A new study published in The Spine Journal shows a stronger correlation between the use of rhBMP-2 for spinal fusions and infertility in male patients than was originally supposed, according to a North American Spine Society news release.
The study was conducted by Eugene J. Carragee, MD, a professor at the Stanford University School of Medicine and the editor-in-chief of The Spine Journal. While the risk of infertility has been associated with biologic bone growth factors, industry-sponsored publications may have downplayed the actual risk in the past.
The study examined patients undergoing anterior lumbar interbody fusion using either rhBMP-2 or a local bone or iliac crest bone graft. After the surgery, retrograde ejaculation (RE) events were recorded. RE can cause permanent infertility in some men.
About 7.2 percent male patients undergoing one- or two-level ALIF with rhBMP-2 experienced RE, which is significantly more than the men undergoing ALIF without rhBMP-2, of whom 0.6 percent experienced RE. Patients undergoing single-level ALIF surgeries were less likely to experience RE with and without rhBMP-2, at 6.7 percent and 0 percent, respectively.
While these results were similar to the results found in the FDA trials, those findings were not widely reported in medical literature, according to the release. "In my opinion, it is important that men who are considering having children have the opportunity to weigh the risks of various available procedures so they can make their best-informed decision," says Dr. Carragee.
The use of rhBMP-2 has also been associated with early inflammatory reactions, including soft tissue swelling and sterile cyst formation, as well as early osteolysis and implant dislodgement. In the commentary on the article, James Kang, MD, of the University of Pittsburgh School of Medicine, mentioned that rhBMP-2 has contributed to the significant increase in spine care spending, at $4,500 per kit, and there hasn't been convincing data that the protein has significantly improved patient-based outcome measures.
Read the release on male sterility after using rhBMP-2 for spinal fusion.
Related Articles on Spinal Fusion:
Spinal Fusion Reimbursement: Q&A With NASS President Dr. Greg Przybylski
Spinal Fusion's Place in the Future: 9 Points on Fusion Efficacy and Coverage
5 Points on Lowering the Cost of Spinal Fusion Care
The study was conducted by Eugene J. Carragee, MD, a professor at the Stanford University School of Medicine and the editor-in-chief of The Spine Journal. While the risk of infertility has been associated with biologic bone growth factors, industry-sponsored publications may have downplayed the actual risk in the past.
The study examined patients undergoing anterior lumbar interbody fusion using either rhBMP-2 or a local bone or iliac crest bone graft. After the surgery, retrograde ejaculation (RE) events were recorded. RE can cause permanent infertility in some men.
About 7.2 percent male patients undergoing one- or two-level ALIF with rhBMP-2 experienced RE, which is significantly more than the men undergoing ALIF without rhBMP-2, of whom 0.6 percent experienced RE. Patients undergoing single-level ALIF surgeries were less likely to experience RE with and without rhBMP-2, at 6.7 percent and 0 percent, respectively.
While these results were similar to the results found in the FDA trials, those findings were not widely reported in medical literature, according to the release. "In my opinion, it is important that men who are considering having children have the opportunity to weigh the risks of various available procedures so they can make their best-informed decision," says Dr. Carragee.
The use of rhBMP-2 has also been associated with early inflammatory reactions, including soft tissue swelling and sterile cyst formation, as well as early osteolysis and implant dislodgement. In the commentary on the article, James Kang, MD, of the University of Pittsburgh School of Medicine, mentioned that rhBMP-2 has contributed to the significant increase in spine care spending, at $4,500 per kit, and there hasn't been convincing data that the protein has significantly improved patient-based outcome measures.
Read the release on male sterility after using rhBMP-2 for spinal fusion.
Related Articles on Spinal Fusion:
Spinal Fusion Reimbursement: Q&A With NASS President Dr. Greg Przybylski
Spinal Fusion's Place in the Future: 9 Points on Fusion Efficacy and Coverage
5 Points on Lowering the Cost of Spinal Fusion Care