Infuse, the artificial bone graft product that has become controversial due to safety issues, continues to pose legal problems for Medtronic. An article published by MedPage Today reports on the product and explores apparent oversight and gaps in regulation that may have contributed to problems for infuse patients. According to a Journal Sentinel/MedPage Today analysis of U.S. Food and Drug Administration (FDA) data, there have been over 6,500 reports of adverse events related to Infuse since it was approved in 2002. Approximately half of those adverse event reports were filed last year alone.
The FDA approved Infuse for a specific type of spinal fusion surgery in 2002. It was approved as a combination product, including both a drug and a device. According to a Journal Sentinel/MedPage Today investigation, the FDA approved Infuse with less testing compared to other combination products despite safety concerns that were raised prior to its approval. It is an expensive product, raising a typical hospital charge by more than $13,000 per patient between 2002 and 2008, a paper published in Spine Journal found.
Bradley Weiner, MD, chief of spinal surgery at the Methodist Hospital in Houston, said “It appears the clinical trials, unfortunately, were not designed to adequately test for safety of the product… We only learned of the harms as they emerged over time.” According to MedPage Today, only 277 patients were tested in the clinical trials for Infuse. Typically, clinical trials for new biologic agents requires between 1,000 and 3,000 people.
In June 2011, the Spine Journal dedicated an entire issue to reprimanding Infuse, reporting that complications were 10 to 50 times more frequent than reported in Medtronic-funded studies. The doctors who authored the Infuse papers received millions in royalties from Infuse. Reported complications with Infuse include an increased risk of cancer, retrograde ejaculation leading to male sterility and excess bone growth, which is mentioned in a number of lawsuits.
Research shows that Infuse is used “off-label” up to 80 percent of the time. In 2008, the FDA warned that off-label use Infuse in the cervical spine could lead to life-threatening airway complications, including difficulty breathing and swelling of the neck and throat.
There are nearly 1,000 Medtronic Infuse lawsuits to date. Last week, Medtronic announced that would be settling about 950 claims for $22 million. The company said it would also be allocating $140 million in anticipation of an additional 3,800, MedPage Today reports.
Last June, independent researchers wrote to the Annals of Internal Medicine found that there was no added benefit to using Infuse over a traditional bone graft. By the time this information was published, more than 1 million had already been implanted with the product.