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New in Equipment-based Treatments (page 11 of 12)
Belvedere USA Corporation announced that it is now a privately held company after completion of a purchase agreement between two senior company managers and parent company Proctor & Gamble. Horst Ackermann was president of Belvedere USA and Barry Sanders served as vice president of finance and administration for the company when it was a subsidiary of P&G. Their new titles are principal/chief operating officer and principal/president, respectively.
Belvedere is a leading North American manufacturer and marketer of salon and spa furnishings and equipment. The company dates from 1927 and has always been based in Belvidere, Ill.
The structure of the company will not change under the new ownership.
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 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.
By Rick Krupnick
Learn how offering LED therapy treatments can boost your spa’s revenue stream and increase your clientele.
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.
The Food and Drug Administration yesterday outlined a plan for tougher monitoring of the safety of medical devices once the products are on the market. It comes just after Democrats , who promise more aggressive oversight of the FDA, wrested control from Republicans in the House of Representatives and Senate.
The FDA said the timing of yesterday's plan was "totally unrelated" to the election outcome. The agency's plan includes an electronic system for reporting serious side effects, to replace the paper reports now filed by medical professionals and patients.
"The entire FDA post-marketing surveillance system is weak both for drugs and devices," said Dr. Steve Nissen , a Cleveland Clinic Foundation cardiologist scheduled to testify at a congressional hearing this month about the FDA. "Unfortunately, adverse event reporting is voluntary and, generally, only 1 to 10 percent of events are reported," Nissen said.
A Democratic-led Congress appears willing to make that and other FDA improvements, starting by shuffling a few key committee chairmen.
Democrats Edward M. Kennedy of Massachusetts , Henry A. Waxman of California , and Bart Stupak and John D. Dingell both of Michigan are poised to head key congressional panels with investigatory powers and FDA oversight.
"With congressional oversight, [the FDA is] going to face a much tougher, much tougher environment," said John Manthei , a partner in the Washington, D.C., office of Latham and Watkins LLP . "Mr. Waxman and Mr. Dingell and Mr. Stupak have made it very clear that FDA is squarely within their crosshairs," said Manthei, FDA counsel for the Medical Device Manufacturers Association .
Kennedy has co sponsored reform legislation that, among other changes, shifts planning for how to handle emerging drug risks to the preapproval phase—when the FDA has more clout—and provides more drug-safety funding.
The FDA said that its plan will help it better detect and take action on risks related to thousands of medical devices, such as mesh stents used to prop open clogged arteries, pacemakers, and implantable defibrillators that tame irregular heart beats.
The agency is under fire for underestimating such problems as long-term heart risks attributed to drug-eluting stents, manufactured by companies that include Natick's Boston Scientific Corp . The FDA relied on short-term studies for the approvals. Next month , it will convene an advisory panel to discuss cardiovascular safety data from longer-term use.
In addition to the electronic reporting system for side effects, the FDA already has assembled a network of 350 hospitals that report problems with devices, shortening the time it takes for the agency to learn about problems. Dr. Daniel Schultz , director of the FDA's Center for Devices and Radiological Health , said the agency will more aggressively tap that database.
In addition, medical devices soon could carry "unique identifiers" that make it easier to track them down, permitting more focused recalls of problematic models.
By Diedtra Henderson, Boston Globe Staff, November 10, 2006
The Board of Laser Safety (BLS)/The National Council on Laser Excellence (NCLE) now offer a collaborative, unified Certified Medical Laser Safety Officer program (CMLSO) to promote overall acceptance of laser certifications. To contact the BLS, call 407-380-1553. For the NCLE, call 614-883-1739.
The California Senate has introduced Senate Bill 1423, which will restrict registered nurses, physician assistants and physicians who have esthetic practices from using laser and IPL systems. In addition, Massachusetts, Georgia and North Carolina are considering similar bills.