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How Safe Are Facial Injectables?
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"Face Time: The New Injectables"
In Wake of Botox Craze, a Raft Of Treatments Hit Market;
Sorting Through the Choices
By RHONDA L. RUNDLE
November 14, 2006; Page D1
When the Food and Drug Administration approved Botox for cosmetic use in 2002, the agency unwittingly helped launch a cultural phenomenon. Botox parties, Botox gift cards, Botox jokes.
The intense popularity of Botox, an injectable muscle relaxant for smoothing foreheads and crows' feet, also helped spur a whole new medical specialty: facial rejuvenation. Today, a raft of new injectable products are coming to market, promising to fill wrinkles and creases and even reshape noses, chins and cheeks.
On the tail of Botox, which is mainly used around the eyes, came Restylane, a filler used mostly in the lower face. Now Botox maker Allergan Inc. is launching Juvederm to compete with Restylane. A number of older products, such as collagen, are being used in new ways. Scores more are on the horizon as pharmaceutical companies chase the growing number of patients eager for alternatives to invasive plastic surgery.
The injections are no fun -- even painful -- but the results are fairly predictable and quick, and patients don't have to hide out for weeks as they would after surgery.
But as new injectable products emerge, so do questions about safety, efficacy and cost. Most of the treatments are temporary, requiring repeated injections every four to six months to maintain the effects. Maintenance costs can add up -- by one estimate, a combination of Botox with a wrinkle filler could cost $4,500 a year or more. Side effects are usually temporary, but can range from redness and bruising to unsightly bumps under the skin.
Last year, the number of cosmetic surgical procedures actually fell by 5% to 1.8 million compared with five years earlier, according to the American Society of Plastic Surgeons. But over the same period, the number of "minimally invasive procedures" including facial injections and laser treatments, grew 53% to 8.4 million. Some physicians say that the surgery group's figures actually under-report the volume of injectable procedures, which are also available from general practitioners, gynecologists, dentists and nurses in medical spas.
Manufacturers are coming out with injectables that are longer-lasting or even permanent. But some doctors fear there may be tradeoffs between longevity and safety. Products such as Radiesse and Sculptra last a year or so, though they are still approved only for therapeutic uses, such as AIDS-related facial wasting in the case of Sculptra. And there have been scattered reports of adverse events including "granulomas" -- bumps under the skin that form in reaction to the foreign substance in the body. For permanent products such as ArteFill or liquid silicone, there are also questions about how such treatments will wear as a face ages over time.
At a recent dermatology meeting in Palm Desert, Calif., one session focused on the safety issue. Amy E. Newburger, a Scarsdale, N.Y., dermatologist who is an FDA consultant, pointed out that there is no global system for reporting so-called adverse events. While some products have been in use for years overseas, she warned, physicians and patients shouldn't draw conclusions from manufacturers' claims about track records of safe use.
In addition, many injectables fall into the same regulatory category as medical devices, and thus the FDA doesn't always subject them to the same rigorous scrutiny as drugs. So, for instance, long-term effects aren't studied as thoroughly. Consumers need to know, stressed Dr. Newburger, that "FDA clearance isn't a Good Housekeeping seal of approval."
Some doctors say that the efficacy and safety of these treatments can depend a great deal on how they are used. The incidence of adverse events is very low when shots are performed by a physician or nurse knowledgeable about facial anatomy, these doctors say. And patients should have realistic expectations about what the products can do. Some work best in deep folds, while others erase small lines, and some can be used together to achieve a certain effect. Here's an overview of the most popular aesthetic injectables, and some that may make it to market soon. Average prices are from the 2005 survey of the American Society of Plastic Surgeons, though consumer prices may vary.
On the Market Now
- Botox: A neurotoxin drug that is by far the most common injectable, with more than three million procedures reported last year. Botox temporarily paralyzes muscles with a series of tiny shots, smoothing frown lines between the eyebrows and crow's feet around the eyes. It is the only neurotoxin approved for cosmetic use in the U.S. Lasts three to four months. Average physician fee: $363. From Allergan Inc., Irvine, Calif.
