Those arguments are still resonating in the courts and in medical journals, although a major study conducted by the Institute of Medicine supports the view that the implants weren't linked to the illnesses. Meanwhile, saline-filled implants have been on the market for 30 years, long before the FDA had jurisdiction over devices. Since the mid-1990s, demand for them has been increasing to an estimated 130,000 patients per year in the U.S. Finally, safety studies involving some 9,000 women were enrolled and completed allowing the agency to reach its decision last week. Now the argument is shifting to the product's label, which guides surgeons on how to describe the risks and benefits to the patients. The FDA says drawings or pictures of bad outcomes will be shown to women prior to the operation.
Plastic surgeons are understandably unhappy with that idea.
Activists want patients to get explicit information. Individual states, not the FDA, must enforce that requirement. The FDA specifically approved the implants for women at least 18 years old, but some doctors at their discretion will probably put the devices in younger patients. No breast is worth your life. All rights reserved.