Bogus surgeon convicted of murder

A Phoenix, Arizona physician who had three patients die during liposuction surgery was found guilty of murder and manslaughter last week in Maricopa County Superior Court. He was not a trained plastic surgeon, nor a surgeon of any kind.

Dr. Peter Normann had been an emergency-room physician, certified as an internist, and had never done a residency in plastic surgery. He had undergone six days of training in liposuction and had done some "hands-on training" in liposuction and breast augmentation.

Normann was pronounced guilty of second-degree murder in the deaths of Ralph Gonzalez, 33, of Scottsdale, and Leslie Ann Ray, 53, of California, and of manslaughter for the death of Alicia Santizo Blanco, 41, of Gilbert.

In her closing arguments earlier this week, Attorney Jeannette Gallagher claimed that two of the deaths constituted second-degree murder because of Normann's "extreme indifference to human life," and the third death was manslaughter because of Normann's "conscious disregard of substantial and unjustified risk of death."

Furthermore, the attorney said, his operating room lacked proper oxygen and monitoring equipment, and he worked without anesthesiologists or nurses, relying on a massage therapist and a former restaurant worker with little or no training as medical technicians.

The massage therapist, who assisted in surgery, has already pleaded guilty to eight counts of unlawful practice of medicine and was sentenced last year to five years in prison.

Source: www.azcentral.com

Editor's note: There seems to be an ongoing problem with surgery done by untrained physicians, with a lack of trained anesthesiologists, in substandard facilities... and the complications that can happen, as in this sad tale, are not at all good.

Whether you call it aesthetic surgery or cosmetic surgery, it's still surgery.

New York man indicted for performing illegal cosmetic procedures

File this under "medical tourism" meets "back-room procedures". Another sad story about discount cosmetic surgery in a foreign country, this time with a twist...

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Hector Cabral of New York has been indicted for illegally performing cosmetic procedures on several women, leaving some of them permanently disfigured. He was charged with 10 counts of unauthorized practice of a profession, in this case medicine, according to the North Country Gazette.

The illegal operations took place between November of 2006 and November of 2009. Cabral allegedly charged the women a fee for consultations and examinations held at various spas and beauty salons in the state of New York. The women would then travel to the Dominican Republic, where Cabral would carry out the procedure.

Following the illegal treatment, Cabral would instruct the women to visit his accomplice, Alma Melo, for "post operative treatment" back in New York. Melo was served with two charges for a first-degree scheme to defraud and a fifth-degree conspiracy.

Cabral could face more than 20 years in prison if convicted. He is currently free on bail, and a warrant has been issued for the arrest of Melo.

Editor's note: I believe this is the first time that someone has been prosecuted for illegal surgical services when the surgery was performed overseas, and only the pre-operative consultation and post-operative recovery phases were performed in the U.S. It sets a new legal precedent.

Source: ASAPS

New Jersey woman charged after giving illegal cosmetic procedures

According to the ASAPS website...

Yamile Mattos of South Plainfield, New Jersey, has been charged with practicing medicine without a license after police discovered that she had been offering Botox injections and buttocks enhancements out of her home.

Undercover investigators were sent to the garage where she was conducting the procedures. According to police, Mattos offered a female officer Botox injections to eliminate wrinkles and a buttocks augmentation injection.

She was arrested on Tuesday, January 12, but there is no information on whether she is being held on bail or if the woman has hired an attorney. In addition to the first charge, she was also accused of possession with intent to distribute a prescription drug and possession of drug paraphernalia.

"Medical procedures performed by unlicensed individuals put the public at unnecessary risk," said Attorney General Paula T. Dow.

Editor's note: OK people, if you are going to someone's garage to have a medical procedure, that's a really bad sign.

The "Stem Cell" facelift

Every so often, a catchy concept comes along, and suddenly, that buzzword is everywhere. The buzz used to be about "laser-this" and "laser-assisted that". Now the popular phrase for plastic surgery is ""stem cells" and in particular, "stem cell facelifts". There was heated discussion about this procedure at the "Hot Topics" portion of the recent Toronto ASPS meeting.

Stem cells, for those who are unfamiliar with the term, are a special type of human cell found in bone marrow, fat and other locations, that have the unique ability to develop into pretty much any other more specialized type of cell, given the right circumstances. As such, their potential uses for repair, regeneration and restoration are potentially huge. Scientifically speaking, our understanding of how to best harvest and properly use these adult stem cells is extremely preliminary. But as the saying goes, "never let the facts get in the way of a good story", and that phrase certainly applies here, with the "stem cell facelift".

The LA Times did a properly skeptical review of stem cell facelifts here. Essentially, this procedure has an old name: fat grafting to the face. Of course, that doesn't sound as sexy as "stem-cell facelift", does it? Especially when traditional fat grafting has been a bit disappointing for many surgeons - with short duration, lumpiness, and unpredictability.

