The Menaflex knee implant is a “C”-shaped piece of resorbable collagen-based material that is surgically implanted in the knee joint to replace damaged meniscal cartilage. It was approved for use in patients with medial meniscus (knee cartilage) damage.
The product was approved through the FDA’s streamlined 510(k) process which allows new medical devices to be approved based on comparison with other versions of similar devices. It must show the same safety and effectiveness. This streamlined process is meant to be used when a technological improvement is made in a medical device.
The FDA says the 510(k) process was inappropriate in this case because Menaflex is used for different purposes and is technologically dissimilar from other knee implant devices on the market. Other knee implants provide replacement or support for damaged tissue, Menaflex is intended to stimulate the growth of new tissue to replace the tissue that was surgically removed.
The device will remain on the market until the FDA officially rescinds its clearance or until ReGen voluntarily recalls the product. The FDA says that Menaflex can be reapproved after it goes through the regular testing and premarket approval process (PMA).
Those who have the Menaflex implant should speak to their physicians about safety concerns; however, the FDA does not believe that removal of the device is necessary.
Despite the FDA’s approval process, many medical devices don’t perform as intended. Injuries from defective medical devices can be debilitating and life-threatening. They may permanently affect a patient’s quality of life.
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