STATEN ISLAND, NEW YORK - When a new medical device or product enters the market for weight loss, wrinkle reduction or breast enhancement, it is followed by whether or not it has been or is up for FDA approval. But what does that mean and why is it important?The U.S. Food and Drug Administration was created in 1906 with the passage of the Pure Food and Drugs Act. While it has undergone several changes since the 1900s, today is has developed into a government agency designed to protect the U.S. consumers from unsafe or inappropriate use of food, drug, cosmetics and medical products, according to theFDA's website.For a product to receive the FDA's seal of approval, it must undergo a series of scientific studies that are presented and evaluated by the FDA. This is by no means a short process and the reason for that is to weed out the less than proven products. After the trails are complete and the investigations are over, the FDA can either choose to approve or deny a product. If the product is approved, the manufacturer is then allowed to advertise the product to the consumer according to what was discovered as proven and effective use.There are instances where a product is FDA approved for a specific use, but some physicians choose to use it in another manner. This is OK with the FDA as long as the way in which they use the product is in the best interest of the patient. An example of this practice is Botox. While Botox was originally approved by the FDA to treat neck spasms, it was found to be effective when used in a non FDA approved manner to treat wrinkles. After further investigations were performed on its use in treating wrinkles, the FDA approved it for that purpose.Breast implants are one of the most investigated medical devices in the history of the FDA because they have been so controversial, saysStaten Island breast augmentationsurgeon. When breast implants were first presented to the FDA over half a century ago the FDA mandated several large studies involving tens of thousands of women. While the FDA has been able to approve several types of implant fillers, their investigations still continue as new filler types are introduced. The most commonly used implants are silicone and saline, and while they are FDA approved, studies are still taking place to ensure they remain safe for use.Medical devices, such as implants, must be approved on two levels:FDA ClearanceThe FDA will approve a device after reviewing its pre-market notification, commonly referred to as a 501k approval, which is filed with the FDA by the manufacturer. The process is considered streamlined, as the manufacturer only has to show that the device is equivalent to another device that is already marketed for the same use.FDA ApprovalAfter reviewing a devices' pre-market approval application, the FDA will grant an approval. To receive approval, the manufacturer must provide reasonable assurance of the devices safety and effectiveness.Products that do not have an equivalent product on the market that has a proven track record to compare it to, the device must go through the pre-market approval process, which involves trials and investigations that can take years to complete."When products first hit the market there is a lot of planning and strategy behind its marketing," said Dr. Elliot Heller, a specialist ofgynecomastiaandliposuction in Staten Island. "Before buying into the claims, it is recommended that you find aplastic surgeonthat offers the product and its competitors. Sometimes the new products are not as effective as the old, so having someone who is knowledgeable on the products is in your best interest."Learn MoreTo learn more about Associates in Plastic Surgery and the performance of itsStaten Island cosmetic surgeon, visit www.AssociatesinPlasticSurgery.com or calling toll-free at 1-800-924-6397.About UsAssociates in Plastic Surgery offers the latest advances in plastic surgery with five convenient locations in New Jersey and New York. Their staff of highly experienced professionals is dedicated to their patients' well-being with state-of-the-art facilities and free consultations.© 2012 Master Google and Associates in Plastic Surgery. Authorization to post is granted, with the stipulation that Associates in Plastic Surgery and Master Google are credited as sole source. Linking to other sites from this press release is strictly prohibited, with the exception of herein imbedded links.
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