FDA wants highest-level warning on breast implants
Hologic CEO Steve Macmillan on health care and how to screen for breast cancer.
The Food and Drug Administration is proposing a new warning label that would alert breast-implant patients to potential risks.
The agency -- which is publishing the proposal in the Federal Register, where the public can offer feedback -- wants to require a boxed notice, considered the most serious type, on marketing information given to people considering the procedure.
The move follows reports indicating a link between a rare form of cancer and a certain textured implant that was partially recalled. A number of patients had previously contacted the agency to complain of health problems believed to be associated with receiving implants, from arthritis to muscle pain and fatigue.
In March, experts told the FDA it was too soon to ban certain types of implants, asking for more research to determine risks posed to patients.
Some studies reported a rare form of lymphoma was discovered in scar tissue that develops around surgically-enhanced breasts, estimating that it occurred in as many as 1 in 3,000 women.
About 400,000 women get implants every year in the U.S., and about 100,000 of them elect to do so after cancer surgery.
While some experts argued pulling textured implants would be an “extraordinary overreaction,” not everyone agreed.
A representative for consumers believed the risk was high enough: “They need to be taken off the market.”
The FDA last pulled silicone gel implants shelves in 1992 amid concerns they could cause breast cancer and lupus. But after a number of studies were published, regulators allowed their use again in 2006.
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The Associated Press contributed to this report.