The Medtronic Infuse system is a medical device used to stimulate bone growth for spinal surgery. It is used as an alternative to the more traditional approach of grafting bone from a patient’s hip. The system uses a grafting material derived from recombinant bone morphogenetic protein-2 (rhBMP-2).
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:
- Swelling of the neck
- Difficulty swallowing, breathing and speaking
- Compression of the Airway
- Respiratory Depression
- Uncontrolled bone growth
- Male infertility
- Inflammatory cyst
- Nerve damage
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.
If you or a loved one has had spinal or neck surgery and experienced serious complications, you may have valuable legal rights. You may be eligible to receive financial compensation for your past, present, and future medical bills, pain and suffering, and additional damages. To find out if you may have a case, contact the lawyers at Heygood, Orr & Pearson by calling toll-free at 1-877-446-9001, or by filling out our free online case evaluation form.