Infuse Bone Graft is a medical technique used to alleviate spinal problems by encouraging the natural process of bone formation. The Infuse Bone Graft is a two-part system where bovine collagen is used to create a framework for new bone tissue to form. The technique works by placing a human recombinant morphogenetic protein into a bovine collagen mold, or graft. In the bone graft, protein is released while replacing the degenerated bone tissue.
The Infuse Bone Graft was designed to be a replacement to the conventional idea of using donated material from the patient’s bones. This way, patients would be able to undergo a quicker bone graft surgery with minimized inconvenience, pain, and recovery time.
The manufacturer of the Infuse Bone Graft is Medtronic Inc. The company is currently involved in court trials regarding the safety of the Infuse Bone Graft. There have been allegations of corporate cover-ups regarding the potential side effects and health problems associated with the Infuse Bone Graft. These allegations revolve around what is known in the medical industry as “off-label usage.” Off-label use is when a prescription medication or medical device is utilized in a way that is not officially approved by the FDA.
Infuse Bone Graft Controversy
According to a study from The Journal of the American Medical Association (JAMA), there was a 15-fold increase in the number of spinal fusion surgeries from 2001 to 2007. This is a direct result of the Infuse Bone Graft, since doctors no longer needed to perform “bone harvest” surgeries before spinal fusion. However, Medtronic Inc. spent millions of dollars in consulting fees and royalty payments. Several officials believe this was an effort to suppress safety concerns from the Infuse Bone Graft.
The Infuse Bone Graft appears to be safe for use in lower back, or lumbar, surgery. In contrast, there were many complications reported from fusions involving the cervical spine, or vertebrae of the neck. This is considered an “off-label use,” since the Infuse Bone Graft is not federally approved for use in the cervical area of the spine.
Numerous injuries resulted from Medtronic illegally promoting off-label uses of the Infuse Bone Graft. As a result, the company faces a series of lawsuits. The simple issue was to have doctors disclose the risks of any non-approved off-label uses. However, any person to have developed complications as the result of the Infuse Bone Graft may be entitled to compensation.
Infuse Bone Graft Side Effects
Among other symptoms of the Infuse Bone Graft, the conditions developed can affect bones and muscles, heart and lung systems, and cause nervous system complications. The effects from the Infuse Bone Graft can affect areas near the surgery site or can cause other bodily harm.
Common side effects from the Infuse Bone Graft include:
- Chronic pain in arm or legs
- Abnormal or uncontrolled bone growth near the implant
- Male sterility due to retrograde ejaculation
- Pregnancy complications
- Uro-genital problems
- Difficulty breathing
- General discomfort
- Partial breakage and migration of implants
- Tissue damage
- Nerve damage
- Allergic reaction
- Excessive bleeding
- Vascular complications
- Tears in spinal cord tissue, or dura
Infuse Bone Graft Lawsuits
Medtronic agreed to pay $85 million as a settlement of a shareholder lawsuit. Accusations allege that Medtronic is guilty of making misleading statements about the Infuse Bone Graft. This illegal marketing strategy increased sales by approximately 85 percent. However, off-label uses that are not approved by the FDA cause serious complications to patients.
Cases of wrongful death, paralysis, and emergency room visits have solicited numerous class action lawsuits against the company. While disputed, the courts have ruled that medical device manufacturers who violate federal law and promote their for non-approved surgeries should be held accountable for any injuries innocent patients suffer as a result of such non-approved Infuse Bone Graft surgeries.