What does it mean if a new device is or isn’t FDA approved.
Everyday our local news broadcasters report to us about the “latest and greatest” medical devices or product that is designed to help us lose weight, reduce wrinkles, or stop smoking. Many of these new advancements prove worthy, but even a greater amount of these great stories become next year’s retractions. Often times the reporter tells us “a product is up for FDA approval or is soon to get FDA approval.” What does that mean?
The FDA was developed in 1906 with the passage of the Federal Food and Drugs Act. It is a government agency designed to protect the U.S. consumers from unsafe or inappropriate use of food, drug, cosmetics, and medical products. Before a device or product gets FDA approval, well designed scientific studies have to be presented and investigated by the FDA. This is a long, arduous process intended to weed out less than proven products. Once a product gets FDA approval, the manufacturers are then allowed to advertise their product to the consumer according to what has been proven effective.
An FDA accepted product is approved for use in a specific manner, but will often get used in another way (“off label use”) by a physician. Our government allows physicians to use an FDA approved product for a non -FDA approved use if it is in the best interest of the patient. A good example of this “off label” use is Botox. Botox was approved by the FDA for neck spasms, but has been used in a non-FDA approved manner by cosmetic surgeons for the past 15 years for wrinkles. The FDA finally approved the use of Botox for the treatment of glabellar wrinkles (wrinkles between the eyes) in 2002.
Although FDA approval doesn’t guarantee safety or effectiveness, it is a successful regulatory body that can be referenced for unbiased information. Finding out about the latest in FDA approved products and medical technology has become easier with the internet. The following sites are useful for the latest information on FDA approved medical products.
www.fda.gov This is the official website of the FDA and provides accurate information.
www.healthfinder.gov This site contains an easy to use search engine to look up information on a product and will also identify recalls.
www.fda.com This site has many useful links, search engines, and consumer forums.
Pub Med web site This site is designed for physicians to search articles or reports published in the scientific literature. This information can be difficult to understand for the layperson.
www.google.com Generals search engines can be an excellent source of information on anything located on the web. However, the consumer will face the dilemma of sorting fact from fiction.
Ultimately, your physician is the best resource for translation of this available information. A physician may know the product from first hand experience. A physician will be able to understand the positive and negative ramifications of the medical product, what constitutes a reliable study, and whether or not the information will apply to each patient as an individual. With knowledge of the FDA’s capacity, reliable internet resources, and verification from a physician, understanding of the “latest medical technology” is now a possibility for the consumer.