Medtronic, Stryker Bone Graft Products Linked to Serious ComplicationsJul 2, 2008 | Parker Waichman LLP
Off-label use of Medtronic Inc.'s InFuse Bone Graft and Stryker Corp.'s OP-1 Implant and OP-1 Putty have been linked to potentially fatal complications, according to the Food & Drug Administration (FDA). The agency says it has received 38 reports over the past four years of complications when these recombinant human Bone Morphogenetic Protein (rhBMP) products were used in cervical spine (neck) fusion surgeries - an unapproved use of the products.
The FDA says that the complications involve 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. The agency said severe dysphagia following cervical spine fusion using rhBMP products has also been reported in medical literature.
Though the cause of these reactions has not been determined, the FDA says that the proximity of the cervical spine to airway structures in the body contributed to the seriousness of the events reported and the need for emergency medical intervention. 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.
The FDA has advised that doctors use rhBMP products only for approved treatments. Those interested in using the products for neck fusion surgeries should consider enrolling as investigators in clinical trials currently underway to investigate the safety and effectiveness of these products when used in neck fusion surgery.
The FDA also cautioned that patients treated with rhBMP in the cervical spine should know:
- the signs and symptoms of airway complications, including 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