oung mothers, middle-aged men and grandparents. All were among at least 32 people who died in Florida in the past decade in the pursuit of beauty – soon after cosmetic surgery.

That's about the same number of deaths that occurred in the 1990s, leading the state Board of Medicine to pass rules restricting cosmetic procedures performed in doctors' offices – rules still considered among the toughest in the nation.
One reason for the continued deaths may be a huge growth in cosmetic surgeries, but some surgeons, malpractice attorneys and industry experts say problems persist, and the state needs to do more.

"If there are that many deaths, there's still something very wrong," said Becky Cherney, an Orlando health care advocate who was a member of the medical board that passed the rules. "People elect to have plastic surgery and they end up dying? It's a senseless loss of life."

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The deceased include four South Florida mothers in their 30s who went under the knife in the past two years to have love handles and bra rolls shrunk via liposuction, state incident reports and police records show.

In one case, a 32-year-old Miami mother of six went for liposuction at a Broward County plastic surgery office in February 2010. She died the next afternoon from a toxic mix of the surgical anesthetic lidocaine and oxycodone pain pills "complicating elective cosmetic surgery,'' according to an autopsy report.

Dr. Brett Coldiron, a University of Cincinnati dermatology surgeon who has researched plastic surgery in Florida, tallied 26 deaths and 131 hospitalizations from 2000 through 2009. The Sun Sentinel documented six deaths since then, through autopsy and police reports.

The deaths have had various causes, including poor medical care by doctors, bad reactions to anesthesia, and heart and breathing emergencies during surgery. Some were due to unavoidable complications that can happen in any type of surgery, even under the best conditions. The causes of the two most recent deaths have not been determined.

Florida's medical board tracks cosmetic surgery deaths and complications, but so far has not identified any trends or patterns that would require a change in the rules, said two board members from Fort Lauderdale, Dr. Zachariah P. Zachariah and Dr. Nabil El Sanadi. The medical board enforces laws involving physicians.

Both said the board should take another look at the issue, based on a cluster of five deaths in the past 21 months in Broward County.

"It's easy to second guess, but there needs to be a systematic approach to looking at all this," El Sanadi said. "Is it one place not complying with laws, or is it the system letting us down?... We don't know.''

The medical board first addressed the dangers of plastic surgery in 1999, after a series by the Sun Sentinel that found 34 deaths in the preceding 12 years. Some were blamed on lengthy surgeries involving multiple procedures at doctors' offices that were not then being regulated.

The board wrangled for two years before imposing rules that included regular inspections of physician surgery offices, a ban on overnight stays, and limits on liposuction and lengthy operations.

Since then, demand for elective cosmetic surgery has mushroomed nationally, fueled in part by public interest in celebrity surgeries and makeover shows on TV. The number of procedures nearly doubled since 2000 to an estimated 13.1 million last year, according to surveys of doctors done by the American Society of Plastic Surgeons.

Appearance-conscious Florida has been in the forefront. The number of doctors' offices registered to perform surgery jumped from 285 in 2004 to more than 400 today, state figures show. Half of those are in South Florida, with about 50 each in Broward and Palm Beach counties, and 100 in Miami-Dade. Some doctors appeal to modest-income families by offering discounted prices and payment plans.

Nationally, studies show a death rate of 2 per 100,000 cosmetic surgeries in physician offices. But no one counts the number of plastic surgery procedures in Florida so a statewide death rate cannot be calculated.

Coldiron said the industry has gotten better, but "cosmetic surgery is still not as safe as it should be in Florida."

Several malpractice attorneys said the state has not done enough to enforce the present rules and does not punish violators severely.

"The governor and Legislature talk a lot about protecting the medical industry," said Michael Freedland, a Weston attorney who represents families in two liposuction death cases. "I'd like to hear more talk about how we protect patients."

A more recently approved version of botulinum toxin type A beat the anti-wrinkle medication Botox in a trial that compared the respective powers of each in erasing those unwanted lines of aging around the eyes known as "crow's feet."
"One month after treatment, on a two-to-one preference basis, patients picked Dysport over the Botox in terms of wrinkle improvement," said study co-author Dr. Corey S. Maas, an associate clinical professor at the University of California, San Francisco, as well as a plastic surgeon with The Maas Clinic, based in San Francisco and Lake Tahoe.

"So, we can say that when it comes to addressing the smile lines around the eyes, the crow's feet, at one month the Dysport is more effective than Botox," Maas said. "And that's a big deal, because Botox is such a recognized household name now. And it's such a great drug. But when you have something that comes in that's as good in some areas, let alone even better, it's big news for all of us, both doctors and patients."

Maas and his colleagues report the findings in the June 20 online edition of the Archives of Facial Plastic Surgery.

