According to an article that was originally published in The Wall Street Journal, each year about half a million people have spinal fusion surgery to repair ruptured discs and to correct conditions such as scoliosis, or curvature of the spine.
Before the introduction of Medtronic’s Infuse Bone Graft, most Kentucky spinal fusions required two surgeries: one to harvest bone from the hip, and a second to do the actual spinal fusion. Patients complained of pain in their hips for months after surgery. Another way to obtain bone is from a cadaver, but that introduces the possibility of tissue rejection.
Enter Medtronic Infuse
In 2002, the Food and Drug Administration (FDA) approved Infuse for use in a very specific form of spine surgery: those that are performed through an incision in the abdomen and fuse a narrow range of vertebrae in the lower back.
Medtronic Infuse involves placing a tiny metallic cage between spinal vertebrae. The cage contains a spongy material that has been soaked in a genetically engineered protein that is similar to a growth agent produced in the human body. Bone growth ensues and eventually fuses the vertebrae. Studies have shown that the vertebrae fuse more quickly than with earlier fusion methods and that the surgeries are more successful.
What Can the Matter Be?
In July 2008, the FDA warned surgeons that it had received 38 reports over a four-year period of life-threatening complications associated with off-label use of Infuse—using the surgery in ways other than those for which it had been approved, primarily in cervical spinal fusions (in the neck area). Patients experienced neck and throat swelling, which caused their airways and other structures in the neck to compress and led to difficulty breathing, swallowing, and speaking.
Many of the problems in the off-label use of Infuse stemmed from unwanted bone growth near nerves or in areas outside the site of the fusion. This circumstance led to pain, additional surgeries, and sometimes emergency intervention.
Then Why Is Off-Label Use Occurring?
In many cases, money was the primary motivation. Doctors who had a financial relationship with Medtronic wrote favorable articles in journals and on websites about off-label use of Infuse. According to David Armstrong in his Wall Street Journal article, “Some of the most influential spine surgeons in the country are consultants to the company. Several of them benefit from sales of the product through royalty deals, according to disclosures they have made in professional journals and at medical meetings.”
What Does the Manufacturer Say?
Medtronic claims to have taken seriously the reports of complications, and they have warned surgeons about off-label use of the device. Medtronic also avers, though, that the incidence of complications is low and represents only about one-tenth of one percent of the Infuse devices implanted.
When a medication or medical device is used in an unsanctioned manner and results in harm to the patient, the persons or companies responsible for the injury must make amends. If you have received a spinal fusion using Medtronic Infuse and are suffering from unanticipated complications, contact the Louisville personal injury lawyers at Gray and White Law. Call 502-210-8942 or toll free at 888-450-4456 and set up a FREE, no-obligation, confidential consultation.