In July, the FDA notified health care professionals of life-threatening complications associated with the recombinant human bone morphogenetic protein (rhBMP) when it is used in the cervical spine. The agency had received 38 reports of complications during the past four years associated with its use in cervical spine fusions, for which it is not approved. The complications included 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.

Recently, reports in the media have alleged that surgeons with financial ties to Medtronic promoted the use of the protein unofficially in a number of unapproved settings, and complications have included bone growths near nerves or in areas not targeted by the therapy. This in turn has resulted in additional medical interventions, including emergency surgeries.