An exciting new product will soon be joining the Juvederm family. Juvederm Volbella XC has just received FDA approval and is expected to be available to patients as early as October 2016.
Juvederm is already well known for its suite of dermal fillers for the temporary correction of lines and wrinkles of the face. Now, the makers of Juvederm, Allergan, can corner a share of the market in lip augmentation and enhancement.
Juvederm Volbella XC
Juvederm Volbella XC has been approved by the FDA to increase the fullness of the lips and to correct perioral rhytids or perioral lines in patients who are at least 21 years of age. Perioral rhytids are a common problem among smokers, former smokers, and individuals who are older than 50 years. Perioral rhytids are wrinkles that develop around the mouth and are especially evident when a person purses her lips. Juvederm Volbella XC can minimize the appearance of these troublesome lip lines and boost lip fullness for about one year before follow-up treatments are needed.
Bill Meury, who is Allergan’s Chief Commercial Officer, hailed the FDA’s decision to approve the product, stating that, “The FDA approval of JUVÉDERM VOLBELLA® XC further demonstrates Allergan’s commitment to developing advanced products and technologies that allow healthcare providers to better address evolving patient needs. Additionally, this approval brings to market a product unlike anything that is currently available in the United States.”
Clinical trials of Juvederm Volbella XC
In announcing the approval of this latest dermal filler, Allergan pointed to several clinical studies that the company said establishes the product’s safety and effectiveness. The U.S. pivotal study included 168 study participants who were treated with the new dermal filler. The scientists used a four point scale to evaluate how effective the product was in smoothing out the lines around the mouth. A five point scale was used to evaluate how well Juvederm Volbella XC was able to plump up the lips of the study participants. According to Allergan, two thirds of the study participants demonstrated improvement in both categories through one year after the treatment.
Patient safety is another important consideration when the FDA decides whether to approve a new product for use. According to Allergan, the side effects seen in the clinical trial were similar to those that arose in a control group. These side effects included redness, itching, firmness, swelling, and bruising at the injection site. These issues were temporary and went away on their own. The reported side effects are comparable to the potential side effects associated with other dermal fillers and injectable cosmetic products.
Lip enhancement in New York City
Juvederm is one of the many cosmetic enhancements available at the NYC plastic surgery office of Dr. B. Aviva Preminger, a board-certified plastic surgeon who has been widely acclaimed for her dedication to healthcare excellence.
During your one-on-one consultation with Dr. Preminger, she will listen carefully to your unique aesthetic concerns before recommending treatment options that are right for you. In addition to the family of Juvederm products, Dr. Preminger is pleased to offer Radiesse, Belotero, autologous fat transfer, and lip injections to her discerning patients.
Call 212-706-1900 today to request your confidential appointment.