Ohio product liability lawyer and medical device defect attorney reviewing Continuing Risks with Medtronic’s InFUSE Bone Graft System
It is estimated that several thousand people have been injured by Medtronic’s InFUSE Bone Graft system since it was approved by the US Food and Drug Administration (FDA) in 2002.
The controversial product has been deemed ineffective and dangerous, and officials at Yale University, after studying data and credible research, have said the InFUSE device offers little to no benefit. Early clinical studies, including those reviewed by the FDA, show the InFUSE procedure has the potential to inflame nearby tissues and bone. 15 to 20 percent of people who have had the InFUSE surgery report regular pain, primarily in the legs and back.
There is also mounting evidence that the graft procedure stimulates cancer growth, and that higher doses of InFUSE carry a greater risk for developing cancer. Many thousands of InFUSE recipients, and also most surgeons, were unaware of these possible risks at the time of operation. As a result, ongoing legal action holds Medtronic accountable for intentionally hiding adverse effects from doctors and their patients.
What are InFUSE Bone Grafts?
Bones grafts are pieces of bone or bone substitute that can replace damaged or diseased bone in a number of joints and bones in the body. The vast majority of InFUSE bone graft operations involve the spine. In spinal fusion, doctors surgically fuse together individual vertebrae, which is meant to eliminate the irritation of nerves in the spine.
Medical implant companies like Medtronic have developed synthetic concentrated protein, called bone morphogenetic protein (BMP), which are injected into the spine to help the body form cartilage and bone, ostensibly to alleviate pain.
While advancements in synthetic bone graft technology play a welcome role in modern medicine, they can cause a myriad of problems, in some cases even, sterility, cancer and death. Bone Graft surgeries are not to be taken lightly. They should be reserved as a last-resort solution to a degenerative spinal condition. In recent years, there have been reports of patients being offered “unnecessary” spinal surgery for pain alone, without significantly abnormal radiographic findings.
InFUSE Bone Grafts Complications
Bone Grafts are risky, and are associated with dangerous side effects. By spring 2011, the FDA had received hundreds of reports of adverse reactions associated with InFUSE Bone Grafts. Patients have reported the following:
• Back and Leg Pain
• Male sterility
• Sexual dysfuction
• Respiratory failure
• Excessive bleeding
• Fetal development problems
• Nerve damage
• Urinary problems
• Possible increased cancer risk
• Inflammatory reactions
• Implant displacement and failure
• Retrograde ejaculation
• Osteolysis (degeneration of bone tissue)
• Abnormal bone formation
These represent a large range of health issues. Many complications even require a second surgery to correct. Some studies suggest a 40 percent reoperation rate for patients over the age of 65, with a 20 percent non-age specific reoperation rate.
The evidence is now clear how risky these procedures can be. However, since Medtronic and its well-compensated research team misled the public, most of these adverse events were unpublished. The full story was not clear until 2011, when independent doctors came forward with their own observations and studies.
Medical Device Corruption
In recent years, Medtronic has faced increased scrutiny for the InFUSE Bone Graft system. In addition to harming thousands of patients with their product, Medtronic is accused of intentionally hiding dangerous side effects.
Also, since its FDA approval, there are multiple reports of clinical investigators receiving generous “consulting” payments from the medical product industry, including Medtronic.
In June 2011, the U.S. Senate launched an investigation into these allegations, and revealed that a number of the researchers received royalties and consulting fees from Medtronic.
With the help of an incriminating article published inThe Spine Journal, the official journal of the North American Spine Society, investigators found that researchers were paid millions to exaggerate the products’ benefits and grossly understate the risks.
The Spine Journal report observed that in multiple industry-sponsored trials, patients reported ZERO complications or adverse effects attributed to their own products. However, documents from FDA documents and other published data reveals a large gap in adverse reactions, and exposes the industry’s “internal inconsistencies,” which ultimately disregarded patient safety for profit. It is estimated that Medtronic’s InFUSE system is used in about 25 percent of the 432,000 spinal fusion procedures a year in the United States. In 2010, they generated almost $900 million in sales.
Medtronic has a horrific ethical track record. In fact, the US Department of Justice (DOJ) has investigated Medtronic several times. In another incident, Medtronic paid $40 million to settle a case where the DOJ accused the company of paying kickbacks to doctors as an incentive to use InFUSE and other similar products.
Unapproved Use of the InFUSE System
The only InFUSE Bone Graft surgical technique that is FDA-approved is a procedure that operates through the abdomen. This procedure minimizes injury to the back muscles and nerves. Even so, Doctors have inadvisably used InFUSE in procedures not approved (“off-label”) by the FDA. Complications are so prevalent in some procedures, that many surgeons who once performed these operations no longer recommend it.
In 2008, the FDA issued a Public Health Notification to health care providers and surgeons regarding serious, even life-threatening complications arising from the unapproved (“off-label”) use of InFUSE in cervical (upper-back) spinal fusion. The FDA received dozens of reports of serious complications, including swelling of neck and throat tissue, which resulted in compression of the airway, and neurological structures in the neck.
The seriousness of some events reported necessitated emergency medical intervention. Patients who suffered these events needed respiratory support, or even a tracheotomy. The FDA reiterated that “safety and effectiveness” have not been demonstrated and “these products are not approved for this use.”
If you or a loved one have suffered the side effects of a faulty InFuse system, and have questions about the legal remedies available to improve quality of life and medical care in Ohio, contact The Lyon Firm at (800) 513-2403. You will speak directly with Mr. Lyon, and he will help you answer these critical questions.