Medtronic’s Infuse bone graft product could be linked to an increased risk of cancer, according to the findings of a new study.
As a result of research presented last week at the North American Spine Society, there is growing concerns over a potential risk of cancer from Medtronic Infuse, which contains rhBMP-2, a bioengineered bone growth protein
Researchers indicate that a higher-dose formulation of the Infuse, known as Amplify, has been linked to a significantly higher number of cancers than were found among those who received a traditional bone graft.
Patients implanted with rhBMP-2 were 2.5 times more likely to develop cancer within the next year than those who were not implanted with the bone growth product, according to the study’s findings. That risk increased fivefold after three years.
While researchers indicate that Infuse is probably not a carcinogen itself, if it is linked to a higher cancer risk, it is probably as a cancer promoter.
The study, which has not yet been published, was headed by Dr. Eugene Carragee, editor-in-chief of the Spine Journal and a professor at Stanford University School of Medicine. Carragee authored a report in June that found that 10% to 50% of Infuse recipients experienced complications during the clinical trials, including cancer, pain, infections and sterility. However, those problems were not mentioned in studies published by researchers with financial ties to Medtronic.
Medtronic Infuse is used to encourage bone growth and replace spinal disks by filling the gaps between vertebrae. It was approved by the FDA in 2002 and generated about $900 million in sales for Medtronic in the last fiscal year.
Suspicions about Infuse’s clinical trials have led to inquiries by Congress, and the company is under investigation by the Department of Justice for illegally marketing Infuse for off-label uses.
Scientists first began raising questions when they suspected a link between male sterility and Infuse, but medical researchers who received millions of dollars from Medtronic, claimed they could find no link. Some of those researchers later revealed that out of six cases of reported sterility noted during clinical trials, five of those were men treated with Infuse.
Besides fears of sterility and cancer, Medtronic Infuse side effects are also suspected of including serious and life-threatening complications caused by airway compression when used “off-label” in the cervical spine.
A number of patients have had to receive respiratory support tracheotomies, insertion of feeding tubes, anti-inflammatory medications and additional surgery after experiencing problems with Medtronic Infuse after a cervical spine surgery.
This has often been caused by swelling of the neck and led to an FDA warning to healthcare providers in July 2008 that highlighted at least 38 reports of cervical spine fusion problems with Infuse. Most of these Medtronic Infuse problems occurred within 2 to 14 days after surgery.