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.
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 also are 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 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.”
THE LOWDOWN ON INJECTABLES
Some doctors say that the efficacy and safety of injectables 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.
— The Wall Street Journal
ON THE MARKET NOW
Botox
A neurotoxin drug that is by far the most common injectable, with more than 3 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. Lasts three to four months.
Average physician fee: $363
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. Lasts six months or longer.
Average price for all hyaluronic acids: $557
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.
CosmoDerm
A collagen product that, unlike its predecessors Zyderm and Zyplast, doesn’t require an allergy skin test several weeks before treatment. 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 also are popular in the lip border and fine lines above the mouth.
Average fee for all collagen products: $390
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
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
ArteFill
A permanent implant approved recently 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.
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.
Products that are coming soon
Evolence
A collagen product developed by Israeli company Colbar LifeSciences, which 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.
Puragen Plus
A hyaluronic acid filler expected to last about six months. 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. Could launch in the U.S. late next year.
Laresse
A biomaterial used in spinal 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.
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.
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.
Puretox
Another potential Botox rival. Technology licensed by Mentor from the University of Wisconsin. A researcher there helped develop the purification process for botulinum toxin that later became Botox.
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ON THE RISE
Last year, the number of cosmetic surgical procedures actually fell by 5 percent 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 percent to 8.4 million.
Some physicians say the surgery group’s figures actually under-report the volume of injectable procedures, which also are available from general practitioners, gynecologists, dentists and nurses in medical spas.
— The Wall Street Journal
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TELL US
Would you have a minimally invasive procedure to improve your looks? E-mail us at ritaredeye@tribune.com. Include your full name, age and neighborhood.
