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.

There’s a good review article on the risk of blood clotting problems known as “VTE’s” and their relationship to abdominoplasty surgery in this months issue of Plastic and Reconstructive Surgery. VTE is the abbreviation for venous thrombo-embolism, and it includes such problems as deep vein thrombosis of the leg and pulmonary embolism.Although this topic may sound obscure, pulmonary embolism can be fatal, and it can sneak up and strike suddenly after major surgery, without warning symptoms. My friend, Dr. Paul Vanek, once described VTE’s as a “scud missile striking randomly in the middle of the night” – and that’s a good way to think about it. So, anything we can learn to understand and prevent this problem better is really very important.

The authors reviewed the plastic surgery literature on VTE’s, and their analysis revealed some findings that should make surgeons sit up and take notice.

In particular:

Risk of VTE with standard tummy tuck: 0.34% (= 1 / 300)

Risk of VTE when tummy tuck is combined with an intra-abdominal procedure (e.g. hysterectomy) 2.17% = 6 x risk

Risk of VTE when tummy tuck is combined with lower body lift (circumferential tummy tuck) 3.40% = 10 x risk.

Both of these findings were highly statistically significant.

Of course, wise surgeons do everything possible to prevent this problem. Using pneumatic compression leggings, which massage the calf area, keeping blood moving during surgery helps. Giving Lovenox, the medication which treats blood clots, helps significantly. And getting people moving as soon as possible after surgery helps too. But the risk of developing a VTE is still not eliminated.

So, what can we learn from this paper?

Personally, I think surgeons should give up doing the procedures that are high risk for these complications, until a proven strategy to prevent these potentially life-threatening problems can be developed and tested.

That mean no “circumferential” tummy tucks, and not doing tummy tucks at the same time as other operations inside the abdomen.

Just my two cents.

In this report from ABC News (link), the Lifestyle Lift organization has been fined $300,000 for deceptive advertising practices.

Apparently, Lifestyle has been having their employees write gushingly positive comments about the Lifestyle facelift procedure on various internet forums and chat rooms, when these people never had the procedure, and certainly weren’t non-biased, independent reports. More than that, they also developed phony websites that purported to be some patients’ own websites, describing their Lifestyle lift in very positive terms.

The Lifestyle lift is, for all intents and purposes, a form of mini-facelift. And as we’ve said before, when you try to get by with performing less surgery, you often get lesser results.

Thanks to Dr. DiSaia’s blog for alerting me to this news item!

Apparently, Diprivan has been found at the former home of the late Michael Jackson. This story is becoming more tragic by the day.

Diprivan, also known generically as propofol, is a powerful intravenous anesthestic agent. In the right hands, it is a useful drug, permitting anesthesia with a low incidence of postoperative nausea and vomiting. In the wrong hands, however, it can be dangerous.

In small doses, diprivan causes sedation. In larger doses, it can induce unconsciousness, and a state of general anesthesia. And a distinct lack of breathing, which can permanently ruin your day.

Sometimes, the same dose in one person will give a different response in another person. Or a slight increase in the dose can push the patient from mere sedation to complete unconsciousness. So, the physician administering propofol needs to know how to monitor and maintain the patient’s airway – which might include intubating the patient. This is everyday stuff for a trained anesthesiologist or nurse anesthetist.

There is no way that this drug has any legitimate use outside of a controlled medical setting like the OR or ICU, and certainly no way it should be in a private residence.

For those of you who are unfamiliar with the term, the Thread Lift was a much-hyped procedure in which a special type of barbed suture would be placed under the skin, to draw the loose facial tissue upward. The idea was to get a facelift-like lift, without actually doing a real facelift. It sounded so promising – just have a few of these magic threads inserted into your cheeks during your lunch break – and voila! – a younger looking you. A number of companies make and promote these barbed sutures, under a variety of trade names.

Well, as we’ve said before – when you do less, you get less.
Here’s some more evidence: in this month’s issue of Archives of Facial Plastic Surgery, a study looked at how well the thread lift procedure held up over a two year follow-up period. The answer: not good.

The authors evaluated the results of 33 patients who underwent a thread-lift procedure alone or in combination with other facial rejuvenation procedures to the brow, midface, jowl, and neck. Long-term aesthetic results were evaluated by 4 independent, blinded surgeons.

The thread lift group had a much smaller degree of improvement than the groups that were treated with standard procedures. Furthermore, any early improvement from the thread lift had vanished by the end of the two year study period.

The authors concluded that the short-term improvement of the threat lift was largely attributed to “post-procedural edema and inflammation” (swelling). After evaluating the thread lift extensively, they’ve decided to abandon it, stating “Given these findings, as well as the measurable risk of adverse events and patient discomfort, we cannot justify further use of this procedure for facial rejuvenation.”

Take home lesson: there is no substitute for a properly-performed facelift for facial rejuvenation. Don’t waste your time & money on thread lifts.

One of the hallmarks of unfortunate plastic surgery in many celebrity photos is the overdone lip augmentation. The lips in these photos generally appear overstuffed, like two tubes, or two sausages lying side by side.

The real reason that these results are bad is that the idea of creating a beautiful normal lip has gone out the window! Real lips have many subtle features in their shapes – and beautiful lips maintain these features. Unskilled practitioners just “pump in” fillers without regard for the details of the anatomy. Skilled practitioners shape and enhance the underlying forms.

