A large dose of Medtronic’s Infuse bone graft, which makes use of a genetically engineered protein called rhBMP-2 to help re-grow bone in the spine, is linked to an increased risk of new cancer.
New York, New York (PRWEB) September 16, 2013
Parker Waichman LLP, a national law firm dedicated to protecting the rights of victims injured by defective medical devices, notes that, according to a Stanford University study published in the September 4, 2013, edition of The Journal of Bone & Joint Surgery, a large dose (of at least 40 mg) of Medtronic’s Infuse bone graft, which makes use of a genetically engineered protein called rhBMP-2 to help re-grow bone in the spine, is linked to an increased risk of new cancer, according to a Stanford University study.
The study used publicly available data from patients with degenerative lower spine conditions who underwent spinal fusion with either a high-dose of rhBMP-2 or a traditional bone graft, which makes use of bone harvested from the patient’s own body. The latter group was designated as the control group for this study. The results: The risk of new cancers in each group was noted at two and five years after surgery. At the two-year mark, with 86% follow-up, there were 15 new cancer events in 11 patients in the rhBMP-2 group, compared with two new cancers in two patients in the control group, according to the study. At five years, there was a 37% loss of follow-up, but again a significantly larger occurrence of cancer was seen in the rhBMP-2 group.
Results of the Stanford study arrive about three months after findings were published from two independent studies overseen by Yale University. In the June 2013 edition* of the medical journal Annals of Internal Medicine, the studies revealed that Medtronic’s Infuse product can result in a litany of harmful, if not fatal, side effects, including retrograde ejaculation, pain and extraneous bone growth. As with the Stanford study, the Yale-overseen studies also revealed that cancer was among the potential side effects of Medtronic’s Infuse. The Yale studies ultimately noted that there is little, if any, difference in the effectiveness of Infuse over a 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 U.S. Food and Drug Administration (FDA) approved the product in 2002 specifically for use in lower spine surgeries in which the surgeon operates on the patient’s spine by going in the front of their body. Infuse was not approved for use on the upper, or cervical, spine, where it has been widely used nevertheless, according to an Oct. 25, 2012 Bloomberg Businessweek report. And this follows the FDA’s July 1, 2008 notification regarding the hazards of off-label usage. In this alert, the agency revealed that the Infuse bone graft had been 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 the off-label use of Infuse in cervical spine fusion, with most complications occurring between two days and two weeks after the procedure. The FDA highlighted the fact 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 Medtronic’s Infuse bone graft product should be aware that:
- The signs and symptoms of airway complications include difficulty breathing or swallowing; or swelling of the neck, tongue, mouth, throat and shoulders or upper chest area.
- They need to seek medical attention immediately at the first sign of an airway complication.
- They need to be especially watchful two to 14 days after the procedure has been done, which is when airway complications are more likely to occur.
Parker Waichman LLP is currently offering free legal consultations to victims of Medtronic Infuse Bone Graft Injuries. If you or a loved one suffered a serious complication or injury after receiving Medtronic Infuse, please contact their office by visiting the firm's Medtronic Infuse injury page at yourlawyer.com. Free case evaluations are also available by calling 1-800-LAW-INFO (1-800-529-4636).
Parker Waichman LLP
Gary Falkowitz, Managing Attorney
1+ (800) LAW-INFO
1+ (800) 529-4636