Some (but not all) physicians who promote the stem cell facelift are working on enhancing and "turbo-charging" the fat to be grafted by adding additional stem cells to the fat. These cells can be obtained through one of two main sources: liberating them from liposuction-ed tissue with collagenase, as is done with Cytori Therapeutics' $100K+ machine, or separating them from blood, using a process known as apheresis. Adding the stem cells to the fat does seem to make the fat transfer process work more reliably. There's decent science on that part.

But so far, we have no evidence - zip, zilch, nada - that there is any actual regenerative effect on skin when the turbo-charged fat is added to the face. We know you get more volume in the treated areas, so the treatment could be useful for those with a volume-depleted area, or those who want fuller cheeks - but that's about it.

Furthermore, under FDA rules, when stem cells get involved with fat transfers, the procedure falls under a whole new set of regulations. The fat and stem cell combo is now seen as a "biologic agent" by the FDA, and regulated as a drug. In the eyes of the FDA, stem cells and fat represent a non-approved drug. Investigational, yes - approved, no.

Interestingly, one of the spin-offs of this change to drug status is a change in whether physicians can advertise this process. They are no longer just advertising a procedure (the stem cell facelift), but they are doing direct-to-consumer marketing for a drug (the fat and stem-cell mixture) which has not yet been cleared by the FDA. And it's illegal to promote non-approved drugs.

So, those websites you are seeing for stem-cell facelifts are advertising a procedure which is:
1) scientifically not yet proven to have any efficacy,
2) morally questionable, (since they are charging big bucks for an as-yet unproven procedure),
3) illegal under Federal statute.

So there are a few problems to be worked out, eh? That being said, this is an area of great research interest, which one day might really be something good. Stem cell facelifts, for now though, should be part of research studies, not commercial promotion.

More imitation Botox stuff...

Remember, back in November, we brought you the story of a Texas lady who was illegally selling fake Botox and filler products under the the name "Discount Med-spa"?

Well, it seems that her conviction and sentencing had no effect, as here's yet another website selling bogus imitation Botox under the name Pretique. (link)

This material is to be avoided.

I have no idea what this product is. And no idea what's really in it, how it's manufactured, how potent it is, or any other quality control information. It's certainly not anything remotely legal, and is in no way associated with any of the authentic manufacturers of botulinum for cosmetic uses, like Allergan. It's a scam.

Avoid the use of these knock-off products. They could, like the people who used one of the other imitation products, known as "Tri-tox", put you in the ICU on a ventilator.

And that's not a good way to spend your summer vacation!

(Thanks to medicalspamd.com for the heads-up on this.)

Problem or panacea: "awake" cosmetic surgery

More and more, I see ads by non-plastic surgeons touting the alleged advantages of having major elective procedures, such as a tummy tuck or a breast augmentation, done "awake" - under local anesthesia. Invariably, these ads tout "avoid risky general anesthesia", or "quick recovery".

While liposuction under tumescent (local) anesthesia is an accepted and validated technique, performing breast augmentation or tummy tucks while awake is very controversial, to say the least. The New York Times recently did an investigation on this issue - their article is here (link)

Typically, these procedures are heavily advertised by cosmetic surgeons who are not board-certified in plastic surgery, and who do not have hospital privileges to work in the operating room. Their offices are usually not accredited, inspected surgical facilities. And they don't typically have an anesthesiologist monitoring the patient.

Really, I feel that the "local anesthesia" angle is a bit of a dodge. It's a clever bit of marketing spin. The reason most of these "wanna-be's" promote this is because it's their only option for anesthesia....they usually can't get the hospital privileges or work in accredited surgery centers, due to lack of credentials.

There are also real disadvantages to the "local only" technique:
- It can be hard to numb large areas completely, even with the tumescent technique. Remember, just like when you visit the dentist, it can take a few painful shots before the injected area is numb.
- If the local isn't working 100%, the patients may be fully aware and in pain, as the procedure goes on. I wouldn't wish that on my worst enemy, thank you.
- You can't get satisfactory muscle relaxation with just local anesthesia, either - which is important for procedures like tummy tucks, or sub-pectoral breast augmentation.
- it isn't good for patients who are nervous, or who are resistant to lidocaine.
- lidocaine, the most commonly used numbing agent, isn't risk free. Toxic doses can occur, resulting in seizures and cardiac arrhythmias.

If you want a rapid recovery from anesthesia, use an expert anesthesiologist, who can monitor the patient, and give them exactly the right doses of medication, keeping them comfortable, but not over-sedated.

Modern anesthesia, administered by an anesthesiologist in an accredited facility, is actually very safe. The risk of something bad happening under anesthesia is less than 1 in 57,000, according to recent studies. Essentially, you are far safer under anesthesia than you are driving your car to work every day.

