How Does the Off-Label Use of Medtronic Infuse Put Patients at Risk?

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Patients who suffered injuries following a spine surgery within the past 10 years may want to speak with the personal injury lawyers at the national law firm of Parker Waichman LLP. In 2002, Medtronic gained clearance for Infuse, a genetically engineered protein that is approved to stimulate bone growth in the lower spine (lumbar). It is often used in patients suffering from degenerative disc disease. However, this artificial bone growth product has become controversial in recent years due to the safety concerns associated with its off-label use.

Using a drug or medical device “off-label” means that it is being used in a manner that is not approved by the U.S. Food and Drug Administration (FDA); although physicians can prescribed drugs off-label as they see fit, it is illegal for companies to promote their products for off-label purposes. According to allegations, Medtronic illegally pushed Infuse for off-label use. Examples of off-label use with Infuse include:

  • Surgery was performed through the back (posterior)
  • Used without a cage
  • Used with an unapproved cage
  • Used in the cervical spine

Injuries associated with Infuse include the need for revision surgery, overgrown bone, sterility, retrograde ejaculation, difficulty breathing or swallowing and potentially cancer.