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Menaflex™ knee implants are orthopedic devices manufactured by Regen Biologics. The implants were fast tracked by the U.S. Food and Drug Administration (FDA) as part of the fast 501(k) track program, which allowed them to avoid appropriate testing.

This period of testing is where problems with Menaflex™ knee implants would have normally been discovered. According to reports, the FDA allowed the knee implants to be a part of the fast track program because of political pressures.

If you have experienced problems with your Menaflex™ knee implant, contact our attorneys for help. You may be eligible for financial compensation for your injuries and loss.

Menaflex™ History

Menaflex™ knee implants use synthetic collagen to stimulate growth in a torn or injured knee meniscus. The meniscus is critical to the proper function of the knee. It not only functions as a buffer between bones, but also gives the knee shock absorption, stability and lubrication.

The FDA first approved Menaflex™ knee implants in 2008 as part of the fast 501(k) track program. This meant that they were so similar to devices already on the market that they did not need extensive testing.

According to reports, however, scientific reviewers said Menaflex™ knee implants should not be put on the market because they were not safe for use. Despite this, the FDA commissioner allowed the device to be approved. It turns out that the device was not similar to other devices on the market, and that the fears of the scientists were well founded.

The FDA admitted that pressures brought to bear by politicians were responsible for the approval, and rescinded market clearance of the Menaflex™ knee implants. After rescinding approval, the FDA prohibits the manufacturer from further U.S. marketing.

Menaflex™ Problems

A med cal study found Menaflex™ knee implants were not firmly attached in 16 percent of the recipients. Studies have also found that between 9 and 19 percent of patients require revision surgery due to premature failures. When a patient requires revision surgery, he or she will likely experience a decreased quality of life due to decreased mobility and severe pain in the implant area.

Contact a Menaflex™ Knee Implant Attorney

If you are experiencing problems with a Menaflex™ knee implant, you should contact one of our Menaflex™ implant attorneys for qualified legal help. You will likely qualify to seek a financial recovery for the cost of revision surgery, lost wages during the recovery process, as well as the pain and suffering you are forced to endure.

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