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Medtronic Infuse Bone Graft Lawsuit

In 2002 the FDA approved the Infuse Bone Graft, created and manufactured by Medtronic Inc. This medical product was designed and used to promote bone growth in the lower spinal area, specifically for the lumbar spine. This product has been linked to signficant medical complications and deaths. Negative effects have been particularly prevalent when used for unintended purposes, such as for the upper spine and neck.

This claim was primarily raised due to reported Medtronic promotion of the Infuse Bone Graft in unapproved circumstances. The unapproved use of the Infuse Bone Graft has resulted in many of its users to have to undergo additional medical treatment or, in more serious cases, additional surgery. Put simply, medical device manufacturers may not promote their products for off-label use and when damages result from such promotion, liability arises.

The Infuse Bone Graft is made of a hollow metallic cylinder called the LT-Cage Device, and is infused with a genetically engineered product that promotes bone growth, called the Bone Morphogenetic Protein-2. The Infuse Bone Graft was approved by the FDA for one specific type of spinal surgery: anterior approach lumbar fusion surgery.

In 2008 the FDA issued an official health warning to medical providers stating that the many complications. Many of the reports received by the FDA indiciated physical complications, such as swelling of the throat or neck tissue. Many users also complained that it was difficult to breathe, swallow, and speak.

Other physical complications which may arise when the Infuse Bone Graft is used for unintended use:

  • Uncontrolled bone growth.
  • Mild to severe chronic pain.
  • Cancer
  • Sterility in males.

The Infuse Bone Graft can cause permanent, life threatening injuries. If you or a loved one has been injured as a result of using the Infuse Bone Graft, you may be entitled to compensation. For more information and a free case consultation, contact the Mass Injury Firm today at (866) 995-6663.

The information on this website is for general information purposes only. Nothing on this site should be taken as legal advice for any individual case or situation. This information is not intended to create, and receipt or viewing does not constitute, an attorney-client relationship.

Phone: (866) 995-6663
Address: 15 Court Square, Suite 800, Boston, MA 02108