Given all the products that have come and gone over the years claiming to rid the body of cellulite, it's OK to be skeptical about the latest miracle treatment.
Yes, you read it right--there is a new noninvasive treatment for that patchwork quilt of skin and fat that is the bane of thighs worldwide. And unlike some of its more dubious cousins, the new therapy--called Endermologie--earned approval from the Food and Drug Administration last month as "an effective treatment for temporarily reducing the appearance of cellulite."
It is the first time a treatment for cellulite has been granted the official right to make this claim.
But before you burst into tears of joy or run for your credit card, there are caveats to consider.
The effectiveness of Endermologie--a mechanical device that administers a deep massage--varies widely among patients.
And, the effects are only temporary.
And the therapy seems to work better among patients who are also exercising and dieting.
"It's safe. No one is having bruising, hematomas or welting. But, in terms of efficacy, the key words are 'temporary' and 'the appearance of.' We can't lead people to believe, by any stretch of the imagination, that this is permanent," says Dr. Deborah Sarnoff, a dermatologist in New York City who has independently studied Endermologie.
UCLA plastic surgeon Dr. Peter B. Fodor has also studied the treatment and concludes that it is the combination of diet, exercise and Endermologie that produces a modest smoothing of the bumpy cellulite surface. Women often have cellulite on the thighs, abdomen and buttocks, while men can accumulate cellulite in the "love handles" area of the abdomen.
It's not a quick fix for anyone.
"One or two treatments is of little value. We do 14 initial treatments, usually twice a week, and we tell them to stay on a diet and do an exercise program. And I'm sure that has something to do with it too."
The recent FDA action, however, may send Endermologie hype through the roof. An estimated 300 doctors--typically gynecologists, dermatologists and plastic surgeons--are installing the $25,000 units. The average cost per initial treatment is $100 for 35 minutes, and many doctors offer packages of $1,500. Because Endermologie is a medical device, it can be offered only by MDs. Trained technicians administer the treatment.
Endermologie was developed in France and introduced in the United States in 1996. The U.S. distributor of the device, LPG USA of Fort Lauderdale, Fla., was authorized by the FDA to market it as a muscle relaxer. However, the company quickly raised the ire of plastic surgeons by making claims that doctors thought were exaggerated.
"In the early photos of Endermologie [results], people had significant weight loss or also had adjuvant liposuction or a tummy tuck and were giving all the credit to Endermologie," Sarnoff said.
Some plastic surgeons were also irritated by the company's initial claims that Endermologie was a noninvasive form of "body sculpting," says Fodor.
"We had our reservations of whether that was the case," he says, acknowledging: "We have a tendency to be somewhat pessimistic. But enough things have gone down the pipeline that look like a novel treatment for cellulite that have not panned out."
Since liposuction--the surgical procedure that removes fat and can help the appearance of cellulite--is the most popular cosmetic surgery, plastic surgeons may have been worried about protecting their turf, says Dr. Harold Lancer, a Beverly Hills dermatologist who offers Endermologie.
"If liposuction is your No. 1 income producer, you don't want to see that suppressed with Endermologie," he says.
Ultimately, LPG USA pulled its ads and gathered scientific data to present to the FDA to substantiate the claim that Endermologie temporarily reduces the appearance of cellulite.
"What we had cleared it for initially was as a muscle relaxer for relieving minor aches and pains," says FDA spokeswoman Sharon Snider. "Then the company submitted specific information on cellulite. If a company wants to make a different claim, other than the one approved, we want to see the data, and we want to make sure it's effective."
Snider confirmed that Endermologie is the first technique to gain permission to make a claim about cellulite.
"The consumer pays a lot of attention to what the FDA does. And I think this will have a big impact," says Lancer.
Consumers are generally very skeptical of products that claim to help cellulite, says Dr. Richard Frieder of the Physician's Body Care Center in Santa Monica.
"Everyone knows that nothing has worked for cellulite," he says. "There are all sorts of procedures and machines that the FDA has turned down, and skepticism is a big obstacle. The FDA approval carries credibility with the general public."
Cellulite consists of pockets of excess fat that usually form among women as they age. The fat is essentially trapped and becomes a reserve against starvation. It cannot be lost by diet or exercise.
"If you are a woman between puberty and menopause, it is the way our anatomy is," Sarnoff explains. "The fat cells are grouped, and in between the groups are separate or dividing areas. During certain times of the month when we retain water, you see more of this dimpling effect. Even if you are very, very skinny."
Endermologie is thought to work by increasing the blood and lymphatic flow through the subcutaneous layer of the skin. It's a high-powered massage tool that consists of a treatment head and two motorized rollers with a suction device. Suction draws tissue up between the two rollers, lifting, folding, pulling. It provides a controlled, repetitive, deep massage.
There is some debate about whether the treatment actually changes the fat cells in the subcutaneous layer.
"It increases blood flow and allows the body to target that part of the body to burn fat," Frieder says. "You can find a cellulite massage in every spa. But they don't work too well because they don't increase blood flow. They work more on the muscle."
Endermologie does not affect muscle, skin or bones. It is painless and feels like a vacuum cleaner pressed against the skin and rolled.
Victoria Davis, a Los Angeles-based actor, tried Endermologie several months ago after winning a free treatment at a health fair. She had big doubts about whether it would help.
"I thought: 'Another one of those bogus treatments.' I was definitely skeptical. But the explanation for how it worked made sense. I appreciated a scientific explanation for how it could work."
At first, says Davis, the treatments didn't seem to be doing much. But after 10 sessions, she noticed a change.
"My saddlebags have gone down and the dimpling in my legs are not as deep. And the best thing is that this isn't any more expensive than getting a massage," she says.
According to the few studies that have been done in the United States, the results of Endermologie vary widely and depend greatly on whether the patient is also eating a low-fat diet and exercising.
Sarnoff was among a group of doctors who studied the technique by performing it on one side of the body only and after numerous treatments, comparing the results with the untreated side.
"As a package [with diet and exercise], I have seen some nice results," she says. "But I think if someone deludes themselves into thinking they can lie down once a week and not make many lifestyle changes, they won't get big results."
According to data presented in April in the journal Aesthetic Plastic Surgery, 90% of patients, (85 women ages 21 to 61) reported good results.
And in a study of six women using magnetic resonance imaging, Endermologie seemed to reduce the rippling phenomenon, especially along the flank or "love handles." But the effects were not uniform in any one patient.
It usually takes 10 to 20 initial treatments to get the best results, Frieder says. The look can usually be maintained with one or two maintenance treatments a month, which run about $45. However, without regular maintenance, the benefits will be quickly lost.
Unlike liposuction, which can remove large quantities of fat, Endermologie is not a treatment for obesity.
"I think the ideal candidate is someone who is pretty much normal weight but who has this dimpling in the saddleback or thigh area," says Sarnoff.
The technique appears to work similarly on all skin types, says Lancer, an expert on how cosmetic skin procedures vary among ethnicities.
But, he adds: "The one thing that does seem to influence results is the patient's age. After age 65, the effect decreases."
Women who have only accumulated cellulite recently and don't have too much will have the best results, Frieder adds, while women who are genetically prone to develop cellulite early in life will need more treatments and may still not get the best results.
Another good use of the technology, many experts suggest, is for liposuction patients. Endermologie can speed the healing process of liposuction from six months to two months, Sarnoff says.
Fodor says he uses Endermologie at a low setting, during and after liposuction.
"What we found then is there was very little swelling and bruising after liposuction when we use the Endermologie machine."