Since most of the industry-sponsored studies reported “no adverse events” with the use of rhBMP-2 a sense of presumption of safety set in and surgeons began doing posterior lumbar interbody fusion (PLIF) procedures for spinal fusion. This was clearly an off-label use of the Infuse bone graft. By 2007, more than 50 percent of primary ALIF, 43 percent of PLIF and transforaminal lumbar interbody fusion (TLIF) were reported to use rhBMP-2. On close review several important observations emerged, which were not reported by authors of industry-sponsored studies.
One of the main observations was ectopic bone growth or unwanted bone growth into the spinal canal in the rhBMP-2 group that underwent PLIF. This was uncontrolled growth away from the intended site. The trial discontinued due to bony overgrowth at the incision site. On evaluation new bone formation into the spinal canal or neuroforamina in 24 of 32 rhBMP-2 patients was seen as compared with four of 31 patients in the control group. Patients also needed reoperation after PLIF procedures. A surgeon in Oklahoma involved in an FDA study reported “two of the Infuse patients had significant posterior bony overgrowth impinging on their nerve roots requiring additional surgery. One patient, who was my patient, required two surgeries to clear excessive bone growth from his spinal canal.” This observation was documented in the FDA record but were not included in the authors’ comments on unanticipated adverse events related to rhBMP-2 in PLIF surgery.
Another surgeon reported ectopic bone growth in the spinal canal on five patients after PLIF or TLIF using rhBMP-2. The patients reported neurological complaints, and three of these patients underwent an extensive and difficult revision surgery.
If you or someone you know suffered painful injuries after being implanted with a Medtronic Infuse Bone Graft device, you may have valuable legal rights. We’re here to answer any questions you may have. For a free case review fill out our online form to the right or call our office at 1 (855) 444-3713.