Parker Waichman continues to investigate the consequences of Infuse on spinal surgery. With the popularity of spinal surgery skyrocketing the way it has, this device had a lot of impact on peoples' lives.
New York, New York (PRWEB) July 08, 2013
Parker Waichman LLP, a national law firm dedicated to protecting the rights of victims injured by defective drugs and medical devices, notes that based on available research, spinal fusions increased 1,500% among Medicare patients between 2002 and 2007, according to a June 27, 2011, report by the HealthWorks Collective. This report divulged that this startling growth rate over the five-year period was a result of the debut of Medtronic’s Infuse, a protein-based bone growth stimulator (also known as rhBMP-2). Now, with two independent studies*—the results of which were published in the June edition of the medical journal Annals of Internal Medicine—calling into question Infuse’s level of effectiveness, as well as highlighting the potential harm it can cause, Parker Waichman LLP is reporting that it continues to investigate allegations of people who claim they were harmed by the product.
Infuse was essentially positioned as a solution that meant the end of the need to harvest bone from patients' hips to help vertebrae fusions, according to the Healthworks Collective report. But the two independent studies, overseen by Yale University, reveal important key findings regarding Medtronic’s Infuse product—namely, that there is little, if any, difference in the effectiveness of Infuse over a traditional bone graft. Additionally, Infuse has the potential to cause harmful, if not fatal, side effects, including:
- Retrograde ejaculation
- Extraneous bone growth.
Medtronic approached Yale University researchers after a June 2011 study published in The Spine Journal disclosed that Medtronic-paid researchers had failed to report serious potential complications from use of Infuse bone graft products in spinal surgery.
“Parker Waichman continues to investigate the consequences of Infuse on spinal surgery,” said Gary Falkowitz, Managing Attorney from Parker Waichman LLP. “With the popularity of spinal surgery skyrocketing the way it has, this device had a lot of impact on peoples’ lives.”
Infuse was approved by the U.S. Food and Drug Administration (FDA) in 2002, explicitly for use in a single type of spinal surgery that involves fusing together vertebrae in the lower spine, with the surgeon using a frontal approach. But it became widely used off-label—meaning for uses not officially approved by the FDA. In 2008, the FDA issued a safety alert to warn about the use of Infuse in the upper spine and the neck region in 2008 after receiving dozens of reports of serious side effects associated with such use of the device. Among the side effects due to off-label use, according to the FDA, are:
- Swelling of neck and throat tissue, resulting in compression of the airway and/or neurological structures in the neck
- Difficulty swallowing, breathing or speaking
- Nerve damage
- Severe dysphagia
The FDA also noted in the 2008 safety alert that, since 2004, 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, tracheotomies and, most commonly, second surgeries to drain the surgical site.”
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