Medtronic Infuse® Bone Graft Side Effects
A range of Infuse® Bone Graft side effects have been reported by patients who were surgically implanted with the bone growth material for off-label uses such as surgery in the neck and cervical spine. Side effects that have been reported include nerve damage, chronic pain, compressed airway, difficulty breathing and problems swallowing.
If you’ve experienced side effects after bone graft surgery, you may be eligible to seek compensation by filing an Infuse® Bone Graft lawsuit today. To schedule a free review of your case, contact us today.
Problems with the Medtronic Infuse® Bone Graft
If the Infuse® Bone Graft is not inserted correctly, it can damage nearby tissue. Another risk of inappropriate use is that the Absorbable Collagen Sponge used along with the Infuse® Bone Graft can leak and cause bone growth where it is not wanted.
According to the FDA, the following life-threatening complications have been associated with recombinant human Bone Morphogenetic Protein (rhBMP) products when used in the cervical spine:
- Swelling of neck and throat tissue, resulting in compression of the airway and/or neurological structures in the neck
- Difficulty swallowing, breathing or speaking
- Severe dysphagia
When the Infuse® Bone Graft has been used in the lower back, doctors have reported patients experiencing retrograde ejaculation. This happens when the semen enters the bladder rather than going out through the urethra (the tube that carries urine as well as semen). This leads to infertility.
The risk of cancer also was cited by the FDA when Medtronic applied for using a modified version of the bone graft product. The FDA declined to approve the device after determining it was unsafe.
In 2008 the FDA said it received reports of serious complications following off-label use in cervical procedures. The reports indicated off-label uses were unsafe. However, off-label use continued. In Medicare patients between 2002 and 2007, the number of complex fusion procedures increased 15-fold.
In addition, an article in the Wall Street Journal reported that two orthopedic surgeon/researchers who wrote that the device was safe received a total of more than $20.5 million between June 2001 and June 2006 from Medtronic.
A critic of the two authors wrote in an editorial in The Spine Journal that "the history of rhBMP-2 [the Medtronic medical device] research is a cautionary tale for all medical professionals, researchers, and patients.
"As this matter demonstrates, the spine care field is currently at a precarious intersection of professionalism, morality, and public safety."
Lawsuits against Medtronic are being reviewed. In June 2011, the U.S. Senate Finance Committee declared it is conducting an investigation to determine if surgeons reporting on their research suppressed information about problems with the Medtronic Infuse® Bone Graft.
Contact an Infuse® Bone Graft Attorney
If you or a loved one has suffered from complications of having a Medtronic Infuse® Bone Graft, you may be eligible for compensation. to schedule a free consultation with one of our Infuse® Bone Graft attorneys, contact us today.