Consumers Beware of Juvederm Dermal Filler Sold Illegally in the U.S.

Public Health Watchdog Breaking News
Public Health Watchdog Breaking News

Juvederm is a soft tissue dermal filler that is a prescription device to treat moderate to severe facial wrinkles. This product should only be injected and sold by or on the prescription of a licensed health care provider. On June 8, 2017, the U.S. Food and Drug Administration (FDA) updated its dermal fillers website to alert the public about unapproved versions of Juvederm (hyaluronic acid), including Juvederm Ultra 2, 3, or 4.

These products are being sold and distributed illegally in the United States. The FDA warned that Juvederm Ultra 2,3, and 4 should not be purchased online by consumers or health care providers, as these products sold online without a medical license may not work as promised, and could have safety and effectiveness issues, reported.

Why People Use Juvederm

Many people choose Juvederm to treat wrinkles and lines, but there are various other reasons: acne scars, lifting the cheeks, filling loose or sagging skin for a younger look (“a liquid face lift”), changing the shape of the nose, to get plumper lips, and even address medical conditions such as lipodystrophy, which cause the loss of fat from the face, in areas of collagen loss.

Juvederm is a non-invasive cosmetic procedure. The type of materials approved for dermal fillers vary from biologic to synthetic material and absorbable to non-absorbable compounds.

Who Should Administer Juvederm

There are a variety of healthcare providers who are permitted to inject Juvederm. The initial consultation should be with a licensed and board-certified doctor, but in some offices, a nurse or aesthetician does the actual injection. Juvederm injections typically result in some bruising and swelling, which may last up to two weeks. Bruising will eventually dissipate, but there are some things that can be done to reduce it. Doctors advise for one to two weeks before the Jevederm treatment to not use alcohol, NSAID drugs (aspirin, Aleve, Advil, or Motrin), Vitamin E, fish oil, the “G” herbs (ginkgo, garlic, and ginseng).

It is common to have small bumps or lumps the first week after injection. If they do not go away in a week, your provider may use massage or heat to smooth the area out. “I recommend you do not massage them yourself,” says Dr. Jerome Edelstein, a Toronto plastic surgeon. The results, when all goes well, usually last from six months to a year.

National law firm Parker Waichman LLP has extensive experience and success representing clients in all types of litigation including product liability. Attorneys at the firm are available to answer questions for any individuals seeking legal information for a potential lawsuit.

Allergic Reactions

Several years ago, a report published on the FDA website found that dermal fillers had been linked to cases of life-threatening allergic reactions and anaphylactic shock. Other problems associated with dermal fillers ranged from mild swelling to facial, lip and eye palsy, retina vascular occlusion, infection, and disfigurement. According to the FDA, 638 reports revealed that patients required treatment with medication, including steroids, antihistamines, and oral antibiotics. Ninety-four reports indicated surgical intervention, 44 of which were among the patients who received drug therapy as well. Surgical procedures ranged from opening an abscess for drainage of pus, excision of nodules, to biopsy of the lesions, reports the FDA.

A report said that many of the side effects occurred in off-label procedures, and could have also been the result of untrained personnel or procedures done outside of a healthcare setting.

“The labeling should be modified to reflect what we’re learning further about the products,” said panel member Mary McGrath, a professor of surgery at the University of California in San Francisco.

More than 1,800,000 Americans used hyaluronic acid cosmetic fillers in 2013, up 18 percent from the previous year, according to statistics kept by the American Society of Plastic Surgeons. One of the properties of hyaluronic acid fillers that makes them so popular is that they are considered to be reversible. An injection of hyaluronidase dissolves the filler, according to Forbes.

If a person is interested in using fillers, or just learning more about them, it is advised to do careful research. The American Society of Plastic Surgeons has a good amount of information on the various fillers available and what they are best used for, reports Forbes.

Legal Information and Advice Regarding Juvederm

If you or someone you know has been injured by Juvederm or other cosmetic fillers, you may be eligible for valuable compensation. The personal injury attorneys at Parker Waichman LLP offer free, no-obligation case evaluations. We urge you to contact us at 1-800-YOURLAWYER (1-800-968-7529).