Partial federal government shutdown
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Bone morphogenic proteins for use in spinal fusion
Bone morphogenic proteins (BMP) are naturally produced cell regulating proteins (TGF-B family) necessary for bone healing and regeneration, but also involved in other tissue configuration processes.
Status: Decision completed
Why is BMP for use in spinal fusion being reviewed?
There have been recent concerns about safety due to adverse event reports and questions about clinical trial methodology and reporting of potential adverse events. Therefore, significant questions remain about the safety, efficacy and effectiveness, and cost effectiveness of recombinant bone morphogenic proteins when used in spinal surgery.
Primary criteria ranking
- Safety = Medium
- Efficacy = Medium
- Cost = High
Documentation
| Type | Materials |
|---|---|
| Assessment (2012) |
Assessment timeline
- Draft report published: January 12, 2012
- Public comment period: January 12 to 30, 2012
- Final report published: February 14, 2012
- HTCC public meeting: March 16, 2012