Probe Pressure Over Knee Implant
Fortunately, it appears the hundreds of patients in the United States and Europe who have had Menaflex hip implant surgery since 2008 will suffer no long-term ill effects. But it appears they will not benefit from the implants, either, according to the Food and Drug Administration.
FDA officials admitted last week they approved sale of the Menaflex implants, intended to reinforce damaged knee tissue, despite protests from scientists in the agency.
The decision to go ahead - again, over the protests of FDA scientists - was made as a result of outside pressure, the agency admits. Some of the lobbying was by four members of Congress from New Jersey, where ReGen Biologics, the Menaflex manufacturer, is located.
Menaflex is being taken off the market, the FDA announced. The devices are intended to be absorbed by the body, so patients should not be harmed.
But, again, they received no benefit from the implants, either, according to the FDA.
Congress should investigate the fiasco - with special attention to lawmakers who improperly pressured the FDA. Americans are entitled to be able to rely on the agency for scientific evaluation of food, drugs and medical devices.
Oct 22, 2010