The Food and Drug Administration (FDA) announced it has received more reports of a rare breast cancer linked to breast implants, and it is making the information available so that patients can have the most up-to-date information about the variety of breast implants available so that they and their doctors can better weight the risks and benefits of various breast implants.
The FDA first alerted the public in 2011 about cases of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), a type of non-Hodgkin lymphoma, from breast implants. Since then, the agency has regularly updated the public as well as health care providers about known BIA-ALCL cases, including deaths and known risks.
The agency announced it had conducted a thorough analysis of adverse events and determined that, from 2019 through September 2018, it has received a total of 660 medical device reports (MDR) involving BIA-ALCL cases in the U.S., 457 of which appear to be unique cases (after it weeded out the duplicates). Among them were nine patient deaths.
“We understand that the information presented shows an increase of 246 new MDRs since last year,” said Dr. Binita Ashar, with the FDA’s Center for Devices and Radiological Health. “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.”
BIA-ALCL is a type of lymphoma and not a cancer of the breast tissue. When breast implants are placed in the body, they are inserted behind the breast tissue or under the chest muscle. In time, a fibrous scar called a capsule develops around the implant, separating it from the breast. AIB-ALCL is generally found adjacent to the implant and contained within the fibrous capsule.
As part of its announcement, the FDA also issued a Letter to Health Care Providers in an effort to increase awareness about the risk of BIA-ALCL in patients with breast implants, especially those with new swelling, lumps or pain around the breast implants. The agency also urged doctors to report to the any cases of BIA-ALCL to the FDA.
“Unfortunately, not every (previous) report provides thorough information about each case, including what type of breast implant (e.g. surface texture) the patient received, which 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,” Dr. Ashar said.
This risk with breast implants will also be discussed in more detail during a meeting of the General and Plastic Surgery Devices Panel at the FDA’s Headquarters in Silver Spring, Maryland, March 25-26, 2019.
FDA Letter to Health care Providers
FDA News Release
FDA – Breast Implants