Medtronic Information Center: __________________ Problems with Medtronic Infuse Bone Growth Product Medtronic Infuse and Serious Issues Medtronic Infuse - Bone Graft Lawsuit Infuse Bone Graft Medtronic Bone Graft Lawsuit Medtronic Bone Graft Death Lawsuit FDA Warning on Medtronic Off-Label Use Cancer Concerns Raised by New Study on Medtronic Infuse Bone Graft

As you may know Medtronic, is a medical products company with a questionable track record.  Now there is an issue with the Medtronic synthetic bone growth product Infuse.

Over the last 6 years Medtronics has paid the federal government $40 million to settle allegations of kickbacks to physicians, then paid $75 million to settle claims of defrauding Medicare. Also in 2008, the U.S. Department of Justice began investigating whether Medtronic had been illegally promoting "off-label" use of Infuse.

Now the reported problems with Infuse have become so widespread that the Spine Journal devoted the entire June 2011 edition to concerns about Infuse and Medtronic's research. In 2004, a small group of doctors wrote multiple papers stating that Infuse did not cause any harm to patients. The doctors who wrote the article would eventually receive millions of dollars from Medtronics.

The Spine Journal reports that those doctors did not disclose their financial ties to Medtronic and that the papers repeatedly failed to report complications with Infuse. Infuse can cause unwanted, and sometimes out-of-control, bone growth. The Spine Journal found that the complication rate for Infuse was anywhere from 10 to 50 times higher than reported in the Medtronic studies.

The United States Food & Drug Administration only approved Infuse for fusions in the lower back. However, doctors have been using it "off-label" for cervical (neck) spinal fusions, too often with disastrous results.

Unwanted bone growth in the neck can result in:

• difficulty with breathing and swallowing
• tracheotomies
• emergency surgery
• the placement of feeding tubes
• revision surgery (additional surgery needed to fix the problem)

Other reported problems with Infuse include:

• male sterility
• infection
• cancer
• bone loss
• unwanted bone growth
• nerve damage
• incontinence

If your doctor used Infuse for your spinal fusion surgery and you were harmed, call us. 

TRADEMARK NOTICE: Sprint Fidelis is a trademark of Medtronic Corporation.

The Carabin & Shaw Law Firm, its' lawyers and this website is in no way affiliated with Medtronic Corporation. The use of this mark is solely for informational and product identification purposes.

Other Medtronic recall information:

On October 15, 2007, the FDA announced a nationwide Medtronic recall for the Sprint Fidelis lead, which is an electrical wire that connects a defibrillator to the heart. The defective lead is prone to fracturing or breaking, which could result in a massive electrical shock or cause the defibrillator to not work when it is needed. The FDA classified the Sprint Fidelis recall as a "class 1" recall since the defect has a substantial likelihood to cause serious injury or death.  Any heart patients who have had a defibrillator implanted since 2004 should consult with their physician or check the patient information card given at the time the device was implanted. The Medtronic recall applies to the following leads:

• Sprint Fidelis model 6930
• Sprint Fidelis model 6931
• Sprint Fidelis model 6948
• Sprint Fidelis model 6949

The Sprint Fidelis lead was introduced by Medtronic in 2004. It was developed in a rush to compete with other cardiac device companies by having a more compact and flexible product. It replaces their thicker lead, known as the Sprint Quattro, which was introduced in 2001. Metronic has received reports of individuals experiencing severe electrical shocks as a result of their defibrillator firing when it was not needed, and at least five deaths could have been caused by the faulty lead wire. A recall was issued following a review of data from a clinical trial involving 650 individuals at 17 hospitals, and a review of pooled data for 25,000 patients collected from CareLink, a system Medtronic has for monitoring implants.

Approximately 268,000 of the recalled Medtronic leads are already implanted in patients. According to industry analysts, the Sprint Fidelis lead is used on about 60% of all Medtronic defibrillators implanted, but it could also be used with other defibrillators manufactured by companies like Boston Scientific/Guidant or St. Jude. It is not used with pacemakers.

The attorneys at Carabin & Shaw P.C. are investigating claims for compensation for individuals who have the Sprint Fidelis lead. As a result of the defective wire which was placed in their chest, Medtronic has forced them to face a future of concern about whether their device will suddenly malfunction. If you, a friend or family member believe you may have this lead, request a free consultation. Any defibrillator implanted since 2004 could have a Sprint Fidelis lead. Medical records and patient information cards can be reviewed to determine if you may be eligible for compensation. There is no obligation to hire a lawyer, and there are no fees or expenses unless a recovery is obtained. Call us toll free at 1-800-862-1260.