Medtronic Bone Growth Agent Linked to Neck Surgery Problems
A new study seems to indicate that the bone growth agent in the Medtronic Infuse bone graft may be linked to life-threatening problems after neck surgery, where it may cause swelling that makes it difficult to breath.
The study, conducted by researchers at Brigham and Women’s Hospital, was published June 30 in The Journal of the American Medical Association, and found that Infuse and other products that use a bioengineered bone growth protein called BMP appear to result in a higher incidence of neck surgery problems when they are used during cervical spinal fusion procedures to correct neck pains.
The study looked at both Infuse, and a Stryker product called OP-1 Putty, which is used in a very limited number of patients where other spinal fusion methods are not an option.
Did You Know?
Millions of Philips CPAP Machines Recalled
Philips DreamStation, CPAP and BiPAP machines sold in recent years may pose a risk of cancer, lung damage and other injuries.Learn More
The bone growth proteins were first approved in 2002 for use during lower back fusions. However, some doctors also use the bone graft to treat upper spinal pain, which the study data indicates can lead to an increased risk of complications. In 2006, the two products were used in 25 percent of all spinal fusion surgeries, with Infuse accounting for most of the BMP use.
Use of BMP has become popular because it allows bone to heal faster after surgery. It also tends to require less repeat surgeries, and doctors do not have to harvest the bone from other parts of the body, such as the hip.
The study found that patients who received bioengineered proteins in upper spinal fusion procedures suffered a complication rate of 7 percent; 50 percent higher than those who did not. When used on lower spinal, or lumbar, fusion procedures, there was no increase in complications, however.
Researchers say the rate of complication is probably higher, because the study only looked at patients who suffered complications while still in the hospital recovering from surgery. Many patients likely had complications after they left the hospital that went unreported.
The FDA issued an alert last year advising doctors not use infuse in upper spinal fusion procedures after receiving 38 reports of potentially fatal complications that included swelling of the neck and breathing difficulties. An FDA advisory panel recommended the FDA not approve OP-1 Putty for wider use in late March.
A number of Medtronic Infuse lawsuits have ben filed on behalf of individuals who experienced problems with breathing and swallowing that developed days or weeks following their neck surgery. This can lead to an emergency tracheotomy or death.
In November 2008, the U.S. Department of Justice initiated an investigation into the actions of Medtronic, Inc., and whether they actively promoted and marketed the Infuse bone graft for use in the cervical spine. While doctors are allowed to use FDA approved medical devices for non-approved purposes, the manufacturer is not allowed to promote or encourage such uses that they have not established as safe and effective.
ChristineOctober 17, 2014 at 6:06 am
I received a BMP bone graft during a surgery on my neck, I have recently become aware of the off label use of this product during cervical surgeries. The bone graft material used for my surgery was manufactured by Stryker and not Medtronic. I have suffered similar symptoms to those described by others that received the Medtronic compound. For 9 long years I have been seeing a Pain management speci[Show More]I received a BMP bone graft during a surgery on my neck, I have recently become aware of the off label use of this product during cervical surgeries. The bone graft material used for my surgery was manufactured by Stryker and not Medtronic. I have suffered similar symptoms to those described by others that received the Medtronic compound. For 9 long years I have been seeing a Pain management specialist because I wasn't aware of what was causing my pain, although I always suspected that it had something to do with the bone graft material thank was used. I have had EMG's that showed nerve irritation at he lowest level of my fusion. I went through another surgery with a different surgeon this year because I was no longer receiving any benefit from the Epidural Steroid injections that I was receiving in my neck due to severe pain. Unfortunately the nerve pain still remains following my recent surgery. My life has been turned upside down because of the surgery I received in 2005. I have tried changing jobs hoping to find something that I could do that would not cause me daily pain. However, this has not helped, I currently am only able to work 2 days a week in my profession and after a day at work I experience increased pain. I truly feel that the bone grafting material has affected me permanently and I am currently considering disability because I am unable to most things due to the pain in my neck and arms. I would love to speak with someone to see if there is anything I can do. If you feel you could help me I would appreciate discussing this with you.
"*" indicates required fields
More Top Stories
A OneWheel nosedive lawsuit claims the battery-operated scooter is defectively designed, causing riders to suffer serious injuries when the device suddenly stops and pitches forward.
A federal judge has approved a plan appointing several dozen plaintiffs' attorneys to leadership positions in Bard Port Catheter litigation.
A ProPublica report reveals that Philips officials hid thousands of reports of problems with sound abatement foam used in millions of CPAP machines, failing to recall the devices for more than a decade after receiving the first complaints.