The Infuse Bone Graft System is a type of medical implant designed to encourage bone growth. However, serious concerns about the safety of the Infuse Bone Graft System have come to light, as well as allegations that the device’s manufacturer, Medtronic, may have engaged in illegal sales practices.

What Is The Infuse Bone Graft System?

The Infuse Bone Graft System is a medical implant containing a metal support cage and a bioengineered gel. The bioengineered gel is designed to encourage the patient’s bone tissue to grow to repair fractures or build up bone. The metal cage is designed to support the bone during growth. Once the new bone has grown, the device is designed to become embedded in the growing bone, further strengthening it.

Medtronic’s Infuse Bone Graft System was originally designed for specific types spinal fusion surgeries. Spinal fusion surgeries are used to join two adjacent vertebrae when a spinal disc fails. Spinal discs are cushions of connective tissue that is designed to support individual backbones. Spinal discs can become damaged or weakened from age, injury, or illness. The standard treatment for severe damage to the spinal discs is to fuse the bones of the spine together to compensate for the failed disc. In older-style spinal fusions, redundant bone is harvested from elsewhere in the body.

The Infuse Bone Graft System is designed to allow doctors to skip this step by using bioengineered gel in the place of the bone. Along similar lines, the Infuse Bone Graft System has also been approved to treat certain other broken bones and for use in some dental and facial surgeries.

Study Confirms Spinal Surgery Popularity

A recent study, published in the Journal of the American Medical Association (JAMA), found that in 2006 roughly 25 percent of all spine fusion procedures involved a bioengineered bone-growth product, like Infuse, just four years after the breakthrough was approved by regulators.

The popularity of spine fusion surgery comes as no surprise — back pain is a leading cause of disability in the United States and is one of the most common reasons people go to the doctor.

These findings no doubt benefit Medtronic, which sells the bioengineered product called Infuse used in spine fusion procedures. Since it was approved by the U.S. Food and Drug Administration (FDA) in 2002, Infuse has proven to be a blockbuster device for the medical technology giant. Michigan-based Stryker Corp. makes a similar product, but Medtronic is by far the market leader.

While Medtronic does not publicize figures for individual products, sales of biologics (including Infuse) have topped $3.6 billion in the past five years. Its spine division, which also markets devices used in spine surgery, is its second-largest with $3.4 billion in annual revenue.

Infuse Lawsuits

Despite the popularity of the Infuse Bone Graft System, many Infuse lawsuits have been filed, alleging that the Infuse Bone Graft System could be dangerous. These Infuse lawsuits claim that the Infuse Bone Graft System can cause serious Infuse Bone Graft side effects, including the overgrowth of bones in the spine. Others have alleged that the Infuse Bone Graft System can cause male sterility, urinary problems, and possibly even an increased risk of cancer.

Medtronic has also allegedly marketed Infuse for off-label uses which has prompted investigations by the U.S. Department of Justice and Congress. Last summer, the FDA issued a warning to doctors about potential complications that could occur if Infuse is used in the neck, an off-label use that is not illegal, but can lead to swelling, hoarseness and difficulty breathing.