IF YOU HAD BACK SURGERY AFTER JULY 2002, YOU MAY HAVE IMPORTANT LEGAL RIGHTS
A recent investigation by the U.S. Senate concluded that the maker of a popular surgical device, known as the InFUSE Bone Graft, deliberately manipulated health studies regarding the safety of this device. As a result, thousands of patients in West Virginia and across the country may have been seriously injured by the non-FDA approved use of the InFUSE Bone Graft during spinal fusion surgery.
The Calwell Practice is Your West Virginia InFUSE Lawyer
The Calwell Practice, PLLC is currently investigating potential claims for individuals who have had unsuccessful back, spine, or disc surgery and were implanted with the Medtronic InFUSE Bone Graft.
Medtronic has promoted and encouraged use of the InFUSE Bone Graft for numerous surgical procedures for which it has not been properly tested. Contact our office today for a free case evaluation.
Background on InFUSE
In 2002, the FDA approved InFuse (also known as rh–BMP–2 or bone morphogenetic protein 2), a genetically engineered protein that stimulates bone growth for use in spinal fusion surgery in conjunction with the LT-Cage Lumbar Tapered Fusion Device to treat degenerative disc disease in the lower spine.
Degenerative disc disease is a condition where the discs between spinal vertebrae deteriorate with age and can be a source of back pain. In some cases, degenerative disc disease is treated with spinal fusion surgery where the degenerated disc is removed and the adjacent vertebrae are joined together with a bone graft material to eliminate pain. Medtronic promotes the use of InFuse for spinal surgery as a way to eliminate surgery and pain associated with the autograft procedure, where bone is harvested from the patient’s hip for use in the spine.
The FDA’s 2002 approval of InFuse was limited to spinal surgeries using the anterior lumbar interbody fusion (ALIF) technique. The ALIF approach allows surgeons to access the spine through the abdomen but does not involve “retraction of the spinal nerves and neurologic structures” which decreases the “risk of neurologic injury.” During the FDA advisory committee hearing prior to the approval of InFuse, concerns were expressed about the high potential for off-label use. The Agency for Healthcare Research and Quality (AHRQ) estimates that, in 2009, only 21,240 of 140,467 spinal fusion surgeries with InFuse were performed using the anterior lumbar technique. The remaining 119,227 hospital stays were associated with off-label spinal fusion techniques such as posterior lumbar fusion and cervical spinal fusion. This AHRQ estimate is consistent with a widely cited figure that “at least 85% of InFuse use is now off-label.”
In 2008, the FDA published a public health notification linking the off-label use of InFuse in the cervical spine with life-threatening swelling in patient’s throats and necks. The Wall Street Journal reported at the time that “the agency . . . received 38 reports over four years of side effects, mainly swelling of neck and throat tissue, which resulted in compression of the airway and other structures in the neck.” In addition, the Wall Street Journal reported that “[a]t least three-quarters of the roughly 200 ‘adverse events’ reported to the FDA involve off-label uses of In-Fuse.”
In March 2011, the FDA declined to approve a higher-strength version of InFuse called Amplify due to concerns that the product may cause cancer. Later that year, Dr. Eugene Carragee of Stanford University presented data at a spinal surgeon conference that he believes demonstrates that the patient group that received Amplify experienced a “significantly higher number of cancers . . . compared to a control group that received a bone graft” but was not reported in a 2009 industry-sponsored publication on Amplify. Dr. Carragee told the New York Times that ”doctors often administered InFuse off-label at levels significantly above the recommended dosages, ones that approach or exceed the amount of rhBMP–2 found in a dose of Amplify.”
Please call us for further information if you, a family member, or someone you know had unsuccessful back, spine, or disc surgery after July 2002. We will help you investigate and determine whether non-FDA approved spinal fusion surgery is the cause of problems you may have suffered in the past or may now be suffering as a result of the improper use of this surgical device.