There’s more bad news for Medtronic Inc.’s (NYSE:MDT) Infuse product after a report that the bio-engineered bone growth protein can increase the risk of infertility in men, according to a study published in the June issue of The Spine Journal.
Of 69 patients treated with the Infuse product, which has been widely used to fuse spinal vertebrae during surgeries since 2002, 7.2 percent developed retrograde ejaculation compared to 0.6 percent of those who didn’t receive Infuse, according to the Stanford University School of Medicine study.
Among 69 male patients treated with Infuse during surgery, five developed retrograde ejaculation compared to one case among 174 men who received a bone graft. The condition leads to temporary or permanent sterility in men.
The Infuse product, already mired in the U.S. Dept. of Justice’s probe of alleged off-label marketing of Medtronic’s bone growth product line, brought in $900 million for MDT in its most recent fiscal year.
The most recent findings regarding male infertility are in stark contrast to earlier research funded by MDT, the New York Times reports. The Infuse label notes sterility-related complications, but attributes them to surgical technique rather than to the product.
The bone growth product line has been problematic for Medtronic this year, beginning when the company was sued by its employees over allegations that the Fridley, Minn.-based company kept them in the dark about problems related to its Infuse bone graft material.
In March the U.S. Food & Drug Administration put the kaibosh on MDT’s Amplify spine device, which was designed to address concerns about off-label use of the Infuse device.