The Medtronic Infuse bone-graft is a bioengineered bone-growth protein used in spine surgery. A recent study suggests that the Medtronic Infuse may increase patients’ risk of cancer. The already controversial Medtronic bone-grown products were criticized because the company promoted its off-label use, which often led to serious side effects. If you or a loved one received Medtronic Infuse bone-graft protein in a spine graft surgery and suffered from side effects or developed certain forms of cancer, speak to a Medtronic Infuse lawyer for a free case review. You may be entitled to compensation for your injuries.

Medtronic Infuse Bone Growth Cancer Link

In July 2011, Spine Journal dedicated an entire issue to studying the risks of the recombinant bone morphogenetic protein-2, or BMP-2, used in the Medtronic Infuse bone grafts. The study found that patients who received procedures using the Infuse more than doubled their cancer risk within one year of use. After three years, the cancer risk grew to nearly five-fold. The investigation from the journal also found that 13 Medtronic-funded studies downplayed or entirely omitted evidence of safety issues with the Medtronic Infuse. Surgeons paid tens of millions by Medtronic Inc., the product manufacturer, failed to report serious Medtronic Infuse complications, such as:

  • cancer;
  • sterility in men;
  • infections;
  • bone dissolution; and
  • worsened back and leg pain.

The study reported that complications occurred in 10 to 50 percent of patients who received the product in the 13 Medtronic backed trials between 2000 and 2010.

The study included both the low-dose form of the Medtronic Infuse currently on the market, and a high-dose version called the Amplify which was rejected by the U.S. Food and Drug Administration (“FDA”) because of its dangers. Dr. Eugene Carragee, a Stanford University School of Medicine professor and editor-in-chief of the Spine Journal and author of the June study, told Reuters that “almost certainly this is cancer promoting and not a carcinogenic.” Dr. Carragee said that Infuse was linked to a cancer diagnosis more often than when the product was not used at all, and the Amplify was tied to more cancer risk that the Infuse.

Medtronic Infuse Bone Graft Off-Label Use Led To Adverse Effects

In July 2008, the FDA issued a warning letter about potentially deadly side effects of rhBMP used in off-label cervical spine (neck) surgery. The Infuse was approved for use in some spinal fusion surgeries and dental procedures, but it was often used in off-label procedures that led to adverse effects. The FDA warning letter stated “that the safety and effectiveness of the rhBMP in the cervical spine have not been demonstrated and these products are not approved by the FDA for this use.”

At a 2008 spine conference, North Carolina surgeons reported on a study that found a complication rate of 59 percent in cervical spine, or off label surgeries using the Medtronic Infuse. Todd S. Jarosz, the Statesville, N.C., spine surgeon who wrote the study, told the Wall Street Journal that Infuse patients suffered a range of side effects including inflammation that required the installation of a feeding tube, and severe breathing problems that required a tracheotomy, which involves an incision and insertion of tube into the airway.

The FDA has received 280 reports of side effects involving the Infuse and about three-quarters of those reports involved off-label use.

The Medtronic Infuse off-label use side effects include:

  • compression of the airway, resulting in difficulty in breathing and swallowing;
  • respiratory depression;
  • nerve damage (causing pain and tingling in neck, legs, etc.); and
  • death.

Learn More About Medtronic Infuse Bone Graft Lawsuits

Our Medtronic Infuse lawyers are investigating cases on behalf of individuals who suffered from Medtronic side effects. If you or a loved one suffered serious side effects or developed cancer after receiving Medtronic Infuse bone graft during surgery, contact our firm immediately for a free case review by calling (877) 779-1414.

You may be entitled to compensation for your medical expenses, lost wages, and pain and suffering. The lawyers at Bernstein Liebhard LLP have extensive litigation experience and have recovered billions of dollars for their clients. In addition to being staunch advocates for your claim, our Medtronic Infuse lawyers also provide personal attention to guide you through the complex litigation process

Published August 28, 2012 by