Research shows the bioengineered bone growth protein, recombinant human bone morphogenetic protein (rhBMP-2)—sold under the brand name Infuse—causes male infertility. The Rottenstein Law Group compassionately advocates for those who have suffered from the harmful side effects of potentially dangerous drugs. If you received Infuse Bone Graft in surgery and believe it harmed you, contact RLG for a free, confidential legal consultation immediately. We will evaluate your case and remain on the lookout for Infuse Bone Graft recalls and Infuse Bone Graft class action lawsuits. We might be the Infuse Bone Graft law firm you are looking for.
Potential Side Effects Include Male Infertility
Medtronic Infuse Bone Graft is the brand name for the naturally occurring recombinant human bone morphogenetic protein (rhBMP-2) and its accompanying Absorbable Collagen Sponge (ACS). This prescription chemical is used to help regrow damaged bone tissue by creating a scaffold to accommodate new bone mass. The U.S. Food and Drug Administration (FDA) approved Infuse for open tibial (shin bone) fractures, degenerative disc disease, and two dental bone grafting procedures. Any other use is off-label. Medtronic sold $900 million worth of Infuse product in 2010.
Since 2002, doctors have used Infuse in two spinal procedures, specifically anterior lumbar fusion (lower back) and cervical spine fusion (neck). This is quite risky as Medtronic Infuse Bone Graft can damage nearby tissue if it isn’t inserted properly or if leaks out of the ACS, which can cause spontaneous bone growth where it is not desired. Surgeons based in North Carolina determined that complications arose in 21% of the cervical fusion procedures that did not involved the Medtronic Infuse, and in 59% of the cervical infusion procedures that did involve Medtronic Infuse. Subsequently, the FDA issued a Medtronic Infuse Bone Graft warning in July 2008. Of the 280 adverse event reports submitted to the FDA, three in four were for off-label uses. Consequently, in November 2008, the Justice Department began investigating Medtronic for illegally advertising the Medtonic Infuse Bone Graft. Later, Medtronic settled two whistleblower lawsuits for $40 million.
According to a May 25, 2011 New York Times article, Stanford University surgeon Dr. Eugene J. Carragee authored a study that was published by the web site The Spine Journal. In the study, Dr. Carragee studied 240 men who underwent cervical fusion surgery. The off-label use of the Medtronic Infuse Bone Graft was involved in 69 of those procedures. Five of the six men who developed a condition called retrograde injection were Infuse recipients. When a man experiences retrograde injection, his semen goes into his bladder, making him infertile. The condition cleared itself in three of the six men. The Medtronic Infuse Bone Graft does not appear to affect women.
Dr. Carragee is not alone in his findings. Two Croatian physicians, Dr. Tommislav Smoljanovich and Dr. Ivan Bojanic, point out that Dr. Carragee’s findings are consistent reports that Medtronic itself submitted to the FDA in 2002 arguing for Infuse’s approval, though Medtronic strenuously denies this interpretation. The University of Pittsburgh’s Dr. James D. Kang notes other complications caused by off-label Infuse use in cervical fusion procedures, “[E]arly inflammatory reactions of soft-tissue swelling and sterile cyst formation … [I]t has resulted in potentially life-threatening airway complications.” These complications occurred in the 2-to-14 day period after surgery, and patients required tracheotomies, feeding tubes, anti-inflammatory medications, and additional surgery.
Several Infuse cervical fusion lawsuits have been filed against Medtronic, and at least one Medtronic Infuse Bone Graft class action lawsuit has been filed against the company by shareholders over illegal advertising.
A June 17, 2013, report in the New York Times focused on some research that indicated that the benefits of the Infuse Bone Graft were overstated. Medtronic released the data after it was accused in 2011 of overstating the efficacy and downplaying the risks of the product in company-sponsored research studies.
RLG’s Lawyers Will Make Things Easier
The process of demanding compensation for the harm you’ve suffered can be complicated, even if it doesn’t seem fair that you should have to go through even more trouble to be made whole again. The lawyers at the Rottenstein Law Group believe that obtaining legal satisfaction from those who harmed you shouldn’t require more hardship. That’s why we do everything we can to streamline the process, and we will file a Infuse Bone Graft lawsuit on your behalf if necessary. RLG will also keep you up to date on any Infuse Bone Graft class action lawsuits, FDA Infuse Bone Graft warnings, and Infuse Bone Graft FDA recall announcements.
If you received Infuse Bone Graft in surgery and believe it harmed you, contact RLG today.