Menaflex™ Implant

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Menaflex™ Implant

The Menaflex™ knee implant is a device used to repair a torn or injured meniscus. Manufactured by New Jersey based Regen Biologics, Menaflex™ was allowed to be marketed by the U.S. Food and Drug Administration (FDA) despite skipping the rigorous testing usually required. It has been announced that the FDA is rescinding its approval. Tantamount to a recall, the rescission signals that the Menaflex™ knee implant may be defective and should have been tested thoroughly before it was implanted in patients.

The Menaflex™ Knee Implant

The Menaflex™ knee implant uses synthetic collagen to stimulate the growth of natural tissue in the body. After a tear to the meniscus of the knee, the Menaflex™ is sutured to the remaining meniscus. The meniscus has many different roles in the function of the knee. As with all cartilage it serves as a buffer between different bones. It also contributes to stability of the knee and lubricates the joint.

After implantation the Menaflex™ creates a scaffold supporting the knee, which acts like a cushion as the knee heals. During this healing process the collagen of the Menaflex™ knee implant is absorbed by the body, and replaced by natural meniscus tissue. This regrowth of tissue is what differentiates the Menaflex™ from other knee implants.

Despite this, Regen was initially able to get the Menaflex™ knee implant approved by using the 501(k) exception to skirt FDA testing procedures. The exceptions are granted to products that are so similar to existing products that testing should not be required. In the case of the Menaflex™ knee it was found that Congressmen, lobbyists, and the FDA commissioner pushed the knee implant through despite objections from FDA scientists.

Menaflex™ Knee Implants

Ignoring the innovative nature of Menaflex™, the FDA allowed Regen to avoid testing the product, claiming it was functionally equivalent to other devices on the market. It was later revealed by the FDA that this exempted approval of the knee implant was allowed because of political pressure from lobbyists and Congressmen being influenced by Regen.

According to reports, the Menaflex™ knee implant has had a high failure rate in its recipients, which require revision surgeries. These defects were recognized by the FDA's own scientists before politics overpowered science.

If you are a Menaflex™ recipient, you may be at risk of complications. If you experience intense pain because of the knee implant, you should contact your doctor. If you experience failure of the device and require a second surgery, our Menaflex™ implant attorneys may be able to help you seek compensation for your injuries and loss. For more information, please contact us today.

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