The sale of breast implants associated with a rare type of cancer which targets the immune system, known as large cell lymphoma (BIA-ALCL), will continue to be allowed in the United States, the Food and Drug Administration (FDA) announced last week.
Allergan’s implants have already been banned in 38 countries. In the United States, more than 450 women in the United States have been diagnosed with the cancer, including nine who have died due to the disease. Worldwide, 17 have died.
"At this time, the FDA does not believe that, on the basis of all available data and information, the device meets the banning standard set forth in the Federal Food, Drug, and Cosmetic Act," the agency said in a statement.
Nonetheless, FDA will be requiring manufacturers to make changes to the labels of implants that could include a black box warning, the FDA’s strictest caution. They will also have to submit adverse event reports instead of the quarterly summary reports that are currently being presented.
“We are considering these actions to help to ensure that all women who consider breast implants have the information they need to have thoughtful and balanced discussions with their health care professional about both the benefits and risks of breast implants based on clear information reflecting the most current understanding of these issues,” the FDA said in a statement.
Besides BIA-ALCL, the agency said it was concerned about the risk of implant rupture and a condition called capsular contracture, in which the breasts become hard and misshapen, causing chronic pain, and an increase in immune system disorders.
"We have heard from patients concerned that their implants may be connected to health conditions involving their immune system's response to these devices, resulting in a variety of symptoms like chronic fatigue, cognitive issues, joint and muscle pain," the FDA said.
While acknowledging that there was no "definitive evidence demonstrating breast implants cause these symptoms," the agency said that the fact that many immune issues disappear when the implants are removed meant "women considering a breast implant should be aware of these risks."
Breast implant manufacturers will also face a significant change in how adverse events are reported, the FDA announced. In the past, manufacturers could provide a summary of any patients problems or concerns, but that method did not capture "unusual, unique or uncommon adverse events, which, in the case of breast implants, included BIA-ALCL," the FDA said.