Additional Claims of Infuse Bone Graft Injuries Since FDA Report

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Tulsa, Oklahoma Personal Injury Attorney Hansen Dirani Responds to Additional Claims of Infuse Bone Graft Injuries Since FDA Report on Swollen Neck Breathing Dangers, Ectopic bone Growth and Nerve Compression Damage—Sterility Now on List

Companies that manufacture medical devices or equipment stand to gain huge profits and they may rush a product into the marketplace without adequately testing it.

The Oklahoma Law Offices of Hansen Dirani says that claims of severe Infuse Bone Graft side effects have continued beyond those cited in the July 1, 2008 Food and Drug Administration’s Infuse Bone and Graft public health warning about Infuse dangers in cervical spine fusions.

Infuse Bone Graft is a medical implant that releases a genetically engineered protein into the body and was developed to treat various health problems including a degenerative spine condition, acute tibia fractures and oral maxillofacial dental issues.

The FDA’s report alone is alarming: “These complications were associated with swelling of neck and throat tissue, which resulted in compression of the airway and/or neurological structures in the neck. Some reports describe difficulty swallowing, breathing or speaking. Severe dysphagia following cervical spine fusion using rhBMP products has also been reported in the literature.”

The FDA added that most complications occur 2 to 14 days after an Infuse Bone Graft procedure takes place. Required treatments have included respiratory support with tracheotomy, second surgeries to drain the surgical site intubation and anti-inflammatory medication.

According to an article that appeared in the New York Times on May 25, 2011, Infuse Bone Graft has also been deemed a defective medical device because it was shown to cause sterility. The articles states that Stanford University surgeon Dr. Eugene J. Carragee found that men treated with Infuse developed a condition that causes temporary or permanent sterility at a far higher rate than men who received a bone graft, another material that is used to fuse spinal vertebrae. He strongly encouraged doctors to counsel men about Infuse’s risks.

Dirani believes anyone who has suffered Infuse Bone Graft injuries from cervical spine fusion, lower back or lumbar pain repair, dental surgery or broken tibia surgery should consult with his or her physician about the Infuse Bone Graft risks. “Every year, companies introduce new medical devices but, unfortunately,” says Dirani, “instead of helping people, some defective medical devices hurt or even kill those who use them. Companies that manufacture medical devices or equipment stand to gain huge profits and they may rush a product into the marketplace without adequately testing it. These big corporations have a duty to make safe devices and alert consumers and doctors about any potential risks.”

According to New York Times, Medtronic, Inc. is the manufacturer of Infuse Bone Graft and has also been taken to task for having their own studies conducted by doctors to whom they have paid millions of dollars from Medtronic in consulting fees or royalty payments. Dr. Kenneth Burkus, who practices in Columbus, Ga., and Dr. Thomas Zdeblick, a professor at the University of Wisconsin, reported far less drastic results and have both stated that their financial connections to Medtronic have not affected their scientific judgment

About the Law Offices of Hansen Dirani
The Law Offices of Hansen Dirani provides aggressive, reliable legal representation to personal injury victims throughout Oklahoma. In addition to defective medical device cases, the firm focuses on Social Security Disability, helping recipients with the SSDI claims process, long-term, short-term and supplemental SSDI issues. It also handles auto accident injury cases and dangerous drug lawsuits.

Hansen Dirani Law
4815 S. Harvard Ave., Ste. 380
Tulsa, OK 74135
1-877-583-0700
http://www.callhansen.com/contact

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Paige Gore
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