Product Liability

When Is It Safe to Use Medtronic Infuse?

The Medtronic INFUSE® device is an implantable bone graft containing a recombinant human protein called bone morphogenetic protein (rhBMP-2). The protein is genetically engineered to promote bone growth in certain areas of the spine.1

Approved uses of INFUSE

Medtronic’s INFUSE BMP bone graft was approved by the FDA in 2002 for use in treating certain conditions in the lower spine, particularly degenerative disc disease.2 This disorder, which involves the wearing away of the connective tissue, or disk, between the vertebrae in the spinal column, is a common cause of lower back pain.3 Patients experience lower back pain that worsens when:

  • Sitting
  • Bending
  • Lifting
  • Twisting
  • Standing for extended periods

Walking tends to ease the pain, and lying down is the most comfortable position.4

The BMP bone graft can also be used to promote bone growth in tibia fractures caused by trauma and certain dental procedures.5 6 However, approximately 85 percent of surgeries using INFUSE are for off-label uses, which are not approved by the FDA.7

Treatment of degenerative disk disease with lumbar fusion and bone grafts

Lumbar fusion is one surgical treatment used for degenerative disk disease. The surgery grafts new bone over the degenerated disks so it can grow between the vertebrae, fusing them into one bone and eliminating their ability to move, alleviating the pain their movement creates.8

Risks of using Medtronic INFUSE

The FDA issued a warning in 2008 about using the rhBMP bone graft in the neck, or cervical spine. Complaints were received about restricted airways and nerve damage in patients who underwent cervical spine fusion with rhBMP products.6

In September 2012, a litigation group was formed to handle lawsuits against Medtronic because the company reportedly supported off-label uses that can cause overgrowth of bone, as well as nerve damage. Some lawsuits also claim that the device can cause cancer.7 Medical studies previously showing that the off-label uses were safe may have been manipulated by the company to boost the use of its product.2

If you or a loved one was injured by the use of the Medtronic INFUSE Bone Graft, a personal injury lawyer can review your case and determine if you have cause for compensation.

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