Medtronic Infuse Bone Graft Device Linked to Serious Injuries
Infuse Complication Symptoms:
- Swelling of the neck
- Difficulty swallowing, breathing and speaking
- Compression of the Airway
- Respiratory Depression
- Nerve damage
The Medtronic Infuse System was approved by the FDA in 2002 for one type of spine surgery – Anterior Approach Lumbar Fusion. It is estimated that approximately 100,000 people per year have had back and neck surgeries using the Infuse System. However, many of these people had neck, back and spinal surgeries for which the Infuse System was never approved. Unfortunately, serious complications have been associated with the Medtronic Infuse System, including: uncontrolled bone growth, male infertility, inflammatory cysts and cancer.
What is the Medtronic Infuse Bone Graft Device?
The Medtronic Infuse system consists of the LT-Cage which contains a grafting material derived from recombinant bone morphogenetic protein-2 (rhBMP-2). The system is used to stimulate bone growth for spinal surgery and is used instead of grafting bone from a patient’s hip.
According to a prominent medical journal, Medtronic may have downplayed the adverse events or complications associated with the Infuse Bone Graft system. The Journal looked back at previous studies and determined that the company may have underreported serious complications in patients who received the Infuse system. The company has also been accused of improperly marketing Infuse for unapproved (off-label) purpose. These allegations have promoted a congressional investigation.
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