Medical device manufacturer Medtronic Inc. has been facing a growing number of Infuse Bone Graft lawsuits alleging that the spinal surgery bone graft is causing debilitating and permanent injuries. Medtronic Infuse patients are also accusing the product maker of intentionally concealing information regarding the dangerous side effects of the bone graft product.

According to the Department of Justice, Medtronic had been promoting the Infuse Bone Graft for off-label uses to be used for certain spinal surgeries since 2006.  Two whistleblower lawsuits had forced the company into a $40 million dollar settlement when the Department of Justice brought their investigation into the court. The product in question, Infuse, has been linked to infection, bone and nerve injury, sterility, urinary problems, and even the possible risk of cancer development.

The Medtronic Infuse Bone Graft is normally used during surgeries to stimulate bone growth and to replace damaged spinal disks.  It was marketed and sold as an alternative to harvesting bone particles from the hip for these spinal surgeries.  It is important to note that this product is not approved for any other use than for what it was approved for by the U.S. Food and Drug Administration.  The Medtronic Infuse Bone Graft was first approved in 2002 to be used in the lower back, and for some dental procedures.  This product is most commonly used to treat degenerative disc disease and to treat open fractures on the tibia.

The Department of Justice discovered that when Medtronic was encouraging physicians to use the Infuse bone graft for off-label purposes for cervical spine procedures that it generated over $3 billion in sales for the company.

The mechanism behind this device is that is contains a recombinant human Bone Morphogenetic Protein (rhRMP), which is a genetically engineered protein that is supposed to initiate growth in specific areas of the spine.  It is meant to give surgeons some control of where the bone regrows.

However, if used for off-label purposes this product can cause severe side effects which could compromise the health of patients.  These Infuse Bone Graft complications include, but are not limited to:

• Difficulty Breathing, Swallowing or Speaking
• Compression of the Airway
• Respiratory Depression
• Nerve Damage
• Death
• Swelling of the neck and throat
• Infection
• Bone injury
• Infertility
• Cyst formation
• Cancer

The FDA notes that most Medtronic Infuse complications typically occurs between two to 14 days following surgery with this device.

Overview of Medtronic Inc. Infuse Bone Graft Marketing

Medtronic Inc. is the largest medical device maker in the United States, providing products and services to millions of patients in the country.  Annually, more than 100,000 patients undergo spinal fusion surgery, in which the Infuse Bone Graft product is used. Unfortunately, many patients who received these bone grafts were using them for off-label purposes, as they were not aware that these products were not to be used outside of approved procedures. The company had allegedly promoted this product to surgeons for these off-label purposes, despite knowing the complications that could arise from them.

As a result, Medtronic is currently facing hundreds of Infuse Bone Graft lawsuits which accuse the manufacturer of deliberately concealing these complications.   The injuries reported include male infertility, bone and nerve damage, urinary problems, and even an increased risk of cancer.  A majority of the patients who were injured had used the product for cervical spine surgery.

Patients who were injured from these products are encouraged to seek legal representation, as they might be eligible for compensation.