GLG News by Robert Frank

Implications: As insurance reimbursements decline, everyone suddenly thinks they're a cosmetic surgeon.

Analysis: While the article in the New York Times accurately points out the fact that more and more dermatologists are moving away from acne and rosasea and toward Restylane and Botox, the trend isn't new and the article only addresses the surface of a growing trend toward fee for service procedures.

Remarkable as it sounds, I get approached on a regular basis by nonsurgeon collegues asking for a "good book to learn how to do liposuction" or a number of other procedures that I trained through residency to do. I feel sorry for the patients who will be guinea pigs for these wannabe cosmetic surgeons but, I understand the forces driving them in this direction. Physicians are getting squeezed from all sides.

Doctors celebrated this past week as Congress overroad legislation that would have caused a 10% drop in Medicare reimbursements -reimbursements that already are so low, many elderly patients in Florida and elsewhere can't find health care providers willing to take it. Forget about a raise in Medicare despite higher costs to run an office, pay malpractice premiums or keep qualified office staff.

Doctors are scrambling for anything that will supplement their falling incomes and cosmetic services seem an easy fix. One practitioner in my area has become the local Amway distributor, another sells vitamins to patients. The point is, when I hear about dermatologists doing cosmetic procedures it doesn't surprise me a bit. When the neurologist who uses Botox for migraines starts touching up wrinkles in addition I begin to wonder if medicine will continue to attract our best and brightest.

Implications: Juvista appears to be effective in improving scar quality according to recently released Phase II results. Renovo reported no clinical improvement in breast augmentation scars treated with a single injection of the drug.

Analysis: Juvista appears to be an effective adjunct in the persuit of improved scars. In the recently released Phase II results, patients had a improvement in scar quality in those scars treated with Juvista as compared to those untreated. These results substantiate preliminary results reported at the March 2007 American Society of Aesthetic Plastic Surgery meeting in New York.

The company was unable to demonstrate improved scars in a cohort of breast augmentation patients treated with a single dose of Juvista. The company contends that additional treatments would show an improvement in the these scars. As a practicing plastic surgeon, these results do not make the drug less viable as these scars are rarely problematic so showing improvement to any degree of statistical significance would be difficult.

Demonstrating improvement in more difficult wounds such as those following sternotomy would go a long way to showing the efficacy of this drug and to justifying the cost to patients and insurance companies.

Implications: Botox from Allergan has enjoyed an exclusive monopoly for the past nine years. Alternative drugs do not appear to be available as soon as was hoped.

Analysis: Botox (Botulinum toxin A) has been a boon to Allergan and to cosmetic surgery. Over 4,000,000 Botox injections were given in 2006 which account for over a third of Allergans profits. Not surprisingly competitor products have been in the works from both Medicis (Reloxin) and Mentor (Puretox). Unfortunately, for patients and clinicians neither of these competitors can come soon enough.

Implications: Changes in the credit market, specifically the subprime market, may impact companies clamoring to finance elective healthcare and cosmetic procedures. This may impact the number of patients ultimately undergoing these expensive procedures.

Analysis: The rise in available credit through the last decade has had influences on elective surgical procedures. Specifically, in the fields of cosmetic surgery, elective opthalmology procedures (LASIK), elective fertility procedures (IVF) and dentistry, financial service companies such as Capital One (COF) have been quick to offer low interest, short term loans with little or no collateral.

These options have been attractive alternatives to patients without the financial resources to afford a $5,000 to $15,000 procedure, many of which must be paid for in full prior to surgery. It seems likely that as credit tightens, these loans will become less available.

The implications of this under-recognized aspect of the credit crunch will likely effect medical device companies, laser companies and others who have come to expect a steady double digit growth in cosmetic and elective surgical procedures.

Implications: With the growth of bariatric procedures and the increased recognition of the health benefits associated with massive weight loss, more insurance providers are beginning to cover bariatric procedures. The problems arise when these patients present to their plastic surgeons after their weight loss and are surprised to find their procedures considered cosmetic and not "medically necessary".

Analysis: The rise in obesity rates in the United States is staggering. Obesity and obesity related illness accounts for over half of our health care dollars. Diabetes, peripheral vascular disease and osteoarthritis are but a few of the system problems resulting from our overweight society.

The search for surgical treatments of obesity has accelerated over the past decade. Refinements in gastric bypass and in prosthetic devices such as the LapBand® have made the option of bariatric surgery more appealing and have broadened the prospective audience beyond the most morbidly obese.

