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FDA warns of dangers of rhBMP

Device Regulation Alert: Safety, Compliance and Reimbursement News, July 21, 2008

An FDA public health notification warns of life-threatening conditions associated with recombinant human Bone Morphogenetic Protein (rhBMP) in cervical spine fusions. The FDA received 38 adverse event reports concerning the product used in cervical spine fusions over the last four years.         

Complications from the device include swelling of the airway and difficulty breathing, speaking or swallowing, occurring within two to 14 days after surgery for the cervical spine fusion. The FDA recommends using alternative treatments—or if the practitioner still wishes to use rhBMP for cervical spine fusion, enrolling as a clinical investigator for an approved study. The FDA notification warns patients of the potential symptoms of complications and recommends they be particularly alert to those symptoms during the two to 14 days after surgery when most of the complications have occurred.

The FDA reminds the industry and providers to report any adverse events even when it involves an off-label use of a device. The notification indicates rhBMP-2 has pre-market approval for certain lumbar spine fusions for degenerative disc disease and some oral and maxillofacial uses, but is not FDA-approved for use in cervical spine fusion. The Humanitarian Device Exemption approval allows use of rhBMP-7 as an alternative to autograft in specific circumstances.  

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