Dermal Filler Side Effects FDA
The water in the fountain of youth may not be as magical as some people assume. Although wrinkle-filling procedures, such as Botox and Juvederm, have skyrocketed in popularity, there are definite risks. As the sheer number of products used to change the face and body increases, the FDA aims to determine their safety and effectiveness.
Wrinkle fillers, also known as dermal fillers, were created about 20 years ago. However, the number of products on the market has greatly increased within the last 10 years. Dermal fillers are made from a variety of ingredients. Materials may be natural or synthetic, as well as absorbable or non-absorbable by the skin.
Most are injected in the mid to deep layers of the skin and are indicated for correction of moderate to severe wrinkles. The National Ambulatory Medical Care Survey stated that 18.4% of office cosmetic procedures are for soft tissue fillers. Recently, customers have also become interested in changing the shape of bodily tissues, such as the neck, feet, or hands, and companies have aimed to please them.
Before meeting on November 18th, 2008, the FDA released a report summarizing the latest data on wrinkle-filling procedures. The organization studied the results of dermal fillers in patients after the procedures. The FDA hopes that such data will lead to better safety regulations for new products, before they are used on people.
Examples of companies and dermal fillers tested by the FDA are Artes Medical’s Artefill, Bioform Medical’s Radiesse, and Allergan’s Zyderm, Cosmoderm, and Juvederm. Currently, they are not indicated for people with severe allergies to filler-type materials or bleeding disorders.
The FDA studied damaging effects of fillers by examining Medical Device Reports from 2003 to September, 2008. 930 total reports were separated by type of damage, frequency of damage, and site of injection. The reports represented a variety of countries, ages, and genders, although a majority of reports were on females. Injection sites included the face and other areas of body, such as hands, feet, and neck.
Of 930 cases, 334 reported swelling at the injection site, 292 reported inflammations, 275 mentioned redness, and 230 included allergic reactions. Other examples include infections and vascular events (e.g., bruising, bleeding, hematoma, necrosis, scarring). While some minor irritation or discomfort is considered normal after dermal filling, severe reactions are not. Serious complications included severe systemic reactions, swelling of the tongue, difficulty breathing, anaphylactic shock, and hives.
Of the more serious side effects, many required oral antibiotics, topical steroids, anti-inflammatory or antihistamine drugs, or steroid injections. A smaller number of injuries needed injection site drainage, nodule removal, or biopsies at the site. Patients with allergic reactions were even admitted to the emergency room or stayed in the hospital for treatment.
After studying these cases, the FDA reached a number of conclusions about wrinkle fillers. The organization stated that many patients are receiving injections that are not indicated by the drug (e.g., in the hands, neck, or feet). New standards are needed for contour-shaping materials, as improper use may damage sensitive tissue and change its ability to function. The FDA also stated that small reactions to wrinkle fillers are expected to disappear quickly, but in reality linger longer and become more serious than they should. Danger may increase in patients who have multiple injections. Many procedures are also performed by those who are unqualified and in unsafe facilities.
Much study remains in the human quest for beauty. This research can be difficult because, as the FDA reported, “effective” beauty treatments are in the eye of the beholder. One person may consider filling forehead wrinkles sufficient, while another desires changes in the lips, cheeks, and nose. What is most important, however, is that such procedures are done safely.
To view the FDA article on wrinkle filler safety, go to:
http://www.fda.gov/consumer/updates/wrinklefillers062608.html.
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