Medtronic Infuse® Associated with Cauda Equina Syndrome
Have you been diagnosed with Cauda Equina Syndrome (CES)?
Prior to your diagnosis, did you undergo a Medtronic INFUSE® spinal fusion surgery? Medtronic INFUSE® is a synthetic form of recombinant human Bone Morphogenetic Protein (rhBMP-2 or BMP2) approved for use in a particular type of spinal surgery and some dental procedures. However, BMP-2 is being used in an off-label fashion for multiple reasons. For instance, rather than performing the surgery from an “anterior” or front approach, it’s being utilized in a “posterior” or rear approach. Additionally, it is being used for the cervical area of the spine as well as for multiple levels of the spine – all of which are off-label. Because the BMP-2 powder is supposed to be mixed with a certain amount of water for a certain amount of time, the lack of precision (in time and amount) may be leading to specific injuries.
Evidence is emerging that doctors may be utilizing too much water or too much BMP-2 during off-label surgical spine procedures. The bone growth product, which is a sealant, can potentially drip onto the spinal cord or spinal nerves, leading to serious, severe injuries, including Cauda Equina Syndrome.
Parker Waichman LLP is offering free lawsuit evaluation to victims of Medtronic INFUSE® injuries and complications. To ensure your legal rights are protected, we urge you to contact a Medtronic INFUSE® side effect lawyer at Parker Waichman LLP today.
For More Information Please Watch Our Video Below.
Cauda Equina Syndrome Injuries
Cauda Equina Syndrome is caused by a significant narrowing of the spinal canal, in which nerve roots below the spinal cord level become severely compressed or inflamed. Although a number of causes of Cauda Equina Syndrome are known, the use of Medtronic INFUSE® in off-label spinal surgery has been associated with this devastating injury. Inflammation typical with Cauda Equina Syndrome is believed to be associated with Medtronic INFUSE® procedures, likely the result of the product coming into contact with nerves and other areas of the body.
Damage to the nerve roots due to Cauda Equina Syndrome following surgery with Medtronic INFUSE® can lead to:
- Altered reflexes
- Decreased strength and/or sensation
Cauda equina syndrome is considered a surgical emergency and, if left untreated, can lead to:
- Permanent loss of bowel and bladder control
- Paralysis of the legs
Other Complications Associated with Medtronic INFUSE®
Data provided to the U.S. Food & Drug Administration (FDA) revealed that at least half of all patients treated with INFUSE® suffered complications including:
- Uncontrolled Bone Growth
- Male Sterility
- Retrograde Ejaculation
- Gastrointestinal Problems
- Nerve Injuries
- Chronic Pain
- Difficulty Swallowing, Breathing and/or Speaking
- Swelling of the Neck Resulting in Injury or Death
The FDA also warned that the product was linked to life-threatening complications. Many injuries have occurred when BMP-2 was used in an unapproved, so-called “off-label,” procedures, which accounts for some 85 percent of all procedures. In fact, Medicare is considering stopping coverage of BMP-2.
Of note, ectopic bone formation is being seen when BMP-2 is used off-label, including back, or posterior method surgeries. A clinical trial created to review this troubling bone formation—which was seen in 75 percent of BMP-2 patients was stopped early over what study authors said was "out of abundant caution."
Medtronic INFUSE® in the News
A U.S. Senate Finance Committee report just revealed that Medtronic Inc., edited journal articles and paid physicians massive sums for Medtronic-sponsored studies of its INFUSE® bone-graft product. Over the last several years, Medtronic has been embroiled in controversies that have shed doubt on the safety of INFUSE® and the company’s marketing of the product.
The Committee’s report found that ties between Medtronic and its physician consultants were questionable and Medtronic is being accused of ghost writing sections of 11 medical papers and of paying physician consultants in the hundreds of millions of dollars in so-called “consulting fees” in exchange for promotion of INFUSE®. This type of so-called "ghostwriting" is not illegal, but is largely thought of as a breach of integrity and puts doctors and patients in a position in which they are relying on incomplete, flawed data when determining important medical decisions, noted WebPage Today. None of the 13 Medtronic-funded clinical trials reported INFUSE® side effects.
Meanwhile, the Spine Journal devoted a full issue in 2011 to proving the INFUSE® research wrong. As a result, Medtronic, Inc., under its then-new CEO, Omar Ishrak, hired Yale University to manage an independent review of INFUSE®’s efficacy and safety. "This sounds eerily familiar to many of the transgressions we've read about from the pharmaceutical industry," Dr. Harlan Krumholz, a professor of medicine at Yale University, told MedPage Today when advised of the Senate report. "It paints a picture of a company very heavily involved in the science; marketing contaminating the science; and the medical profession and researchers being complicit. It's no wonder the public has lost confidence in the drug and device industries," Krumholz added. Krumholz is in charge of the Yale review of Infuse.
Dr. Harlan Krumholz—described by Forbes magazine as “the most powerful doctor you never heard of”—and his team at Yale will address two fundamental questions: Does INFUSE® work? Is it safe? “I’m not seeking to address how the product was marketed,” Krumholz told the Star-Tribune. “I’m just sticking to the science. I’m trying to set in place a new way of doing business.”