title: Adverse events reported after the use of recombinant human bone morphogenetic protein 2.
abstract: OBJECTIVE
  The US Food and Drug Administration has approved recombinant human bone morphogenetic protein 2 (rhBMP-2) (Infuse Bone Graft; Medtronic Sofamor Danek, Minneapolis, MN) as an alternative to autogenous bone graft for sinus augmentations and for localized alveolar ridge augmentations for defects associated with extraction sockets. The objective of this analysis was to characterize adverse events reported after the use of rhBMP-2 in oral and maxillofacial procedures.
  
  
  METHODS
  The US Food and Drug Administration's Manufacturer and User Facility Device Experience database contains reports of adverse events involving medical devices. The publicly available version of the database was searched for reports for the brand name Infuse Bone Graft. Descriptive statistics were used to summarize the procedures and adverse events.
  
  
  RESULTS
  As of April 30, 2011, the Manufacturer and User Facility Device Experience database contained 83 reports of adverse events after oral and maxillofacial operations involving rhBMP-2. Of these reports, 55 (66.3%) described off-label uses, such as reconstruction of the mandible after fracture or cancer or alveolar cleft repair. The most commonly reported adverse events included local reactions, graft failure, infections, and other wound complications. Of the reports, 25 (30.1%) stated that the patient required additional surgery to address the reported adverse event.
  
  
  CONCLUSIONS
  Serious adverse events, some of which may require a second operation, can occur after the use of rhBMP-2 in oral and maxillofacial procedures. In this analysis graft, failure and pseudarthrosis were more commonly reported after off-label uses of rhBMP-2 than approved uses.
authors.affiliation: US Food and Drug Administration, Rockville, MD, USA. jane.woo@fda.hhs.gov
authors.forename: Emily Jane
authors.initials: EJ
authors.lastname: Woo
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems / Q000706:statistics & numerical data*; D000539:Alveolar Process / Q000002:abnormalities; D055396:Bone Morphogenetic Protein 2 / Q000009:adverse effects*; D002972:Cleft Palate / Q000601:surgery; D019992:Databases as Topic; D016903:Drug Monitoring / Q000706:statistics & numerical data; D006085:Graft Survival / Q000187:drug effects; D006801:Humans; D008337:Mandibular Fractures / Q000601:surgery; D008339:Mandibular Neoplasms / Q000601:surgery; D056687:Off-Label Use / Q000706:statistics & numerical data; D019647:Oral Surgical Procedures / Q000706:statistics & numerical data*; D011542:Pseudarthrosis / Q000209:etiology; D011994:Recombinant Proteins / Q000009:adverse effects; D019651:Plastic Surgery Procedures / Q000706:statistics & numerical data; D012086:Reoperation; D013530:Surgical Wound Infection / Q000209:etiology; D016212:Transforming Growth Factor beta / Q000009:adverse effects*; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D055396:Bone Morphogenetic Protein 2; D011994:Recombinant Proteins; D016212:Transforming Growth Factor beta; C499469:recombinant human bone morphogenetic protein-2