Given the fact that this has happened what has been put in place to prevent this from happening again?

“The agency’s scientific reviewers repeatedly and unanimously over many years decided that the device, known as Menaflex and manufactured by ReGen Biologics Inc., was unsafe because the device often failed, forcing patients to get another operation.

But after receiving what an F.D.A. report described as “extreme,” “unusual” and persistent pressure from four Democrats from New Jersey — Senators Robert Menendez and Frank R. Lautenberg and Representatives Frank Pallone Jr. and Steven R. Rothman — agency managers overruled the scientists and approved the device for sale in December.”
http://www.nytimes.com/2009/09/25/health/policy/25knee.html?pagewanted=1&_r=1&hp
September 24, 2009

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