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RETROGRADE EJACULATION, MALE STERILTY LINKED TO MEDTRONIC INFUSE

Jun 13

Written by:
6/13/2012 5:42 AM

February 2012

A study published last year by Dr. Eugene Carragee, a prominent spinal surgeon and researcher with Stanford University, linked Medtronic Inc.’s Infuse bone growth product with retrograde ejaculation, a condition that causes male sterility. Dr. Carragee's study, published on The Spine Journal’s website last May, found that men who underwent anterior lumbar fusion with Infuse developed retrograde ejaculation at a much higher rate than those who received a traditional bone graft.

According to a report from The New York Times, Infuse is used in about half of such procedures, and men make up about half of the patients who undergo spinal fusions.

“It is important that men who are considering having children have the opportunity to weigh the risks of the various available procedures,” said Dr. Carragee, according to The Times.

Dr. Carragee's study involved 240 men who had undergone anterior lumbar fusion some years prior. Sixty-nine patients had received Infuse, while 174 had received the traditional bone graft. Five of the Infuse patients developed retrograde ejaculation, while one in the other group developed the condition. Of the six men who suffered retrograde ejaculation, only three experienced resolution.

Retrograde ejaculation is listed on the Infuse label as a possible side effect. However, according to The Spinal Journal report, this potential side effect is not widely known in the medical community.

According to The New York Times, Medtronic-paid doctors who worked on the clinical trials for Infuse purportedly found no connection between the product and male sterility, and instead blamed the problem on the surgical technique used to implant Infuse. While their studies specified which surgical technique was used in each of the men who suffered retrograde ejaculation, they did not indicate whether or not the patients had received Infuse. In his article Dr. Carragee questioned the decision not to specify which patients had received Infuse, asserting that was the standard way clinical trial results are presented.

Dr. J. Kenneth Burkus and Dr. Thomas A. Zdeblick, the researchers who conducted the Infuse clinical trial, have each received millions of dollars from Medtronic in consulting fees or royalty payments. Some have speculated that their financial relationships with Medtronic could have influenced the way trial data for Infuse was reported, though both have emphatically denied that was the case.

In an editorial accompanying Dr. Carragee's study, Dr. James D. Kang of the University of Pittsburgh mused that industry support was one way to explain the different conclusions reached by Dr. Carragee and the authors of the Medtronic-sponsored trial, writing that there was not "any rational explanation for these observational differences."

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Medtronic Infuse Off-Label Use Lawsuit

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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.