Women's Implant Information Network
This article was originally published in The Gray Sheet
Executive SummaryWrites FDA to object to an Aug. 4 Public Citizen Health Research Group's citizen's petition on the premarket approval of saline-filled breast implants. The HRG petition asked FDA to immediately call for premarket approval applications for the devices and to restrict use of the devices to controlled clinical trials until more safety data is gathered ("The Gray Sheet" Aug. 8, p. 7). WIIN criticizes the HRG petition's "blatant omission of recent peer-reviewed epidemiological studies that indicate no causal relationship between breast implants and disease" and says that "many" articles cited in the petition "are as much as 20 years old." The group asserts that "in the absence of adverse scientific studies, implants should be available to women regardless of motivation"
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