- Restylane: The second-most-common injectable, with about 700,000 procedures in the U.S. last year, Restylane is a filler that plumps up creases under the skin and is mostly used on the lower face. It is made from hyaluronic acid, a natural sugar that binds to water, creating temporary volume. Lasts six months or longer. Average price for all hyaluronic acids: $557. From Medicis Pharmaceutical Corp. (A thicker version, Perlane, is awaiting FDA approval. Medicis is also developing other versions to complement its brand, including Lipp, Fine Lines and SubQ.)
- Juvederm: A new hyaluronic acid in limited release that is going up against Restylane. Doctors like its ease of injection, but competition will focus on relative cost and duration. The cost to physicians is slightly more than Restylane, but retail pricing won't be clear until after Allergan officially launches Juvederm in January. Allergan's older Hylaform and Captique products don't last as long as Juvederm or Restylane.
- CosmoDerm: A collagen product that, unlike its 18-year-old predecessors, Zyderm and Zyplast, doesn't require an allergy skin test several weeks before treatment. Zyderm and Zyplast are harvested from cows, whereas CosmoDerm and its sister product CosmoPlast are made in a laboratory from human collagen, a natural component of the skin. CosmoPlast is used in deeper lines and furrows. Treatments are also popular in the lip border and fine lines above the mouth. Average fee for all collagen products: $390. Allergan.
- Radiesse: Made from tiny calcium particles that create a scaffold for the body's own collagen to grow. Approved for craniofacial surgery. In August, an FDA panel recommended approval for smile-line wrinkles, but the agency hasn't ruled yet. Some dermatologists who use it off-label for cosmetic applications caution that particles can migrate and cause nodules, especially in the lips. Some tests show it lasts perhaps a year or longer. Average fee: $914. From BioForm Medical Inc., San Mateo, Calif.
- Sculptra: A synthetic polymer that stimulates new collagen production. Approved in 2004 for treating facial fat loss in HIV patients, but used off-label by some cosmetic dermatologists. It is reported to last a year or more. There have been some reported incidences of delayed small bumps under the skin. Average physician fee: $876. From Dermik Laboratories, a unit of France's Sanofi Aventis.
- ArteFill: A permanent implant approved last month for treating smile lines. Early versions of the product, sold in Europe and Canada, caused reactions called granulomas in some patients. Many doctors won't use it, but advocates say it's especially good for acne scars. Results are reported to be very dependent on the medical practitioner's technique. Price hasn't been announced. Artes Medical Inc., San Diego.
- Silicone: A permanent, liquid injectable that is making a comeback. Many doctors stopped using it a decade ago, especially after silicone breast implants were taken off the market. It remains controversial, but some dermatologists are using a purified product sold by Alcon Inc. for eye surgery. Like ArteFill, it's an option for permanent filling of facial scars.
Coming Soon
- Evolence: A collagen product developed by the Israeli company, Colbar LifeSciences, that was recently purchased by pharmaceutical titan Johnson & Johnson. Evolence is reported to be in late-stage human tests in the U.S. Dermatologists are buzzing about its potential to last a year or more and supplant other collagens on the market.
- Puragen Plus: A hyaluronic acid filler, expected to last about six months, about the same duration as Restylane and Juvederm. Mentor Corp. launched Puragen in Europe last year. Puragen Plus includes an anesthetic, lidocaine, that the company says make the injections less painful than those of other fillers. Mentor hopes to launch in the U.S. late next year.
- Laresse: A biomaterial used in spine surgery that has been developed as a filler, expected to last about six months. Launched in the U.K. this summer. Entering U.S. human tests soon, possibly on the market in 2008. FzioMed Inc., San Luis Obispo, Calif.
- Aquamid: A permanent filler made from a biomaterial used in contact lenses and other medical devices. Sold for cosmetic use throughout Europe. FDA human tests expected to begin in the U.S. soon. Contura International A/S, Denmark.
- Reloxin: A Botox-like drug undergoing human tests in the U.S. Expected launch in 2008. Physicians hope it will break Botox's monopoly and bring down prices. Sold in Europe under the brand name Dysport. At the Palm Desert meeting, preliminary data were presented by a U.K. physician indicating it might not last as long as Botox. Medicis has U.S. rights.
- Puretox: Another potential Botox rival. Technology licensed by Mentor from the University of Wisconsin. A researcher there decades ago helped develop the purification process for botulinum toxin that later became Botox.
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