A new study by a Stanford physician shows a possible connection between Medtronic Inc.’s spine device Infuse with male sterility. The study is significant since earlier studies funded by Medtronic showed no such correlation. Infuse is a bone growth protein that has been used in spinal fusions since 2002.
The NY Times quoted Dr. Eugene J. Carragee who performed the study, ““It is important that men who are considering having children have the opportunity to weigh the risks of the various available procedures,” said Dr. Carragee, who based his study on 240 patients he treated several years ago with Infuse or a bone graft.
The procedure in which Infuse is used is called an anterior lumbar fusion. There are approximately 80,000 such procedures performed each year.
The new Stanford study renews the debate concerning the accuracy and effectiveness of studies that are funded by the companies themselves. Two surgeons who published favorable Infuse results had financial arrangements with the maker of Infuse, Medtronic, Inc.
In publishing his findings, Dr. Carragee noted that his study was prompted by a complaint he received from a Croatian doctor. “Since 2006, an orthopedic surgeon in Croatia, Dr. Tomislav Smoljanovic, has written more than 35 letters to medical journals questioning the claims. In their 2002 report, Dr. Burkus and Dr. Zdeblick reported that a major clinical study involving Infuse had found no adverse effects with the product, including the sterility-related complication.”