Insurance companies are increasingly being approached by subscribers demanding coverage for bariatric procedures. The weight of data suggesting the medical necessity of weight loss surgery makes denying claims based on "cosmetic" grounds more difficult and specific exclusions of bariatric procedures have not widely appeared yet in new policies. Patients needing bariatric surgery often communicate via internet message boards and chat rooms sharing approaches to facilitate insurance approval and appeal denials. As a result, more and more patients are having their bariatric procedures covered by their health care insurance.

Many of these patients who undergo bariatric procedures, will need cosmetic surgey once their weight loss is complete. Any patient who loses over 100 lbs will likely overwhelm their skins ability to recoil and will be left with a thin person in a heavy persons skin. Plastic surgeons have responded with record numbers of thigh lifts, "belt lipectomies" inwhich a traditional abdominoplasty is continued around the patients back, breast lifts, arm lifts and face lifts. Unfortunately, the vast majority of these procedures are viewed as cosmetic and are not covered by insurance. Patients who have successfully argued in favor of their bariatric procedures, frequently encounter insurmountable insurance hurtles when it comes to their plastic surgery.

The trend in health insurance has been to reduce payments to in network providers so doctors who take commercial insurance will likely be forced to some extent to accept lower payments for covered patients. In all likelihood many docs will tend to opt out of insurance plans rather than accept these greatly reduced payments. Patients will continue to pay for these procedures out of pocket, hopefully understanding the financial implications of their decisions at the time of their bariatric procedures.

Implications: Ultrashape appears to offer a painfree noninvasive alternative for patients seeking minimal correction of bulges due to fat. The technique does not appear to be a replacement for traditional liposuction but, may have applications for patients with limited problems.

Analysis: One need look no further than the success of Botox (R) and fllers such as Restylane and Juvaderm to see the public interest in limited invasive or noninvasive cosmetic procedures.  Ultrashape is the latest device seeking to capitalize on this trend.

Ultrasonic energy was shown in the mid-90s to be effective in disrupting the cell membrane of fat cells. Lysonix, Mentor and Wells Johnson among others made liposuction machines outfitted with ultrasonic generators. The basic principal was introduction of the energy using a probe with a tip that occilated at a high frequency generating the ultrasonic energy. The probes were all somewhat larger than traditional liposuction cannulas and all suffered in requiring fat evacuation using traditional liposuction after the application of ultrasound which prolonged the procedure time.

In the early part of the decade, several studies appeared in the Plastic Surgery literature showing higher complications with ultrasound assisted liposuction as well as results similar to those with traditional tumescent liposuction. The ultrasonic equipment was significantly more expensive than traditional liposuction equipment and the ultrasonic probes needed to be replaced after a number of treatments. Gradually ultrasound assisted internal liposuction has fallen from favor. Over the past ten years, all the companies mentioned above have exited the ultrasonic liposuction market.

Barry Silberg, MD was among the first to try using external ultrasound for treatment of fatty deposits. Silberg's device used ultrasonic energy applied through the skin which was then followed by traditional liposuction. Silberg reported that the external ultrasound helped to separate fat and made the traditional liposuction more effective with less bruising postop. The technique was not widely embraced by the plastic surgery community partially because of concerns about heat generated at the skin level from application of ultrasonic energy and partially because the energy effected not just fat cells but other types of tissues as well.

Ultrashape is the latest attempt to use ultrasonic energy to treat fat but this time without the use of traditional liposuction. The idea is that focused ultrasonic energy at a discrete depth can be used to break down fat which is then removed by the body over time.  The device is the product of Ultrashape, LTD from Israel and the study in the September 2007 issue of Plastic and Reconstructive Surgery was performed by surgeons who have been paid by the company to participate in the study.

The study of roughly 150 patients in several countries demonstrated small but significant changes after a single application of Ultrashape. The average change in the treated area was 2 cm. Patients had few complications and tolerated the treatment with little discomfort. Routine laboratory values, lipid levels, pulse oximetry and liver ultrasound was performed on patients treated without any notable changes in postop levels.

This study demonstrates a new technique which, while unlikely to replace liposuction, offers another alternative for patients with minimal fatty deposition. The device appears so far to be safe and to produce good patient satisfaction. Ongoing trials will hopefully reflect its utility in patients with more significant body contour problems.