Laser Treatment MD

A Plastic Surgery Group out of Albany, along with several of its staff, have been charged following guilty pleas that they were using non FDA approved Botox products on their patients.

The Plastic Surgery Group, LLP (TPSG), of Albany has been sentenced and ordered to pay restitution in the amount of $106,686, and a fine of $200,000, in connection with TPSG's plea of guilty to one felony count of misbranding drugs.

The company was sentenced in Federal District Court in Albany, along with Doctors William F. DeLuca Jr., Douglas M. Hargrave, Jeffrey L. Rockmore, Steven M. Lynch, and John D. Noonan, who were all sentenced to probation with community service and ordered to pay restitution in the amount of $106,686 and a fine of $5,000.

TPSG's practice administrator, Peter M. Slattery, and supervisory nurse Susan F. Knott were also sentenced and ordered to pay
restitution in the amount of $106,686, and fines in the amount of $1,000 and $500, respectively.

All the individuals were sentenced in connection with their guilty pleas to one misdemeanor count of misbranding drugs.

According to plea agreements, starting in approximately February 2004 and continuing to December 2004, defendant TPSG ceased using the FDA-approved BOTOX and BOTOX Cosmetic and began exclusively using a non-FDA approved TRI-toxin on its patients seeking treatments with Botulinum Toxin Type A for facial wrinkles.

Five physicians, whose professional corporations were partners of TPSG (the "treating physicians"), with the assistance of TPSG nurses, injected approximately 150 patients with the unapproved product.

The charges follow an investigation by the Food and Drug Administration, Office of Criminal Investigations, New York Field Office.

Not nice telling people you're injecting them with BOtox and using TRI-toxin.

Venezuelans commonly borrow for plastic surgery.

In the subway you can see ads for clinics that offer credit for plastic surgery, Thermage, Fraxel, laser hair removal, breast augmentation, laser treatments and Botox treatments, and that women who work use their vacation bonuses and borrow from their work savings accounts. The cosmetic surgery and medical spa industry will make sure that cosmetic work remains within reach to ensure a steady flow of income.

THE NEED TO BE BEAUTIFUL

Despite the hefty price tag, the choice to get plastic surgery, Botox, or laser treaments is not considered a luxury for some Venezuelans.

"We need to be beautiful," said Patino.

Competition among women, by far the biggest consumers of plastic surgery in Venezuela, to look their best is fierce, and social pressure to get work done is high.

"Socially, there is a lot of demand, especially from men, to have a good body," said Prem Pratita, a 27-year-old who had a breast augmentation a few weeks ago.

In this image-conscious country, famous for beauty queens who win record numbers of international pageant titles, the idea of getting cosmetic surgery is instilled at a young age.

Patino recalls how, as a child, her mother and aunt dreamt of surgery to get rid of wrinkles. Now, with a child of her own, the subject is already on the table.

"I told my husband, 'Look honey, if she has your nose, she's going to get plastic surgery,'" said Patino.

Some young women even describe moving up a few cup sizes through plastic surgery as a rite of passage.

"It's a transformation from being a girl to being a woman," said Pratita, who said she was one of the last in her circle of friends to have the procedure.

"Everybody has a breast augmentation. Three or four of every seven women have one," said plastic surgeon Angel Pena, who likens his surgery to body decoration practiced for centuries.

"By nature, human beings have the desire to look better ... this desire is timeless and it's a desire that doesn't depend on your economic situation ... it's not that frivolous."

Cosmetic surgery can carry risks as well as benefits

Several newspapers have reported the dangers associated with cosmetic surgery, including a lack of regulation in some areas of the industry. The reports also feature warnings from Nigel Mercer, the president of the British Association of Aesthetic Plastic Surgeons, who voiced his views as part of a series of medical articles on cosmetic surgery.  Mr Mercer called for tighter regulation and testing of drugs, procedures and implants to offer more protection to patients.

The Times reported that the number of cosmetic surgical operations conducted by “audited members of the profession” has more than tripled to 34,000 since 2003, but that many additional procedures are being carried out on the black market. The newspaper says that these are “fuelled by internet promotions, magazine advertising and aggressive discounting”.

What is the basis for these news reports?

The reports were based on a special edition of the journal Clinical Risk, which featured several articles on the issues surrounding cosmetic surgery. These issues include the potential for physical and psychological harm, and the need for tighter regulation of the industry, better training programms for surgeons and measures to improve patient experience.

Nigel Mercer, president of the British Association of Aesthetic Plastic Surgery, wrote an accompanying editorial arguing that the availability of consumer credit and a change in public attitudes has led to an explosion in cosmetic surgery in recent years. According to Mercer, this growth, combined with increasing public expectation and media hype, has resulted in “the perfect storm in the cosmetic surgical market”.

What is cosmetic surgery?

Cosmetic surgery, sometimes called aesthetic surgery, was described by a doctor in the journal Clinical Risk as being “purely elective, a lifestyle choice undertaken to enhance physical appearance, improve self-esteem and boost confidence”. Another doctor says that it differs from all other forms of surgery in that it is a treatment for “want” rather than for “need”.

In the 2005 Regulation of Cosmetic Surgery report, published by the Department of Health, cosmetic surgeries are defined as “operations and other procedures that revise or change the appearance, color, texture, structure or position of bodily features, which most would consider otherwise to be within the broad range of ‘normal’ for that person”.

Cosmetic surgery differs from plastic surgery, which is generally surgery to repair or reconstruct tissue or skin damaged by congenital (inherited) disease, injuries or burns. The primary role of plastic surgery is to restore function, and aesthetic improvement is secondary.

How is cosmetic surgery currently regulated in the UK?

At present, there are measures and standards to help regulate the industry but some cosmetic surgeons operate outside these regulations. Some treatments and procedures are unlicensed for cosmetic use, but can be given the discretion of doctors, or “off license”, by some clinics.

Surgical practice in the UK is regulated by the General Medical Council (GMC) and practicing surgeons should be enrolled on its specialist register. However, some concessions are made for private cosmetic surgeons who have been practicing since before April 2002. By satisfying certain criteria, these doctors can practice without the need to be on the specialist register.

Invasive cosmetic surgery and laser treatments are also regulated under the Care Standards Act 2000. The Healthcare Commission inspects all registered establishments that carry out invasive procedures and laser surgery in the UK, and has the power to revoke practice licenses and to take enforcement action.

Some cosmetic surgical procedures are not covered by current regulations, such as Botox, Restylane, and Juvederm injections and injections of aesthetic fillers. Botox is not licensed for cosmetic use, but it can be prescribed “off license”, in which circumstances the doctor assumes liability for its use. Most fillers are tested in the UK as “devices” rather than as drugs. This means that they are regulated based on the standard of their production and not on whether the treatment works.

The Department of Health report concluded that the regulatory situation for cosmetic surgery was not satisfactory because of the group of doctors who can practise without being on the GMC specialist register and the lack of clarity around the definition of “fillers”. Although practitioners of cosmetic surgery must demonstrate certain competencies, these may not be the equivalent standard of NHS consultants.

What do these journal articles say about cosmetic surgery?

The authors of these articles have argued several opinions, including that:

• Patient psychology should be considered by clinical staff as issues of mental health and body image may be behind the desire for cosmetic changes. These could also arise in people who feel disappointed or upset by the results of their surgery.
• Surgeons should keep records detailing their patients’ expectations and provide them with guidance on whether these are realistic.
• There are risks associated with any type of surgery and patients should be informed of these and their surgeon’s success rates when considering procedures.
• It is important that patients are given time to consider their options. Doctors should also inform patients about alternative treatments that may be available.
• Before procedures are carried out, it should be clear who will be financially liable for the correction of any complications.
• There may be some merits to adopting a regulation system similar to that in France. Under this system, patients must be given information on costs, risks and the surgeon’s qualifications to perform their selected procedures.
• The way that cosmetic surgery is marketed should also be regulated.

What is the problem with plastic surgery marketing?

Mercer says that cosmetic procedures are often marketed using special offers, including vouchers, two-for-one deals and surgery holidays, and that these practices contribute to an “unregulated mess”. 

The articles also feature a call to ban advertising of cosmetic procedures, stating that, like tobacco, there should perhaps be a Europe-wide ban on advertising all cosmetic surgical procedures, including on internet search engines. While advertising can be powerful, says Mercer, it is often misused by the cosmetic surgery industry and misinterpreted by those it is aimed at.

Where can I find more information on reputable plastic surgeons?

The British Association of Aesthetic Plastic Surgery is a not-for-profit organization based at the Royal College of Surgeons. It was established to advance the education and practice of cosmetic surgery for public benefit. While it is not a regulatory body, it has long been involved in giving the public information on the safety of cosmetic surgery.

Its research into cosmetic surgery tourism was discussed at a recent conference and its press releases highlight a number of dangers associated with unregulated procedures, including DIY injectable treatments available over the internet.

