Injury Lawyers announce launch of Medtronic Infuse Bone Graft Lawsuit Division and Medtronic Infuse Bone Graft Helpline
to educate individuals and families harmed by off-label bone graft procedures and to help them understand the complications and how to pursue legal action with a Metronic Infuse Bone Graft Lawyer.
Medtronic faces an increasing number of product liability and personal injury lawsuit. Most recently, a Louisiana man, filed a lawsuit alleging that the company’s Infuse bone graft caused unwanted bone growth along his spinal cord, which worsened his back pain following a lumbar fusion.
The plaintiff, Martin Gavin alleges that Medtronic concealed information about the risk of complications from the Medtronic Infuse bone graft.
What is Medtronic Infuse?
Infuse, also known as bone morphogenetic protein-2, is a powerful bioengineered agent used in spinal fusion surgery. The product stimulates bone growth and eliminates the need to harvest a small amount of a patient's own bone to create a fusion between two vertebrae. As a result, it is highly popular with spine surgeons.
FDA Approved Infuse for limited use
The FDA approved Infuse in 2002 for use during anterior lumbar fusion surgeries. But as a result of slick and pressured marketing, it has been widely used off-label for a number of other types of spinal surgery, which have been found to increase the risk of severe adverse side effects.
Plaintiffs allege that they were never told that the Infuse was only approved for single-level anterior lumbar fusion, and had ever been adequately tested or approved for the type of spine surgery they underwent.
Medtronic Infuse Off Label Use
Off-label use of the Medtronic Infuse bone graft during procedures other than single-level anterior lumbar fusion have been linked to the growth of bone in those areas, leading to swelling and nerve damage.
FDA 2008 Warning
The FDA issued an alert in 2008, advising doctors not to use the Medtronic Infuse in neck or cervical spinal fusion procedures. The FDA had received numerous adverse event reports, involving potentially fatal complications that included swelling of the neck and respiratory difficulties.
U.S. Department of Justice investigation
The U.S. Department of Justice initiated an investigation focusing on the actions of Medtronic in 2008. The U.S DOJ was particularly interested in investigating whether Medtronic illegally promoted and marketed the Infuse bone graft for uses that were never approved by the FDA.
Other Medtronic Infuse Side Effects
Last year, concerns also emerged that the Medtronic Infuse bone graft may increase the risk of cancer. There have also been concerns that med treated with Medtronic Infuse may face a risk of sterility.
Shareholders said Infuse sales and Medtronic's share price fell after the company revealed that the U.S. Department of Justice was probing off-label marketing and the U.S. Senate began its own inquiry.
he Infuse Bone Graft is manufactured by Medtronic. The infuse Bone Graft is a biologically-engineered protein (known as rhBMP-2) that is used to promote bone growth and replace damaged spinal discs. It is used in conjunction with a metallic cage implant (LT-Cage Device) that works to stabilize the spine as the new bone grows. Infuse Bone Graft is designed to reduce the pain and complications that are associated with treating degenerative disc disease (DDD) by eliminating the second surgery that is typically required to remove bone from a patient’s hip for transplantation to the spine for repair.
FDA Alerts on the Infuse Bone Graft
The FDA put special emphasis on the fact ”that the safety and effectiveness of rhBMP in the cervical spine have not been demonstrated and these products are not approved by FDA for this use.”
The FDA stated that they had received at least 38 reports of complications during the last 4 years with the use of rhBMP in cervical spine fusion. These complications were associated with swelling of neck and throat tissue, which resulted in compression of the airway and/or neurological structures in the neck. Some reports describe difficulty swallowing, breathing or speaking. Severe dysphagia following cervical spine fusion using rhBMP products has also been reported in the literature.
The Infuse Bone graft has been Approved for
DDD occurs when a spinal disc deteriorates to the point of causing back pain, a diagnosis that must be confirmed by history and x-rays. Spinal fusion is a surgical method used to treat DDD and involves removing the damaged disc and replacing it with bone graft that will fuse – or join – the two adjacent vertebrae together in order to stabilize the spine. Infuse Bone Graft is used in over 100,000 U.S. spinal fusion surgeries each year.
Infuse Bone Graft is currently approved by the U.S. Food and Drug Administration (FDA) for use in anterior spinal fusion of the lumbar spine, as well as for the repair of open tibial shaft fractures and two minor dental procedures.
Infuse Bone Graft should not be used for
- Women who are pregnant or who suspect pregnancy
- Individuals with infections near the area of the surgical incision
- Individuals who have had a tumor removed from the area of the implantation site
- Individuals who currently have tumors in or near the area of the implantation site
- Individuals whose bones have not stopped growing
- Individuals who are sensitive to titanium, titanium alloy, bovine (cow) Type I collagen or rhBMP-2.
The Infuse Bone graft is being Used for off label not FDA approved Use
The FDA originally approved Infuse Bone Graft in 2002 but as with many drugs and devices, off-label use of Infuse Bone Graft was permitted once the device received FDA approval. The practice of using a drug or device off-label is permitted if physicians believe it will benefit their patients and if they fully advise their patients of the risks associated with the off-label use. In July of 2008, the U.S. Food and Drug Administration issued a warning to healthcare providers about reported life-threatening complications associated with the off-label use of Infuse Bone Graft for cervical (neck) spinal fusions. This warning was issued in response to 38 reports of complications received by the FDA between 2004 and 2008. These complications include neck and throat swelling leading to airway compression, swallowing and breathing difficulties, as well as problems with speech. In the warning, the FDA noted that “the safety and effectiveness of rhBMP in the cervical spine have not been demonstrated and these products are not approved by FDA for this use.”
Infuse Bone Graft lawyers are Filing lawsuits for complications from the infuse bone graft
The Medtronic Infuse Bone Graft has been linked to life-threatening complications in patients who were given Medtronic off-label. Medtronic bone graft complications include swelling of the airways, which can cause difficulty breathing, speaking and swallowing. Medtronic Infuse has also been linked to retrograde ejaculation which can lead to male sterility. A number of Medtronic lawsuits allege the manufacturer illegally promoted the Medtronic bone product for off-label uses.
Speak to a Medtronic Bone Graft Lawyer
If you or someone you know has experienced complications after being treated with a Medtronic bone growth product call the medtronic Bone graft helpline today. Our lawyers are currently reviewing Medtronic lawsuits nationwide.