New Research Questions INFUSE Bone Graft Safety

The controversial Medtronic INFUSE bone graft treatment may increase the risk of cancer, according to two independent studies published this month in The Annals of Internal Medicine. The research also found the product to have no benefit over traditional spine surgery.

The studies contain data from all clinical trials involving the use of Medtronic’s product. The data indicates frequent side effects, failure rates and other INFUSE bone graft problems.

Throughout the nation, product liability lawsuits allege severe Medtronic INFUSE side effects. Plaintiffs contend that the company influenced the initial trial data gathered on their product. The INFUSE bone graft also allegedly used ‘off-label’ in surgeries for which it was not intended.

INFUSE bone graft problems reported in off-label use

Medtronic INFUSE is a bone morphogenetic protein (BMP) which is implanted into the spine to encourage bone growth and fuse the gaps between vertebrae. It is used in place of traditional spinal surgery, where bone is taken from elsewhere in the body, or from a third party, and used to promote fusion of the vertebrae.

The FDA approved the product for use during a single-level anterior lumbar interbody fusion (ALIF), a procedure whereby the incisions are made from the front of the body. But it has been used ‘off-label’ for other types of spine fusion surgery, and INFUSE bone graft problems have been widely reported.

Congressional Report Says Medtronic ‘edited’ studies

In 2012, congressional investigators found that Medtronic had manipulated previous studies to make it appear that the risk of experiencing INFUSE bone graft problems was low, and that the product was superior to traditional surgery. The report stated that Medtronic paid $210 million to people conducting studies on their behalf. When those studies appeared, they omitted crucial potential side effects, including sterility, ectopic bone growth and cancer.

The company went further still, editing and writing section of the research papers before publication. The report states: “Medtronic was heavily involved in drafting, editing, and shaping the content of medical journal articles authored by its physician consultants who received significant amounts of money through royalties and consulting fees from Medtronic.”

Medtronic also inserted language into studies that suggested being implanted with INFUSE was a more effective, less painful procedure than traditional surgical grafts. Medtronic’s never disclosed their involvement in the studies to the public.

INFUSE is no better than traditional surgery, according to study

Contrary to the fabricated findings of the Medtronic-sponsored research, the two recent  studies found the outcomes of surgery conducted with INFUSE were no better than the outcomes of traditional surgery. One of the studies found an increased cancer risk in patients in the two years after surgery.

The critical reports – conducted at Oregon Health & Science University and York University in England – both asserted that Medtronic had overstated the advantages of INFUSE. The Oregon study concluded that “adverse events were underreported for more on- and off-label uses, with results not previously available to the public.”