Medtronic Off Label Use in Neck Surgery May Cause Injury

Infuse, a liquid bone graft made of bioengineered morphogenetic protein (BMP), is manufactured by the pharmaceutical company Medtronic. Soaked into a small sponge, encased in a metal cage, and implanted into the vertebrae, Medtronic Infuse has proven to encourage quick bone growth in spinal fusion surgeries. At the same time, it has been linked to several devastating side effects, which may have gone unreported by Medtronic.

Medtronic Infuse Neck Surgery

The FDA has approved Medtronic Infuse bone grafts for use in spinal fusion surgeries on the lower lumbar portion of the spine, located in the lower back region of the abdomen. There are no other approved uses of the product. However, Medtronic infuse off label use makes up 17% of the procedures it is used in, most often in surgeries on the cervical spine in the neck region. Reportedly, the likelihood of injuries like Medtronic Infuse sterility and Medtronic Infuse cancer is higher when off label use on the neck is implemented.

Additionally, patients have experienced swelling in the tissues of the neck and throat, which has caused difficulties in swallowing and breathing due to a constriction of the airway. This has led to the need for tracheotomies, feeding tubes, and second surgeries for some patients. The development of cysts and severe pain have also been linked to Medtronic Infuse off label use, as has unwanted bone growth, which can result in nerve damage and, in some cases, a need for emergency care.

Medtronic Negligence

Beginning in late June 2011, the Senate Finance Committee began looking into allegations that Medtronic paid off doctors running 13 clinical trials to keep the frequency and severity of Infuse side effects out of their reports. These doctors were allegedly paid over $62 million collectively over the course of many years. Their writings on the trials failed to mention the 10-50% incidence rates of serious Infuse bone graft complications that are reflected in the raw data and the reports the company sent to the FDA.

Medtronic may have also deceptively marketed the Infuse, potentially encouraging off label use among doctors and healthcare providers. Certain doctors who have written and spoken about the positive off label uses of Medtronic Infuse were reportedly found to have been on Medtronic’s payroll.

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