Absence of bone morphogenetic protein-2 in human breast milk after spinal surgery

Abstract

Background context: Bone morphogenetic protein-2 (BMP-2) has been used extensively in recent years to enhance the process of spinal fusion. However, numerous side effects have been reported. This raises concerns regarding the safety of using this material in human beings. There are no published reports, that we are aware of, that demonstrate detectable levels of BMP-2 in human milk.

Purpose: The purpose of this study was to determine the presence/absence of recombinant human bone morphogenetic protein-2 (rhBMP-2) in milk samples taken from a patient who underwent spinal surgery using rhBMP-2 shortly after delivering a child.

Study design/setting: The study design comprises a case report dealing with analyzing milk from a patient who underwent spinal surgery using rhBMP-2 shortly after delivering a child.

Methods: We report the analysis of milk samples from a patient who underwent spinal surgery using rhBMP-2 shortly after delivering a child to determine the presence/absence of rhBMP-2. The milk samples were taken before and after the spinal surgery. Enzyme-linked immunosorbent assays were performed repeatedly to the samples.

Results: The standard curve for the assay had an r(2) value of 0.9853 indicating an acceptable degree of statistical reliability. The dose range for the standard curve was 62.5 to 2,000 pg/mL. None of the samples had an optical density greater than that of the lowest standard.

Conclusions: No rhBMP-2 was detected in human milk in this single case report. Although this result seemed promising, it did not eliminate the concern regarding the potential risk of rhBMP-2 on child development. We still need further studies including more cases to verify this conclusion.