A new Stanford University study has found that use of Medtronic’s Infuse increases new cancer risks.
According to a Stanford University study published in the September 4, 2013, edition of The Journal of Bone & Joint Surgery, a large dose—at least 40 milligrams—of Infuse is tied to increased risks of new cancer.
The controversial bone graft product is a synthetic, or genetically engineered, recombinant human Bone Morphogenetic Protein (rhBMP-2) approved by the FDA in 2002 for specific uses. Specifically, Infuse was designed to stimulate spine growth in patients who suffer from lower spinal degenerative disease and was approved for use in one type of spinal surgery and some dental procedures. Infuse is not approved for use on the upper, or cervical spine; however, the bone graft product is widely used in off label procedures. On July 1, 2008 the U.S. Food and Drug Administration (FDA) issued a notification warning about the product’s ties to serious complications when used in cervical spinal fusions.
This Stanford study used publicly available data from patients diagnosed with degenerative lower spine conditions who underwent spinal fusion with either a high-dose of rhBMP-2 or a traditional bone graft, the study’s control group. In traditional bone graft, bone is harvested from the patient’s own body.
The study revealed that the risk of new cancers in each group was noted at two and five years after surgery. At two years and with an 86 percent follow-up, there were 15 new cancer events in 11 patients in the rhBMP-2 group and two new cancers in two patients in the control group. At five years, there was a 37 loss of follow-up but, again, a significantly larger incidence of cancer in the rhBMP-2 group.
These Stanford research results followed findings published from two independent studies overseen by Yale University. Those studies revealed that Infuse can result in a number of harmful, some fatal, side effects, including retrograde ejaculation, pain, and extraneous bone growth, according to the June 2013 edition of the medical journal Annals of Internal Medicine. Both the Stanford and the Yale-overseen studies revealed cancer among Infuse’s potential side effects. The Yale studies also found that there is little, if any, difference in the efficacy of Infuse when compared to traditional bone graft.
“We have yet another study that provides us with compelling detail regarding the increased risk of injury among patients who undergo a Medtronic Infuse spinal fusion,” said Gary Falkowitz, Managing Attorney from Parker Waichman LLP. “As we have noted, why would a patient choose this device over a traditional bone graft—an option that is not only just as effective but, according to the Stanford study, as well as the Yale-overseen studies, safer?”
The FDA issued a July 1, 2008 notification regarding the hazards of off-label Infuse use and revealed that the product was associated with serious complications – including excessive swelling in the neck, compressed airways, difficulty breathing, problems swallowing, and nerve damage – when used in cervical spinal fusions. Specifically, the FDA noted that it had received reports of “life-threatening complications associated with” Infuse when it was used off-label in the cervical spine. The agency reiterated that “these products are not approved by FDA for this use.”
The FDA also noted that, in the four years leading up to June 2008, it had received nearly 40 reports of complications arising from off-label Infuse use in cervical spine fusion; most complications occurred between two days and two weeks following the procedure. The FDA noted that, “[w]hen airway complications occurred, medical intervention was frequently necessary. Treatments needed included respiratory support with intubation, anti-inflammatory medication, tracheotomy and, most commonly, second surgeries to drain the surgical site.”
The FDA declared that patients implanted in the cervical spine with Infuse should be aware that:
- The signs and symptoms of airway complications include difficulty breathing or swallowing and/or swelling of the neck, tongue, mouth, throat and shoulders, or upper chest area.
- Medical attention must be immediately sought at the first sign of an airway complication.
- Airway complications are more likely to occur from two to 14 days after the procedure.
Medtronic’s marketing of Infuse has been the focus of growing controversy and there are concerns over how Infuse research was conducted, such as that it was Medtronic-funded. Medtronic has been accused of promoting Infuse off label, of downplaying the device’s risks, and of overstating Infuse benefits. This led to a Senate probe, the FDA warning, and the independent studies.