For example, the upper lip and lower lip are not the same size. Usually, the lower lip is about twice the height of the upper lip. It’s important to maintain this 2:1 ratio when enhancing lips. If the lips are made to be the same size, this will make the upper lip appear excessively large, which is not desirable.

Secondly, lips have subsections or segments to them. The upper lip has three segments, the lower lip has two. It’s important to recognize these segments and maintain their individual shapes when performing lip enhancement with fillers. For example, since the lower lip should have two symmetric halves, with a slight depression in between – the plan for the filler treatment should be designed this way too.

The central portion of the upper lip and the adjoining skin is particularly unique, with features known as “cupid’s bow” and the “philtral columns”. A well done lip augmentation preserves and enhances these normal contours, rather than obliterating them through excessive filling. Plastic surgeons have a unique understanding of the anatomy of the lip, as the surgical repairs for children with congenital cleft lip problems also require the restoration of these same anatomic features with careful attention to subtle anatomic details.

In addition to enhancing the outline of the lips, adding volume to the lips is also helpful to restore a loss of lip fullness that happens with aging, or to enhance the look of lips that were naturally thin. Once again, respect for the segmental lip anatomy is key to getting a good result. So is restraint.

Excessively sized “pillow lips” will not look attractive, no matter how you do them. Sometimes patients get carried away with their desires for lip fullness… and the results may look peculiar. In these cases, a responsible physician will have to tell the patient, “No – that won’t look good.”

The bottom line:
1. Careful communication about the desired result with your practitioner is essential.
2. Start small / be conservative at first, using a more subtle approach.
3. Avoid long-lasting or permanent fillers, such as silicone, radiesse or artefill, in the lip. If there is an unsatisfactory result, you could be stuck with it. The options for correcting lumpy looking permanent fillers are very limited.
4. Look at lots of before and after photos when evaluating the previous results of your practitioner. Your injection specialist should have a light touch and an artistic eye. If you see some of the problems we’ve discussed here, go elesewhere!

Happy Father’s Day!

As we’ve discussed earlier, Botox injections are the most popular cosmetic procedure overall in the U.S. But Botox is expensive – and Allergan, the manufacturer, has been steadily raising their prices each year.

This has created a black market for Botox, with counterfeit and imitation Botox knock-offs. These imitations are not FDA-approved, and vary widely in their potency, quality, and source. But they certainly are cheap….

Many of these imitators originate in China. Brand names such as BTX-A, Botutox, Estetox-A, Refinex, Novotox, Canitox, QuickStar and Linurase are commonly seen knock-offs.

A recent review of these products showed their potency varied widely: from zero potency (no effect at all) to 5 x the indicated potency (way too much).

Counterfeit Dysport is also beginning to show up as well.

Allergan has put holographic stickers on the bottle, in an effort to deter counterfeiting.

If the Botox price quoted appears unusually low, watch out for:
– over-dilution (watered-down) with fewer units of Botox per syringe,
– use of grey-market / black market Botox imitators

If the price seems “too good to be true”, ask to see the official Botox hologram.

Can Botox be purchased from Canada? According to U.S. Federal regulations, physicians or corporations can not legally import large quantities of Botox (or any other medication) from anywhere, even if the Botox product was legitimately made by Allergan. Cross-border drug importation is a BIG DEAL to the FDA, who frowns on this practice. Despite this, there are some people that take the legal risk of Federal-level drug importation & trafficking prosecution, in order to save a few dollars of expense.

Caveat emptor.

Over the last few months, I have seen an alarming increase in the number of patients that come in for a second opinion about poorly-performed liposuction (done elsewhere, I might add.) All of these casse have been performed with new high-tech liposuction machines, either laser-assisted (like the SmartLipo) or ultrasonic (like the VASER).

I’ve seen major skin laxity, uneven liposuction, and obvious over-resection of fat leaving major divots and dents. Many of these problems are very difficult to fix, even with fat grafting techniques.

Here’s a few observations:

1. All of these cases were performed by physicians and surgeons operating way outside of their specialty. They were not done by plastic surgeons or dermatologists, who are trained during residency in this technique.

2. In the majority of these patients, physical examination of the patient revealed crummy skin tone and poorly elasticized skin. In other words, since this skin won’t contract like we want it to after liposuction, it’s completely predictable that the post-op results will be poor, with floppy, deflated areas, and a worsened appearance. A surgeon with any significant training or experience in liposuction would have recognized this – and would have avoided performing liposuction in these patients. It’s the wrong tool for the job!

3. All of these patients were preoperatively told by their physicians, “This new wonder lipo machine will tighten your skin”.

4. All of these patients now say, “Skin tightening clearly did not happen…now I look worse.”

5. None of these patients have an easy fix for their issues. All will require complex and expensive revisional surgery.

Lessons:

A fancy hammer does not a good carpenter make. Any doctor can buy (or rent) a fancy lipo machine.

There is, as yet, no reliable scientific evidence that laser-assisted liposuction:
a) tightens the skin, or
b) works better than standard liposuction.
Any claims to the contrary are “spin” or marketing hype; consider the source and what they’re selling.

That being said, the problems seen here were not caused by the type of liposuction machine – but by the doofus using it! While the concept of liposuction is easy, getting excellent results with liposuction takes significant skill.

Please be careful about whom you choose to perform your liposuction. Even if it’s performed in an office setting, with local anesthesia, liposuction surgery is still SURGERY. Training, experience and credentials matter.

RealSelf
Plastic Surgery In Florida