Archive for the ‘MedSpa’ Category
Laser Relief Skin Care
Author: newsroom20 Mar
Who Can Operate Aesthetic Lasers
Author: newsroom18 Mar
http://www.medscape.com/viewarticle/562488
Use of Cutaneous Lasers and Light Sources: Appropriate Training and Delegation
M. Alam, MD; J. S. Dover, MD, FRCPC; K. A. Arndt, MD
Skin Therapy Lett. 2007;12(5):5-9. ©2007 SkinCareGuide.com
Abstract and Historical Overview
Abstract
In recent years, there has been increasing concern among physicians, patient advocacy groups, and media watchdogs that laser, light, and cosmetic surgery are being practiced by poorly trained professionals, with resulting preventable injuries to patients. In response, several professional organizations have developed guidelines for the delegation of laser services to nonphysician providers. These guidelines delineate appropriate qualifications for delegating physicians and nonphysician providers, and also describe the circumstances and settings in which delegation is appropriate.
Historical Overview
As early as 8-10 years ago, reports documented the increasing tension between dermatologists and electrologists over the training required to perform laser hair removal, with dermatologists advocating for supervision by licensed physicians who are on-site. Some states that do not require licensing for electrologists to administer laser treatments, such as Texas, were of particular concern.[1,2] Yet concurrently, data showed that “properly trained” nurses had no greater risk than physicians of inducing undesirable outcomes, such as pigmentation change and blistering after laser hair removal with the long-pulsed alexandrite laser.[3] Recent studies suggest that a proportionately greater number of complications are arising from dermatologic care delivered by physician extenders. Nearly 53% of 488 dermatologists surveyed in Texas in 20044 reported seeing a greater number of complications associated with delegation to nonphysicians. Of those surveyed, 33% asserted that they knew of such complications arising in the absence of a supervising physician on-site during treatment delivery. This confirmed earlier results of a survey of 2,400 members of the American Society for Dermatologic Surgery (ASDS) in 2001, which ascribed the preponderance of post-treatment patient complications to “nonphysician operators,” including cosmetic technicians, estheticians, and workers in medical/dental offices who performed procedures for which they were not appropriately trained, or who were inadequately supervised.[5] Further studies under the auspices of the ASDS are ongoing. A growing body of evidence suggests that nonphysician provision of laser services and insufficient physician supervision of extenders may be jeopardizing patients, unnecessarily raising complication rates, and leaving dermatologists vulnerable to public censure and legal liability.[6,7]
Training for Provision of Laser Services: Formal Guidelines and State Regulation
Several professional physician groups have attempted to delineate appropriate training standards for those using lasers on patients. Such standards have typically been embedded in larger position papers on the scope of practice or laser use. Moreover, given that even the physician leadership can differ on exactly how training standards should be implemented, these guidelines tend to be firm in tone, but vague in terms of specific benchmarks for competency.
American Academy of Dermatology
On February 22, 2004, the Board of Directors of the American Academy of Dermatology (AAD) approved a Position Statement on the Use of Lasers, Pulsed Light, Radiofrequency, and Medical Microwave Devices.[8] This one-page document notes that physicians using the aforementioned devices must be trained in relevant “physics, safety, and surgical techniques.” Regarding physician and nonphysician roles during delegation of laser procedures, the following precautions should be observed:
A physician who delegates such procedures should be fully qualified by residency training and preceptorship or appropriate course work prior to delegating procedure to licensed or certified nonphysician office personnel and should directly supervise the procedures. The supervising physician shall be physically present on-site, immediately available, and able to respond promptly to any questions or problem that may occur while the procedure is being performed.
Any nonphysician office personnel employed and designated by a physician to perform a procedure must be under the direct supervision of the physician. For each procedure performed, the nonphysician office personnel must have appropriate documented training and education in the physics, safety, and surgical techniques of each system, be properly licensed in their state if required, and be adequately insured for that procedure. The nonphysician office personnel should also be appropriately trained by the delegating physician in cutaneous medicine.
In summary, the AAD document notes that the “Academy endorses the concept that use of properly trained nonphysician office personnel under appropriate supervision allows certain procedures to be performed safely and effectively.” The earlier exhortation that the supervising physician be present on-site is thus balanced by the concession that delegation of laser procedures to nonphysicians is inherently acceptable.
