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FDA issues notification about recombinant bone morphogenetic proteins used in spinal fusion
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The U.S. Food and Drug Administration has issued a notification letter concerning life-threatening complications associated with recombinant human bone morphogenetic protein (rhBMP) when used in the cervical spine.
The FDA notes that the safety and effectiveness of rhBMP in the cervical spine have not been demonstrated and these products are not approved for this use.
Inciting the notification letter were at least 38 reports of complications during the past 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,” FDA officials said in the notice.
“Since the safety and effectiveness of rhBMP for treatment of cervical spine conditions has not been demonstrated, and in light of the serious adverse events described above, the FDA recommends that practitioners either use approved alternative treatments or consider enrolling as investigators in approved clinical studies,” according to the notice.
The agency said the seriousness of the events reported is due to the proximity of the cervical spine to airway structures and the resultant need for medical intervention.
“The mechanism of action is unknown, and characteristics of patients at increased risk have not been identified,” the agency noted.
Most complications occurred between 2 and 14 days postsurgery, with only a few events occurring prior to day 2. When airway complications occurred, medical intervention was frequently necessary. Required treatments included respiratory support with intubation, anti-inflammatory medication, a tracheotomy and, most commonly, second surgeries to drain the surgical site.
The FDA has approved the use of two rhBMPs for well-defined medical conditions in limited patient populations:
- rhBMP-2 (contained in Infuse Bone Graft; Medtronic Sofamor Danek) has received premarket approval for fusion of the lumbar spine in skeletally mature patients with degenerative disc disease (DDD) at one level from L2-S1 and for healing of acute, open tibial shaft fractures stabilized with an IM nail and treated within 14 days of the initial injury. rhBMP-2 is also approved for certain oral and maxillofacial uses.
- rhBMP-7 (referred to as OP-1 and contained in OP-1 Implant and OP-1 Putty; Stryker Biotech) has received humanitarian device exemption approval as an alternative to autograft in recalcitrant long bone nonunions where use of autograft is unfeasible and alternative treatments have failed. It is also approved as an alternative to autograft in compromised patients requiring revision posterolateral (intertransverse) lumbar spinal fusion for whom autologous bone and bone marrow harvest are not feasible or are not expected to promote fusion. Examples of compromising factors include osteoporosis, smoking and diabetes.