Angry women, anxious that officials were failing to protect their health, besieged a federal Food and Drug Administration hearing in the spring. That unusual outcry may have helped push regulators off their bureaucratic backsides, getting them finally to warn about risks of one of the most commonly used medical devices for women: breast implants.
But will a similar gender uprising be required to quash a rising and dubious medical testing of women, the so-called “3D mammogram?”
The FDA’s sudden, fast stepping on breast implants is occurring after years of inaction. Under new rules proposed by the agency, the devices’ packaging would be required to carry “boxed warnings,” the FDA’s most serious caution. The agency also would call on surgeons to step up their discussions with women about implant risks, including for rare cancers. As the Washington Post reported, doctors also would be told to tell patients: