When it was first discovered a year ago about surprising new evidence that Botox and other drugs containing the neurotoxin botulinum could travel from the site of injection to the brain, it wasn’t clear whether this posed a threat to patients (the study cited described was done on lab animals).

Earlier this week however, the Food and Drug Administration announced that the risk was all too real: effective immediately, the FDA will now require Botox, Myobloc and all other botulinum treatments to carry what is known as a “black box warning” — the strongest FDA warning of record — alerting doctors and patients alike that the toxin can spread to distant parts of the body, well enough away from the injection site(s), posing serious risks such as trouble breathing and swallowing.

The FDA is also requiring manufacturers to send doctors and all other licensed practitioners a letter warning of the risk.

The action comes in response to a petition from Public Citizen, which in 2008 asked FDA to require both a black box and the warning letters. Initially, it was expected that FDA would have limited the warnings to non-cosmetic uses of the drugs, since that’s where most of the problems with adverse side effects had occurred (Editors note: botulinum is used to treat cervical dystonia, eyelid spasms and a few other medical conditions in addition to cosmetic applications such as treating frown lines), especially in unapproved uses such a limb spasticity in children with cerebral palsy.

But the administration said it found 225 cases in which the drug had migrated beyond the injection site, sometimes as far as to deep internal tissue. That was alarming enough to justify the black-box decision, even on cosmetic Botox.

According to the FDA, “there is insufficient information to fully characterize the safety profile and potential risk factors for spread of botulinum toxin at this time, given that the mechanism by which spread may occur has not been confirmed…Based on available information, it is not possible to precisely predict the role of injection site, injection technique, or dose in the spread of toxin or severity of the event. Therefore, we are seeking safety labeling changes for the both the dermatologic and neurologic indications.”

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Two California and two Las Vegas women have been charged with organizing, and participating in a scheme to defraud the local Culinary Union’s health insurance program. The women submitted claims for unauthorized cosmetic surgery procedures performed on union members in Mexico, according to U.S. Attorney Greg Brower of Nevada.

Rebecca Acosta, 46, of Chula Vista, Calif., was indicted Wednesday by a federal grand jury on three counts of mail fraud. Acosta was arrested April 14 in San Diego and released Wednesday on a $150,000 bond. Three other women have been charged by criminal complaint for their involvement in the scheme, Brower said. Ana Bertha Acosta, 39, of Dulzura, Calif., was arrested Monday in San Ysidro, Calif., and Sara Casales, 47, of Las Vegas was arrested April 14 in Las Vegas. Both are charged with health care fraud and aiding and abetting. Lucia Solano, 49, of Las Vegas, also arrested April 14 in Las Vegas, is charged with making false statements to investigators.

In 2006 federal investigators initiated an investigation to determine if Las Vegas insurance providers were being targeted for fraudulent medical claims by Mexican medical providers, according to court records. The investigators found that the Hotel and Restaurant Employees International Union Welfare Fund, also known as the Culinary Fund, which offers medical insurance to at least 50,000 people in the hospitality industry in Las Vegas, had been billed about $4.9 million for “out of country” claims from about January 2002 to February 2006. Those “out of country” claims were almost entirely from Mexico, investigators discovered. Most of the claims were for “emergency procedures” in Mexico.

When investigators began interviewing a number of the patients, they were told that the insurance claims were fabricated and that they had actually had cosmetic surgery in Mexico, not emergency services. The Culinary Fund does not provide coverage for cosmetic surgeries, unless they are medically necessary, such as breast reduction and certain types of rhinoplasty.

Rebecca Acosta, the prinicple suspect, and her cohorts allegedly devised a scheme to defraud the Culinary Fund of money through submitting false health care claims. Acosta and the others met with prospective patients at a Summerlin residence and elsewhere for consulting on cosmetic surgeries, court documents say.

Acosta told the patients that she would bill the Culinary Fund for the cosmetic surgery, such as breast augmentations or “tummy tucks,” even though such procedures were not covered through the insurance program. She told patients that she would make it appear as if the patient suffered an unexpected injury in Mexico and had received emergency medical care, and then allegedly made arrangements for the prospective patients to receive a cosmetic procedure at a Tijuana, Mexico, clinic. She followed by charging the patients a fee in addition to any reimbursement they would receive from the Culinary Fund. Acosta instructed each patient not to disclose the true nature of the treatment they received in Mexico.

