A bone graft is a fragment of bone or material that mimics bone that is used to repair damaged or lost bone anywhere in the body. Bone grafts can be done with a piece of bone from the patient, donated bone, or synthetic material. Using real bone from within the patient requires additional surgical procedures, which increases the risk of complications. With a synthetic material, like the INFUSE Bone Graft, this extra surgical step can be avoided.
INFUSE Bone Grafts are made by Medtronic and have been on the market since 2002. This synthetic material combines proteins and collagen from cows and is used in treating degenerative disc disease. The INFUSE product has caused some serious issues in some patients, including cancer, infections, and nerve pain. Lawsuits have been filed against Medtronic for the grafts that have led to some of these issues accusing the company of deceptive marketing.
What Are Bone Grafts?
Bone grafting is a surgical procedure used to repair, heal, and regenerate bone. There are four main reasons that a patient may need a bone graft. One reason is to help heal a bone fracture that is not healing well enough on its own. A bone graft may be used to heal a diseased joint. Finally, a bone graft can be used to regenerate lost bone and promote the growth after regeneration begins. This may be needed after an injury, disease, or infection causes bone loss.
A bone graft acts like a scaffold to support bone growth. Bone tissue can regrow on its own, but it needs something to grow on, a scaffold. A bone graft can act as that scaffold and allow the natural process of bone regrowth to occur. A bone graft can be a piece of bone harvested from somewhere else in the patient’s body or can come from a donor. A bone graft can also be a synthetic material that is similar to real bone and that will be absorbed into the bone tissue.
Degenerative Disc Disease
The U.S. Food and Drug Administration (FDA) approved INFUSE Bone Graft in 2002 for the treatment of degenerative disc disease in the lumbar region, or the spine in the lower area of the back. Degenerative disc disease occurs when a disc in the spine is damaged and causes pain. Discs exist between the vertebrae, the bones, of the spine and act like shock absorbers. They provide cushioning and flexibility.
The discs in the spine have minimal blood flowing to them so when they get damaged they can’t repair themselves very well. When a disc becomes damaged it only gets worse over the years, causing pain and reducing mobility. Treatments that involve exercise, physical therapy, or medication can help, but for some patients, nothing but surgery will relieve the pain and increase flexibility and movement. Using a bone graft is one way to repair the damage.
INFUSE Bone Graft
The INFUSE Bone Graft includes two main components that make it work for re-growing bone and healing spinal discs. The first is an engineered protein based on human bone protein, called rhBMP-2. This protein stimulates and regulates the growth and healing of bone tissue. The scaffold for the bone graft is a sponge made from bovine collagen. This carrier releases the rhBMP-2 in small amounts to stimulate bone growth and is absorbed into the bone tissue.
The benefits of using INFUSE Bone Graft instead of a piece of bone harvested from the patient’s body is that it negates the need for this secondary surgery. Performing one instead of two surgeries to treat lumbar degenerative disc disease reduces the risks of complications and reduces recovery time.
Although the idea is to reduce the risk of complications by eliminating one surgical procedure, there are still possible complications from using INFUSE Bone Graft to treat a degenerative disc. These include allergic reactions, bone fractures, abnormal bone formation and growth, tissue damage, infections, pain, a bad reaction to anesthesia, paralysis or neurological problems, spinal cord damage, or nerve damage. The bone graft may also fail, break, bend or loosen, which may require additional surgery.
The INFUSE Bone Graft is not indicated for use in pregnant women, and so women who could become pregnant are urged to have pregnancy tests and use contraception if having the surgery. The graft is also contraindicated for children or anyone whose bones have not finished growing or in areas in which a patient has a tumor or had a tumor removed.
Controversial Trial Data
Nearly ten years after the INFUSE Bone Graft came on the market, information started to come to light that Medtronic may not have been completely transparent about the risks posed by rhBMP-2, the protein used in the graft. It was also uncovered that several researchers involved in early studies of INFUSE, which did not disclose all the side effects, were given monetary kickbacks, in the form of millions of dollars in consulting fees and royalties.
Some of this information was brought to light by Dr. Eugene Carragee, the editor of The Spine Journal. By reviewing the literature and getting letters from surgeons complaining of complications with INFUSE, he found that there were some serious issues with the graft that hadn’t been communicated to doctors or the public by Medtronic. After a thorough review of reported adverse events, Dr. Carragee determined that the risk of complications was ten to 50 times higher than what had been reported in studies sponsored by Medtronic. The Spine Journal published this review to warn doctors and patients about the risks.
The U.S. Department of Justice investigated Medtronic over the INFUSE Bone Graft for several years. While only approved by the FDA for use in lumbar degenerative disc disease surgeries, it was found that nearly 80 percent of the use of the graft was for other, off-label surgeries. While doctors may choose to use devices or medications for off-label use, the company cannot advertise a device off-label. The Department of Justice investigation ended without taking any action against Medtronic.
FDA Adverse Events
The FDA collects reports of adverse events that occur with devices and medications. For the INFUSE Bone Graft those reports have included failures of the graft, leg and back pain, and breathing difficulties. Many of these cases required second surgeries, or more, to correct the issues. Because of the reports, the FDA issued a warning in 2008 that INFUSE Bone Grafts should not be used for off-label upper spine procedures. This off-label use caused many of the cases of difficult breathing because the graft sometimes caused swelling in the neck or throat. Many of these cases were severe and had to be treated in the hospital with a tracheotomy.
Although the Department of Justice ultimately took no action against Medtronic, several individuals have. Lawsuits against the company have accused it of false advertising, marketing a device for off-label uses, and not communicating the risks of using the bone graft. A lot of people been hurt by misuse of INFUSE and the lawsuits are likely to end in settlements for them. If you had surgery with INFUSE Bone Graft and suffered the consequences, a lawyer can help you figure out what options you have for a lawsuit.