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Dermal Filler News

U.S. FDA Approves Juvederm Ultra XC for Use in Lips

Posted 1 Oct 2015 by Drugs.com

DUBLIN, Oct. 1, 2015 /PRNewswire/ – Allergan plc, (NYSE: AGN), a leading global pharmaceutical company, today announced that the company has received approval from the U.S. Food and Drug Administration (FDA) to market Juvederm Ultra XC for injection into the lips and perioral area for lip augmentation in adults over the age of 21. Juvederm Ultra XC instantly adds fullness to the lips and is the only dermal filler that has proven results lasting up to one year for lip augmentation. "As the leader in medical aesthetics, Allergan is committed to continued research and development in this area," said Philippe Schaison, Executive Vice President & President, Allergan Medical. "Providing physicians and patients with premium products that allow them to achieve the aesthetic results they want is always our goal. Understanding that the desire with lip augmentation is to achieve a ... Read more

Related support groups: Juvederm, Dermal Filler, Lip Augmentation

FDA Medwatch Alert: Unintentional Injection of Soft Tissue Filler into Blood Vessels in the Face: FDA Safety Communication - Risk of Serious Patient Injury

Posted 1 Jun 2015 by Drugs.com

[Posted 05/28/2015] ISSUE: The FDA has reviewed information that suggests unintentional injection of soft tissue fillers into blood vessels in the face can result in rare, but serious side effects. Unintentional injection can block blood vessels and restrict blood supply to tissues. Sometimes this can result in embolization. This means the filler material has traveled to other parts of the body. This can cause vision impairment, blindness, stroke and damage and/or death of the skin (necrosis) and underlying facial structures. While unintentional injections into blood vessels may occur with injection sites anywhere on the face, the FDA’s review of literature and adverse event reports submitted to the FDA identifies certain injection locations where blood vessel blockage have been reported more often. These sites include the skin between the eyebrows and nose (glabella), in and around t ... Read more

Related support groups: Facial Wrinkles, Juvederm, Bellafill, Radiesse, Perlane, Restylane, ArteFill, Dermal Filler, Captique, Hylaform Plus, Evolence

Choose Wrinkle Treatments Wisely, FDA Advises

Posted 14 Aug 2014 by Drugs.com

THURSDAY, Aug. 14, 2014 – Injectable dermal fillers are widely used by people seeking to smooth out wrinkles, but it's important to know the risks of these products before using them, a U.S. government expert says. Dermal fillers use a variety of materials to treat facial wrinkles. Most of these products are temporary and last for about six months or more. Only one permanent wrinkle filler is approved by the U.S. Food and Drug Administration. Dermal fillers are not approved for use anywhere else but on the face. "As with any medical procedure, being injected with dermal fillers poses some risks. You should ask what you can expect and contact your health care professional if you are concerned about a particular side effect," Dr. Janette Alexander, an FDA medical officer, said in an agency news release. Common side effects include bruising, redness, swelling, pain and itching. Other side ... Read more

Related support groups: Facial Wrinkles, Juvederm, Radiesse, Perlane, Restylane, ArteFill, Dermal Filler, Captique, Hylaform Plus, Evolence

FDA Medwatch Alert: Expression Injectable by Enhancement Medical: FDA Safety Communication - Adverse Events Associated with Unapproved Use As a Dermal Filler

Posted 7 Aug 2014 by Drugs.com

ISSUE: The FDA has become aware of adverse events associated with the unapproved use of the Expression product, hyaluronic acid that is packaged in a syringe, as a dermal filler. Events have included swelling, tenderness, firmness, lumps, bumps, bruising, pain, redness, discoloration, itching, and the development of hard nodules. BACKGROUND: Expression is listed with the FDA as an intranasal splint, and is intended to minimize bleeding and swelling and to prevent adhesions (sticking together) between the septum and the nasal cavity. Intranasal splints are placed in the nasal cavity after surgery or trauma and are usually constructed from plastic, silicone, or absorbent material. The FDA issued a warning letter to Enhancement Medical LLC on June 4, 2014, advising the company of multiple quality system, correction/removal, and medical device reporting violations that were revealed during ... Read more

Related support groups: Facial Wrinkles, Juvederm, Radiesse, Perlane, Restylane, ArteFill, Dermal Filler, Captique, Hylaform Plus, Evolence

Merz Aesthetics Announces FDA Approval of Belotero Balance Dermal Filler for the Correction of Moderate-to-Severe Facial Wrinkles and Folds

Posted 17 Nov 2011 by Drugs.com

SAN MATEO, Calif., November 16, 2011 – Merz Aesthetics today announced that the United States (U.S.) Food and Drug Administration (FDA) has approved Belotero Balance for the correction of moderate-to-severe facial wrinkles and folds. Belotero Balance filler is a hyaluronic acid-based cohesive gel dermal filler designed to deliver natural-looking results with little recovery time. Belotero filler is currently approved for aesthetic use in the United Kingdom, Germany, Italy, Russia, Austria and Switzerland. “Belotero Balance is a soft dermal filler that is designed to achieve meaningful results by integrating into facial skin tissue,” said Rhoda S. Narins, M.D., lead investigator and Clinical Professor of Dermatology at New York University Medical School, New York, N.Y. “With Belotero Balance, patients are able to see a visible softening in their lines for a natural look that lasts.” Belo ... Read more

Related support groups: Facial Wrinkles, Dermal Filler

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Further Information

Related Condition Support Groups

Facial Wrinkles, Lip Augmentation, Facial Lipoatrophy

Related Drug Support Groups

Juvederm, Bellafill, Radiesse, Perlane, ArteFill, Restylane, Belotero Balance, Captique, Juvederm XC, Evolence, Restylane Lyft, Restylane Silk, Hylaform Plus