It is estimated that INFUSE Bone Grafts/ LT-CAGE Lumbar Tapered Fusion Devices are used in 100,000 spinal fusion procedures a year in the United States. However, INFUSE Bone Grafts are risky and can come with dangerous side effects, including:
- male sterility,
- bone and nerve injury,
- urinary problems and
- possible increased cancer risk.
Further, doctors may be engaging in non-FDA approved uses of INFUSE Bone Grafts, notably for cervical spinal fusions.
Additionally, the primary maker of INFUSE Bone Grafts, Medtronic, is accused of paying off doctors to use its products, intentionally hiding the possible side effects and using deceptive marketing practices.
In recent years, Medtronic has faced increased scrutiny for the INFUSE Bone Graft. A 2011 publication in The Spine Journal revealed that a number of Medtronic-sponsored studies failed to disclose possible side effects associated with rhBMP-2, the synthetic protein component of the INFUSE Bone Graft system. It also revealed that a number of the researchers in these studies received between $1 million and $23 million a year from Medtronic in royalties and consulting fees.
The FDA had received hundreds of reports of adverse events associated with INFUSE Bone Grafts, including severe back pain, leg pain, difficulty breathing and implant failure. Many of these complications required a second surgery to correct. The FDA originally approved INFUSE only for use in the lower back and only with ALIF surgery. This approved use is called "on-label use." However, a number of studies released by Medtronic-sponsored doctors promoted several "off-label," or unapproved, uses of the product.
In 2002, the FDA approved the INFUSE Bone Graft/LT-CAGE Lumbar Tapered Fusion Device system. The system is designed for use in people with degenerative disc disease, including Grade I Spondylolisthesis, more commonly known as a slipped disc in the spine. It is only approved for use in the lower back (lumbar spine). INFUSE is not approved for use in the cervical spine. Furthermore, the FDA has not approved INFUSE for use in anyone younger than 21.
Individuals that have had procedures using INFUSE Bone Grafts/ LT-CAGE Lumbar Tapered Fusion Devices may be at increased risk for these adverse side-effects, and may have not been informed of such risks by the doctors.