Infuse Linked to Infertility in Men
BY LAUREN UZDIENSKI, MAY 25, 2011
A retrospective review of Medtronic's Infuse study published in the Spine Journal this week showed a correlation between male patients treated with Infuse and sterility. Medtronic and the surgeon investigators in the study attributed the side effect to surgeon technique and not Infuse itself, which is why it had generally been excluded in previously published studies.
The latest study was authored by Dr. Eugene J. Carragee of Stanford. He found that among male patients who underwent anterior fusion in the main arm of Medtronic's Infuse study, the data that formed the basis of the product's PMA approval, five of 78 men (6.4%) treated with BMP-2 developed retrograde ejaculation, which leads to sterility. Among patients who received autograft, one of 68 men (1.4%) experienced the adverse event. In another arm of the study, six of 57 men (10.5%) treated with BMP-2 also developed retrograde ejaculation.
Medtronic did disclose the adverse event in FDA documents, and surgeon supporters of Infuse attested that there was "no relationship" between Infuse and retrograde ejaculation in a JBJS article in 2010. Further, the events in the main arm of the study were not statistically significant, and the surgeons state that the condition resolved itself in five of the 11 patients (45%) affected.
While Dr. Carragee's analysis may not establish a clear causal relationship between the use of Infuse and sterility, adverse events and bad press continue to mount for Infuse. The product is known to be associated with inflammatory reactions, sterile cyst formation, bone damage, loss of alignment and respiratory complications when used in the cervical spine, over which the FDA issued a warning in 2008.
