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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, Restylane, Radiesse, Perlane, ArteFill, Evolence, Dermal Filler, Captique, Hylaform Plus

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, Restylane, Radiesse, Perlane, ArteFill, Evolence, Dermal Filler, Captique, Hylaform Plus

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, Restylane, Radiesse, Perlane, ArteFill, Evolence, Dermal Filler, Captique, Hylaform Plus

FDA Takes Closer Look at Wrinkle Treatments

Posted 18 Nov 2008 by Drugs.com

TUESDAY, Nov. 18 – U.S. health advisers were taking a closer look Tuesday at those increasingly popular cosmetic treatments called dermal fillers that help to smooth away deep lines and wrinkles on the face. While side effects are relatively rare, the U.S. Food and Drug Administration has received reports of allergic reactions, including some that were life-threatening, such as anaphylactic shock, the agency said. That's why an FDA advisory panel is reviewing those reports to see if stronger warning labels are needed for the injectable products, some of which are made from natural substances, while others come from synthetic materials. Brand names for some of these products include Restylane, Juvederm, Artefill, and Perlane. The FDA has also asked the panel to make recommendations on testing the dermal fillers, post-approval follow-up and informing consumers about potential risks. The ... Read more

Related support groups: ArteFill, Frown Lines

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Facial Wrinkles