Retrograde ejaculation after anterior lumbar interbody fusion using rhBMP-2: a cohort controlled study
Abstract
Background Context
The commercially available growth factor recombinant bone morphogenic protein-2 (rhBMP-2) used in spinal fusion has been associated with numerous adverse reactions, including inflammatory reactions in soft tissue, heterotopic bone formation, radiculitis, osteolysis, and cage or graft subsidence. The original Food and Drug Administration Summary of anterior lumbar interbody fusion (ALIF) reported 12 retrograde ejaculation (RE) events (8%) in the rhBMP-2 groups compared with (1.4%) in the control group. It had been debated whether this finding was related to rhBMP-2 use.
Purpose
To compare the incidence of RE after ALIF in patients with and without rhBMP-2 use.
Study design
Retrospective analysis of prospectively gathered outcomes data on consecutive subjects having ALIF with and without rhBMP-2 use.
Patient sample
Male patients with lumbar spondylosis or spondylolisthesis having ALIF of the lowest one or two lumbar levels with and without rhBMP-2.
Outcome measure
Report of RE as a new finding after ALIF.
Methods
From the comprehensive outcome database at a high-volume university practice, male subjects having ALIF for one- (L5/S1) or two-level (L4/L5, L5/S1) lumbar fusion were identified. Retrograde ejaculation events were recorded and comparative incidence compared.
Results
The two groups were comparable for age and additional procedures performed. There were 69 L5/S1 ALIFs performed with rhBMP-2 and 174 ALIFs performed without rhBMP-2 during the study period. Of those, 24 and 64 were two-level ALIFs performed with and without rhBMP-2, respectively. There were five RE events (7.2%) reported in the rhBMP-2 group and 1 (0.6%) in the control group. Comparing single-level L5/S1 ALIF, there was a 6.7% and 0% rate of RE in the rhBMP-2 versus control groups, respectively. At 1 year after surgery, three of six affected subjects reported resolution of the RE.
Conclusion
This study confirms previous reports of a higher rate of RE in ALIF procedures using rhBMP-2. This may be an important consideration in subjects concerned with sterility after surgery.
Further Reading:-
1. http://www.thespinejournalonline.com/article/S1529-9430(11)00139-2/fulltext
This study is of tremendous importance since INFUSE manufactured by Medtronics has been used extensively in the US. An earlier report by Dr. J. Kenneth Burkus and Dr. Thomas A. Zdeblick, who have done the INFUSE trial had not described these complications. But Eugene Carragee, the editor of spine journal has come out with this particular complication. In an e-mail, Dr. Zdeblick said Dr. Carragee’s study was of limited value because it reflected the results of a retrospective look at patients rather than a clinical trial. Such reports “are notorious for being misleading,” he wrote.
This news article from the NewYork times maybe disturbing for many.
http://www.nytimes.com/2011/05/25/business/25spine.html?_r=1
I had always believed the use of BMP would have to be soon tempered for the potential inflammation it causes and the uncontrolled bone formation often reported.
I was honestly not aware of this particular paper but it has highlighted what we suspected all along- that ALIF is not too safe with BMP; and revision is a dangerous
proposition in that region. Having said that there are several tips for avoiding the pre sacral plexus while dissecting the retroperitoneal area
http://www.aaos.org/news/aaosnow/sep11/cover2.asp