Hundreds of Infuse Bone Graft lawsuits allege that numerous patients have experienced Infuse complications after being implanted with this Medtronic Inc. medical device. Some of these serious Infuse side effects include male sterility, cancer, infection, and nerve pain.

The Infuse Bone Graft is a synthetic protein product that is primarily composed of rhBMP-2 (also known as recombinant human bone morphogenetic proteins), which are then mixed with bovine collagen and then injected into site of implantation.

In 2002, the FDA approved the Infuse Bone Graft to be used in spinal fusion surgeries. According to medical reports, it has been reported that Infuse Bone Graft has been used in over 100,000 spinal fusion surgeries every single year within the United States alone.

However, despite Infuse’s popularity, this bone graft product has been linked with a number of serious, severe, and even deadly complications. Additionally, many Infuse bone graft lawsuits claim that Medtronic paid off doctors to promote their products for approved and unapproved uses, as well as intentionally hid possible Infuse side effects and employed deceptive marketing practices to promote the Infuse bone graft.

Infuse Bone Graft Complication

Early Infuse clinical trials, including those trials reviewed by the FDA, reportedly demonstrated that Infuse has inflammatory properties that can irritate tissues and bones located near the site of injection. It was also found to have the ability to cause urinary problems and even increase the growth of cancer.

Some common Infuse Bone Graft side effects include:

• Inflammation
• Pain in the back and legs
• Radiculitis (pain that spreads through the spinal nerves)
• Implant displacement
• Retrograde ejaculation (when semen enters the bladder)
• Male sterility
• Cancer
• Infection
• Degeneration of bone tissue
• Ectopic bone formation (unwanted bone in the spinal canal)
• Death

Infuse Bone Graft Side Effects Studies

A 2011 Infuse Bone Graft review by Dr. Eugene Carragee and several colleagues, which was later published in The Spine Journal, allegedly found that a number of Infuse Bone Graft studies sponsored by Medtronic neglected to disclose all the possible Infuse side effects. This Infuse review also revealed that a number of researchers who had participated in these early Infuse side effects studies allegedly received anywhere from $1 million to $23 million per year in consulting fees from Medtronic.

Additionally, Dr. Carragee’s report found that Infuse bone graft complications are 10 to 50 percent more likely to occur than what was previously reported to doctors, patients, and the FDA.

In its Infuse bone graft marketing materials, Medtronic allegedly made claims that their product was superior to traditional bone grafts, since Infuse bone graft patients are not medically required to undergo a second surgery in order to harvest bone from the hip. This second bone harvesting surgery is generally associated with serious side effects; however, Dr. Carragee’s Infuse review allegedly found that the known Infuse complications held about the same or greater risks than hip bone harvesting.

Despite this Infuse study and the various cancer, pain, and other complications alleged in Infuse bone graft lawsuits, Medtronic continues to deny Infuse side effects claims.