A Medtronic product designed to spur new bone growth after spinal surgery can increase the risk of infertility in men, according to researchers whose study is published in the June issue of The Spine Journal.
The company's Infuse is a bioengineered bone growth protein used since 2002. And while the Infuse label notes the sterility-related complication as a possible side effect, Medtronic-sponsored researchers in published reports attributed that complication to surgical technique, not the product itself, the New York Times notes. Indeed, the sterilty connection was never mentioned in at least four published papers from Medtronic-sponsored physicians, according to the Journal Sentinel, which did a profile of doctor payments.
However, Eugene Carragee, chief of spinal surgery at Stanford School of Medicine, found that 7.2 percent of his patients treated with the product during spine surgery developed retrograde ejaculation versus 0.6 percent of those who didn't receive Infuse. "This product became quite fashionable when it came out, and it started to be used in people who didn't have any risk factors" that might have hindered bone growth, Carragee said in a telephone interview with Bloomberg. "For someone who is young and healthy, they are probably going to heal just fine. In men who might want children, they should be counseled to think about what the alternatives are."
The NYT reports the two surgeons involved in the original Infuse trial, Dr. J. Kenneth Burkus and Dr. Thomas Zdeblick, defended their findings in statements. The paper also notes the two men have each received millions of dollars from Medtronic in consulting fees or royalty payments.
A Medtronic spokeswoman said the company believed that it had provided the FDA and healthcare providers with all available medical information about Infuse, which had estimated sales of about $900 million in the company's most recent fiscal year, the NYT notes.
The Journal-Sentinel points out Medtronic is under investigation by the Justice Department over allegations of off-label marketing of Infuse, a case that could be settled in the near future with civil and criminal penalties, according to a Wells Fargo analyst's report issued last month.
ALSO: Medtronic said Tuesday that its fourth-quarter earnings plunged 19 percent in a report Wall Street analysts characterized as "disappointing" and "lackluster." Story