American Society of Laser Surgery and Medicine
The most extensive work in this area has been by the American Society of Laser Surgery and Medicine (ASLMS), which has incorporated the relevant guidelines established by the American National Standards Institute (ANSI) Z136.3 Standard Safe Use of Lasers in Healthcare Facilities.[9] Regarding operator qualification in the context of laser safety, ASLMS guidelines include the following clauses:
The laser will be operated only by those who have had training in laser theory, techniques of control, and operation of the laser(s) or IPL.
A program for laser safety training will be made available to ALL personnel working around the lasers. The Laser Safety Officer shall have discretion, according to ANSI standards, in delineating which personnel are required to undergo which levels of training. All of the training shall be documented and kept on file.
ASLMS also further clarifies training requirements in documents on office-based laser procedures[10] and nonphysician use of lasers.[11,12]
The ASLMS Principles for Nonphysician Laser Use,[11] and Educational Recommendations for Laser Use by Nonphysicians,[12] reproduced below, are slightly more specific:
Principles for Nonphysician Laser Use. Any physician who delegates a laser procedure to a nonphysician must be qualified to do the procedure themselves by virtue of having received appropriate training in laser physics, safety, laser surgical techniques, pre- and postoperative care, and be able to handle the resultant emergencies or sequelae.
Any nonlicensed medical professional employed by a physician to perform a laser procedure must have received appropriate documented training and education in the safe and effective use of each laser system, be a licensed medical professional in their state, and carry adequate malpractice insurance for that procedure.
A properly trained and licensed medical professional may carry out specifically designed laser procedures only under physician supervision and following written procedures and/or policies established by the specific site at which the laser procedure is performed.
Since the ultimate responsibility for performing any procedure lies with the physician, the supervising physician should be immediately available and shall be able to respond within five minutes to any untoward event that may occur. Ultimate responsibility lies with the supervising physician.
The guiding principle for all physicians is to practice ethical medicine with the highest possible standards to ensure the best interest and welfare of each patient is guaranteed. The ASLMS endorses the concept that use of properly trained and licensed medical professionals, under appropriate supervision, allows certain laser procedures to be performed safely and effectively.
Educational Recommendations for Laser Use by Nonphysicians. Individuals should be trained appropriately in laser physics, tissue interaction, laser safety, clinical application, and pre and post operative care of the laser patient. Prior to the initiation of any patient care activity the individual should have read and signed the facilities policies and procedures regarding the safe use of lasers.
Continuing education of all licensed medical professionals should be mandatory and be made available with reasonable frequency (including outside the office setting) to help ensure adequate performance. Specific credit hour requirements will be determined by the state, and/or individual facility.
A minimum of TEN procedures of precepted training should be required for each laser procedure and laser type to assess competency. Participation in all training programs, acquisition of new skills and number of hours spent in maintaining proficiency should be well documented.
After demonstrating competency to act alone, the designated licensed medical professional may perform limited laser treatments on specific patients as directed by the supervising physician.
American College of Surgeons
Among major specialties approved by the American Council on Graduate Medical Education (ACGME), surgery has been among the most active in promulgating outlines for laser training and use. This broad field is experienced at incorporating and regulating new operative technologies, but the breadth of laser use in surgery limits the specificity of the relevant parts of the American College of Surgeons (ACS) Statement on Laser Surgery,[13] revised in 2007 from the original statement published in 1991:
Surgery is performed for the purpose of structurally altering the human body by the incision or destruction of tissues and is a part of the practice of medicine. Surgery is also the diagnostic or therapeutic treatment of conditions or disease processes by any instruments causing localized alteration or transposition of live human tissue, which include lasers, ultrasound, ionizing radiation, scalpels, probes, and needles. All of these surgical procedures are invasive, including those that are performed with lasers, and the risks of any surgical intervention are not eliminated by using a light knife or laser in place of a metal knife or scalpel.
The American College of Surgeons believes that surgery using lasers, pulsed light, radiofrequency devices, or other means is part of the practice of medicine and constitutes standard forms of surgical intervention. It is subject to the same regulations that govern the performance of all surgical procedures, including those that are ablative or nonablative, regardless of site of service (that is, hospital, ambulatory surgery center, physician’s office, or other locations). Patient safety and quality of care are paramount, and the College therefore believes that patients should be assured that individuals who perform these types of surgery are licensed physicians (defined as doctors of medicine or osteopathy) who meet appropriate professional standards. This is evidenced by comprehensive surgical training and experience, including the management of complications, and the acquisition and maintenance of credentials in the appropriate surgical specialties (that is, board certification) and in the use of lasers, pulsed light, radiofrequency devices, or other similar techniques.
Individuals who perform laser surgery utilizing lasers, pulsed light, radiofrequency devices, or other techniques should meet the principles of the College in all respects, to include the avoidance of any misrepresentations to the public regarding unfounded advantages of the laser compared with traditional operative techniques.[13]
Furthermore, the ACS Statement on Issues to Be Considered Before New Surgical Technology is Applied to the Care of Patients, the subsection on “Is the individual proposing to perform the new procedure fully qualified to do so?” includes the following passage:
In order to determine and apply proper indications for a procedure and to select the appropriate patients for applications of the technology, comprehensive knowledge of the disease process and experience in management of patients with the disease is essential. Prompt recognition and management of complications can only be achieved when the individual or team member is fully qualified in all aspects of treatment of the disease.[14]
American Society for Dermatologic Surgery
Within dermatology, the American Society for Dermatologic Surgery (ASDS) has been most active in developing guidelines for the nonphysician practice of medicine, in particular, the use of lasers. This multi-pronged approach has included alerting state medical boards to the potential hazards to patients, publishing statistical data in the professional medical literature, making information easily available to patients on the Internet, and conducting a public relations campaign to apprise patients of the dangers inherent in receiving laser services from unqualified personnel.
At present, the ASDS guidelines assert that cosmetic procedures, including cutaneous laser procedures, be delivered only by MDs and DOs who have been adequately trained. A qualified physician may delegate some procedures to certified or licensed office personnel (e.g., RN, CMA, LPN, PA, NP) if, and only if, the delegated individuals are properly trained in the specific procedure and the physician remains physically on-site and available to respond in a timely manner to questions or problems that may arise.[15]
In recognition of the fact that laser hair removal procedures, in particular, are likely to be performed by nonphysicians, the ASDS provides, in the public portion of its web-site, a statement entitled Don’t Get Burned What You Need to Know About Laser Hair Removal,[16] which reads in part:
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State Medical Boards
State medical boards have taken notice of the media furor surrounding adverse events resulting from laser use by nonphysicians. The Louisiana State Board of Medical Examiners has begun to require that the use of medical lasers and chemical peeling procedures be under direct supervision by an on-site physician. Similarly, the New York State Board of Medicine has construed laser hair removal by lasers and intense pulsed light devices to constitute the practice of medicine, and hence to be permissible only when performed by a physician or under a physician’s direct supervision. The Massachusetts legislature established a task force within the Board of Medicine to report back to the legislature by May, 2007 with draft standards or regulations on medi-spas.
Practical Issues in Nonphysician Laser Practice: Financial Incentives, Patient Safety, and Adverse Events
From a practical standpoint, the dangers of inappropriate delegation of laser services or nonphysician practice of medicine include:
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In the case of laser use in a spa, the financial incentives for delegation are further enhanced by the nature of the business model, which resembles a retail store rather than a medical practice, and to a greater extent than in a physician practice, service providers may be compensated on an incentive basis. There may be no physicians present at most times, and there may even be a dearth of medical personnel. In many spas, services are provided by estheticians and nonmedical, nonphysician providers, who are not inculcated as are physicians and nurses in the need to ensure patient well-being.
Problems that have been commonly seen in unsupervised or nonphysician laser centers have been numerous and varied and include:
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Some of these problems, like hyperpigmentation, will eventually resolve, but hypopigmentation and configurate scarring can be persistent and disfiguring. Rampant infection can result in functional loss, including permanent impairment of facial sensory structures.
The problem of impaired safety is exacerbated by the lack of general dermatologic training among nonphysician providers of laser services. In general, low-level and even some high-level nonphysician providers are trained mostly in the technique of laser service delivery, with lesser training in the management of adverse events, and little or no training in general cutaneous medicine. Adverse events, and especially unusual cases, may be recognized late by such providers, who may then treat them incorrectly. Especially when physician supervision is light, incorrect treatment may continue for some time, until the problem has worsened and permanent sequelae may be inevitable. It is a truism in cutaneous laser therapy that firing a laser handpiece may be the least important portion of the treatment; it is everything but the actual treatment, including patient selection, parameter selection, and recognition and management of undesirable outcomes, that requires judgment and training. In the spa environment or in a poorly supervised laser practice, the pressure to “convert” all consultations into treatments may result in poor patient selection, which in turn may dramatically increase the rate of adverse events.
