Off-Label Use of rhBMP and Infuse Bone Graft Have Potentially Deadly Side Effects
Recombinant human Bone Morphogenetic Protein (rhBMP) has received a lot of attention since July 2008 when the FDA issued a warning letter about potentially deadly side effects when rhBMP is used in off-label cervical spine (neck) surgery. rhBMP is a protein used in conjunction with the InFuse Bone Graft. The InFuse Bone Graft is made of titanium and acts as a “cage” that houses and releases the rhBMP, which promoted bone growth. According to the products directions, rhBMP should be soaked first in a collagen sponge before being placed in the case. Some doctors, however, have been reported to use rhBMP outside the case and inject it directly into fractures. Regardless of how it is used – inside or outside the device – there is the potential for deadly side effects when it used for neck surgery.
As the FDA warned in July 2008, “the safety and effectiveness of rhBMP in the cervical spine have not been demonstrated and these products are not approved by the FDA for this use.” The FDA warning went on to state that “at least 38 reports or complications during the last 4 years with the use of rhBMP in cervical spine fusion” were reported. The rhBMP side effects, as described by the FDA, were associated with:
- swelling of neck and throat tissue, which may result in compression of the airway and/or neurological structures in the neck
- difficulty swallowing
- difficulty breathing
- difficulty speaking
- severe dysphagia
According to a WSJ report, a group of North Carolina surgeons reported on a study that showed a side effect rate of 59% in cervical spine surgeries with InFuse, as compared to a 21% side effect rate using conventional fusion surgery, which typically involves bone grafts or collagen. The study was conducted between July 2005 and December 2007 and examined 76 patients. Dr. Todd Jarosz, who authored the study, said InFuse patients suffered a variety of side effects ranging from inflammation that required a feeding tube to severe breathing problems that required a tracheotomy. A tracheotomy requires an incision and insertion of a tube into the airway of the patient.
The FDA has warned that patients treated with rhBMP in the cervical spine should know:
- the signs and symptoms of potentially adverse and fatal side effects include airway complications, which can include difficulty breathing or swallowing, or swelling of the neck, tongue, mouth, throat and shoulders or upper chest area
- that they need to seek medical attention immediately at the first sign of an airway complication
- that they need to be especially watchful 2-14 days after the procedure when airway complications are more likely to occur.
If You or a Loved One has Potentially Suffered from rhBMP or InFuse Bone Graft Side Effects, Contact Our InFuse Bone Graft and rhBMP Attorneys Today.
If you or a loved one underwent spine graft surgery in the neck area and suffered any of the above reactions, contact our attorneys and lawyers today for a confidential free lawsuit evaluation to determine whether rhBMP or the InFuse Bone Graft was used in your surgery and caused your injuries. You may have claims against the surgeon, Medtronic and/or Wyeth for the off-label use of rhBMP and the InFuse Bone Graft and entitle to compensation.