Dr Sidney Wolfe, chief of Public Citizen’s Health Research Group, called the implants “the most defective medical device ever approved by the FDA. The approval makes a mockery of the legal standard that requires ‘reasonable assurance of safety.’’
Amy Allina, programme director at the National Women’s Health Network, predicted the companies would begin a “massive, massive marketing campaign,” and women might be taken in by it and assume the FDA’s stamp of approval means implants are safe.
-STEPHANIE SAUL