Incentives for nonphysician providers to maximize revenue generation in a spa or thinly supervised setting can increase the risk of adverse events by:
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To the extent that nonphysician providers may have a skewed financial incentive structure, wherein they are more often rewarded for revenue generation than penalized for adverse events and patient dissatisfaction, the impetus to increase business may dominate. The result means greater risk for the patient, and for the ostensibly delegating but possibly off-site physician, who may have medico-legal responsibility for problems accruing from delegated services.
Beyond adverse events, such incentives may lead to unnecessary treatments motivated by the desire to increase financial yield by extending the number of sessions. Indeed, more revenue may be generated by systematically undertreating patients to ensure that they return for more visits. Subtherapeutic treatments may also reduce the risk of adverse events when laser treatments are delivered by minimally trained nonphysician providers. While undertreatment is unlikely to cause irrevocable physical injury, it is a form of fraud that wastes patients’ time and money.
Conclusions
While current guidelines on appropriate cutaneous laser training and delegation are not detailed and comprehensive, some recommendations occur repeatedly in guidelines proposed by various national professional organizations. In particular, it is apparent that:
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References
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1Northwestern University Medical School, Chicago, IL, USA
2Yale University School of Medicine, New Haven, CN and Dartmouth Medical School, Hanover, MA, USA
3Beth Israel Hospital and Harvard Medical School, Boston, MA, USA
An Increase in Cosmetic Laser Treatments Reported by AACS
Author: newsroom17 Mar
The American Academy of Cosmetic Surgery is a professional medical society whose members are dermatologic surgeons, facial plastic surgeons, head and neck surgeons, general surgeons, oral and maxillofacial surgeons, plastic surgeons, or ocular plastic surgeons — all of whom specialize in cosmetic surgery.
The AACS has completed its annual Procedural Survey and the most notable finding is the shift towards non-invasive laser treatments.
Over the past three years, cosmetic surgeons have seen a significant increase in both males (456%) and females (215%) electing to have laser resurfacing. Laser resurfacing is performed with a carbon dioxide (CO2) laser that delivers short bursts of high-energy laser light to minimize wrinkles and lines on the face. In addition, laser hair removal has jumped to the overall number two most performed non-invasive cosmetic procedure.
“Cosmetic surgery technology is advancing at the speed of light,” states AACS President Patrick McMenamin, MD. “As we learn more about the cosmetic uses for lasers, the more patients benefit from effective results and quicker recovery time. It is an exciting time for both cosmetic surgery patients and physicians.”
Although the economy is struggling, these laser procedures seem to be recession resistant. For instance, laser resurfacing has seen an approximate $450 decline in price since 2002. “As long as these procedures are effective and affordable, their demand will continue to remain steady.”
Other notable findings from the survey include:
In 2008, cosmetic surgeons have seen a 29% increase in their female clientele. Despite the economy, women are continuing to invest in their appearances. In addition, cosmetic surgeons have seen a 2% decline male patients proving that when times are tough, cosmetic surgery is the one of the first things men delete from their wish lists.
The top three most performed invasive cosmetic procedures in 2008 include: liposuction, blepharoplasty and breast augmentation; while the most popular non-invasive cosmetic procedures were Botox(R) injections, laser hair removal and hyaluronic acid.
The 2008 Procedural Data is based on a survey of U.S.-based AACS members completed in December 2008. The entire report, conducted by RH Research, is available by contacting the Academy.
Related Documents
Texas IM Doctors Turn to Aesthetics to Meet the Demand and Bring New Business to Their Practices
Author: newsroom16 Mar
A review of an article published in Houston Business Journal – by C. Richard Cotton
Originally trained in internal medicine, Dr. Kim Vo shares her new field of medicine — aesthetics — with other Houston doctors like Jim Cain, whose original specialty was interventional radiology.
Both physicians eventually ended up in the field of aesthetics, which, quite simply, is where many people turn to look better and younger.
Laser treatments, Botox injections and wrinkle fillers are the new Fountain of Youth — a step up from over-the-counter potions, but less expensive and intense than cosmetic surgery. And, weary of chasing insurance and Medicaid payments, physicians nationwide are capitalizing on the trend.
