Infuse Bone Graft
Patients who suffer from degenerative disk disease, a painful back condition in which discs in the back gradually become more and more damaged, sometimes try surgery to ease their pain. Degenerative disk disease surgery involves replacing damaged disks with bone grafts. The bone grafts acts as a substitute disk, fusing the vertebrae together without causing pain. One commonly used bone graft, the infuse bone graft, can cause uncontrolled bone growth and serious complications if used in other areas of the back besides the lower back.
If you or a loved one receives an infuse bone graft in an area other than the lower back, you might have difficulties speaking, swallowing or even breathing. You might also have chronic pain in your arms and legs or develop cancer as a result of the graft. You may be entitled to compensation if you have these problems; contact a personal injury lawyer for more information.
About Infuse Bone Grafts
The outside of the graft, called the LT cage, is made out of metal. This part of the bone graft is analogous to the outside of a real bone. While your bones are filled with marrow, however, the graft is filled with a biologically engineered protein. The protein is used to stimulate growth of surrounding bones.
During the surgical procedure, damaged disks are removed. Then, surgeons mix the protein with water and place it on a collagen sponge, which is put inside the infuse bone graft. The entire device is then placed in between the vertebrae where the disk used to be.
The FDA has approved this procedure only for the lower back, but surgeons sometimes use it in other areas of the back where they think there may be a health benefit. This can be dangerous because any medical device can have unpredictable effects when used in a manner other than what it was approved for.
When the graft is used in any area other than the lower back, it can cause uncontrollable bone growth, sometimes leading to fatal symptoms. It is particularly dangerous to use this graft in the cervical spine. Patients who have this procedure done often have swelling of the throat and may have difficulty breathing or speaking.
Although this product has been implicated in injuries to 40 percent of patients who had cervical spine surgery, neither the FDA nor the manufacturer has issued a recall. The FDA issued a public health advisory in 2008 against using the product for this purpose. In addition, the manufacturer of this product is under investigation for not disclosing negative side effects associated with the product during clinical trials.
Infuse bone grafts may have been marketed improperly. Although they were not approved for use in cervical surgery, Medtronic–the manufacturer of this device–may have marketed them to doctors and hospitals as appropriate for this use. As a result, patients were not informed adequately of the risks of using this device in cervical spine surgery.
Patients who were injured as a result of having this device implanted may be eligible for compensation. If a patient wasn’t informed of the dangers of using infuse bone grafts, he or she may also be entitled to sue doctors for malpractice. Finally, if a patient died as a result of infuse bone graft surgery, the patient’s family may be entitled to compensation for wrongful death. Contact your personal injury attorney immediately to find out your options if any of this applies to you.