Once the patients received treatments in Tijuana, Acosta and the others submitted false and fraudulent claims to the Culinary Fund, requesting reimbursement for emergency medical services, even though they knew that the patients had actually received breast implants and body contouring surgery, court documents state.

Between September and October 2005, Acosta allegedly submitted three fraudulent claims for reimbursement for emergency procedures performed on three patients and the Culinary Fund paid more than $42,000 on the claims. If convicted, Acosta faces up to 20 years in prison and a $250,000 fine on each count; Ana Bertha Acosta and Sara Casales face up to 10 years in prison and a $250,000 fine each; and Lucia Solano faces up to five years in prison and a $250,000 fine.

The case is being investigated by the Office of Inspector General for the U.S. Department of Labor, and the U.S. Postal Inspection Service. It is being prosecuted by Assistant U.S. Attorney Crane Pomerantz.

“This indictment sends a stern message to those medical providers that defrauding union health and welfare benefit plans by filing fraudulent claims will not be tolerated by my agency,” said Daniel R. Petrole, deputy inspector general for the U.S. Department of Labor. “We are firmly committed to working with other law enforcement agencies to investigate this type of crime.”

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Our second “Cosmetic Surgery FAQ” post in the series, we take a closer look at Tummy Tuck surgery. A plastic surgery mainstay, but often overlooked for other less invasive procedures such as liposuction, “abdominoplasty” deals with removal and/or tightening of excess skin and fat in the abdominal region. Today, we take a look at a couple of the most common questions that prospective body contouring patients have, when considering a tummy tuck.

Q. Is getting a tummy tuck the right decision for me?

A. Choosing to undergo an abdominoplasty or any kind of body contouring surgery is a major decision. This is due in no small part to the extensive and invasive nature of the surgery itself, the risks and side effects involved and the amount of recovery time the surgery typically requires. However, many thousands of men and women choose the procedure every year to get rid of unwanted fat and sagging skin in their mid-section. A consultation with a qualified tummy tuck surgeon will make sure that you are thoroughly informed about the procedure, its risks, your alternatives, and whether a tummy tuck is right for you.

Q. What should I expect before, during and after my tummy tuck surgery?

A. Your cosmetic surgeon will provide a thorough and unique list of things for you to do to prepare for your surgery. Most of what will be included on the list are medications and activities to avoid during the two weeks prior to and after the surgery in order to minimize risk during the surgery itself, and during your recovery period. For example, if you smoke, you will be strongly advised to quit for two weeks prior to and after surgery, as smoking significantly slows the healing process. There are a number of medications, vitamins and supplements that should be avoided prior to surgery that your surgeon will discuss with you. Upon his or her asking, full disclosure with your doctor about any and all medication is the best way to anticipate and hopefully avoid any post-operative problems. If you are in generally good health and lead a healthy lifestyle, then you should not expect to have to make any significantly drastic changes in the weeks leading up to your surgery.

Most abdominoplasty surgeries are done in a hospital with the patient under general anesthetic. This being said, you will be unconscious during the surgery itself, so you should not expect to experience any discomfort. Typically, abdominoplasty lasts anywhere from two to four hours.

A tummy tuck is a very involved, invasive procedure that requires the patient to spend a few days in the hospital afterward. You will be given pain medication during and after your time in the hospital. You will also be advised to begin walking around and doing light exercise as soon as possible after the surgery in order to prevent the formation of blood clots in your legs. Expect a week to pass before being able to walk normally and without discomfort.

Q. What about scarring?

A. You should expect to have a permanent or near-permanent scar. The length of the scar or scars will depend on how extensive your surgery is. Tummy tuck scars generally run from hip to hip, across the lower abdomen. Extra attention is given to the placement of the incisions to ensure that your scars will be minimal and inconspicuous. Typically, the incision site is well-hidden beneath undergarments and swimming attire.

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Despite personal views, plastic surgery has gone mainstream, and is obviously here to stay. The release of plastic surgery statistics has become an annual ritual, almost on par with announcing awards show nominees. Every year the numbers are analyzed to see what trends are revealed, and the 2008 data, released last month from the American Society of Plastic Surgeons (ASPS), provided a few surprises.

Paramount among these was the emergence of breast augmentation as the number one cosmetic surgery procedure, knocking off liposuction which has traditionally held the spot. Though cosmetic surgery overall declined in 2008 (which also happens to be a first), the surge in cosmetic implant use was mirrored by an increase of approximately 39% in breast reconstruction. This comes on the heels of FDA clearance for silicone gel breast implants 2 years ago, suggesting that the controversies that have plagued this breast implants type in the past have since faded.

