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.
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(PRWEB) February 14, 2012
Flood Law Group, LLP, a litigation firm, is announcing the launch of the new website, BoneGraftLawsuit.org, designed to assist individuals in learning about the possible risks associated with Medtronic’s Infuse® Bone Graft.
According to Flood Law Group, LLP, the Infuse® Bone Graft has been linked to serious injuries when used for off-label surgeries of the cervical spine or neck. Complications that have been reported include excessive swelling in the neck, compressed airways, difficulty breathing, problems swallowing and nerve damage.
The injury lawyers at the firm are investigating Infuse® Bone Graft lawsuits on behalf of people who believe they might have a claim.
The Infuse® Bone Graft is a bone graft material approved for use in specific types of spinal surgery, oral maxillofacial procedures and acute tibia fractures. The bone graft is surgically implanted into the affected area and works by releasing rhBMP-2, a bone morphogenetic protein (BMP) to stimulate bone growth.
The Infuse® Bone Graft is only approved for certain types of spinal surgery, but has been used for other types of surgery, known as off label uses.
The FDA issued a public health notification in 2008 to warn the public about the possible life threatening complications associated with using rhBMP in the cervical spine.
“FDA has received at least 38 reports of complications during the last 4 years with the use of rhBMP in cervical spine fusion,” the FDA said in the notification. “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 agency said that use of rhBMP in the cervical spine is not approved by the FDA and recommended that practitioners use treatments that are actually approved for use in the cervical spine.
The agency noted that rhBMP-2, found in the Infuse® Bone Graft, is only approved for use in the lumbar spine in patients with degenerative disc disease; for treatment of acute, open tibial shaft fractures; and for certain oral and maxillofacial uses.
Patients treated with Infuse® Bone Graft in the cervical spine and who experience the following symptoms should talk to their doctors right away:
- Difficulty breathing or swallowing
- Swelling of the neck, tongue, mouth, throat, shoulders or upper chest
These could be signs of airway complications and should be treated immediately.
The injury lawyers at Flood Law Group, LLP say that anyone who experiences such complications following surgery in the cervical spine may qualify for compensation.
About Flood Law Group, LLP
Flood Law Group, LLP helps patients and families that are affected by Infuse® Bone Graft injuries seek compensation. BoneGraftLawsuit.org is an online resource designed to assist people in learning about the potential injuries associated with off label uses of Infuse® Bone Graft.
For more information or to schedule a free review of your case, please call 1-800-580-3491.