A study in the Journal of the American Academy of Dermatology says if you want to see a skin doctor about a changing mole, get ready to wait. The average wait time is 26 days. But if you want a Botox shot, it's just eight days, two-and-half weeks shorter. Here in mid-Missouri, two dermatologists say that's not true.

"There's a shortage of dermatologists nationally," dermatologist John Despain said. "Also, patients have direct access to dermatologists for skin care."

Dr. John Despain owns Despain Dermatology Center and Skintuition Medical Spa in Columbia, focusing on cosmetic dermatology like Botox. He says at his practice, clinical appointments always come before cosmetics.

"They are seen on a priority basis within a few days," Despain said. "If they're a new patient, if there's the ability to put them in a new patient slot, they priority over anyone calling for cosmetic concerns, of course."

At Dr. Lindall Perry's practice in Columbia, they treat all appointment requests the same.

"We don't have, quote, 'cosmetic appointments,'" he said.

Although Perry is booked through January, he says patients with skin problems can get appointments.

"We have open appointments in two weeks with our newer staff and they would take both a cosmetic patient, an acne patient, a wart patient," Perry said.

Perry says it can be a challenge juggling business and patient care.

"I like to think I have sound business practices," she said. "I do schedule myself very fully. My staff would say too full. My patients would say too full. We pay attention though to the frustration of long waits."

With a heavy focus on clinical treatments, Perry says he tries to see as many patients as possible. Often leaving the Botox appointments for after hours. He says money is a benefit of his practice, not the motivator.

"My desire everyday is to find every melanoma that's in front of me and not to miss that," he said. 

As for Despain, he likes biopsies just as much as Botox.

"I view them as a compliment to each other," he said. "If I had to choose how to spend my time out of enjoyment or profitability, they're probably equal."

Both doctors say there's certainly a demand in mid-Missouri for cosmetic dermatology, but most of their patients and profits stem from clinical work. In the meantime, if you want to see a dermatologist, the best idea is to plan ahead.

Paula D. Young RN joins Medical Spa MD

I've seen and head about medical estheticians, medical assistants and even front desk staff administering Botox injections.

It's not legal, as this story on the prosicution of a medical assistant clearly shows.

If you're a plastic surgeon or dermatologist running a skin clinic, laser clinic or medical spa you might want make sure that your medical estheticans and medical assistants are well within the guidelines for their individual scope of practice.

Dysport is often called the “New Botox.” However, Dypsort has actually been available in Europe for therapeutic indications since 1991 and for cosmetic applications since 2001. In April 2009, Dysport (officially known as BoNT-A/D) was approved in the United States for the “temporary improvement in the appearance of moderate to severe glabellar lines.” These are the lines between your eyebrows. However, just like Botox Cosmetic, Dysport can be used “off-lable” for treatment of crow’s feet (squinting lines around your eyes), forehead wrinkles, chemical brow lifts, platysmal bands (neck bands) and sweaty palms and armpits.

The molecule in Dysport is exactly like Botox Cosmetic but is covered by a different coating, which dissociates (dissolves) at a different rate. That is why the onset of action of Dysport is thought to be faster than Botox Cosmetic since the coating comes off faster. In Botox Cosmetic Treatment the usual onset of action is 3 to 7 days where the Dysport onset of action seems to be a few days faster. The dosing is different with Dysport, so there may be some confusion when translating Botox “units” with Dysport “units.” This is why you need to see an injector who has experience specifically in Dysport injections. Also, there is a learning curve with Dysport injections, so you may not initially achieve the same results as you are used to receiving with Botox Cosmetic.

There is also some confusion about the pricing of Dysport with many reports on the Internet and advertising claiming that it is cheaper than Botox Cosmetic. There is a discrepancy in the potency of units. A “unit” of Botox is not equivalent to a “unit” of Dysport, so unit pricing is not comparable. There is a slight savings with Dysport, but it is about 5% - nothing substantial. So, do not expect to go to your plastic surgeon to achieve the same results as Botox Cosmetic for half the price. However, with competition, hopefully prices will come down. Allergan (Botox Cosmetic) is currently offering a $50 mail-in rebate for Botox Cosmetic customers and Medicis Aesthetics (Dysport) is offering a $75 mail-in rebate. With these rebates and introductory pricing, you may be able to get a better deal than your last injection.

In the end, it is great to have another minimally invasive product approved on the market which can give consistent and noticeable results with virtually no downtime and minimal risks.