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American Board of Cosmetic Surgery wins lawsuit California surgeons gain specialty board recognition

Article-American Board of Cosmetic Surgery wins lawsuit California surgeons gain specialty board recognition

SACRAMENTO, CALIF. After a decade-long struggle to gain specialty board recognition in California, the American Board of Cosmetic Surgery (ABCS) recently won its petition in a lawsuit against the Medical Board of California. As a result, board-certified cosmetic surgeons in California will be allowed to refer to their board certification in cosmetic surgery in advertisements and in telephone listings.

The ABCS first filed its application for specialty board equivalency recognition with the Medical Board of California in the mid-90's, which was denied in 1997. The ABCS submitted the current application based on its new certification requirements.

Following two presentations by the ABCS, the Medical Board of California rejected the organization's follow-on application without stating its reason. The ABCS subsequently filed suit in the California Superior Court against the Medical Board of California and the State. In September, the Superior Court directed the Medical Board to grant ABCS's application for equivalency.

The California decision is one important step in the public's education about cosmetic surgery and those who perform it, according to Peter Canalia, ABCS's executive director. "This ruling provides consumers vital information regarding cosmetic surgeons, which fosters patient safety and choice," he says.

In 1979, the ABCS was established to test and verify legitimate training and experience by surgeons performing cosmetic surgery. Most training in cosmetic surgery is postgraduate, occuring after a surgeon has obtained specialty certification by a separate American Board of Medical Specialties (ABMS).

According to Robert Jackson, M.D., ABCS president, theirs is the only board that evaluates cosmetic surgeons.

"Only ABCS certification represents a surgeon's education and experience in the cosmetic surgery specialty," he says. "The court ruled in our favor because our certification requirements meet or exceed the ABMS's and satisfy California's statutory requisites," he concludes.

Anti-gravity: Augmentation, mastopexy combine for optimal result

Article-Anti-gravity: Augmentation, mastopexy combine for optimal result

Toronto: Breast augmentation combined with mastopexy can yield long-lasting results depending on the technique that is used, explains a plastic surgeon here.

Speaking at the annual meeting of the Canadian Society for Aesthetic (Cosmetic) Plastic Surgery (CSAPS), Brian Peterson, M.D., a plastic surgeon based in Kelowna, British Columbia, Canada, and a clinical instructor in the department of plastic surgery and faculty of medicine at the University of British Columbia in Okanagan, British Columbia, describes how he performs the procedure to correct sagging breasts and give breasts a more youthful appearance.

SHAPE AND POSITION "The augmentation is to enhance the shape and fullness of the breast, and the mastopexy is to reposition the nipple-areola complex to a more elevated and youthful position on the breast," explains Dr. Peterson, current CSAPS president.

"The women who want this procedure have breasts that are saggier than they would like," Dr. Peterson explains. "The reason this happens is that the breast is primarily made up of fat and breast tissue. It has internal support. With time, you end up with sagging breasts."

OPTIMIZING THE STANDARD With the standard operation, Dr. Peterson says that the skin envelope that holds the breast tissue in place is tightened, but that the procedure is a temporary fix and that gravity has a downward pulling effect.

"With gravity, the breast will sag over time," he says. "The tissue would be sagging off of the implant in five years. If we just augmented the breasts, they would end up bigger and saggier in the long term. I don't think that is the appearance that women desire."

In Dr. Peterson's operation, he places saline implants underneath the pectoralis muscles. During the breast lift component, he removes a moderate amount of breast tissue when elevating the nipple-areola complex. The glandular tissue that is being resected would sag in the future, so this technique avoids potential sagging, giving a more youthful result in the long term, Dr. Peterson says.

To perform this procedure, he makes a longer incision around the nipple-areola complex, which results in a greater scar running around the nipple-areola complex and running vertically down the lower pole of the breast, likening the scar to that which appears in breast reduction. Surgeons would choose an implant size in keeping with the amount of breast tissue that is being resected, Dr. Peterson explains.

"If you see someone pre-operatively and plan to take off 100g to 150g of breast tissue, I would then use an implant that is 150 cc's larger than what we initially size for the patient," Dr. Peterson says.

The technique is not difficult to perform for surgeons who regularly perform breast augmentation, according to Dr. Peterson.

"There are no more challenges to this than in learning any other new procedure," he says. "There is a learning curve to any new technique."

