Not conclusive, but it gives competitors another talking point in their breaking into the InFuse market.
Bacterin's OsteoSponge for instance has demonstrated equal clinical efficacy to rhBMP-2 without the negative side effects of InFuse at 1/3 the cost. Stryker's Vitoss as a graft extender and OsteoSponge to fill the spinal fusion cage are a great combination in the effort to convert surgeons from InFuse.
Hospitals want to contain costs, Dr's want to stay away from controversial products and the inherent liability that goes with prescribing them.
Medtronic Infuse Bone-Growth Cancer Risks and Side Effects, Potential Lawsuits | Spinal Fusion Procedures, Bone Growth Product, Medtronic Amplify
Medtronic Inc's Infuse, a bioengineered bone-growth product used in spinal surgery, has been linked to a greater cancer risk than previously thought in patients treated with high doses of Medtronic's controversial protein, including pancreatic, breast and prostate cancers. Recent research has linked high doses of rhBMP-2, the bioengineered bone growth protein found in Infuse, to an increased cancer risk. Amplify, another Medtronic product that contained a higher dose of rhBMP-2, was rejected by U.S. regulators because of its association with cancer. However, it is known that doctors often use equally high doses of Medtronic Infuse off-label.
Parker Waichman Alonso's defective drug lawyers are actively investigating potential lawsuits on behalf of anyone who developed cancer after treatment with Medtronic Infuse. If you or someone you love developed cancer, especially breast, pancreatic or prostate cancer, following spinal fusion surgery with Medtronic Infuse, you may be entitled to compensation. Parker Waichman Alonso LLP offers free lawsuit evaluations to possible Medtronic Infuse cancer victims. We urge you to contact one of our experienced attorneys today to discuss your potential Medtronic Infuse cancer lawsuit by completing the form at right or calling us at 1-800-LAW-INFO (1-800-529-4636).
Types of cancer linked to Medtronic Infuse bone growth could include breast cancer, pancreatic cancer and prostate cancer.
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.