Medtronic's InFuse Bone Graft Exposed
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Medtronic’s InFuse bone graft is a medical device used during surgery to stimulate bone growth and replace damaged spinal disks. In 2002, the Food and Drug Administration (FDA) approved the Medtronic InFuse bone graft for limited use in the lower back, and for some dental procedures. However, Medtronic allegedly encouraged doctors to use its InFuse bone graft off label for other purposes on the spine, which helped boost the products sales.
Complications with the Medtronic Bone Graft
One of the off label uses of InFuse encouraged by Medtronic was to stimulate bone growth in the cervical spine. According to medical reports, use of the InFuse bone graft in the cervical spine presents a variety of serious problems, including.
- Compression of the Airway
- Nerve Damage
- Difficulty Breathing, Swallowing, or Speaking
After receiving reports of several complications arising from the off label use of Medtronic’s InFuse bone graft, the FDA issued a warning highlighting the risks of using the product in the cervical spine. Reporting that many patients who received the InFuse bone graft experienced the serious complications listed above, the FDA discouraged doctors from using the product in the cervical spine or for any other use not approved by the agency.
The FDA noted that most Medtronic InFuse complications occurred between 2 and 14 days after surgery, and required the need for respiratory support, insertion of feeding tube, anti-inflammatory medication, and additional surgery
Medtronic Investigated for Tampering with InFuse Studies
In June 2011, the US Senate Finance Committee began an investigation into reports that some doctors who wrote favorable articles about InFuse in medical journals were paid by Medtronic to downplay negative side effects associated with the device. Reports allege that Medtronic paid several millions of dollars to a handful of doctors to either promote the off label use of InFuse, or to hide the serious side effects.
The Senate discovered that independent experts had identified the negative side effects associated with the off label of use of InFuse, and took investigative action to determine if Medtronic had been paying doctors for favorable reports. In November 2012, the Senate committee concluded that there was sufficient evidence that Medtronic had paid doctors to produce falsified medical studies that encouraged off label use of InFuse despite the risks. For a full article on the Senate investigation and its results, click here
Since 2011, Medtronic has faced a number of personal injury lawsuits for failure to disclose the risks associated with off label use of InFuse bone grafts. The lawsuits allege that patients who received Medtronic InFuse bone grafts during surgery suffered severe complications resulting in severe pain, difficulty breathing, and, on occasion, death.
With the results of the Senate committee investigation concluding that Medtronic not only knew of the risks associated with the off label use of InFuse, but paid doctors to falsify reports that downplayed those risks, the company is further exposed to legal liability for injuries associated with InFuse. Plaintiffs can have further evidence that the company was not only negligent in suggesting off label use of InFuse, but was purposefully hiding the negative side effects that caused patients serious harm.
Anyone injured by use of Medtronic’s InFuse device should consult an attorney immediately. A personal injury attorney can help prepare a lawsuit against Medtronic, and ensure the injured party receives the compensation they are due for the injuries they have suffered.