A longer view reveals a more telling trend, however. While cosmetic surgery was down by a few percentage points, non-surgical and minimally invasive cosmetic procedures-Botox or dermal filler injections, lasers and the like-were up. One widely held interpretation of this is that people are shifting into “maintenance mode” by opting for more affordable procedures with minimal or no downtime until the economy improves and they can justify their facelift. Botox might be the new lipstick, a modern version of the historical increase in lipstick sales with every major economic downturn in the past.

Forecasting Plastic Surgery Trends

But broader analysis reveals that non-surgical cosmetic procedures have been increasing a lot more than surgery for several years. Although 1.7 million surgical procedures were done in the U.S. last year, non-surgical procedures checked in at more than 10 million. This is due, in part, to continually improving products and technologies, and with this has come greater social acceptance. Many of them are even household words now. Plastic surgeons have adapted by expanding their repertoires to include minimally invasive technologies and beauty services at their practices.

The big question on everyone’s mind is what all this means for the economy and where we are headed. One could easily subscribe to the theory that plastic surgery bookings anticipate an upturn, and if the first quarter of the year is an indication, then the economy is headed in the right direction. Some are freshening up their appearance as they change careers, others taking advantage of time off in between jobs. Either way, it is a vote of confidence; whether it is right for you, as always, is a personal choice.

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Recent findings in a report in the Aesthetic Surgery Journal states that more than 40% of cosmetic surgery patients take some form of herbal supplement in the 2 weeks leading up to their operation.

Many supplements can aid recovery, but experts are concerned that others can be harmful around the time of surgery and may also interact with conventional post-operation medicines.

These include some of the most popular supplements, typically used to boost the immune system, such as ginkgo biloba, ginseng, garlic and echinacea.

Dr. Alan Gold, president of the American Society for Aesthetic Plastic Surgery (ASAPS), said that despite the well-documented side-effects of some herbal supplements, “many patients do not fully appreciate the importance of discontinuing these treatments before surgery”.

Dr. Gold also added: “Stopping certain herbal supplements prior to surgery is just as critical as stopping aspirin, ibuprofen and many other common drugs.”

When undergoing any elective surgery, the most serious and potentially dangerous effects of alternative medicines and herbal supplements occur during the operative and in the immediate postoperative periods.

“In considering the dizzying array of supplements available, the main concerns of the plastic surgeon are interaction with other medications, cardiovascular effects, alteration of coagulation [bleeding] and sedative effects,” adds David J. Rowe, M.D., author and Assistant Professor of Plastic Surgery at the University Hospitals Case Medical Center, in Lyndhurst, OH.

This situation is not unique to North American pateints either. The advice may be relevant to a significant number of British people as well, as several plastic surgery clinics recently told British newspaper, the Mirror, that there is likely to be as much as a 26% increase in the number of women undergoing breast enlargement surgery in April compared to March.

Herbal Medications to Avoid Within 2 Weeks of Plastic Surgery:

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Huntington Beach, LOS ANGELES – A California woman who has earned the nickname “The Boob-Job Bandit” in local media, has turned herself in to police after being accused of using a fake identity to obtain breast implants from a Huntington Beach plastic surgery clinic.

Yvonne Jean Pampellonne, 30, surrendered to local authorities on Tuesday (March 4th) afternoon in Huntington Beach, California, where she was wanted on charges of commercial burglary, identity theft and grand theft. Pampellonne arranged her surrender through her attorney and has been released on $20,000 bail pending an arraignment on the charges on May 27.

Police say that in September of 2008 Pampellonne used the personal information of another woman to establish a fraudulent line of credit at the Pacific Center for Plastic Surgery in Huntington Beach. By the time it was discovered, doctors performed $12,000 in liposuction and breast augmentation surgery at the center, say police.

The Orange County Register newspaper reported that Pampellonne was caught by police detectives using breast implant tracking numbers. Medical staff at the center became suspicious after Pampellonne returned for follow-up appointments and, after police identified her through the tracking numbers on her old implants, picked her out of a photo line-up.

