A Different Way

to look at Life, Health, Business and Politics

FDA reports life-threatening complications with cervical spinal fusion

Posted by Marietta chiropractor on July 4, 2008

Every surgery has risks. I thought it very important to get this information from the FDA out as soon as possible. Many surgeries can be prevented with gentle, specific chiropractic adjustments. Check with your chiropractor before taking this risk. There should be absolutely NO problem consulting BOTH a chiropractor and MD for the same problem. A good chiropractor will tell you when the problem is beyond his/her scope.

If you need a referral to a good chiropractor in your area, e-mail me.

MedWatch logo MedWatch - The FDA Safety Information and Adverse Event Reporting Program

FDA informed healthcare professionals of reports of life-threatening complications associated with recombinant human Bone Morphogenetic Protein (rhBMP) when used in the cervical spine. The safety and effectiveness of rhBMP in the cervical spine have not been demonstrated and these products are not approved by FDA for this use. There have been at least 38 reports of complications during the last 4 years with the use of rhBMP in cervical spine fusion. These complications were associated with swelling of neck and throat tissue, which resulted in compression of the airway and/or neurological structures in the neck. Some reports describe difficulty swallowing, breathing or speaking. FDA recommends that practitioners either use approved alternative treatments or consider enrolling as investigators in approved clinical studies.

FDA requires hospitals and other user facilities to report deaths and serious injuries associated with the use of medical devices. If you suspect that a reportable adverse event was related to the use of rhBMP, you should follow the reporting procedure established by your facility. Reporting adverse events is everyone’s responsibility, even if the event involves off-label use of medical devices.

Read the entire 2008 MedWatch Safety Summary, including the FDA’s Public Health Notification regarding this issue at:

http://www.fda.gov/medwatch/safety/2008/safety08.htm#Protein

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