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CANCER FINDINGS RAISE MORE MEDTRONIC INFUSE WORRIES

Jun 13

Written by:
6/13/2012 9:38 AM

April 2012

A study presented this past November raised serious concerns about cancer risks that could be associated with Medtronic Inc.'s Infuse Bone Growth product. The study was conducted by long-time Infuse critic, Dr. Eugene Carragee, and found that within a year of implantation, cancer risks more than doubled in Infuse patients. At three years after implantation, the increased cancer risk grew to nearly five-fold.

Carragee's cancer study, presented at the annual North American Spine Society meeting in Chicago, isn't the first time the Stanford University professor and Spine Journal editor has raised concerns about Infuse. This past summer, he edited an entire issue of The Spine Journal dedicated to rhBMP-2 products which raised serious questions about the validity of the research that was used to gain regulatory approval of Infuse. One of the articles included in the journal, co-authored by Carragee, found that Medtronic-paid surgeons had failed to report serious complications from Infuse, including:

Cancer
Sterility in men
Infections
Bone dissolution
Worsened back and leg pain

Carragee's cancer study pooled clinical trial data from Infuse, and a high-dose version of the same protein, called Amplify. Medtronic also developed Amplify, but failed to garner U.S. Food & Drug Administration (FDA) approval for the product because of concerns it could increase cancer risks.

According to a report from The New York Times, Carragee’s analysis of Medtronic trial results for Amplify showed a significantly higher number of cancers in the study group that received the product when compared to a control group that received a bone graft as part of a spinal fusion. At three years after surgery, there were 20 cancers in the Amplify group versus five cases in the bone graft group.

Carragee pointed out that the Amplify findings could be important for Infuse patients, many of whom received Infuse in off-label procedures. Doctors often administered Infuse off-label at levels significantly above the recommended dosages, ones that approach or exceed the amount of rhBMP-2 found in a dose of Amplify, he said.

It is estimated that roughly 85% of Infuse procedures involve off-label use.

One interesting note, during his presentation, Carragee pointed out that the industry-sponsored studies upon which his analysis was based neglected to discuss the association between rhBMP-2 and cancer.

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“Off-label” use of Medtronic Inc.’s Infuse bone graft product in cervical spine surgeries, as well as lateral approach or posterior approach spinal procedures, has been linked to serious, and even life threatening side-effects. Some of these Medtronic Infuse injuries include ectopic or uncontrolled bone growth at or near the site of the surgery; ongoing or chronic radiating pain in the legs or arms; male sterility, retrograde ejaculation, or other uro-genital injuries; nerve injuries causing severe and chronic pain; and even cancer. In cervical spine surgeries, which is an off-label use of Infuse, some patients experience acute severe neck swelling several days after surgery resulting in death or permanent injury. Medtronic has been accused in lawsuits of aggressively promoting unapproved uses of Infuse, and it has also been alleged that research sponsored by the device maker downplayed many serious Infuse bone graft side effects.

Our lawyers are investigating these allegations, and would like to hear from anyone who suffered a serious Infuse bone graft complication. If you sustained a serious injury after undergoing an off-label Medtronic Infuse surgery, you could be eligible for compensation for your medical bills, lost wages, and pain and suffering. If you or a loved one were injured due to a procedure where this product was used inappropriately, it is vital you contact Holland, Groves, Schneller & Stolze, LLC as soon as possible to protect your legal rights.

INJURIES LINKED TO OFF-LABLE USE OF INFUSE BONE GRAFT INCLUDE:

Acute severe swelling of the neck several days after surgery, resulting in death or permanent injury;
Cancer – may types including stomach, thyroid, breast, skin (melanoma), ovarian, lung, leukemia, prostate, laryngeal, lymphoma, pancreatic;
Difficulty swallowing;
Difficulty breathing
Difficulty speaking
Ectopic or uncontrolled bone growth at or near the site of the surgery (a study found that 75% of Infuse patients experienced ectopic bone growth)
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 (Independent researchers at Stanford University found evidence that Infuse was linked to a complication that causes sterility in men)
Retrograde ejaculation, or other uro-genital injuries in male patients.

In 2008, the FDA warned Infuse bone graft and similar products had caused serious problems when they were used off-label in cervical spine surgeries. At the time, the agency said that it had received dozens of reports of side effects linked to off-label Infuse procedures, mainly swelling of neck and throat tissue, which resulted in compression of the airway and other structures in the neck. Patients reported difficulty swallowing, breathing and speaking. Several required emergency treatment, including tracheotomies and the insertion of feeding tubes, as well as second surgeries.

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. 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.

MEDTRONIC INFUSE OFF-LABLE USE COMPLICATIONS:
Medtronic Infuse, which contains rhBMP-2 (recombinant human Bone Morphogenetic Protein-2, a protein that stimulates bone growth), was approved by the U.S. Food & Drug Administration (FDA) for use in a type of spine surgery called anterior approach lumbar fusion. This is the ONLY type of spine surgery for which Infuse is approved, though the FDA did later grant clearance for its use in two types of dental surgeries. Despite its limited approval, it has become clear that Infuse bone graft is frequently used off-label in other spine procedures, especially cervical (neck) spine surgery, as well as in lateral approach (through the side of the body) or posterior approach (through the back of the body) spinal procedures. Unfortunately, it has also become apparent that such off-label use puts patients at risk for serious, and even life-threatening, injuries.

If you or someone you know sustained an injury due to off-label use of the Medtronic Infuse bone graft, you have valuable legal rights. To learn how Holland, Groves, Schneller & Stolze, LLC can help you, please fill out our online form, or call 1-877-255-3352 to discuss your case.