Injured after a Medtronic Infuse implant?
You may be entitled to a CASH SETTLEMENT
The FDA has warned about serious complications connected to the off-label use of BMP spinal implants such as Infuse®. A large majority of the uses of the Infuse® product have been shown to be off-label usage, according to a recent legal settlement by Medtronic®.
Facts about Medtronic Infuse:
- The Infuse® BMP spinal implant was only approved by the FDA for use in spinal fusion surgeries using an anterior approach (through the front of the body). This approval was limited to the lumbar region of the spine. For more information about the FDA findings, visit: http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/ucm062000.htm.
- Lawsuits have brought to light the fact that Medtronic may have used marketing techniques to push the Infuse® Bone Graft implant for “off-label” use not approved by the FDA. When used for off label purposes, the Infuse® Bone Graft implant has the potential to cause severe side effects, including swelling of the throat, bone formation in the spinal canal, radiculitis and even death.
- An unprecedented medical journal review of Infuse found unreported complications and undisclosed financial conflicts among doctors. The complications range from sterilization in men to unwanted bone growth.
- In November 2008, Medtronic disclosed that the U.S. Department of Justice (DOJ) was investigating the off-label use of a Medtronic’s Infuse bone graft. According to a report from The Wall Street Journal, at least 280 reports of side effects involving Infuse had been made to the FDA when the investigation was announced.
- The Wall Street Journal also reported that Medtronic paid approximately $800,000 over three years to a surgeon who was accused of fabricating a study that reported positive results for the Infuse Bone Graft.
- About three-quarters of those reports involved off-label use. While doctors are permitted to use approved medical devices in any way they see fit, it is illegal for manufacturers to market products based on such uses.
- In March 2011, the FDA rejected Medtronic’s approval application for the Amplify bone graft product because of concerns it could increase cancer risks among patients who received it.
- In June 2011, the US Senate Finance Committee announced it is investigating surgeons who were paid consultants for Medtronic. The inquiry will result in a study showing that the bone graft product was linked to complications during clinical trials but those complications were not properly reported. Some of those complications reportedly include swelling in the neck and throat, abnormal bone growth and sterility.
- One implication of the findings so far has been that Infuse was linked to a cancer diagnosis more often than when the product was not used at all. However, Amplify was tied to more cancer risk than Infuse.
- A recent issue of the Spine Journal in June 2011 indicated numerous problems with the process in which the Medtronic® Infuse® bone graft product was approved by the FDA in the first place. The Spine Journal points to a variety of conflicts of interests between the doctors reporting to the FDA that may have gone unreported.
- Lawsuits are now being investigated across the nation due to information concerning “off-label” promotion of the BMP spinal implants like the Medtronic Infuse Bone Graft.
If you or someone you know experienced serious side effects that might be associated with the implant of a Medtronic Infuse Bone Graft, our defective drug lawyers want to hear from you today. To discuss your potential Medtronic Infuse lawsuit due to an “off label” implant or other Medtronic Infuse side effects lawsuit with an experienced defective drug lawyer, we urge you to contact us today.