Recent Survey Suggests Complications with Permanent Fillers
1 in 4 UK surgeons have seen patients with complications
June 18, 2009 - A new survey completed by the British Association of Aesthetic Plastic Surgery (BAAPS) suggests that patients may experience higher complication rates with permanent cosmetic fillers than with other types of cosmetic injections. The survey reveals 38.5% of surgeons saw 1-3 patients over the past year experiencing complications with permanent facial fillers, and 23% of surgeons saw 1-3 patients in the past year with complications so severe surgery was needed to treat those complications. "Permanent fillers present challenges, particularly for inexperienced injectors," says Coalition leader Julius Few, MD, a plastic surgeon practicing in Chicago, IL. "In addition to potential complications that may develop years after injection, the challenge of a permanent, synthetic filler is the anticipation of aging changes and the need for outcomes that will not look unnatural over time. To date, fat continues to be the option closest to a permanent filler with a proven safety record."
British surgeons reported far fewer complications with non-permanent fillers: 81% of surgeons did not see any complications with hyaluronic acids (Restylane, Perlane, Juvederm and Prevelle in the U.S.), collagen (Evolence, Cosmoderm), or calcium hydoxyl appetite (Radiesse). "Permanent fillers are very different than temporary dermal fillers, because the results from temporary fillers do diminish over time," said Coalition leader Roger Dailey, MD, an oculoplastic surgeon practicing in Portland, OR. "Temporary fillers can then be placed in subsequent years in a customized fashion to adjust for the changes that occur with age in the surrounding untreated areas."
In addition to complications from synthetic permanent fillers, 29% of British surgeons report a range from 1-12 patients per year with complications from the "lunchtime boob job," a procedure that uses skin-plumping injections like hyaluronic acid to enhance breast size. "There is no commercial dermal filler approved for breast augmentation in the U.S., nor is injecting the breasts with a synthetic filler an accepted practice among U.S. physicians. There simply is not enough data on the safety or outcomes for synthetic dermal filler injections to the breast or buttocks Fat injections to the breast are still considered investigational - they being carefully researched, but fat is widely used and accepted to enhance the buttocks," said Dr. Few.
The survey also revealed the top reason BAAPS doctors cited for complications with fillers: Unqualified practitioners are administering fillers incorrectly. "The problem of unqualified practitioners is not only in the United Kingdom, it's here in the United States. Consumers need to always be aware of who is injecting them and what they are injecting them with," says Dr. Dailey. "You should only accept an injection that has been prescribed by a physician, that is FDA approved, and do not allow yourself to be injected by someone who has not clearly defined his or her qualifications to you." Studies conducted by the U.S. FDA report that patients experiencing adverse events from temporary dermal fillers are mostly the result of an injection by an unqualified provider. The number of overall complications in the U.S. with temporary dermal fillers is less than 1 in 10,000 .
The Coalition, which has launched a new, consumer friendly site with video, FAQs and more, offers consumers extensive, easy to use resources including a cosmetic injection planner with all the questions you must ask your provider at http://www.injectablesafety.org. In addition, an up-to-date listing of the status of investigational and approved cosmetic injection drugs and devices is available on the site, as well as pictures that will help consumers identify a genuine brand. In addition consumers are urged to ask and consider these simple questions before considering any cosmetic injectable procedure:
- Doctor: Is the injectable recommended by a qualified doctor who regularly treats similar conditions, in an appropriately licensed and equipped medical facility? Has the doctor examined the prospective patient before recommending treatment?
- Brand: Is the injectable recommended approved by the U.S. FDA, and by equivalent agencies in the country of origin, for cosmetic indications and is it appropriately labeled and packaged to reflect its authenticity and approval?
- Safety: Is the setting a proper medically-equipped office, with safety and sterilization procedures? Has the physician evaluated conditions, recommended treatment, offered alternatives and clearly defined the potential outcomes including any complications?
About Us The Physicians Coalition for Injectable Safety is an alliance of specialty physician organizations including the American Society for Aesthetic Plastic Surgery, American Academy of Facial Plastic and Reconstructive Surgery, the American Society of Ophthalmic Plastic and Reconstructive Surgery, the American Society of Plastic Surgeons, the International Society for Aesthetic Plastic Surgery, the International Federation of Facial Plastic and Reconstructive Surgeons, and the Canadian Society for Aesthetic Plastic Surgery. The mission of the Coalition is to provide the public with unbiased and necessary information on injectable cosmetic treatments, appropriate injectors and where to safely access cosmetic medical procedures. Our goal is to promote treatment supervised by properly qualified and trained, board-certified doctors and to promote only the use of U.S. FDA-approved, appropriately administered product. More information can be found at http://www.injectablesafety.org.
U.S. FDA Executive Summary, Dermal Filler Devices, November 18, 2008 (http://www.fda.gov/ohrms/dockets/ac/08/briefing/2008-4391b1-01%20-%20FDA%20Executive%20Summary%20Dermal%20Fillers.pdf)
Industry Insights, data review and summary, November 25, 2008. http://www.injectablesafety.org/downloads/ASAPSReviewofFDAReport112508.pdf)