Last week, I participated in an appeal to the FDA by a small, medical device company based in the U.S. seeking to be granted approval of its device for moderate to severe stress urinary incontinence in women, in particular those who have undergone unsuccessful surgery or surgery that failed them after several years or more. I was present because it's my job to represent the interests of the patients.
What exactly are those interests? They are not only varied, they can even be in conflict, such as applying a new technology and offering a greater choice in solutions versus restricting choice to only what is known and previously tried for safety reasons. I want all Americans to have ease of access to options that are considered both safe and effective for the condition for which they are prescribed. But despite the collection and statistical interpretation of clinical data from the most elaborate of randomized trials - including those with multicenter studies and with stringent end points for measuring success - results from trials alone are not necessarily going to be generalizable to the broad population. The product at some juncture needs to get into usage, still under supervision, so that post-market surveillance can record the real world encounters of a broad spectrum of patients.
Herein lies the greatest risk. Some devices or drugs may get into the marketplace that need to be returned to the lab for refinement. Others we will find need to be more narrowly targeted to certain patient populations to avoid harmful adverse side effects or events. Still others, based on more widespread data, may even need to be pulled off the market. But many will represent genuine progress, with innovative creativity and advancement of technology, in delivering both improvement in quality outcomes and lower costs. Just as in relationships, the biggest risk with something new and adventuresome is the potential for disappointment, that the product will fail to meet expectations.
There's a famous song by LEE ANN WOMACK entitled "I Hope You'll Dance" that comes to mind when I weigh the risks of venturing forward versus doing nothing. There is an element in the entrepreneurial spirit of innovators that keeps them dancing and looking for a better way. Hope is what propels them.
And so should hope propel you. Keep searching, keep the dialogue going, and keep visiting our web site and others for the latest in answers. That includes products that help you better manage your symptoms. NAFC has a new section just for that: FIND A PRODUCT. For all innovations in the past year including even those in the pipeline, there is DISCOVERIES. You can even be a part of the process, by participating in a CLINICAL TRIAL to help evaluate something in the works, aimed at bringing to market a better answer for others. It may simply be time to revisit your doctor to discuss all of the options.
And as the song goes, promise me you'll give faith a fighting chance. And when you get the choice, I hope you'll dance.
Nancy Muller, Executive Director
National Association For Continence (NAFC)
Published On: April 06, 2010