On July 1, 2008, the U.S. Food & Drug Administration (FDA) issued a public health notification (warning) to healthcare practitioners regarding the Medtronic Infuse Bone Graft product and its use in off-label procedures.
The letter highlighted reports of life-threatening complications associated with the Medtronic Infuse Bone Graft product, also known as recombinant human Bone Morphogenetic Protein (rhBMP) when used in the cervical spine.
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.
Anatomical proximity of the cervical spine to airway structures in the body has contributed to the seriousness of the events reported and the need for emergency medical intervention. The mechanism of action is unknown, and characteristics of patients at increased risk have not been identified.
Most complications occurred between 2 and 14 days post-operatively with only a few events occurring prior to day 2. When airway complications occurred, medical intervention was frequently necessary. Treatments needed included respiratory support with intubation, anti-inflammatory medication, tracheotomy and most commonly second surgeries to drain the surgical site.