As for the claims of "quicker recovery", the recovery from the surgery depends more on the nature of the surgery, on delicate handling of the tissues by the surgeon, good hemostasis, and avoidance of tension on the tissues, all of which are skills that are stressed in Plastic Surgery school.

If I were to have a surgery done, I don't want to feel it, see it, or smell it, thank you very much. Wake me up when it's all over. Most of my patients feel the very same way.

FDA issues warnings about Lipodissolve

From the FDA website...

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It's a tempting premise: Get a series of drug injections and see pockets of fat on your body go away for good. But the Food and Drug Administration (FDA) is alerting consumers about false and misleading claims being made about products used in lipodissolve, and about other misbranding of these products.

Recipients of lipodissolve get a series of drug injections intended to dissolve and permanently remove small pockets of fat from various parts of the body. The process is also known as injection lipolysis, lipozap, lipotherapy, and mesotherapy.

“We are concerned that these companies are misleading consumers,” says Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research. “It is important for anyone who is considering this voluntary procedure to understand that the products used to perform lipodissolve procedures are not approved by FDA for fat removal.”

The drugs most regularly used in the lipodissolve injection regimen are phosphatidylcholine and deoxycholate (commonly called PC and DC, respectively). Other ingredients may also be used, including drugs or components of other products such as vitamins, minerals, and herbal extracts.

What Consumers Should Know:
- FDA is alerting consumers that it has not approved products for use in lipodissolve.
- It is not aware of evidence supporting the effectiveness of the substances used in lipodissolve for fat elimination.
- The safety of these substances, when used alone or in combination, is unknown.
- It is not aware of clinical studies to support medical uses of lipodissolve.

In addition, FDA has reports of unexpected side effects in people who’ve undergone the lipodissolve procedure. These side effects include: permanent scarring, skin deformation, and deep, painful knots under the skin in areas where the lipodissolve treatments were injected.

FDA Actions:
On April 7, 2010, FDA announced it had sent warning letters to six medical spas in the United States—and a cyber letter to a company in Brazil—for making false or misleading statements on their Web sites about drugs used in the procedure, or for otherwise misbranding lipodissolve products.

The U.S. medical spas receiving warning letters make various unsupported claims about lipodissolve, such as assertions that the products used in lipodissolve:
"are safe and effective"
"have an outstanding safety record"
"are superior to other fat-loss procedures, including liposuction".

The U.S. companies receiving warning letters in regard to lipodissolve products are
Monarch Med Spa, King of Prussia, Pa.
Spa 35, Boise, Idaho
Medical Cosmetic Enhancements, Chevy Chase, Md.
Innovative Directions in Health, Edina, Minn.
PURE Med Spa, Boca Raton, Fla.
All About You Med Spa, Madison, Ind.

Six New Jersey Women get Industrial Silicone Injections...and big problems.

Here's a story from CBS News - it belongs in the "You've got to be kidding me " file. These women had buttock injections from a bogus MD in a hotel room. With bathroom-type silicone caulking. In large volumes. This story did not end well.

Astute (no pun intended) readers of this blog should recognize several "red-flags" already.....


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Women Hospitalized After Fake Silicone Injections: 6 Individuals Thought They Were Improving Their Curves But Ended Up Getting Tumor-Like Infections Instead


J-Lo and Kim Kardashian have curves women would kill for. This may have been the shapely image six New Jersey women were trying to achieve when they got injections from bogus medical providers to enhance their behinds, but instead ended up in hospitals with severe tumor-like infections.

"The product used was, first of all, not manufactured with the intention to inject into the body," Dr. Steven Marcus of NJ Poison Control told CBS station WCBS-TV.

Health officials believe bathroom caulk may have been used in the injections. It's made from silicone and used to seal cracks in tubs and tiles in bathrooms.

Poison control officials said the women were lucky to be alive. "You could inject this into a vein, and then that substance floating in your bloodstream could damage your heart, your brain, you could have a stroke from it," Marcus said.

The women, five of them from Essex County, apparently got the injections in motel and hotel rooms. The Board of Medical Examiners was investigating to see if they all got it from the same unlicensed provider.

"I was thinking about doing that," for a more plump buttocks, said Joan Sorbino of Newark, but she's thankful she didn't. "Very scary," she said.

"If you have somebody whose entire buttock is injected with this material, you occasionally will need to do a fairly radical incision as if it were a cancer," said Dr. Mark Granick, chief plastic surgeon at University Hospital. "Plastic surgeons don't inject large volumes of anything in anybody. It's just not safe. You can have a buttock implant put in. Some doctors will do that, and buttock implants are also well-tested and relatively safe, although they do have a separate set of complications," Granick said.

With any kind of procedure, you should always check with the American Society of Plastic Surgeons to make sure your surgeon is legitimate.

(Dr. Fiala's note: In addition, only FDA-approved, medical-grade products should ever be used for any kind of injection. In general, for buttock augmentation procedures, I recommend fat grafting techniques or appropriately designed and approved buttock implants.)