Medtronic Inc.’s Infuse bone graft system, the target of numerous Infuse bone graft lawsuits, is not superior to traditional bone grafts and, in fact, carries risks of serious side effects, according to a new study published in the Annals of Internal Medicine.

Because the Infuse bone graft synthetic protein can be injected directly into the operation site, it is typically less invasive that traditional bone grafts, and thus very appealing to doctors and consumers. Research analyst Joanne Wuensch told Bloomberg Businessweek: “[Infuse] became like the magic sprinkle powder in orthopedic and spinal surgeries[before 2009], and other operations throughout the body.”

However, two independent medical reviews of the Medtronic product have linked its use in spinal fusion surgeries with increased patient risk of male sterility, cancer, and secondary infections. Medtronic Inc. is a Minneapolis-based medical device and therapy manufacturer and distributor. It is currently the biggest maker of spinal treatments in the world and generated $528 million in Infuse bone graft sales worldwide during the 2013-14 sales year.

Even after facing numerous Infuse class action lawsuits documenting serious bone graft complications among patients, Medtronic continues to sell the spinal fusion and bone graft product. Despite bad publicity, negative medical reports, and an initial drop in its stock price, Medtronic Infuse sales are up and continue to grow.

But the Infuse lawsuits hang over Medtronic, which recently settled a $22 million product liability lawsuit with more than 950 individual Class Members last month. Additionally, Humana Inc. has filed a lawsuit against Medtronic for selling the company thousands of Infuse products that it had claimed to be both effective and safe.

Background  on Infuse Bone Graft

Medtronic’s Infuse bone graft system is used in many surgical situations, but is largely used by surgeons in spinal fusion surgeries. Infuse is comprised of synthetic proteins mixed with bovine collagen meant to replace bone matter in damaged joints and bones. In the case of spinal fusion surgery, the Infuse product is directly injected into a spinal injury, and is supposed to alleviate pain and encourage bone growth in the damaged area.

More than 100,000 patients a year have received a Medtronic Infuse bone graft treatment since it received approval from the U.S. Food and Drug Administration in 2002. Because of its popularity and strategic marketing, Medtronic now controls 40 percent of all bone graft sales worldwide.

Infuse class action lawsuits say Medtronic Inc. neglected to inform physicians and patients of all the risks associated with the Infuse product. Infuse bone graft side effects include:

• Infection
• Male sterility
• Bone and nerve damage
• Urinary problems
• Increased risk of cancer