Pampellonne’s arrest marks the second similar plastic surgery-related case this year in Orange County, which recently has been portrayed as an oceanfront playground for the wealthy on such TV shows as “The Real Housewives of Orange County” and “The O.C.” In January and February, a still-unidentified woman who gave the names “Miriam Gombar” or “Miriam Flemings” had thousands of dollars worth of Botox injections and facial fillers at a pair of Newport Beach plastic surgery clinics and left without paying.

According to the Register newspaper, a worker at one of the two plastic surgery clinics described the mystery woman as having a dark complexion and shoulder length hair, adding that she was in her late 40s to early 50s, adding that she was “not very attractive”, despite the work she had.

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In our continuing efforts to bring our readers the most information on a wide variety of cosmetic surgery procedures, we’re taking this opportunity to answer some common cosmetic surgery FAQs! In this and future Frequently Asked Questions posts, we’ll take a look at one or two of the most commonly asked questions regarding a given procedure and share our wealth of knowledge with you, our readers and potential patients.

Q. What is breast augmentation?

A. Breast augmentation is a plastic surgery procedure designed to enhance the size, shape, and symmetry of a woman’s breasts. The procedure can be done in a variety of ways, however, the most common method uses either silicone gel or saline (salt water) breast implants. The result of breast enlargement surgery is an enhanced figure, and a potentially heightened sense of self-confidence.

Breast augmentation is a procedure that has definitely evolved drastically, since its inception. Many years ago, the earliest breast enhancements consisted of women getting silicone injected directly into their breasts. But not long after the injections, the silicone would move and distort the breast augmentation. Some enterprising people (not necessarily physicians) found that if they put certain chemical impurities into the silicone, the material would stay in place. Unfortunately, these impurities caused infections and problems for many patients. Soon after, plastic surgeons improved the technique by putting silicone into a thin containment device and the modern day field of breast augmentation was born.

Q. What actually happens during the breast augmentation procedure? Is there multiple ways to do the surgery?

A. As with all things in life, there is always more than one way to do something. The basic breast enhancement procedure involves making an incision in and around the breast, creating a tunnel under the skin or muscle and putting an implant in that tunnel.

Here is where it gets a little interesting. Different surgeons advocate making incisions in different areas: under the arm, in the belly button, around the nipple or underneath the breast. Each method has its advantages and a disadvantages. Typically, the best procedure for you is what your doctor says it is. Each surgeon has his own preference and his own comfort level with different techniques. However, it is also important to address your own comfort level and personal needs, as well.

Our suggestion is this: Pick a plastic surgeon that offers multiple options for your procedure so that you get the one that’s best for you. If your surgeon offers only one way to do your procedure, you may not be getting the best possible solution for what bothers you. Ultimately, your plastic surgeon should be able to provide you with both a variety of options and an objective opinion on what will be the best method for you

As always, get several opinions before undergoing any sort of cosmetic surgery.

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Despite being historically seen as a luxury, reserved for the wealthy, it doesn’t take a board certified plastic surgeon to tell you that appearances matter in our society. The emphasis on this popular notion, however, is being challenged by the economic restrictions many of us are now facing, during the recession.

The idea of foregoing cosmetic enhancement is starting to show, across the board, in the field. Recent national and regional surveys by the American Society of Plastic Surgeons (ASPS) shows a 62% decrease in overall cosmetic procedures of all kinds, since 2007. Invasive surgical procedures have shown a 44-64% drop, depending on the procedure, while 73% of ASPS-surveyed surgeons have shown an increased or stable demand for minimally or non-invasive procedures.

A fair amount of surgeons expressed cautious optimism amidst the downturn in business, noting that while business is definitely slowing down, the expectations are that it won’t be a permanent change in the field. Many surgeons are advocating that patients focus on only one aspect of their appearance to improve and then return when they are financially capable.

“Instead of getting their whole face addressed maybe they’ll narrow it down to the eyes or their lips”, says St. Louis plastic surgeon, Dr. Bruce White, M.D.

While some surgeons and practices opt to push less obtrusive procedures like Botox or fat grafting in lieu of procedures like a facelift and body contouring, others are taking a different approach to keep their business booming. Dr. White’s practice, for example offers 10-15% discounts for first time patients.

Says ASPS president, Richard D’Amico, M.D., “It is very clear the economy is affecting the demand for surgical cosmetic procedures. We are hearing that from consumers and plastic surgeons. And while ASPS Member Surgeons are feeling the impact of the economy, we anticipate the historic bounce when patients return as the economy improves.”

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