This recent lawsuit, Danna v. Medtronic Inc. et al, filed on January 17, 2014 in the North Carolina Eastern District Court, alleges that Infuse is a defective design and its defects are exacerbated when utilized in the various “off-label” applications and procedures Medtronic has marketed to doctors as being safe, regardless of not having FDA approval for off-label uses.
Sandra F. Danna claims that her Medtronic Infuse surgery off-label in October 2010 left her with debilitating injuries. Medtronic complications began with severe back and leg pain and tests showed that she had uncontrolled ectopic bone growth near the implantation site as well as impingement of neighboring nerves. Three months later, revision surgery intended to remove the overgrowth and mitigate the damage, but her lawsuit says she is still in constant pain and can’t even do regular household tasks. Danna had to move so her adult children could help her and it is highly unlikely that she can return to work - Medtronic has also caused a huge financial burden.
The FDA approved the Infuse bone graft (used to stimulate bone growth) in 2002 for a limited type of spinal fusion surgery to alleviate severe back pain, namely in the lower spine, but was not approved for use in the cervical spine, which runs from the shoulders to the head. Regardless, a number of patients have undergone cervical spine surgery - often to treat neck pain - off-label and without being told by their physician that their Medtronic Infuse surgery has not been FDA-approved.
Many of these patients have found themselves at risk for dangerous infuse bone graft complications, such as difficulty swallowing, breathing and speaking, as well as swelling of the neck and throat tissue.
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According to Transparency Market Research Team (December 19, 2013), serious side effects caused by Medtronic Infuse have created negative impact on its sales. According to the American Academy of Orthopedic Surgeons, about 465,000 spinal surgeries were performed in the US alone in 2011, and this trend is expected to grow in the future owing to baby boomers reaching the geriatric population. Attorneys expect more Medtronic Infuse lawsuits to follow.