| Abstract: | The superheated debate over breast implants awakened a sleeping giant of an issue clouding "medical devices"--the government's clumsy nomenclature for any medical product that is not a drug, from breast implants and artificial hips to X-ray machines and surgical thread. Some 130 categories of high-risk devices are in use with little or no proof of safety, reliability or effectiveness. All appeared before 1976, the year that the Food and Drug Administration got the authority to regulate such products. Under activist chief David Kessler and with added clout from a 1990 law, the FDA plans to scrutinize the entire 130-item list. Five will get special attention starting early next year: saline-filled breast implants, inflatable penile implants, testicular implants, heart-bypass pumps and cranial stimulators. U.S. News has looked at all five devices, using FDA data obtained through the Freedom of Information Act. In-depth computer analysis suggested that penile implants deserve closer examination. Why is clear from the following report. |
