Medtronic Infuse Controversy, Lawsuits Gaining Steam

The controversy surrounding the safety of Medtronic’s Infuse bone growth product in spinal fusion and neck surgeries continues to grow.

Medtronic Inc. has actively worked to suppress evidence that Infuse (bone morphogenetic protein-2), especially when used for unapproved procedures, is responsible for myriad health problems, including a link to cancer. The medical device maker has spent tens of millions of dollars essentially buying evidence that supports the theory Infuse is a safe product.

The Minnesota-based medical device firm paid surgeons large sums of money to provide that research and when studies did show complications with Infuse, Medtronic worked to suppress that evidence.

This “research” has been widely published since Infuse reached the U.S. market in 2002. Until recently, purportedly medically-sound research has shown that Infuse was effective as a bone growth material. Its real-world results though, have proven otherwise and concern is growing among surgeons who aren’t on Medtronic’s payroll that Infuse is, in fact, dangerous.

The Spine Journal, a specialty medical journal, devoted an entire edition last year shedding light on the conflicts-of-interest surrounding Infuse, focusing on Medtronic’s financial influences on the clinical research available. Rarely, if ever, were financial disclosure statements accompanying studies appearing in medical journals – including one pro-Infuse study previously published by The Spine Journal – which showed the authors of a particular study were receiving large “royalties” payments for their work with the medical device maker.

The journal’s own research discovered that since the advent of Infuse on the market, surgeons have become more aggressive in treating common back and neck problems, often ordering surgeries when they weren’t always warranted, simply to use the product and collect fees for their use from Medtronic.

And while Medtronic had spent millions to promote its product, the real-world results were becoming more evident as use of Infuse. Though more and more research was published supporting its use, people who’ve had Infuse used in their surgery were experiencing something completely different. The Food and Drug Administration has received at least 280 reports of serious complications associated with use of Infuse.

A growing number of lawsuits against Medtronic have been filed recently accusing the company of hiding evidence of the dangers of Infuse. Lawsuits allege Infuse is responsible for unwanted bone growth in many recipients. Men claim Infuse has caused them to go sterile and some also believe Infuse is responsible for cancer.

As the evidence showing Infuse was purportedly safe, Medtronic began to push for off-label uses of the product, which is in violation of federal laws for medical device firms. The company began touting its effectiveness in neck surgeries but had no evidence to support this so they used the public as its for-profit clinical trial group. Typically to get any drug or device approved for another use, the company manufacturing it must conduct costly pre-market clinical trials to prove its effectiveness. Medtronic opted for another route and this has led to even more complications. Complaints associated with Infuse used in an off-label application, such as neck surgeries, are excessive swelling of the neck and throat, difficulty breathing and speaking, compression of the airway.