Cain compares the influx of physicians into aesthetics with a similar rush into pain management a decade ago: “It was mainly an economic thing — and this is the same thing.
“Doctors are looking for a way to get cash into their businesses,” he says, “and aesthetics is a cash business.”
Few insurance policies cover aesthetics procedures since they are primarily cosmetic and elective. But the economic times, Cain admits with a laugh, are not optimal for entrepreneurial endeavor: “There probably isn’t a worse time in history to start this.”
The Patients
Vo says the typical patient at her Dermagenix Medical Spa, which she opened in the spring of 2007, falls into two main categories; younger patients seeking hair removal and treatment for acne and older patients in their forties or fifties.
“They want to continue looking good for jobs or their social lives,” Vo says of the latter group. “They want something more than the moisturizers found at the mall.”
Of the younger set, she says, “By the time they come here, they’ve been to the dermatologist and through over-the-counter products.”
Vo came to aesthetics through “personal interest” in the field, wanting to explore her own anti-aging options: “I’m getting older and wanted to know what’s out there.”
Through Continuing Medical Education, she studied the procedures for two years, “until I was comfortable with them.”
Her choice of names for her clinic describes its perceived duality of purpose, as much spa as sterile clinic; expect, as Vo describes it, “a combination medical facility in a spa environment with music and ambiance.”
The Procedures
Dermagenix offers the full range of aesthetics, from laser to injections. Vo says Botox injections run $200-$300; fillers of hyaluronic acid, $500-$800; and lasers, $300-$2,000.
Vo notes that lasers, in particular, are coming into more and more applications, including tightening skin, hair removal, vein treatment and skin resurfacing.
She says that in Texas, lasers are in something of a regulating gray area; a physician must purchase them but, beyond that, there is little regulation. Employing them in treatment, for example, is not restricted to a physician. Texas law, in fact, doesn’t mandate the purchasing physician even be on the property — or in the state, for that matter — where the laser is operated.
“Since it is my responsibility, I operate the laser,” Vo says.
“I have lasers that can burn a hole through the wall,” says Cain, co-owner of Innovative Aesthetics. With his initial training in interventional radiology, Cain already had experience in the laser arena.
The Doctors
Cain opened his clinic six months ago but still also practices radiology. Through his explorations of other specialties, particularly anesthesiology and pain management, Cain says he became fascinated with anti-aging medicines.
“I’ve just got to get into it,” he recalls thinking before becoming a fellow in aesthetics medicine through a program established by the American Academy of Anti-Aging Medicine.
Cain and his partners opened Innovative Aesthetics in extra space on Audley Street at one of their two imaging centers.
Dr. German Newall offers both aesthetic treatments and cosmetic surgery through Aesthetic Center for Plastic Surgery, of which he is a co-owner. The group maintains two offices and a surgery center.
“While I’m interested in aesthetic surgery,” says Newall, “these (aesthetic treatments) are part of the practice.” He adds that not all plastic surgeons delve into the aesthetics arena.
Newall, who is certified by the American Society of Plastic Surgery, says as a surgeon he’s “more readily available to deal with complications if they arise.” He adds this caveat: “If you do enough through the years, you’re going to have complications.”
And he says he’s dealt with patients who received less-than-ideal results from physicians who have gotten into aesthetics as a way to increase the bottom line.
“I do understand because of economic situations doctors want to subsidize their salaries through aesthetic procedures,” says Newall, “but I do think that making it readily available to MDs is maybe not such a good idea.”
He notes that those times when botched aesthetic and cosmetic procedures and surgeries get the media’s attention, which they periodically do, “it takes all the good guys with the bad guys.
“I think we need stricter regulations. We’re working toward that but it’s not easy.”
He points out that filler and laser manufacturers, naturally, want to be able to sell as much of their product as possible so tighter regulation is not necessarily in their best economic interests. There is, however, one regulator that works to keep the field of aesthetics from being even more flooded. Newall reports that laser machines can cost hundreds of thousands of dollars each.
“Easily,” says Newall, “the investment for a clinic start-up can run $700,000 to $1.5 million for equipment.”
