Infuse Bone Graft is a product developed by Medtronic Spine, a company which seems to have a history of product issues and sanctions by the FDA. Infuse Bone Graft consists of a genetically-engineered protein and a carrier substance, which, when combined, encourage the growth of new bone at the location where the substance is placed.
Infuse Bone Graft has been approved by the FDA for some very specific purposes, but, as often happens, doctors have been using the substance for "off-label," non-approved purposes as well. In July 2008, the FDA put out a warning reminding doctors that the approved use of this product is for very specific and well-defined conditions and in a limited patient population.
The medical publication Spine Journal devoted the entire June 2011 issue to problems and concerns about both the product and Medtronic's research supporting its use, and in 2008 the Department of Justice began an investigation into Medtronic and the possibility of an illegal promotion of off-label uses of the protein substance. Medtronic reported that trials found no serious side effects from off-label use and pointed to papers written by doctors supporting that finding, however, the Spine Journal article revealed that those doctors received millions of dollars from Medtronic for their support. The article also alleged that these doctors repeatedly ignored patient reports of serious complications which included unwanted and sometimes uncontrolled bone growth.
This is not the first time Medtronic has been accused of paying off doctors to promote its products. In 2006, Medtronic paid over $40 million to the United States to settle kickback allegations, and in 2008 Medtronic paid over $75 million to settle allegations of Medicare fraud.
Medtronic, which is one of the largest producers of medical products and devices in the U.S. seems to regard these settlements as just a cost of doing business. In June of 2011 the United States Senate launched an investigation into reports that doctors with multi-million dollar financial ties to Medtronic were aware of serious complications with the product, yet failed to reveal those problems in medical journal articles. The Spine Journal report found that doctors had been paid between $12 and $16 million per study and despite the fact that the infection rate was three to five times higher in Infuse patients than in a control group, no mention of that fact was made in five subsequently published papers. Data provided to investigators, however, showed that up to 50 percent of Infuse patients suffered seriously adverse effects.
Among the problems found with Infuse Bone Graft were life-threatening inflammation and inflammatory cysts, infections, cancer risk, and other serious complications. Overgrowth of bone in the spine and neck can cause nerve impairment, difficulty in breathing and swallowing, incontinence and male sterility.
Infuse Lawsuits are being filed in droves, not only by patients but by federal agencies with reason to question the huge amounts of money Medtronic accrued as the result of some shady marketing practices, as well as questionable research, the results of which were evidently bought and paid for at high-dollar rates, while dangerous outcomes were hidden from the public and potential patients.