In 2002, the U.S. Food and Drug Administration first approved a particular form of botulinum toxin type A; this drug is popularly known as Botox and is manufactured by Allergan Inc.

An alternate version of the same botulinum toxin was approved in Europe in 2001 for general cosmetic applications. The drug, known as Dysport, is manufactured by Medicis Aesthetics; this version of botulinum was approved for use in the United States in 2009.

To compare the efficacy of both, the research team focused on 77 women and 13 men aged 18 and up between 2009 and 2010. None had previously undergone a facelift, brow lift or laser/chemical resurfacing. None had been exposed to botulinum in any form in the six months prior to the study launch, nor had any experienced adverse side effects as a result of previous exposure to botulinum.

Pre-procedure photographs were taken of all the patients, both while at rest and while contracting their foreheads and eyebrows. Wrinkling was subsequently graded on a five-point scale.

Next, the team the launched a so-called "split face" study, in which the right and left sides of each patient's face were each exposed to one of the drugs. Calculating that the strength ratio of the two drugs is about three-to-one, the researchers injected 10 units of Botox into the crow's feet region of one side of the face, compared with 30 units of Dysport on the other, according to the report.

One month following injection, the patients were asked to contract their muscles as hard as they could, while photographs were again taken.

The result: both the researchers and a majority of patients concurred that Dysport appeared to produce a better outcome. Specifically, two-thirds of the patients expressed a preference for Dysport, ranking Dysport nearly one point higher on the five-point wrinkling scale.

The authors noted, however, that when the patients relaxed their faces there was no appreciable difference between the Dysport and Botox sides.

"Now we want to be careful not to overplay this," stressed Maas. "From our findings, it's clear that there's a better smoothing effect and clearing of lines around the eyes with Dysport. But does that also mean that Dysport is better at achieving the same thing around the mouth or forehead or neck? We really can't make that conclusion."

Maas added that, "the cost of the two amounts respectively are about the same. Maybe actually a little bit less for Dysport, but not substantially less."

He also acknowledged that although the manufacturers of both drugs were approached to support the current investigation, only the maker of Dysport ultimately contributed funding to the effort.

"And what I would personally say about that," noted Maas, "is that if you already own 90 percent of the market why would you fund a study where if you tied you lost? But I will add that Allergan didn't like the dosing or the statistical analysis we used, despite the fact that I believe the body of scientific evidence supports the way we handled both."

But Allergan issued a statement Monday that challenged the findings on several grounds, which included the small size of the study, the short length of the trial and, most importantly, the dosing ratio the researchers used when deciding how much of each product to use on the patients' faces.

"It is important to understand that no two botulinum toxins are alike and each has a unique molecular structure, formulation, potency and safety profile," the company said in its statement. "In fact, the U.S. FDA-required product labels for BOTOX Cosmetic and other botulinum toxins state that different botulinum toxin products are not interchangeable and no consistent dose ratio exists among botulinum toxin products."

"The most significant flaws in this study's design were the attempted dose conversion and injection pattern. In this study, patients were treated with 10 units of BOTOX Cosmetic and 30 units of Dysport. As stated above, BOTOX Cosmetic and Dysport are not interchangeable and there is no established dose conversion, meaning 10 units of BOTOX Cosmetic does not equal 30 units of Dysport. When patients are treated with BOTOX Cosmetic for its approved indication in the glabellar (vertical frown lines between the eyebrows), they typically receive 20 units, which is the FDA-approved dose. In addition to specific dosing regimens, BOTOX Cosmetic also has a unique injection pattern for proper administration, pending the treatment area and individual patient."

Dr. Doris Day, a dermatologist with Lenox Hill Hospital in New York City, also cautioned that the attempt to analytically stack two "very similar" drugs against one another can pose difficulties.

Commenting on the study, she said, "The problem with any study trying to compare them is that there are variations in the reconstitution measures and final numbers of units used for each drug, and that can have a large impact on the final effect of the treatment. Because these are biologics, and because there are slight differences in the manufacturing process, there will be some differences in how the final product works."

Day pointed out that both drugs are FDA-approved and have good safety track records to date.

YUBA CITY, Calif.—A Northern California dental assistant has been ordered to serve three years in prison for stealing $203,000 from her former employer and reportedly using the money to purchase jewelry and cosmetic surgery.

Tiffany Lynae Lovell was sentenced Friday in Sutter County Superior Court for embezzling funds over the five years she worked as an office manager for a Yuba City dentist.

Prosecutors say the 31-year-old Biggs resident charged personal items on a company credit card and altered time sheets to collect pay for days she didn't work.

A county probation department report says Lovell used money stolen between 2005 and 2010 to buy jewelry, clothing and electronics for herself and others.

She is also suspected of spending some of it on cosmetic procedures including breast augmentation, the Appeal-Democrat of Marysville reports.

Silicone breast implants are relatively safe despite frequent complications and a small increased risk of the disease lymphoma, US drug regulators have said.

In a new report, the Food and Drug Administration said the risks were well enough understood that prospective patients could make informed decisions.

But it found as many as one in five breast augmentation patients had the implants removed within 10 years.

The US approved the implants in 2006 after a long absence from the market. Market removal - On Wednesday, the FDA released a 63-page report on the safety of the silicone gel-filled implants that compiled studies performed by the two companies approved to manufacture the products.

Approximately five to 10 million women across the world have breast implants, the FDA said.

In 2006, the FDA approved two brands of silicone gel implants for women over 22, Allergan’s Natrelle implants and Memory Gel implants from manufacturer Johnson and Johnson’s Mentor division.Silicone implants had been off the market since 1992, when the FDA removed them amid concerns about implant rupture and silicone leakage.

The agency allowed saline-filled implants to remain on the market, and allowed limited distribution of silicone implants for mastectomy patients and other cases of medical necessity.

Increased risk. According to the new report, as many as one in five breast augmentation patients and half of breast reconstruction patients had to have the implants removed within 10 years.

Studies found no association between the silicone implants and connective tissue disease, breast cancer, or reproductive problems, the FDA reported.

But they did find a “very small” increased risk of anaplastic large cell lymphoma.

The most frequent complications from the implants included implant rupture, wrinkling, asymmetry, scarring, pain, and infection.

‘Shape and size’. The report found that the risk of those local complications increases with time.

“Breast implants are not lifetime devices,” the FDA cautioned women. “The longer you have your implants, the more likely it will be for you to have them removed.”

But the agency also found that most women who had breast implants “report high levels of satisfaction with their body image and the shape, feel and size of their implants”. “Despite frequent local complications and adverse outcomes, the benefits and risks of breast implants are sufficiently well understood for women to make informed decisions about their use,” the FDA concluded.

KUALA LUMPUR: Health authorities will soon start clamping down on beauty salons and beauticians offering invasive treatment like botox injections and laser procedures.

This will be enforced by the end of the year with the Aesthetics Medical Practitioner guidelines and programme to regulate the industry.

The Health Ministry is drafting the guidelines under the Medical Act and is also working with the Malaysian Medical Council and Higher Education Ministry to introduce a mandatory course for practitioners.

“Once implemented, the public, medical practitioners and those in the industry should come forward to report beauty salons or those offering invasive aesthetics treatment without authorisation,” Health Minister Datuk Seri Liow Tiong Lai said.

“The Government is highly concerned over recent cases where patients seeking beauty or weight loss treatment were left in great pain and suffering following invasive treatment.

“In light of this, the ministry will be issuing clear guidelines for all beauty salons, hospitals and practitioners,” he said after launching the Health Education and Health Awareness campaign here yesterday.

On June 8, Tham Mei Leng, a 30-year-old clerk from Pahang, underwent liposuction of her tummy and transferred the fat to her breasts.

But the procedure by an unlicensed cosmetic surgery company, which cost RM13,100, went awry and resulted in serious infection to her breasts.

Liow said general medical practitioners would also come under the new guidelines and would have to undergo the course and training if they wish to offer beauty services.

Women need to beware that while breast implants are safe, they are not meant to last a lifetime and could lead to problems later on, the top US drug agency said Wednesday.

"Breast implants are not lifetime devices. The longer a woman has silicone gel-filled breast implants, the more likely she is to experience complications," the US Food and Drug Administration said in a report.

The FDA approved the sale of silicone breast implants in November 2006 for women age 22 and above.

But in updated safety guidelines it warned that one in five women who have had breast implants to increase their cup-size or for reconstruction surgery will have to undergo another operation within 10 years.

"For patients who received implants for breast reconstruction, as many as one in two will require removal 10 years after implantation," the report said.

And one in five patients who received implants to boost their appearance will need them removed within 10 years.

Most complications occur from hardening of the breast tissue around the implant, from a rupturing of the implant, or "wrinkling, asymmetry, scarring, pain and infection," the FDA said.

It stressed its preliminary investigation showed no risk of cancer or any reproductive problems linked to breast implants, but recommended that there should be further studies.

The American Society of Plastic Surgeons said that last year 390,000 breast implant operations were carried out, the vast majority to increase bust size. Those figures include both silicone implants and those filled with saline water.

"The FDA will continue to monitor and collect safety and performance information on silicone gel-filled breast implants, but it is important that women with breast implants see their health care providers if they experience any symptoms," said Jeffrey Shuren, director of FDA's Center for Devices and Radiological Health.

"Women who have enrolled in studies should continue to participate so that we may better understand the long-term performance of these implants and identify any potential problems."

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