rhBMP-2/ACS must be applied within 14 days after the initial fracture. Like all implanted medical devices, rhBMP-2/ACS may have side effects. The most frequent side effects included: 

abnormal healing at the surgical site; abnormal lab tests which included those related to pancreas and liver function, anemia, and decreased concentrations of calcium and potassium; constipation; nausea and vomiting; allergic reactions at the surgical site; infections at the surgical site; local and surgical site inflammation; altered mental status; altered sensations at the surgical site; and respiratory difficulties.

Some patients in the clinical trial who were treated with rhBMP-2/ACS 1.5 mg/mL had an antibody response to either rhBMP-2 (9 patients) or the ACS (29 patients).  Because of the small numbers of patients who developed antibodies,it was not possible to determine if there was a connection between the antibody formation and the need for additional treatment to heal their fracture.

Among the less frequent side effects, some patients (6 percent) treated with rhBMP-2/ACS had abnormal bone healing at the fracture site.

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