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New in Medical Esthetics (page 23 of 24)
Nearly 11.5 million cosmetic surgical and nonsurgical procedures were performed in the United States in 2006, according to statistics released today by the American Society for Aesthetic Plastic Surgery (ASAPS). Compared to 2005, cosmetic surgical and nonsurgical increased 1%. The Aesthetic Society, which has been collecting multispecialty procedural statistics since 1997, says the overall number of cosmetic procedures has increased 446% since the collection of the statistics first began. The most frequently performed procedure was injectable fillers and the most popular surgical procedure was liposuction.
The top nonsurgical cosmetic procedures include injectable fillers, hyaluronic acid, laser hair removal, microdermabrasion and laser skin resurfacing.
A new Dermacare Laser & Skin Care Clinic location, called Dermacare of Brooklyn Heights, recently opened. Owned by two former obstetricians hoping to boost women’s confidence, the medical spa will provide both medical and esthetic treatments. 718-625-7546, email@example.com
A visit to a skin treatment clinic in a Florida suburban mall in late 2004 changed 52-year-old Jordan Miles' life forever.
She had responded to an ad from the clinic that promised help for her teenage son's acne. He didn't get the treatment, but Miles made an appointment for herself for laser treatments to remove sunspots on her arms, back and chest.
Two women ended up performing the procedure -- neither, Miles later found out, had the necessary training.
"They started with the laser on my chest, and when they got to my back, they decided the sunspots were worse, and so they upped the laser, further intensifying the procedure," Miles recalled.
The outpatient procedure left Miles, a mental health counselor, in such excruciating pain that she vomited on her way home. Getting no helpful response from the clinic, she consulted a dermatologist, who confirmed that she was covered in red, stripe-like second- and third-degree burns that would leave lasting scars.
The redness subsided, but each burn drained the pigment from her skin, leaving Miles open to further skin problems should she ever expose the affected areas to the sun.
"I now have what looks like zebra stripes everywhere," Miles said. "I'm restricted from a lot of activities and types of clothing. It's terrible."
Miles' experience is hardly unique. In the past few years, reports of fraudulent or shoddy cosmetic and plastic surgery procedures have grabbed headlines:
- In 2003, New York City financial analyst Maria Cruz died after a fatal reaction to lidocaine, delivered by Dean Faiello, a 46-year-old from Newark, N.J., who had been posing as a cosmetic surgeon. Faiello fled to Costa Rica but was apprehended by U.S. authorities in 2006 and is now in prison.
- In 2004, four people in Florida became paralyzed after Bach McComb, an osteopath with a suspended license, administered lab-strength botulism toxin -- not the much weaker Botox -- to himself, his girlfriend and two others. McComb was later sent to prison for three years.
- In 2005, a 46-year-old California woman died of multiple organ failure after receiving a buttock injection of what had been billed as a "French polymer" but was actually cooking oil. The beautician who delivered the shot, 39-year-old Martha Mata Vasquez, was sentenced to 15 years in prison in January.
It's tough to tell how often these types of dangerous procedures are being performed in the United States, experts said.
"I think that, especially in big cities, it's more common than you think, because I see lots of patients with problems who have been treated in hotel rooms, for example," said Dr. Rhoda Narins, past president of the American Society for Dermatologic Surgery (ASDS) and a clinical professor of dermatology at New York University Medical Center.
"Sometimes, when I ask patient what it is that they have had, they really have no idea," she said. In many cases, procedures are performed in non-medical settings -- hotel rooms, private homes, beauty clinics and spas, Narins said. "I've seen several patients who had spa treatments and got comfortable there, and then they were offered non-medical-grade silicone. They ended up having horrendous reactions."
Dr. John W. Canady, vice president of the American Society of Plastic Surgeons (ASPS), said that the underground nature of these sub-par procedures makes them especially hard to track.
He and Narins said consumers should watch out for the following "red flags" when seeking out cosmetic injections or surgeries:
- Check for credentials. It's not enough that your "doctor" is wearing a white lab coat and has a certificate on the wall. A number of organizations -- the ASDS, the ASPS, the American Board of Plastic Surgery and state medical boards -- have online resources that people can check to verify credentials and experience.
- Be wary of cheap deals. "If a procedure has an unbelievable price that nobody else is offering, then you really have to slow down and examine why it's so cheap -- why is it so out of line with the rest of the market?" said Canady, who is also professor of plastic surgery at the University of Iowa.
- Look for nearby medical support. Even procedures conducted by the best-qualified staff can go awry, so make sure your practitioner has equipment and qualified personnel on hand to deal with allergic reactions, clotting and other events. Most reputable clinics will have hospital affiliations. "As a patient, you want to know what things are available if things don't go right," Canady said.
Most of all, the experts said, ask questions.
"It's important to be a responsible consumer, to do your homework, to not be afraid to ask the tough questions," Canady said. "If you ask people legitimate questions in a non-offensive way, and they get angry or hostile with you, then you need to go find somebody else."