Non-thermal Focused Ultrasound for Non-invasive Selective Fat Cell Disruption
Author: newsroom15 Mar
S. Brown, PhD et al
Characterization of Non-thermal Focused Ultrasound for Non-invasive Selective Fat Cell Disruption (lysis): Technical and Pre-clinical Assessment
currently available on PRS Advance Online at http://www.plasreconsurg.com
In this new paper, Spencer Brown MD et. al. performs four pre-clinical experiments to elucidate the acute biological effects of the Ultrashape device for non-invasive fat cell disruption. Brown’s five co-authors are Ultrashape employees. In general, the presented work appears to be careful and the results accurate. Unlike the previously reviewed Zeltiq pre-clinical study, however, several important pre-clinical experiments were not performed, so we still do not know how the acute biological effects of the Ultrashape device are related to ultimate clinical outcomes.
In the first two experiments, the authors characterize the energy delivery of the UltraShape probe in water, which is a standard method for characterizing ultrasound energy fields. Brown shows that the device focuses the ultrasound energy in a volume that has a diameter of about 8mm, and a depth that ranges from about 5mm to about 25mm from the probe. Brown shows that the energy density (power per cm2) at the probe-water interface is very small, as desired. Further, the authors showed that the ultrasonic energy created air bubbles in the focal region, consistent with a non-thermal cavitation effect. Quantitative measures of ultrasonic power density were performed at 0mm and 14mm depth, and showed an absence of “hot spots.” An improvement to the study would have included power density measurements at 1.5-2mm (approximately the depth of the dermal-fat junction) and 25mm (to characterize the extent of the ultrasonic energy transmission).
In the third experiment, the UltraShape probe was characterized in a gel phantom intended to simulate the ultrasound transmission properties of skin and fat. In this case the focal volume was 9mm in diameter (slightly less focused than in water) and extended about 18mm in depth (the distance from the surface was not reported, but appears to extend from about 4mm to 22mm from the probe according to the figure). Again, bubbles were seen in the focal region in this model, consistent with a non-thermal cavitation effect.
In the fourth experiment, porcine skin was treated and then immediately evaluated with both frozen sections and histologically stained sections. Untreated control skin was also evaluated to ensure that results were not due to processing artifact. Importantly, no effect on skin color or skin appearance was seen on the animals receiving this treatment, and histology showed that the dermis and epidermis appeared to be completely unaffected by the treatment. The subcutaneous fat, however, showed evidence of tissue injury in both the frozen sections and the histology. Histological staining for LDH activity using NTBC (elevated levels of LDH indicate tissue breakdown) demonstrated a layer of adipocyte cell breakdown extending from about 15mm to 25mm of tissue depth. In the treated tissue, but not the control tissue, frozen sections and two other histological stains (H&E and Masson’s Trichrome) indicated a “defined area of tissue destruction” extending from approximately 8mm to 18mm of tissue depth. This region showed clear disruption of fat cells, while connective tissue, blood vessels and nerves remained intact. No evidence of any thermal damage was seen in any treated tissue, again “consistent with initial cavitation followed by the mechanical destruction of cells.” The authors state that fourteen animals were treated in this study, and the results were “consistent over time” despite the use of “multiple devices, [and] multiple transducers [by] numerous users.” No quantification of subject-to-subject variability was provided. For example, the authors should have measured the zone of tissue damage in each animal, and presented the results as averages with 95% confidence intervals.
So far, the results are promising, with clear evidence of non-invasive damage to subcutaneous fat and no apparent impact to the dermis. Unfortunately, the analysis stops there. For example, it is clear from the presented images that not all fat cells in the treated region were disrupted, but the authors do not quantify the percentage of the treatment volume that was disrupted. Further, the response of the animal to this treatment was not studied. Biopsies of treated and control areas were not performed at meaningful time durations subsequent to treatment (such a 1 day, 1 week, 1 month and 3 months post-treatment). Unlike the recent Zeltiq study, we have no idea how the skin and subcutaneous fat respond to these injuries. Does inflammation occur? While no changes to the histology of the dermis were seen immediately post-treatment, could an inflammatory response occur over time? Are non-viable cells removed or replaced? Does this treatment cause meaningful changes in fat thickness compared to control volumes over time, and if so, when do these changes occur? Lastly, blood lipid profiles were not analyzed in this study. We cannot know if release of lipids from the disrupted adipocytes has any systemic effect, either on blood lipids or the liver.
