FDA approval for a drug or procedure is a rigorous process. In order to gain FDA approval for a use, a drug or procedure must proven safe and effective, ideally within any reasonable doubt. This is determined through clinical trials and a lengthy application review process, with clinical trials that can take years and can become very expensive. Few companies want to go through this type of process to get approval for every use on every body part.
By letting doctors use procedures off label, the products can be used on the market faster, often for procedures and medical treatments that would likely still receive approval.
For cosmetic purposes, off-label uses are usually extensions of the FDA approved use. For example, CoolSculpting has been approved on love handles and abdomen, but is commonly used on the arms, since the science behind CoolSculpting is sound for arm fat. It’s also used often with injectables, like BOTOX in lips or for crow’s feet. Often these uses are just one step ahead in the process and many end up getting approval from the FDA.
Is it Safe?
Off-label uses for drugs or procedures are typically safe, and are completely legal. These drugs and procedures have been tested for both their safety and efficacy in treating at least one condition. If the use is similar, the risks can be inferred to be relatively safe. However, not all off label procedures are created equal, and the safety depends on the doctor/surgeon, and the procedure they are completing. That is why it is so important to know your surgeon and make sure that you’re using someone you can trust.
Using Off Label Procedures in Plastic Surgery
Off-label use is a regular practice in all areas of medicine. From cancer treatments to migraines, many doctors prescribe drugs off-label with no issues. In plastic surgery, off label services may be a medically sound way to address a particular issue, or may not be ideal depending on the FDA approved options available. Dr. Agha has an excellent record of finding the right treatment for his patients, so if you’d like to learn more about the procedure that you can use to reach your cosmetic goals, contact us today.