Surgical Devices, said in an agency statement.

While the FDA’s medical device reporting system allows patients, providers and manufacturers to each file their own reports, even if it’s about the same case, not every report captures thorough information—such as the type of breast implant, reasons for use and characteristics such as surface texture.

This “makes it 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 said.

For transparency, the agency provides a breakdown of the raw data it has collected on its website. The FDA also reviews medical literature and registry data from confirmed patients to get a bigger picture of the risks involved.

In addition, the agency issued a letter to providers, including primary care physicians and gynecologists, encouraging to learn about BIA-ALCL and its risks.

“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.”

Source: FierceBiotech