The Food and Drug Administration (FDA) and its evaluation of new health products is under scrutiny after the agency admitted to an error that led to the approval of a potentially flawed medical device for injured knees.
On September 24, 2009, the FDA admitted the lapse in judgment, stating that they approved Menaflex knee patches, manufactured by ReGen Biologics Inc., despite scientific reviews that determined the device to be unsafe. Menaflex knee patches are collagen meniscus implants that generate new tissue growth in knee injury victims who have torn their meniscus.
Despite reports of frequent failure in the knee patch — failures that may necessitate secondary surgical procedures for users — agency managers overruled the reports after receiving inquiries by four New Jersey legislators who had received campaign contributions from ReGen Biologics Inc.
In light of the situation, the FDA has agreed to re-evaluate Menaflex knee patches, and has invited the Institute of Medicine to review the process of medical device approval.
Filing a Menaflex Knee Patch Lawsuit
Patients who have undergone knee surgery as a result of Menaflex knee patch failure should contact the attorneys of Aylstock, Witkin, Kreis and Overholtz to seek the compensation they deserve. Many patients who received the medical device required secondary procedures, severely interfering with their careers and social lives, as well as creating expensive medical bills. The attorneys of AWKO Law can help victims build a strong case against those liable to help victims earn compensation to offset the costs of medical bills, lost income, lost opportunities and pain and suffering. To learn more about filing a Menaflex lawsuit, contact AWKO Law at (888) 255-2956.