Medtronic INFUSE Bone Graft Injury
Has a Medtronic INFUSE Bone Graft Injured You?
For over a decade, the Medtronic INFUSE bone graft has been popular for promoting bone growth after surgery. The INFUSE bone graft was approved by the Food and Drug Administration (FDA) in 2002 for certain spinal surgeries. Later, in 2004, it was approved for tibia repairs, and in 2007 for dental procedures. Once thought to be a game changer for bone surgeries, many lawsuits have been filed alleging injury from the INFUSE bone graft.
How Does the INFUSE Bone Graft Work?
The INFUSE bone graft contains a synthetic liquid protein that encourages bone growth. The bio-engineered protein is surgically implanted between vertebrae during spinal surgeries.
The INFUSE graft was developed as an alternative to traditional bone graft procedures. During a traditional procedure, real bone is harvested from other parts of the patient’s body, like their hips, or bone is used from a cadaver.
Complications of the INFUSE Bone Graft
While the Medtronic INFUSE bone graft was approved by the FDA for use on the lower spine, Medtronic is accused of marketing their product for “off-label ”uses. “Off-label” is the unapproved use of a pharmaceutical product. It’s generally legal for a doctor to prescribe a drug for an off-label use, but it’s illegal for a drug company to market their product for an off-label use.
Medtronic is accused of promoting their bone protein for unapproved, off-label uses in the upper back. When used in unapproved settings, complications can include:
- Excessive bone growth
- Retrograde ejaculation
- Back and leg pain
- Swelling in the next and throat
- Airway compression
- Male sterility
Can I Seek Legal Action?
Roberts & Roberts urges you to get a thorough legal evaluation if you have experienced complications from the Medtronic INFUSE bone graft. Thousands of patients have considered filing claims against the company for hiding adverse effects of the product and promoting unapproved uses of the bone graft. If you’ve experienced painful side effects from the INFUSE bone graft, you might be eligible to receive compensation for medical expenses, lost wages and punitive damages. Roberts and Roberts is offering legal consultations to persons injured by the Medtronic INFUSE bone graft. To learn more about the legal options available to you, please contact us.