Claims the Food and Drug Administration negligently approved a knee implant at the urging on Congress members instead of scientific evidence in 2008 is causing the department to remove the device from the market.
Menaflex Collagen Scaffold hip device was approved on a fast-track by the FDA in December 2008 based on the fact that the technology is similar to devices already on the market. FDA scientists, however, wanted a full review of its effectiveness and safety. After the device was passed, the scientists complained to Sen. Charles E. Grassley, R-Iowa, that the approval process was an example in which politics won over scientific decision-making.
Four New Jersey Democrats - Sens. Frank R. Lautenberg and Robert Menendez and Reps. Steven R. Rothman and Frank Pallone Jr. - lobbied FDA administrators on behalf of ReGen, according to news reports .
As a North Charleston personal injury lawyer , it's frustrating to think that politics wins over safety sometimes. It is good, however, that the FDA is admitting errors rather than ignoring them and potentially having a defective product implanted in other patients.
Menaflex has been used in approximately 3,000 European patients over nearly 10 years and implanted in about 50 patients in the United States. The FDA said it was unlikely people using the device would need to have it removed, but recommended they check with doctors.