Medtronic INFUSE Serious Side Effects Disregarded Because of Financial Payments to Researchers?
November 23rd, 2011 tmccoy
It was supposed to revolutionize spinal fusion surgery. It was supposed to be the gold standard for treating degenerative disc disease. It was supposed to alleviate the pain.
Forget what it was supposed to be and let’s focus on what it actually is. And for that, can’t we just ask the researchers? Usually, yes. But what if the researchers have such a significant financial relationship with the manufacturer that their reports and conclusions are deemed inaccurate… Now, what? Let me explain.
INFUSE, the brand name for bone morphogenetic protein-2, is a powerful biological agent used in spinal fusion surgery. The product stimulates bone growth and eliminates the need to harvest a small amount of a patient’s own hip bone to create a fusion between two vertebrae.
Recently, a United States Senate committee launched an investigation into reports that doctors with financial ties to the medical device company Medtronic were aware of serious complications involving Medtronic’s spine surgery product, INFUSE, which was approved by the Food and Drug Administration (FDA) in 2002. It was revealed (you can’t make this stuff up, can you?) that large payments made to prominent surgeons around the country were involved in the clinical testing of INFUSE or who wrote positive medical journal articles that failed to link the product to serious complications.
As if the idea of spinal surgery isn’t scary enough, now there’s evidence that this product, which has been implanted in more than 500,000 patients by more than 2,300 surgeons, may be linked to a complication that causes sterility in men; something which doctors knowingly omitted in their research.
Since 2002, according to the Journal Sentinal, Medtronic and a group of doctors with financial ties to the company were actually aware of this link BUT did not reveal this crucial information in medical articles written by these doctors, including surgeons who would receive millions of dollars in various royalties from Medtronic.
From our research, we’ve noticed a link between the implant of Medtronic INFUSE and the following injuries:
- Acute severe swelling of the neck several days after surgery, resulting in death or permanent injury
Cancer - Difficulty swallowing
- Difficulty breathing
- Difficulty speaking
- Ectopic or uncontrolled bone growth at or near the site of the surgery
- Nerve injuries causing severe and chronic pain
- Ongoing or chronic radiating pain in the legs or arms (i.e., neuritis, radiculopathy, or radiculitis)
- Male sterility
- Retrograde ejaculation, or other uro-genital injuries in male patients
If you’ve had the Medtronic INFUSE implanted inside of you and you suffer from one of the above injuries, call us to discuss. You may have a claim against Medtronic for your injuries.
