June 23, 2011 – New reports have surfaced indicating that researchers who were financed by Medtronic may have hidden information regarding potential Infuse bone graft side effects. U.S. Senators are now questioning the researchers’ motivations, and whether their official conclusions about the device were reached because they were being paid millions of dollars by the manufacturer. Side effects currently linked to the Medtronic Infuse include an increased risk of fatal swelling of the neck, harmful bone growth and male sterility.
Medtronic Infuse Bone Graft Lawsuit Update 12/10/12: A medical malpractice lawsuit has been filed on behalf of a Pennsylvania man who allegedly experienced severe side effects after undergoing a spinal fusion procedure where the Medtronic Infuse BMP was used as an alternative to a traditional bone graft. The complaint alleges that the design of the Medtronic Infuse, as well as a lack of proper medical care by the surgeon, caused the plaintiff to suffer permanent injuries following the surgery. Click here to learn more.
Medtronic Infuse Bone Graft Update 10/26/12: The U.S. Senate Committee on Finance published a report today accusing medical device manufacturer Medtronic Inc. of editing health journal articles and giving kickbacks to physicians who conducted company-sponsored studies of its Infuse Bone Graft product. According to the report, Medtronic’s role in editing the articles was not disclosed by the company, and that by law, “Medical journals should ensure industry role contributions be fully disclosed.” Click here to learn more.
What’s the problem?
In a letter dated June 21, 2011, Senators Max Baucus and Charles Grassley asked Medtronic to release documents detailing research communications over the development and testing of the company’s Infuse bone growth products. The request comes on the heels of newly-surfaced reports that Medtronic researchers may have covered up the potential risks of Infuse side effects including severe neck swelling, harmful bone growth and sterility.
In the letter addressed to Omar Ishrak, Medtronic’s CEO, senators Baucus and Grassley requested that the company turn over all communications relating to the Infuse bone graft, as well as detailed accounts of payments to researchers involved with the device’s clinical trials and a host of other sensitive documents. The senators emphasized the fact that the finance committee controls Medicare and Medicaid, which in turn reimburse medical device manufacturers.
In May 2011, a Medtronic Infuse study published in the Spine Journal reported information contradicting studies sponsored by the company that claimed sterility suffered by a number of Infuse recipients was due to shoddy surgical techniques. Additionally, there has been increasing concern from a growing number of healthcare professionals that researchers who conducted Infuse clinical trials were being paid by Medtronic, and covered up the device’s potential side effects.
“These reports that doctors conducting medical trials while on Medtronic’s payroll may have hidden serious side effects for patients are deeply troubling,” senator Baucus said in a press release. “Patients have a right to know the risks associated with their treatments, and medical device companies have a duty to disclose this information. We need to do everything we can to ensure companies aren’t concealing serious medical complications from patients just to increase profits.”
Medtronic Infuse & Male Sterility
Many in the medical community have long suspected a link between the Medtronic Infuse bone graft and male sterility. However, in 2009 studies sponsored by the company found no such link, claiming that male sterility in anterior lumbar fusion surgeries were the fault of the doctors. Many questioned the conclusion of the studies, and pointed to the fact that Medtronic was paying the researchers millions in ‘consulting fees.’ It was later revealed that out of the six cases of sterility identified in the studies, five of the individuals were implanted with an Infuse graft.
Airway Compression Caused by the Medtronic Infuse Bone Graft
In addition to the increased risk of male sterility, a number of other complications have been associated with the Medtronic Infuse bone graft including serious and life-threatening airway compression when used in the cervical spine in ‘off-label’ capacities. Sadly, numerous patients have had to receive respiratory support tracheotomies, anti-inflammatory medications and revision surgeries after experiencing adverse events following treatment with a Medtronic Infuse device. Reports of these types of side effects prompted the U.S. Food & Drug Administration (FDA) in 2008 to issue a press release warning that highlighted no fewer than 38 reports of cervical spine fusion problems with Infuse. The majority of these problems occurred within two weeks of having surgery.