Balloon Sinuplasty for Treatment of Chronic Sinusitis
Balloon sinuplasty is being offered as an alternative to endoscopic sinus surgery for individuals with chronic sinusitis. The procedure is performed under anesthesia. A guide wire equipped with a balloon is inserted into the nostrils and up to the blockage. Once the balloon is placed, it is inflated approximately a quarter of an inch. The balloon is then deflated and removed. The procedure provides a way to dilate the sinus cavities, which may help restore sinus drainage.
Things to Consider
- Approximately 32 million individuals living in the United States are affected annually with chronic sinusitis.
- Balloon sinuplasty is being proposed to treat approximately 5 to 10 percent of those who have exhausted less aggressive treatment options.
Results
Will I live longer if I have a balloon sinuplasty?
Scientific evidence is not available to show if a balloon sinuplasty may cause you to live longer.
Will having a balloon sinuplasty improve my quality of life?
Long-term scientific evidence is not available to show whether a balloon sinuplasty improves your quality of life.
Safety
How safe is this for me?
More information, including data from a large number of individuals who have had the procedure and have had long-term follow-up, is needed to determine the safety of a balloon sinuplasty.
Comparison
At this time there are no comparative studies of balloon sinuplasty to current surgical (e.g., cleaning and draining the sinuses, functional endoscopic sinus surgery) or medical treatments (e.g., steroid nasal sprays, antibiotics if an infection present) for chronic sinusitis. Therefore, the effectiveness of a balloon sinuplasty is not known.
Cost
The cost of a balloon sinuplasty may range from $5,000 to- $10,000 or more.
The cost may or may not be covered by insurance.
Sources
The following are off-site links 
:
· U. S. Food and Drug Administration. (2005, August). Center for Devices and Radiological Health. 510(k) summary for relieva sinus balloon inflation device. Retrieved October 17, 2007 from http://www.fda.gov/cdrh/pdf5/K052198.pdf.
· U. S. Food and Drug Administration. (2005, April). Center for Devices and Radiological Health. 510(k) summary for relieva sinus balloon dilation catheter. Retrieved October 17, 2007 from http://www.fda.gov/cdrh/pdf4/K043527.pdf.
Next Review Date
10/17/2008
This document has been classified as public information.
Table of Findings
results: possible harm / no value
safety: possible harm / no value
comparison: possible harm / no value
cost: possible harm / no value
total: possible harm / no value
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