In 2002 the Food and Drug Administration (FDA) approved the use of INFUSE® (rhBMP or rhBMP-2). However, it was approved for only one type of spine surgery. The surgery for which INFUSE® was approved was a single level lumbar spine fusion. More restrictive, the INFUSE® approval was only for one "approach" to the lumbar spinal fusion. The anterior approach (as opposed to the posterior approach, for example) was the only approach the FDA approved. INFUSE® or rhBMP or rhBMP-2 has not been approved for several other orthopedic surgeries such as multi-level spinal surgeries or fusion surgeries or fusion in the cervical (or neck) area.
Infuse® Bone Graft, also known as rhBMP-2, is a bioengineered liquid bone protein that promotes bone growth. It is used by doctors as an alternative to more traditional bone grafts in spinal fusion surgery. Historically, bone grafts have been from bone harvested from the patient's hip, a cadaver, etc.
Since its initial release, Infuse® Bone Graft has enjoyed tremendous growth in use among doctors, primarily in cervical neck fusion procedures. But with this growth in use, rhBMP-2 (Infuse® Bone Graft) was subsequently tied to medical complications in many patients. These medical complications primarily arose from off-label use of INFUSE®. Off-label use of INFUSE® resulting in the complications addressed by this article include use in spine surgery other than single-level lumbar fusions and, further, anterior approach, single level lumbar fusions. INFUSE® (rhBMP-2) complications resulted in the FDA issuing a warning in 2008 that INFUSE® (rhBMP-2) should not be used for off-label purposes, especially cervical (neck) spinal fusions.
The maker of Infuse®, Medtronic, has been named in lawsuits alleging that Medtronic illegally promoted off-label use of Infuse. Former employees have claimed Medtronic financially incented doctors to use Infuse® and other Medtronic products. In June of 2011, Congress began looking into allegations that orthopedic surgeons with financial links to Medtronic may not have reported complications during their clinical trials of INFUSE® Bone Graft. More specifically, there were 13 trials funded by Medtronic which now appear to have under-reported complications. The Spine Journal released its July 2011 edition that detailed the complications associated with the use of Infusion Bone Graft as well as the questionable tactics used by Medtronics to promote the use of INFUSE®.
The off label use of INFUSE® Bone Graft/rhBMP-2 can cause a patient to have swelling in the neck and throat tissue. This swelling can cause blockage and compression of the patient's airways, leading to labored swallowing, breathing and speaking. These symptoms usually arise within a 2 to 14 day window of surgery. The risks may require patients to endure further surgery, mandate respiratory aid, require use of a feeding tube, or undergo a tracheotomy. Other complications from the use of INFUSE® (rhBMP-2), many of which stem from excessive bone growth, may include:
- Nerve damage
- Retrograde ejaculation
- Male sterility
- Cancer risks
The off-label use of a drug or medical device by a doctor is not illegal. However, it is illegal for a drug company to promote off-label use. It also may be inappropriate for doctors to promote off-label use if they are financially incented by a drug company. Furthermore, doctors must make patients aware of any and all risks associated with off-label use of a drug or medical device.
In certain cases the doctors and surgeons using the INFUSE®/rhBMP-2 may not be responsible for the patients complications. Assuming the doctor did not know of the mis-information and under-reporting of complications, the doctor may have a legitimate defense that he or she was unaware of the risks. However, if the surgeon knew of the risks of the off label use and failed to adequately advise the patient, the surgeon may share responsibility.
If you or a loved one has had serious health problems that you believe arose from the use of Infuse® Bone Graft (rhBMP-2) then you should consider contacting a Kentucky attorney to evaluate your case. Cases such as these carry a statute of limitations (a time limit for filing a law suit), so it is important to have an attorney help you to determine if your case merits investigation as soon as possible. Please contact Brett H. Oppenheimer, PLLC a Kentucky attorney, who can help to guide you through the legal process. Email firstname.lastname@example.org or call toll free 866-935-5729 for a consultation on your Infuse® Bone Graft (rhBMP-2) claim.