FDA declines to ban breast implant that's linked to cancer but intends to increase information about risks
The FDA has decided not to ban a type of breast implant linked to a rare cancer — at least for now.
According to a story by Laurie McKinley in last week's editions of The Washington Post, the decision, which came a month after a dramatic hearing in which many women expressed fears, complained about the implants and called on the Food and Drug Administration to execute such a ban, the agency plans instead to "increase efforts to collect and disseminate information about risks involving the device."
A joint statement by Amy Abernethy, FDA principal deputy commissioner, and Jeff Shuren, director of the agency's Center for Devices and Radiological Health, maintains that the FDA doesn't believe the textured implant "meets the legal standard for being banned at this time, based on available data and information."
Other countries have either banned or restricted sales of similar products "because of concerns about what's called breast implant-associated anapestic large cell lymphoma, or BIA-ALCL," McKinley's story contends.
The FDA also notes that "while textured implants make up as much as 80 percent of the market share in some other countries, they represent only 10 percent or less of the implants sold in this country," the Post article continues.
Federal officials also say they don't have "definitive evidence" demonstrating that the implants cause "'breast implant illness,' a constellation of auto-immune problems that includes joint and muscle pain and allergies and fatigue — a topic that was repeatedly raised at the March hearing." But they do add, according to McKinley's piece, that evidence supports "that some women experience systemic symptoms that may resolve when their breast implants are removed."
|Diana Zukerman, PhD|
Historically, the agency tends to be reluctant to ban devices — having done so only twice, with powdered surgeons' gloves and prosthetic hair fibers.
The FDA has, however, "said it is considering requiring implants to carry what's called a boxed warning — the agency's strongest safety warning. And it may require doctors and patients to sign checklists of risks to make sure women have the necessary information to make an informed decision."
McKinley's story states that "bout 400,000 women a year get implants in the United States — 75 percent for cosmetic reasons and most of the rest for breast reconstruction about cancer surgery."
For more information on implants and reconstruction, check out "Rollercoaster: How a man can survive his partner's breast cancer," a VitalityPress book I, Woody Weingarten, aimed at male caregivers.