Doctor Raises Questions About New Sinus Treatment

You may have heard about a new procedure that helps clear the nasal passages of people who suffer from chronic sinusitis — it’s called Balloon Sinuplasty. Recently approved by the FDA, the procedure uses a tiny balloon to open blocked sinus passages, much as angioplasty uses balloons to open blocked blood vessels. But don’t be so quick to sign up — some otolaryngologists (ear, nose and throat specialists) have expressed concern that their patients may believe there’s more evidence-based research behind this treatment than there is. In fact, as yet, it’s not clear whether it works long term or even if it is really safe.

Sinuplasty is being marketed as a less invasive alternative to traditional sinus surgery. Acclarent, the private company in Menlo Park, California, that makes the device used in Sinuplasty, cites more than a dozen studies showing short-term benefits — for instance, one trial documents sinus improvements in 65 patients for two years. Yet it is important to note that when Sinuplasty reached the marketplace in 2006, it did so under somewhat lax FDA policies that regulate medical devices. That is, Acclarent did not need to prove that Sinuplasty was safe and effective in and of itself — only that the device was roughly equivalent in safety and effectiveness to similar devices that had already received FDA approval. Called “grandfathering,” this practice is now being scrutinized and may in fact be changed… but that’s not protecting anyone in the meantime.

What We Don’t Know

I spoke with Greg E. Davis, MD, MPH, assistant professor of otolaryngology-head and neck surgery at University of Washington in Seattle, who told me the evidence is insufficient, in his view, that Sinuplasty is effective over the long-term. He also said there’s a possibility that the treatment could cause harm. Sinuplasty works by creating micro-fractures in the bony openings of the sinuses in order to make the openings larger. Small fragments of bone that have the potential to lead to further blockage of the sinuses may be left behind.

Another issue is that medical indications for Balloon Sinuplasty haven’t been clearly established, so there is no agreed-upon set of circumstances defining when it should and should not be used. Hospitals are already promoting Balloon Sinuplasty as being the best treatment to address minor sinus problems — but without more research, we really don’t know that for sure. It is also important to be aware that Sinuplasty is more expensive than traditional sinus surgery, and your health insurer may or may not cover it.

Further Evidence Is Needed

At present, Dr. Davis says it is best to view this as one more surgical approach to treating blocked sinuses, recognizing that high-quality clinical research is needed to determine whether it fulfills its promise and has lasting benefits. If you’re considering it, be aware that the verdict isn’t yet in — and don’t forget to check whether your doctor has enough experience using the device and to learn if your health insurance will pay for it.