Medtronic Infuse Bone Graft
Did you, or someone you love, undergo surgery to repair a spinal disc in your upper spine (cervical spine)? Did you receive an Infuse Bone Graft and suffer from severe side effects?
If so, you're not alone. The Infuse Bone Graft has been a controversial medical product since 2008. Thousands of people have reported serious problems. You may have a case if your life has been affected by this unsafe medical product. Our experienced attorneys at the Pennsylvania law firm of Edgar Snyder & Associates are ready to explain your legal rights and help get you justice.
Medtronic Gave False Information About Infuse Bone Graft Approval
The Infuse Bone Graft – manufactured by Medtronic – is used as a substitute to stimulate growth and help repair damaged spinal discs. The Food and Drug Administration (FDA) originally approved the medical product for limited purposes in 2002. However, the product has been widely used by doctors for off-label purposes (mainly for the upper spine instead of the lower spine), which now accounts for 85% of its use.
FDA Issues Warning
The FDA issued a warning in July 2008, after thousands of people reported suffering serious side effects when they received the grafts for off-label use. Complications included severe neck swelling that resulted in death or permanent injuries.
Then, in May 2009, officials discovered that a study promoting the use of the Infuse Bone Graft on severely injured soldiers contained false claims and overstated benefits.
Most recently, The Spine Journal questioned the information Medtronic used to get FDA approval for the product. According to the publication, surgeons funded by the company did not report serious complications from using the product, which include:
- Uncontrolled bone growth near the surgery site
- Neck swelling
- Difficulty breathing, speaking, or swallowing
- Respiratory problems
- Chronic arm and leg pain
- Male sterility, retrograde ejaculation (when semen is redirected to the urinary bladder instead of the urethra), or other urogenital (relating to the urinary and genital organs) injuries
- Nerve injuries
- And more
These complications occurred in 10-50% of patients who received the graft from 2000-2010. Over half a million patients have received the graft. Many patients needed respiratory support, feeding tubes, tracheotomies, and additional surgeries.