TECHNIQUE TRADE-OFFS He estimates recovery at approximately 10 days compared to two to three days for a standard procedure. He adds that it takes up to a year for the scar to fade with his procedure.

"You do see a more visible scar with this procedure. There is a more limited incision with a standard breast augmentation. However, the results that are achieved are more consistent," he says.

In terms of general contraindications, heavy smokers are excluded as surgical candidates. Dr. Peterson notes that any operation that is done on the breast can affect nipple sensitivity, but that in the vast majority of instances, the sensitivity is recovered over time.

"If nipple sensitivity is an important aspect of the patients' sexual life, and it would be greatly affected if they didn't have that sensitivity, then doing an operation would be something to re-think," he notes.

SUPPLEMENTARY PAIN DATA On an adjunctive note, in a prospective series of breast augmentation cases published in Plastic Surgery in 2004 by Dr. Peterson and his colleagues, the investigators found that there was a trend to less postoperative pain and less time spent recovering with the use of ketorolac and bupivacaine compared to ketorolac alone or bupivacaine alone in 100 patients who underwent retropectoral breast augmentation.

For more information
Brian Peterson, M.D.

Cultural impression: Fashioning a favored facial feature

Article-Cultural impression: Fashioning a favored facial feature

Quezon City, Philippines Patients born without dimples in their cheeks or whose dimples have faded as they grew older now have a surgical option available to create or restore that special attribute emblematic of a youthful appearance.

Using a straightforward outpatient procedure, physicians can create facial dimples for those patients who desire them. Although not commonly performed in the United States, facial dimple creation has found favor in other parts of the world.

Dimples, those indentations of the skin caused by an attachment of the skin to underlying muscle tissue, are common in babies and young children, but tend to diminish or become less noticeable with age as the underlying muscles stretch through use. This pattern of appearance contributes to the association of facial dimples with youthfulness.

From his offices in the Philippines, Carlos I. Lasa, Jr., M.D., is one of a number of physicians in Asia who surgically create dimples for patients. Dr. Lasa is a plastic and reconstructive surgeon who specializes in aesthetic/cosmetic surgery and liposuction. His training has included a fellowship in aesthetic plastic surgery at the Institute of Aesthetic Plastic Surgery in Atlanta, and a second fellowship in aesthetic plastic surgery and maxillofacial surgery at Mount Sinai Medical Center in Cleveland.

Dr. Lasa has performed the facial dimple creation procedure since 1987 on patients ranging from 18 to 50 years of age — perhaps interestingly, on approximately equal numbers of men and women. Although it can be combined with other cosmetic procedures, Dr. Lasa reports that his patients who desire dimple creation usually request only this one procedure.

"Asians find this an attractive facial feature," he says.

DIMPLE CONNECTION the key to the creation of a facial dimple is to create an attachment between the skin and the cheek muscle underneath. with this attachment successfully in place, contraction of the muscle will result in the presence of a dimple.

"A punch biopsy instrument is placed against the buccal mucosa and circular motions are made to cut through the mucosa, submucosal fat, and cheek muscle," Dr. Lasa says. "A circular core of these tissues is removed, leaving the skin intact, which will create a shallow cylindrical-shaped defect under the skin."

"This 'defect' then is closed by placing an absorbable suture through the cheek muscle on one side of the defect, then through the dermis layer of the skin, and finally through the cheek muscle on the other side of the defect," Dr. Lasa says.

"A surgical knot is tied, which, in turn, will result in dimpling of the skin even without smiling."

As the suture is absorbed the dimple will flatten out, according to Dr. Lasa. This process will usually take a week or so. As the site heals, internal scarring resulting from the presence of the suture will connect the skin and muscle, creating the dimple.


Silicone uptake: Cosmetic surgeons embracing silicone gel — mostly

Article-Silicone uptake: Cosmetic surgeons embracing silicone gel — mostly

NATIONAL REPORT Experts weighing in on the advantages of silicone gel versus saline implants offer equivocating observations. Some say silicone gel breast implants represent a welcome option for informed patients, while others question whether manufacturers have adequately studied silicone's potential risks. Experts also point out that saline isn't going away; some patients will continue to prefer it over silicone.

In November, the Food and Drug Administration (FDA) approved the marketing of silicone gel-filled breast implants made by Allergan Medical (formerly Inamed) and Mentor for breast reconstruction in women of all ages and for breast augmentation in women ages 22 and older.

An FDA press release states, "Now that the products have been determined to be safe and effective, the FDA will continue to monitor them." The FDA is requiring manufacturers to study 40,000 women for 10 years post-implantation (and to continue core studies for 10 years). At the same time, the products' labeling emphasizes risks including rupture and the need for MRIs starting three years after implantation and every two years thereafter.

DIVERGING OPINIONS All but one cosmetic surgeon contacted by Cosmetic Surgery Times applaud the FDA's announcement.

Dr. Rosenberg
The decision "hasn't convinced me the implants are safe. I was comfortable with that based on review of the literature in the last 15 years," says Michael Rosenberg, M.D., a cosmetic surgeon in private practice in Mount Kisco, N.Y. "The FDA's decision has allowed me to have an upfront discussion with my patients and let them choose what's best for them," adds Dr. Rosenberg, who began using silicone for breast augmentation in late November.

Availability was never intended to mean silicone gel implants will suit all patients, he adds. Rather, Dr. Rosenberg says that the availability of silicone implants "empowers women to make well-educated choices and keeps the decision between patient and physician."


Dr. Berman
LONG OVERDUE DECISION Although the MRI requirement "sounds a little excessive," according to Mark Berman, M.D., F.A.C.S., a Santa Monica, Calif.-based cosmetic surgeon in private practice, he says the FDA's decision is long overdue.

"Silicone implants are much more natural, and women tend to like them better," he says. Some women have "gotten it in their heads that silicone is somehow dangerous, so they prefer saline. But in all honesty, if a silicone implant were to rupture, the woman would still preserve her breast mound" while awaiting repairs, whereas the body resorbs saline, adds Dr. Berman.

Nevertheless, some sources are approaching silicone implants with great caution.

"Will I now change to all silicone implants? Absolutely not," says Rod J. Rohrich, M.D., professor and chairman, department of plastic surgery, University of Texas Southwestern Medical Center, Dallas.


Dr. Rohrich
Dr. Rohrich says he'll offer silicone implants only to patients with no breast tissue who have failed other implants. And he'll tell them that, with silicone, "The incision is much larger," and the incidence of implant hardening is significantly higher — five percent for saline, 20 percent to 30 percent for silicone. He adds that, although both silicone and saline implants last 13 to 15 years, "one doesn't know" when silicone implants have ruptured.

Study identifies silicon implant surface proteins leading to immune reactions

Article-Study identifies silicon implant surface proteins leading to immune reactions

Innsbruck, Austria — Researchers at the Innsbruck Medical University have released results of a study aimed at identifying proteins that adsorb to the surface of silicone and have been long regarded as key components in the onset and perpetuation of local immune reactions to the implant material.

The study identifies 30 of the most abundant proteins deposited on the surface of silicone — the largest known inventory of such proteins so far, write the study’s authors. Structural and extracellular matrix proteins predominated, followed by mediators of host defense, metabolism, transport, and stress-related proteins. In addition, several biochemical modifications of fibronectin, vitronectin and heat-shock protein 60 were detected. The research team’s analyses also showed previously undetected proteins deposited on the surface of silicone, and concluded that as tentative initiators and/or modulators of the response to silicone, they are valuable candidates for prognosis and therapy.

The researchers note that because of its “assumed high degree of biocompatibility,” silicone is the most widely used implant material, even though its use can have detrimental side effects in many patients. The study sought to more thoroughly understand the extent to which certain proteins adsorb to implants because, as the study notes, “the composition of the proteinaceous film on the surface of silicone implants is poorly understood, especially in vivo.”

The study focused on 23 healthy women undergoing breast augmentation; 13 patients were having implants removed or replaced due to fibrotic complications, while 10 (the control group) were undergoing primary breast augmentation. No difference in protein deposition was observed between gel- or saline-filled implants, and no correlation in relative protein amount was found with regard to implant size or surface texture. In implants of more than five years duration, however, the amount of protein deposited on the surface was significantly higher than those in place for shorter periods.

The study concludes that previously undetected proteins deposited on the surface of silicone are tentative initiators and/or modulators of the response to silicone, and that they are valuable candidates for disease prevention, therapy, and as a parameter to assessing silicone’s biocompatibility. The study’s authors note that, while the causative relation between autoimmune-disease development and silicone implants is still a matter of debate, their study shows that silicone promotes at least the adhesion of altered self-proteins, which in turn may trigger an autoimmune response of the immune system.

