Navigation Links
Wrinkle Fillers Need Better Label Warnings: FDA Panel
Date:11/18/2008

Reports of allergic reactions, other problems have surfaced with these products, experts say

TUESDAY, Nov. 18 (HealthDay News) - American women who turn to cosmetic treatments called dermal fillers to ease wrinkles must be better informed as to the health risks these products pose, an advisory panel to the U.S. Food and Drug Administration recommended Tuesday.

The panel of independent experts urged the agency to revise product labeling to warn of potential reactions to the fillers, including bumps, blotching and scarring.

While side effects are relatively rare, the U.S. Food and Drug Administration has also received reports of allergic reactions, including some that were life-threatening, such as anaphylactic shock, the agency said.

"The labeling should be modified to reflect what we're learning further about the products'' in various post-marketing studies and elsewhere, panel member Mary McGrath, a professor of surgery at the University of California in San Francisco, told Bloomberg News.

According to the American Society for Aesthetic Plastic Surgery, nearly 1,449,000 procedures involving fillers were performed in the United States last year.

The FDA is not bound to follow the recommendations of its advisory panels, although it typically does so. As part of their review, the group reviewed a variety of reports to see if stronger warning labels were needed for the injectable products. Some fillers 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 meeting was spurred by reports of 823 injuries caused by dermal fillers that included allergic reactions, swelling, sores, pain, blisters and cysts.

Overall, 638 patients needed additional medical treatment. Nineteen patients were seen in emergency rooms with life-threatening allergic reactions, such as difficulty breathing. Twelve patients had to be admitted to hospitals due to infections, the FDA said.

Medications used to treat problems ranged from topical steroid creams to multiple courses of oral antibiotics, topical steroids, anti-inflammatory or antihistamine drugs, and intra-lesion steroid injections. Ninety-four of the 823 reported injuries required surgical intervention, ranging from opening an abscess for drainage of pus, to biopsy of lesions, the FDA said.

One of the FDA's concerns is that some of the products are being used in ways that they weren't approved for -- called "off-label use."

"The trouble is that once this material is in the hands of physicians, there's really not much control over how it's used and where it's placed," Dr. Scott Spear, a Washington plastic surgeon., told the AP. "That creates the potential for a certain amount of mischief."

There's limited data on how darker-skinned people may react to the dermal filler treatments. Hispanic, black and Asian patients may develop blotches and other complications, the FDA said.

"Off-label" use of these products may be the cause of some of these problems. Lip enhancement is a common off-label use, the FDA said.

Another concern is what happens to the fillers as they break down and circulate throughout the body. Most of the products appear to cause no problems, but one contains small plastic balls that aren't absorbed by the body, the FDA has noted.

More information

For more on cosmetic surgery, visit the American Society of Plastic Surgeons.



SOURCE: U.S. Food and Drug Administration; Nov. 18, 2008, Associated Press, Bloomberg News


'/>"/>
Copyright©2008 ScoutNews,LLC.
All rights reserved  

Related medicine news :

1. Cougars Crave Biocap, The Haute Pepper Wrinkle Eraser
2. New Study Provides Scientific Evidence That DermaLastyl Face Cream Reduces Wrinkles
3. Botox Cosmetic Alternatives Are Available: Surgical Procedures Offer Solution for Wrinkles
4. FDA Grants Over-The-Counter Clearance to GentleWaves(R) for the First Home Use Light-Based Device to Treat Wrinkles
5. GFX: Wrinkle-Killer or Botox(R) Hit-Man?
6. Grassini & Wrinkle Law Firm Are Awarded Largest PI Verdict in Ventura County History
7. New Medical Technology is Changing the Face of Wrinkle Treatment
8. Another new wrinkle in treating skin aging
9. Clinical Trial Concluded For New Wrinkle Treatment
10. FDA Takes Closer Look at Wrinkle Treatments
11. Dr. Arnold Klein Warns of Dangers With Permanent and Longer Lasting Injectable Fillers
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
Wrinkle Fillers Need Better Label Warnings: FDA Panel
(Date:5/26/2016)... , ... May 26, 2016 , ... ... clinical outcomes, hosted members and suppliers for its inaugural Member Conference at the ... their mission of elevating the operational health of America’s healthcare providers. , The ...
(Date:5/26/2016)... Washington, D.C. (PRWEB) , ... May 26, 2016 , ... ... the men and women who lost their lives in military battle for the country. ... discount cards in 2015 to provide more programs that empower independence for disabled military ...
(Date:5/26/2016)... ... May 26, 2016 , ... There are nearly 14.5 million people ... cancer survivors worldwide. On Sunday, June 5, 2016, communities around the world will gather ... Day®. , National Cancer Survivors Day® is an annual worldwide Celebration of Life ...
(Date:5/26/2016)... ... 2016 , ... Dr. James Maisel will present on “Macular ... on June 4, 2016, 1:30-3:30 pm at the Farmingdale Public Library. The presentation ... of New York , is a Board Certified ophthalmologist who completed his fellowship ...
(Date:5/26/2016)... ... May 26, 2016 , ... Memorial Day Weekend marks the unofficial ... is sharing tips to make sure your family and vehicle are ready to ... Council, there may be 439 deaths and an additional 50,500 serious injuries from motor ...
Breaking Medicine News(10 mins):
(Date:5/27/2016)... SAN FRANCISCO , May 27, 2016 ... biotechnology company focused on developing products for Regenerative Medicine, Neurology and ... Commissiong will be presenting at two upcoming investor conferences: ... Conference Center, 730 Third Avenue, New York City ... at 3:00pm Marcum MicroCap Conference   ...
(Date:5/26/2016)... May 26, 2016   Change Healthcare ... analytics, network solutions and technology-enabled services designed ... entered into a strategic channel partnership with ... software solutions and revenue cycle management services ... and rehabilitation clinics to optimize revenue, operational ...
(Date:5/25/2016)... and GERMANTOWN, Maryland , May 25, 2016 ... ; Frankfurt Prime Standard: QIA) today announced that the company ... Diagnostics GmbH to develop and commercialize predictive assays in oncology. ... as a marker to predict effectiveness of anthracycline treatment in ... "We are pleased to partner with Therawis, which developed the ...
Breaking Medicine Technology: