The Year in Cosmetic FDA Approvals

The FDA has approved many new cosmetic products this year. Some of the most notable include:


BELOTERO Balance® is a dermal filler that contains the popular wrinkle busting ingredient hyaluronic acid. The product is manufactured by Merz Aesthetics and was approved to treat moderate and severe facial wrinkling by the FDA on November 14, 2011. In a study of 118 patients, BELOTERO Balance® was used to treat facial wrinkles on one side of the face, while bovine collagen was used on the other side of the face. According to the results of the study, BELOTERO Balance® resulted in less facial wrinkling, for a longer of a period of time when compared to collagen. Alternatives to BELOTERO Balance® include facelift, browlift, and eyelid surgery.

Restylane® Injections for Lip Enhancement

On October 11, 2011, the FDA approved Restylane® Injectable Gel for use in injectable lip augmentation treatments for patients that are 21 years of age or older. Restylane®, made by Medicis, is a hyaluronic acid-based filler that temporarily adds fullness to the lips. It was previously approved for the treatment of nasolabial folds, the vertical facial creases that develop on both sides of the mouth. Plastic surgeons and dermatologists have been safely and successfully using Restylane® off-label in lip augmentation procedures for years. Now that the FDA has officially expanded its uses, patients can feel more comfortable when undergoing treatment.


The LIPOSONIX® system is designed to reduce the size of the waist and destroy belly fat. The FDA cleared the device for sale in the United States on September 8, 2011. Manufactured by Medicis, the device uses ultrasound technology to contour the body. The system is directed at the area of fat, and then the highly focused ultrasound waves target fat through the skin. In a controlled study using the LIPOSONIX® system, patients experienced, on average, a 1-inch reduction in the size of their waists. An alternative to LIPOSONIX® treatments is liposuction.


On July 21, 2011, Merz Aesthetics announced that the FDA approved Xeomin® for the treatment of moderate to severe glabellar lines. The primary active ingredient in Xeomin®, botulinum toxin, temporarily relaxes the muscles that cause frown lines. Xeomin® is similar to products like BOTOX® Cosmetic and Dysport®; what sets Xeomin® apart is that the product does not have to be refrigerated prior to use.


LaViv® was approved by the FDA on June 21, 2011. The injectable treatment utilizes the patient’s own cells, or fibroblasts, which are processed and then re-injected into facial wrinkles. The advantage of the treatment is that patients consider it to be a natural treatment; the downside is that several treatments are needed to achieve desired results.


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