Breast implant victims suffering from a rare cancer and other debilitating ailments demanded action from the U.S. Food & Drug Administration (FDA) yesterday, during the first day of two-day meeting to address long-term health risks potentially associated with the popular devices.
“We do not feel we have been effectively and appropriately informed,” one attendee told a panel of FDA advisers.
“Don’t ignore us,” she demanded “We are real.”
An estimated 400,000 women receive silicone or saline breast implants in the United States every year. While the majority undergo cosmetic procedures to enlarge their breasts, roughly 100,000 get the implants during reconstructive procedures following mastectomy.
Although silicone breast implants first sparked safety concerns over a decade ago, it’s widely assumed the controversy has been put to rest. In actuality, however, tens of thousands of women have continued to report chronic fatigue, muscle pain, cognitive issues and other serious health problems after receiving the devices. Hundreds of others have developed anaplastic large cell lymphoma (ALCL), a rare cancer that occurs in the scar capsule that eventually develops around breast implants.
During yesterday’s FDA meeting, multiple breast implant victims said they were assured by their doctors that the devices were safe, and only received information on the routine risks associated with any surgery. In some cases, surgeons even failed to provide patients with informational pamphlets from manufacturers that described breast implant risks in more detail.
The women who spoke at the meeting asked manufactures to disclose the materials used in their breast implants, and called for a Black Box Warning on the devices. A few even urged the FDA to ban textured breast implants, which are most-closely associated with ALCL.
At least one FDA adviser was frustrated by the lack of good, long-term data for breast implants, as well as manufacturer failures to complete post-market studies mandated when the agency approved their devices.
“We have a surprisingly limited amount of clear and consistent data given the number of years and the number of women involved,” said patient representative Natalie Compagni Portis.
“I feel like we failed women with regard to implants,” she continued. We failed to inform, we failed to follow and we failed to listen.”
Only a few FDA advisers favored any sort of ban. However, a majority were supportive of efforts to identify factors that might make certain patients more vulnerable to breast implant illness and cancer.
Later today, the same panel will make recommendations for studying and defining the long-term risks associated with breast implants. While the FDA is not required to implement any of the recommendations made by its various advisory committees, it usually does so.