The US Food and Drug Administration (FDA) has just recently issued warning letters regarding false or misleading statements about drugs claiming to eliminate fat in a procedure called “lipodissolve.” The procedure, also referred to as mesotherapy, lipozap, lipotherapy, or injection lipolysis has been advertised as a painless, non-surgical method to remove fat.

“The agency urges this company and all companies and individuals to stop making misleading or false claims about the drug’s benefits,” said Kathleen R. Anderson, PharmD, deputy director of the Division of New Drugs and Labeling Compliance, with the FDA’s Center for Drug Evaluation and Research.

According to Dr. Anderson during an FDA press briefing yesterday, claims have been made that the lipodissolve procedure can eliminate unwanted fat, has an outstanding safety record, and is superior to other fat-loss procedures. She added that claims have been made stating that lipodissolve products can treat medical conditions, such as male breast enlargement, benign fatty growths, and surgical deformities. “FDA is not aware of any credible scientific evidence to support any of these medical uses,” she emphasized.

ASPS (American Society of Plastic Surgeons) and ASAPS (the American Society of Aesthetic Plastic Surgery) have also stated concerns about the short- and long-term safety of the products used. The drugs used for injections most often included in the lipodissolve injection regimen are phosphatidylcholine and deoxycholate. Other ingredients, such as vitamins, minerals, and herbal extracts, may also be incorporated.

Complications that may result from this ‘outstandingly safe’ procedure can included include injection-site reactions, such as prolonged swelling, redness, and pain; skin reactions, such as panniculitis, ulceration, abscess, necrosis, and scarring; and skin infections. According to the FDA, these adverse events may be caused by the drug itself, the injection technique, and/or the formulation of the solution.

In addition to misleading safety claims, these procedures have yet to demonstrate real results in controlled scientific studies.

Less is less, and more is more. You can’t expect liposuction-like results from non-liposuction techniques. In fact, there are no real studies we are aware of that do show any real improvement in fat reduction following these studies.

A young, completely healthy woman had breast augmentation performed. The surgery was completely uneventful. Her recovery from anesthesia seemed perfect. She woke up and was immediatelly fully alert and comfortable. She had no pain, she was not feeling sick, she was not throwing up.

After being discharged from a Toronto hospital, she was picked up by another person. On the way home they stopped by a pharmacy to fill her prescription. Her companion should have picked up the prescription while she waited in the car. However, the opposite happened. He stayed in the car while he sent her in. Can you guess what happened?
The patient fainted, fell, and cracked her head. Really. This is not a made up urban myth. This really happened and it is a perfect example why it is so important to follow you doctor’s instructions.

Luckily this patient is alive and recovering from her fall. But this story stresses an important point. After surgery, a patient should not be left alone for the first 24 hours! Because of all the drugs, pain and possibly dehydration, patients are prone to fainting and falling.

Why do I bring this up? Because patients and families often need to be reminded of this fact. So often people want to leave alone in a taxi, some even want to go back to the office. It’s a BAD idea. Take it easy and arrange for someone to spend time with you.

Martin Jugenburg,MD, FRCSC
Toronto, ON

Reliable sources of Certification in Canada

• The Royal College of Physicians and Surgeons of Canada (requires the surgeon to pass a rigorous training program and a final exam)
• The Canadian Society of Plastic Surgeons (requires the applicant to have trained in an accredited Plastic Surgery Training Program)
• The Canadian Society of Aesthetic Plastic Surgeons (requires the applicant to fulfill all the requirement for the above qualifications, in addition to documented history of four years in practice in good standing)

Unreliable sources of Certification (Membership here does NOT represent any qualification or training. Click on the links below to see their membership criteria for yourself)

• American Academy of Cosmetic Surgery (No surgical examination/ qualification required. Membership fee of $350 annually buys a ‘certification’)
• American Society of Cosmetic Breast Surgery (No surgical examination / qualification required. Membership fee of $300 annually buys a ‘certification’)
• Canadian Academy of Cosmetic Surgery (No surgical examination/ qualification required. Membership fee of $300 annually buys a ‘certification’)
• American Society for Laser Medicine and Surgery, Inc. (No surgical examination / qualification required. Membership fee of $200 annually buys a ‘certification’)
• American Academy of Liposuction Surgery (this Academy has no known website and we were not able to verify their existence and their requirements for certification)
• many other American and International “Academies” and “Societies” that are created to sell fancy looking titles and diplomas to members who simply pay membership fees.

As you can see from the above unreliable certification sites, all you need to join is to go to their “Join” section, fill out the application form and send them a cheque. There. Now you a Certified “Surgeon”. Done. Congratulation! Now all you need is to build your own clinic and you’re all set.

Martin Jugenburg,MD, FRCSC
Toronto, ON

Martin Jugenburg,MD, FRCSC
Toronto, ON

New Brunswick, Scotland, France, Germany and at least five Australian states have banned anyone under 18 from accessing artificial tanning equipment. In the U.S., 29 states have restrictions on youths using tanning beds, with many requiring parental consent.

Sun tanning causing skin cancer and skin aging that is abnormal. Do you want proof? Ask any older person to show you they skin on the abdomen (area that was probably protected from the sun) and compare it to their facial skin (which was probably unprotected). See the difference? I rest my case.

Martin Jugenburg,MD, FRCSC
Toronto, ON

Martin Jugenburg,MD, FRCSC
Toronto, ON

“The vitamin D position statement supports the Academy’s long-held conviction on safe ways to get this important vitamin — through a healthy diet which incorporates foods naturally rich in vitamin D, vitamin D-fortified foods and beverages, and vitamin D supplements,” dermatologist and AAD president David M. Pariser, MD, FAAD, said in a news release.

The AAD recommends supplementation with 200 IU vitamin D from birth to age 50 years for those who are not at increased risk for vitamin D insufficiency. However, the American Academy of Pediatrics recommends supplementation with 400 IU vitamin D per day for children younger than 18 years of age, including infants.

Because vitamin D can be toxic in high doses, the US Food and Nutrition Board has set an upper limit for safety for vitamin D intake of 2000 IU per day for individuals older than 12 months of age and 1000 IU per day for infants.

For vitamin D supplementation, vitamin D3 (cholecalciferol), which is the form of vitamin D naturally produced in the skin, is preferred to vitamin D2 (ergocalciferol).

For those out there still considering tanning salons, I will remind you that skin cancer is the most common form of cancer out there, even though breast, lung, and prostate get most of the attention. Skin cancer range in severity, with Malignant Melanoma being a very aggressive and vicious type of cancer that is very difficult to control. Most importantly, you need to remember that skin cancer is very preventable.

Finally, below is the ABC’s of melanoma:
Asymmetry
Border Irregularity
Color Variation
Diameter >6mm

Martin Jugenburg,MD, FRCSC
Toronto, ON

Martin Jugenburg,MD, FRCSC
Toronto, ON