FDA approves cosmetic tissue augmentation product

Article-FDA approves cosmetic tissue augmentation product

Washington — The Food and Drug Administration (FDA) has approved Anika Therapeutics Inc.’s cosmetic tissue augmentation (CTA) product, an injectable soft-tissue filler for facial wrinkles, scar remediation and lip augmentation.

The product is based on Anika’s chemically modified hyaluronic acid proprietary technology and incorporates lidocaine. In a statement, Woburn, Mass.-based Anika said it anticipates filing amendments with the FDA and European Union regulators to enhance product features prior to the launch of the CTA product, and added that the company anticipated marketing the enhanced version of its CTA product in mid-2007.

Study review questions HGH as anti-aging therapy

Article-Study review questions HGH as anti-aging therapy

New YorkA review of studies that was published recently in the Annals of Internal Medicine concludes that human growth hormone (HGH) may not be the miracle anti-aging elixir that many have touted it as being — and that it could have serious side effects for regular users.

ABC News reports that the review suggests HGH provides few of the touted benefits for adults who are healthy — and that the side effects could jeopardize the health of regular HGH users. The study review says HGH has been associated with diabetes and pre-diabetic conditions.

The ABC News report states that despite the fact that it is illegal to distribute HGH as an anti-aging therapy in the United States (though it is FDA-approved for other medical indications), as many as 30,000 healthy American adults used HGH as for that purpose as recently as 2004.

The report says many consumers likely obtain HGH on-line or through their doctors, and adds that though HGH is beneficial to patients suffering from certain specific diseases, regular use can cause more harm than good in healthy individuals.

The ABC News report also says HGH proponents state that other research has shown HGH to be beneficial as an anti-aging therapy when used under proper clinical guidelines and in appropriate dosages.

FDA warns topical anesthetic creams compounders

Article-FDA warns topical anesthetic creams compounders

Washington — The Food and Drug Administration (FDA) has issued warnings to five firms — Triangle Compounding Pharmacy, University Pharmacy, Custom Scripts Pharmacy, Hal’s Compounding Pharmacy and New England Compounding Center — in an effort to stop compounding and distributing standardized versions of topical anesthetic creams.

According to an FDA statement, companies that fail to resolve violations cited in the warning letters risk injunctions against continuing violations and seizure of illegal products.

The statement says the FDA is concerned about the serious public health risks related to compounded topical anesthetic creams. Exposure to high concentrations of local anesthetics, such as those in compounded topical anesthetic creams, can cause serious reactions that include seizures and irregular heartbeat.

Compounded topical anesthetic creams are commonly used to lessen pain in procedures such as laser hair removal, tattoos and skin treatments. They may be dispensed by clinics and spas that provide these procedures, or by pharmacies and doctors’ offices. FDA-approved topical anesthetic products are commercially available and properly labeled, and are regularly used in health-care settings. However, some pharmacies create their own standardized versions of these products, often including combinations of ingredients that are at higher strengths than those found in FDA-approved products—and that often lack appropriate warnings or usage directions.

British court deals blow to Allergan's Botox patent claims

Article-British court deals blow to Allergan's Botox patent claims

London — A British high court dealt Allergan a substantial blow recently when the court revoked the patent for Botox. According to British news reports, the pharmaceutical company now faces a worldwide battle to retain the trademark for the drug.

Allergan owns a patent portfolio for Botox, which according to reports is under attack in a number of jurisdictions. One report quoted a UK patent specialist not connected with the case as saying the judgment “reveals a naked commercial attempt by Allergan to prolong and expand its monopoly rights over Botox” and said rival pharmaceutical company Basic Research/Klein-Becker has retained a law firm to coordinate a multinational trademark dispute aimed at revoking the Botox trademark.

At press time, a UK trial was scheduled to get under way.

FDA issues approvals for Radiesse®

Article-FDA issues approvals for Radiesse®

Washington — The Food and Drug Administration has approved Radiesse®, a filler marketed by San Mateo, Calif.-based BioForm Medical Inc., for use in treating moderate to severe facial wrinkles and folds.

The product received a second FDA approval for use in correcting facial fat loss (lipoatrophy) in people with human immunodeficiency virus (HIV).

According to the company, Radiesse® is the first filler with calcium-based microsphere technology that stimulates production of new collagen as well as provides volume replacement. It is made of calcium hydroxylapatite microspheres in a water-based gel carrier.