Narins agreed that an educated, proactive consumer is the best defense against fraud and abuse in her industry.
"People shouldn't take chances with their health. When you inject something into your body, this is not the same as getting a massage," she said. "This is something that can seriously affect you, and for a long time."
That's a lesson Miles said she learned the hard way, but she's hopeful that her story can at least help others. The clinic she received her laser treatment from has since closed down, and Florida state law was recently toughened to mandate that all laser procedures be done under a doctor's supervision.
But Miles said her scars are a daily reminder that patients remain vulnerable.
"Make no assumptions, and don't be afraid to ask questions," she advised. "The mistake I made was that I never asked these women if they were a nurse practitioner, or if they had any experience doing this before, or how many times they had done it before. All of those were major mistakes."
HealthDay News, 2/26/2007, By E.J. Mundell
A handheld laser device designed to treat hair loss has been approved by the U.S. Food and Drug Administration.
The Florida company that makes the Hairmax Lasercomb said 26-week trials found that the device does increase the numbers of thick hairs on the scalp, the Associated Press reported.
Lexington International LLC said its device combines a low-level laser with a comb. When it's drawn through the hair, the laser affects the scalp in way that promotes hair growth.
According to the company, the Hairmax Lasercomb is the only FDA-approved drug-free product for home use in fighting hair loss. The device sells for $54 on the Web, the AP reported.
HealthDay News, February 16, 2007
IRIDEX Corporation completed its acquisition of the esthetics business of Laserscope.
The U.S. Food and Drug Administration (FDA) has approved Radiesse, a cosmetic dermal filler, for the long-lasting correction of moderate to severe facial wrinkles and folds such as nasolabial folds.
Radiesse is composed of calcium hydroxylapatite microspheres in a water-based gel carrier. The product provides immediate improvement so a patient looks better the moment the product is injected. The calcium microsphere technology also enables the body to generate new collagen. Further, Radiesse provides physicians a high level of control, predictability and finesse for facial applications.
FDA approval of Radiesse for treatment of facial wrinkles and folds was based on the results of a clinical trial supporting Radiesse’s safety and effectiveness. In this study, conducted at four medical centers in the United States, 117 patients with nasolabial folds were treated with Radiesse on one side of the face and a control agent (Cosmoplast, a human collagen product) on the other. Results based on the ratings of three blinded evaluators showed that six months after treatment, Radiesse was more effective than the control on every comparative efficacy outcome (p<0.0001).
Key clinical findings include:
· 82 percent of nasolabial folds treated with Radiesse showed improvement after six months. This was significantly higher than the control, which showed improvement in only 27 percent of treated folds (p<0.0001).
· After six months, the fold treated with Radiesse was more improved in 79 percent of patients compared to the control-treated fold. The folds treated with the control rated more improved in only 5 percent of patients.
· The nasolabial folds treated with Radiesse required approximately half as much volume (1.22cc) than the folds treated with the control (2.35cc).
· Both products were safe and well tolerated, with no serious adverse events reported. In the 117 patients treated, Radiesse had zero granulomas and the same low rate of nodules as the control.
The U.S. Food and Drug Administration has approved a new treatment for moderate-to-severe frown lines, medically called nasolabial folds.
BioForm Medical issued a statement describing its Radiesse as a longer-lasting alternative to existing wrinkle fillers. The company said its calcium-based microsphere technology not only fills in facial folds and depressions, but also stimulates the body to produce collagen, the fibrous protein that gives the face its structure and fullness.
The drug was also newly approved to improve the appearance of people with AIDS-causing HIV who have significant facial fat loss (lipoatrophy), the San Mateo, Calif.-based company said.
Radiesse was first FDA approved in 2002 for use in facial reconstructive surgery.
HealthDay News, December 28, 2006
When it comes to treating the aging face, patients have their pick of numerous laser therapies for successful skin rejuvenation. But finding an effective treatment for the delicate skin of the neck can often be a real pain in the neck. Now, a retrospective review presented in a recent issue of Lasers in Surgery and Medicine, the journal of the American Society for Laser Medicine and Surgery, finds that a skilled practitioner can successfully resurface an aging and photodamaged neck using the Carbon Dioxide (CO2) laser if a series of treatment parameters are strictly followed.
In her article entitled “Safe and Effective Carbon Dioxide Laser Skin Resurfacing of the Neck,” laser expert Suzanne D. Kilmer, MD, of the Laser & Skin Surgery Center of Northern California, Sacramento, CA, outlines three key components essential to effective laser resurfacing of the neck with the CO2 laser that she and her colleagues have used to safely treat more than 1,000 patients over the past 10 years.
“We have found that for the CO2 laser to work safely and effectively on the neck, 1) the skin has to be sufficiently hydrated with a pre-operative topical anesthesia; 2) the laser has to be administered at a low density with only a single pass; and 3) the treated epidermis must not be wiped following the procedure,” explains Dr. Kilmer. “These three ingredients, in a sense, make up the ‘recipe’ for how to safely use the CO2 laser for neck resurfacing. And like all recipes, every step must be followed and all the ingredients must be added properly for the end result to turn out right.”
