Medtronic Inc., facing a mountain of lawsuits over complications patients reported from using the company’s Infuse Bone Graft, remains the leader in the bone graft market.

Patients have alleged using the Infuse Bone Graft for off-label purposes and as a direct result had suffered a variety of complications. Some of these complications include swollen airways, breathing difficulty, male sterility, extreme pain, and ectopic bone growth, among other side effects.

Many of these patients have filed Infuse Bone Graft lawsuits against Medtronic, alleging the company illegally marketed the product for off-label purposes, and misled patients to believe Infuse was safe to use for unspecified spinal surgeries.

The Infuse Bone Graft consists of a recombinant human bone morphogenetic protein (rhBMP), which is basically a genetically engineered protein. Ideally, this substance could be implanted into specific areas of the spine, which allows surgeons to have a certain amount of control over bone growth.

Bone grafts can substitute or replace damaged or diseased portions of the spine, which will eventually allow the patient to have normal spinal function again. The Infuse Bone Graft is used in approximately 100,000 spinal fusion surgeries a year in the United States, with sales going as high as $900 million in 2011.

Even with competitors like Stryker Corporation, Medtronic is on top of the bone graft market with a 44 percent of the total $1.9 billion market. This includes products such as allograft bone, cell-based matrices, bone substitutes, demineralized bone, along with 90 percent of the bone morphogenetic protein (BMP) market.

Overview of Infuse Bone Graft Complications

The problems associated with Medtronic’s Infuse are believed to stem as far back as 2003, not long after it was released in 2002, and was when the company started its aggressive marketing campaign.

During this period, Medtronic allegedly encouraged physicians to use the Infuse Bone Graft for off-label purposes, in cervical spine procedures most commonly. However, the Infuse was only approved by the FDA to treat certain lower lumbar procedures, such as degenerative disc disease and open tibia fractures.

When used according to the label, the Infuse Bone Graft proves to be an ideal alternative to highly invasive spinal surgeries, which would normally require bone marrow harvesting. However, when used in the cervical segment of the spine, the Infuse proteins reportedly cause unwanted bone growth of the spine, leading to severe injuries.

This problem had become so widespread that in July 2008, the FDA released an official public warning regarding Infuse Bone Graft complications. Specifically, the agency warned that these complications would most likely occur if Infuse is used in the cervical spinal area.

Many of these patients reported constricted airways, nerve damage, or had to undergo emergency treatment or surgeries. Additionally, the FDA noted that Infuse Bone Graft complications typically occurred two to 14 days after surgery.

While it is not illegal for doctors to prescribe medications or use devices for off-label purposes, it is illegal for a company to market them for those uses. There are thousands of Infuse Bone Graft lawsuits filed across the country by patients who suffered injuries due to using the product for off-label procedures the company allegedly promoted.