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Significance of FDA Approval for Cosmetic Devices and Treatments

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FDA Approval for Cosmetic Devices and TreatmentsWith the advancements in technology, plastic surgeons offering body contouring in NYC are using innovative devices and treatments to help men and women achieve their aesthetic goals. The excitement starts when the news breaks that a product or procedure has earned approval from the U.S. Food and Drug Administration (FDA). FDA-approved cosmetic devices include Smartlipo Triplex, CoolSculpting, and injectables such as Kybella. The FDA has also approved dermal fillers containing hyaluronic acid to smooth out facial wrinkles. Saline, silicone, and IDEAL breast implants are also FDA-approved.

What is the role of FDA approval in aesthetic treatment and devices? Is it important that a treatment that you are considering has FDA approval? To answer these questions, let’s take a look at what FDA approval means.

It is the FDA’s responsibility to grant and oversee a company’s interstate medical product marketing, that is, when drug companies develop a new medicine, they have to do various tests to make it sure that the drug is safe and effective before it can be sold and prescribed. The FDA’s role is to approve the medication for the specific use the drug is made for. Usually, drugs are approved on the basis of a specific disease or diseases, a specific age group, a specific problem and a specific health condition, like weight or pregnancy. A Hudson Institute report states, “The FDA’s valuable and important role is to conclude whether products are appropriately labeled as determined by risk analysis, assessment, monitoring of approved product clinical studies, evaluation of a company’s safety and efficacy claims, and then to grant interstate marketing licenses.”

Besides medications for humans and animals, the FDA monitors food, vaccines, tobacco products, dietary supplements, radiation-emitting electronics, cosmetics, and medical devices. According to the American Society of Plastic Surgeon (ASPS),”almost half (48%) of the approvals made by the FDA are for medical devices. One third (33%) are given to foods intended for human consumption. The next largest share is cosmetics (8%), followed by housewares and food-related items at 5%, and drugs and “biologics” at 3%.”

Though some products are FDA-approved for a particular use, providers may use them in other ways too. For instance, though Botox is FDA-approved for frown lines, crow’s feet and now horizontal forehead lines, it is also used to smooth out lines on the nose, to enhance the appearance of the lips and to uplift the eyebrows to a more naturally relaxed position. These uses, though not officially recognized by the FDA, are known to have a history of successful and safe use by qualified providers.

If a particular aesthetic device has obtained FDA approval for one purpose, then the surgeon can prescribe the treatment for a patient which is called prescribing medication “off-label.” Continued research on the same device for other purpose requires FDA approval for that purpose too. For example, CoolSculpting in NYC is a unique nonsurgical treatment that is FDA-approved to remove unwanted fat from various areas of the body such as the chin, thighs, abdomen and flanks or love handles. This fat freezing method was first cleared for by the FDA for non-invasive fat layer reduction in the flank or love handles and got FDA approval for abdominal fat reduction in 2012.Later, it received FDA approval in 2016 for reducing fat around the bra straps, back, and underneath the buttocks. In 2017, the FDA approved this fat-freezing device for “improving the appearance of lax tissue” (or loose skin) in the under-chin area.

The FDA’s goal is to safeguard people from harmful drugs and procedures. Companies must prove their offerings to be both safe and effective before they can be put on the market. A device or drug gets approval only after a detailed presentation in well designed scientific studies and investigations led by the FDA which 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.

While FDA approval doesn’t guarantee safety or effectiveness, it is a successful regulatory body that can be referenced for unbiased information. If a drug or device doesn’t obtain this approval doesn’t mean that it is not safe and effective, but the term “FDA approval” provides comfort to the consumer.

FDA approval is important for a cosmetic devices and injectables, but their safety and effectiveness would also depend on the plastic surgeon who uses them to perform a procedure. To ensure optimal outcomes and safe body contouring in NYC using approved modalities, choose an AAAASF accredited plastic surgery practice with qualified surgeons with expertise in performing the procedure you are considering.

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