In order to adequately hydrate the skin prior to the laser procedure, Dr. Kilmer recommends that patients wash their entire face and neck with hot water and then immediately apply a thick layer—like frosting on a cake—of the topical anesthesia EMLA. The area is then sealed using a plastic wrap, and this process is repeated 45 minutes before the procedure. Dr. Kilmer notes that proper hydration is critical, as it “plumps up” the skin and creates a protective buffer against the laser that also aids in absorbing the laser’s energy.
During a typical laser skin resurfacing of the face with the CO2 laser, the epidermis is completely removed. For neck resurfacing, the laser energy is lowered so the epidermis is not removed and stays intact. This low density coupled with a single pass of the laser creates less trauma and less wounding on the neck. Dr. Kilmer points out that while the face would normally be wiped to remove the epidermal debris following the procedure, it is important not to wipe the treated epidermis from the neck because it serves as a natural dressing that protects the skin and aids in the healing process.
“Most of our patients that undergo CO2 laser skin resurfacing on their face also get their neck done at the same time,” says Dr. Kilmer. “Performing both procedures helps to blend the results, eliminating the noticeable line of demarcation that usually occurs when the neck is left untreated.”
While non-ablative laser treatment for skin rejuvenation has gained in popularity during the past few years, Dr. Kilmer notes that the CO2 laser produces longer-lasting results than its non-invasive counterparts and only a single treatment session is needed instead of a series of treatment sessions.
“As with any procedure, patients need to be informed of the potential risks, how much downtime is involved, and the importance of post-operative care before undergoing CO2 laser resurfacing,” adds Dr. Kilmer. “But for any single resurfacing treatment, the CO2 laser delivers the most overall improvement—hands down.”
Patients with a personal or immediate family history of vitiligo are not considered candidates for this procedure, as laser resurfacing can trigger depigmentation of the treated area consistent with this condition.
Personal misuse of super-strength botulinum toxin caused a Florida osteopath, his girlfriend, and two of his patients to become paralyzed and hospitalized for months in 2004.
Details of the much-publicized incident—which ended in the practitioner being sentenced to three years in prison—are only now published in this week's issue of the Journal of the American Medical Association.
At the time of the incident, Bach McComb was an osteopathic physician who was continuing to practice in Oakland Park, Fla., after his license had been suspended. In the four cases described, McComb did not use a medical version of Allergan Inc.'s Botox.
Instead, he mistakenly gave himself and the three others four to six injections of a preparation of paralyzing botulinum toxin that was 2,800 times stronger than that typically used on patients, according to the authors of the JAMA article. This formulation was only intended for laboratory work.
The vial's labeling clearly marked the product as not being suitable for human use.
"The fact that clinical practitioners were using an unlicensed product was very disturbing," said Dr. Christopher R. Braden, a medical epidemiologist at the U.S. Centers for Disease Control and Prevention, and an author of the report. "It needed to be highlighted and the issue dealt with so that it does not recur."
"A 100-microgram vial of toxin taken from the same manufacturer's lot as the toxin administered to the case patients contained a toxin amount sufficient to kill approximately 14,286 adults if disseminated evenly," according to the JAMA report.
McComb, his two patients, Eric and Bonnie Kaplan, and McComb's girlfriend, Alma Hall, were each paralyzed by the time they were admitted to a hospital.
All of the patients eventually survived but were hospitalized for months and required assistance for basic functions such as breathing, speaking and walking. McComb was later sent to prison for three years.
The incident does not reflect on the safety of standard treatments of Botox, stressed Dr. John Canady, a professor of plastic surgery at the University of Iowa and vice president of the American Academy of Plastic Surgeons.
"This was clearly not Botox," Canady said. "More than 3 million people got Botox injections in 2005, which is the last year we have statistics on, and I don't believe any reaction such as this has been reported."
The real Botox is carefully packaged by its manufacturer, Allergan, Canady explained. "Botox comes in a vial that does not have an excessive dose, and it is reconstituted in the same vial," he said. "None of these safeguards were in place" in the Florida case, Canady added.
Basic precautions against such misuse are obvious, Canady said.
"It is important to go to a board-certified plastic surgeon," he said. "You should feel free to ask that person what his track record has been in the use of Botox. Probably the biggest take-home message is that it is important to do your homework before any medical procedure, and that includes Botox."
In addition, "It's absolutely fair to ask what material is being injected into you personally," Canady said. "I don't think it's too much to ask to see the container or the material."
And Braden cautioned consumers about bargain-hunting.
The last time he looked at the Internet, he saw advertisements for "Botox-like" medications. "I would be very suspect of those kinds of products," Braden said.
By Ed Edelson, HealthDay Reporter, November 21, 2006
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