Medical Companies are constantly looking to find the fastest and most effective way to cure patients while still managing to minimize harmful side effects. However, the immense pressure to get the product to market often causes these companies to take shortcuts. Medtronic, a medical device company that developed the “Infuse Bone Graft,” is learning this lesson the hard way.

What is an “Infuse Bone Graft”?

According to Medtronic’s website, an “Infuse Bone Graft” is a surgical procedure designed to stimulate bone growth. The procedure requires combining a genetically engineered protein that is naturally found in the human body, which regulates bone growth and healing, with a natural carrier for delivery. The natural carrier releases the protein over time and also provides a framework for new bone to grow into, where it is later absorbed and replaced by bone. An “Infuse Bone Graft” is beneficial because it eliminates the need for a painful pre-surgery harvest surgery that requires bone to be removed from a different part of your body (generally your hip) to help repair your bone fracture.

Has the FDA Issued any Warnings on the “Infuse Bone Graft” Procedure?

In 2008, six years after the FDA approved the “Infuse Bone Graft” for cervical procedures, the FDA issued a public health warning to practitioners. The warning pointed out of multiple life threatening side effects that accompany an “Infuse Bone Graft” procedure when used in the cervical spine. The warning mentioned over 30 documented cases of harmful side effects from the procedure. The side effects included swelling of the neck and throat tissue causing airway passages to become obstructed as well as nerve damage to the neck. In order to mitigate the risk and citing the lack of safety and effectiveness of these procedures the FDA recommended practitioners use alternative forms of treatment.

Did Medtronic Pay Off Doctors?

Today, U.S. Senators are questioning whether Medtronic paid doctors who lead clinical trials on the “Infuse Bone Graft” so they wouldn’t disclose side effects stemming from the procedure. The ramifications of this case could be enormous for Medtronic because they face both a strict products liability lawsuit as well as charges of fraud. In a fraud case Medtronic could potentially be subject topunitive damages.

 

What do you think? Does eliminating a painful harvest surgery outweigh the possible life-threatening complications of an “Infuse Bone Graft” in a cervical procedure? Should Medtronic be liable for punitive damages in a civil lawsuit if convicted of fraud?

 

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