The authors state that these study “observations do not directly lead to predict clinical results,” and they recommend further clinical evaluation. However, the real need is for further pre-clinical evaluation. Perhaps this partly explains why this device, widely available in Europe and Canada, is not yet cleared by the FDA.
Non-surgical procedures and drugs could leave you disappointed
Author: newsroom11 Mar
There is an excellent article/slide show on MSN today. You will enjoy reading and watching it. It deals with:
- Botox breast lift
- “Doctor fish” manicures and pedicures
- Waxing
- Eyelash-thickening drops
- UV-activated teeth whitening
- Permanent makeup
- Chemical peels
- Brava breast enhancement, and
- Thermage
We find the “Doctor fish” manicure and pedicures especially entertaining. Well, we, however, should stay focused on the subject of our blog and comment on three treatments, that are near and dear to us.
LaserOffers.com comment
Waxing. Add up what you have and will spend on waxing and think about laser hair removal again.
Chemical peels. They work great in skilled hands. In most cases you will have oddly colored, patchy skin, redness, scaling and blisters; and the possibility of triggering previously dormant cold sores. Low concentration products you can buy OTC or online do not work and can cause unwanted side effects. High concentration in unskilled hand may cause scarring. Laser resurfacing is a very comparable, but much safer alternative.
Thermage. Remember the buzz initiated in 2002 by Oprah about this ”non-surgical facelift” by radio waves? Expensive glossy marketing has put this machine in thousands of aesthetic practices. Few doctors are still very happy with their investment. The number of unhappy patients with burnt the skin, scars, dents and grooves on the face, is much greater. Neither complication is very common, but both happen often enough that doctors say potential patients need to be more aware of the risks.
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High-frequency Ultrasound Evaluation of Cellulite Treated with 1064 nm Nd:YAG Laser
Author: newsroom8 Mar
J Cosmet Laser Ther. 2009 Mar;11(1):34-44
Bousquet-Rouaud R, Bazan M, Chaintreuil J, Echague AV.
Dermatological Laser Unit, Millenium Clinic, Montpellier, France.
http://www.ncbi.nlm.nih.gov/pubmed/19214861
This article presents the first evaluation of the use of a high-power pulsed Nd:YAG laser for the treatment of cellulite. Three of the four authors are employees of Candela Corporation, the maker of the laser.
The study at first appears to be well-designed. Quantitative endpoints of dermis thickness and ultrasound density were chosen, and preliminary studies were performed to show that measurement methods were not subject to intra-observer or inter-observer error. Twelve patients were treated, with one thigh randomized to treatment and the other randomized to control. In addition to pre-treatment ultrasound measurements, follow-up measurements were performed at 1 month and 3 months after the final treatment of the series of three treatments. Adjunctive photographs were taken before each treatment, and presumably at the follow-up visits. The example photograph appears to be of high quality. The treatments were appropriately standardized to minimize the impact of dosage variation on outcome. Likewise, the patient population appears to be reasonably homogenous in terms of age, body mass index, and pre-treatment evaluation of cellulite severity, to minimize the impact of patient variation on outcome variation.
Given the apparent care taken in the study design, the analysis was extremely disappointing. The analysis presents only the variation in ultrasound measurements of the treated thigh, and completely ignores the control thigh. The authors claim that the mean dermal thickness of treated thighs decreases from the beginning to the end of the study, but this is a flawed claim. Because they do not present data on the control thigh, we cannot know if this result stems from a treatment effect, or from a natural variation in the patient population over time. For all we know, the dermal thickness of the control thigh improved more than the treated leg. This is the whole point of having a control thigh. No other control variables, such as BMI or weight, were presented.
Further, the authors include the raw data for the dermal thickness measurements in all 12 patients, but offer no explanation why some patients have increased thickness at 1 month follow-up which then decreases at 3 months, while other patients show decreased thickness at 1 month with subsequent increases at 3 months. Presumably, the treatment effect would go in generally the same direction in this homogeneous group that recieved the same treatment regime. This variation adds to the concern that something else was going on with these patients during the study that might effect dermal thickness. The same comments apply to the raw data on dermal echogenicity.
The exclusion of measurements of the control thigh from the analysis renders any conclusions moot. The authors further present patient satisfaction data. This type of data is notoriously challenging to interpret, as patients often feel satisfied that they are taking steps towards treating a condition. In this case, on average the patients reported being somewhat satisfied, and no patients reported being very satisfied. Readers of the article should not be satisfied at all.
