Medtronic Infuse Bone Graft Questioned As Allegations Unfold
According to a public health notification released by the FDA in July of 2008, Infuse bone graft products were used in procedures that the FDA did not grant approval for use with this product.
Senator Max Baucus has personally written a letter to Medtronic stating that "These reports that doctors conducting medical trials while on Medtronic's payroll may have hidden serious side effects for patients are deeply troubling".
John Bisnar, managing partner of the Bisnar Chase law firm, alleges that patients who have suffered injuries while utilizing the Infuse Bone Graft devices may be eligible for compensation.
According to Medtronic's numbers, 500,000 patients have been treated with the Infuse Bone Graft product. The product was designed to assist in the treatment of degenerative disc disease (DDD).
Infuse (recombinant human Bone Morphogenetic Protein-2, rhBMP) is a genetically engineered protein that would normally be found naturally in one's body. Medtronic claims that if it is used properly, one can stimulate bone formation and avoid additional surgeries during treatment.
The FDA's 2008 public health notification stated that reports had been received associating life-threatening complications with rhBMP when used in the cervical spine. The notification went on to say that "the safety and effectiveness of rhBMP in the cervical spine have not been demonstrated and these products are not approved by the FDA for this use."
The numbers released by the FDA in their public health notification included 38 reports detailing complications when using Infuse Bone Graft products in cervical spine fusion. Similar complications were reported including swelling of the throat tissue and compression of the airway. Some patients had difficulty speaking, swallowing, and breathing.
According to the Journal Sentinel's June 27th Watchdog Report, a number of complications were associated with use of the Infuse Bone Graft product amongst human trial participants between 2000 and 2009. The report alleges that the Medtronic sponsored trials were conducted by physicians that failed to report the severity of the side effects sustained by the participants.
The doctors associated with the Medtronic Infuse Bone Graft clinical trials stated that "Although not desirable, bone formation in the spinal canal does not appear to have a discernible effect on patient outcomes." "Even though bone formed, no negative outcomes were found," according to the Journal Sentinel.
Reports to the FDA, cited in and leading to their public health notification, produced evidence to the contrary.
Brian Chase, Infuse Bone Graft attorney, has been assisting defective product victims for decades. Mr. Chase has observed first-hand the devastation that product defect victims undergo following the negligence of large corporations.
"Too often, large companies produce products without their consumer's safety in mind. Product defect victims do not want to believe that businesses may be operated by people who place the priority of their profit margins above their consumer's level of safety."
"When manufacturers fail to provide a reasonable level of safety for those who use their products, victims have a right to pursue compensation for their medical expenses, as well as any pain and suffering that may have been caused", says Brian Chase.
About: Bisnar Chase, Infuse Bone Graft Lawyers, Orange County, CA
Bisnar Chase is an Orange County, California based defective product law firm that has developed a reputation as trusted professionals delivering outstanding results. Brian Chase, senior partner, has obtained several multimillion dollar verdicts and settlements on behalf of his product defect clients, including a 24.7 million dollar verdict in August of 2011.
Bisnar Chase attorneys assist product defect victims throughout the United States.