The Medtronic Infuse Bone Graft: A Helpful or Harmful Medical Product?
In 2002, the Food and Drug Administration (FDA) approved the Medtronic Infuse Bone Graft for use in spinal fusion surgery. The FDA’s approval limited the use of the Medtronic Infuse Bone Graft for use in surgeries of the lumbar spine (lower back) and for some oral and dental procedures.
The Benefits of the Medtronic Infuse Bone Graft
The Medtronic bone graft contains recombinant human Bone Morphogenetic Protein (rhBMP). This protein is a genetically engineered version of the naturally released protein produced by the human body. The Bone Morphogenetic Protein initiates bone growth in specific areas of the spine. With its ability to target specific areas of the spine, this genetically engineered protein gives surgeons some control over where the bone re-growth occurs. When used for its FDA approved purpose for surgery in the lumbar spine region, the Medtronic Infuse Bone Graft stimulates bone growth and replaces damaged spinal disks without having to harvest a bone graft from the hip.
The Risks and Harms of the Medtronic Infuse Bone Graft
Despite the limitation of the FDA’s approval, the manufacturers of the Medtronic bone graft marketed their product to doctors to use for off-label purposes.
In fact, Medtronic allegedly encouraged physicians to use their product in the cervical spine. Use of the Protein in the cervical spine helped the manufacturer generate increased profit – but caused serious and life threatening side effects for many individuals.
The serious medical complications that Medtronic may cause if inserted into the cervical spine include:
- Difficulty Breathing, Swallowing or Speaking
- Swelling of the Airways
- Retrograde ejaculation which may lead to male sterility
- Respiratory Depression
- Nerve Damage
- Excess cancers
The FDA noted that the majority of Medtronic Infuse complications occurred between 2 and 14 days following surgery. Complications can result in the need for respiratory support, insertion of a feeding tube, tracheotomy, male fertility treatment, additional surgery and/ or the need for anti-inflammatory medications. The FDA warned as early as 2008 that “ the safety and effectiveness of rhBMP in the cervical spine have not been demonstrated and these products are not approved by the FDA for this use.”
The Wall Street Journal (09/08/08) reported that the FDA had recorded 200 adverse events where patients experienced serious complications after the bone graft was used in an off-label manner. Therefore, investigations have been launched into whether Medtronic marketed the device for off-label use in the cervical spine.
Medtronic Infuse Bone Graft Investigation
In addition to marketing the device for off-label purposes, Medtronic is also under investigation for reports that physicians who may have received millions of dollars from the manufacturer may have failed to reveal serious complications associated with the product.
In June 2011, The Spine Journal conducted an independent review of Medtronic Bone Infusion Graft studies that had been conducted by doctors who had allegedly received millions of dollars from the medical device manufacturer. The Spine Journal researchers found that those studies had either ignored or downplayed the serious complications associated with the bone growth stimulator when it was used in the cervical spine of patients.
This controversy sparked a U.S. Department of Justice investigation. The investigation did not amount to any criminal charges being filed. However, a U.S. Senate Committee investigation is still ongoing. Moreover, Medtronic has recently voluntarily launched a review of its trials by Yale University researchers. The results of the Yale study are still pending.
Have You been Harmed? Get Legal Help.
Medical device manufacturers have a duty to patients to market their products only for their FDA-approved uses. They also owe it to patients to properly warn of any risks associated with their products.
If you or a loved one received a Medtronic Infuse Bone Graft and suffered complications as a result of the product, you may be eligible for compensation for the injuries you suffered. Contact an experienced defective medical products attorney at The Rothenberg Law Firm LLP to discuss your case.