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

I have written on the topic of Plastic Surgery Certification before, but I though I’d include someone else’ view point as well. Of note, this is an American article and some details differ in Canada. In the United States ABMS (American Board of Medical Specialties) is the body that oversees various specialty boards. Boards that are not overseen by ABMS do not need to conform to quality standards and they often do not. In Canada a similar body is the Royal College of Physicians and Surgeons, in that only their certification can be trusted as reliable.

There has been some debate in the medical profession about the need for board certification to perform plastic surgery. Medscape’s Pippa Wysong spoke with James Wells, MD, about these issues. Dr. Wells is a past president of the American Society of Plastic Surgeons (ASPS) and currently sits on the board of the American Board of Plastic Surgery (ABPS). He is involved with many ASPS committees and with the Plastic Surgery Educational Foundation, the educational arm of the ASPS.

Medscape: The topic of being board certified before performing plastic surgery seems to be a sticky issue in some circles. Can you describe to Medscape readers what certification is and some of the background?

Dr. Wells: First, board certification is a voluntary activity. There’s no mandate that anybody become board certified. But it has become a gold standard when looking for credentials of physicians. For the public, it assures them that doctors have a certain amount of training in their specialty and have been tested by examination in their field of training. For doctors, it helps keep our skills up to date.

Medscape: Who provides the certification for plastic surgery?

Dr. Wells: I’m talking about the ABPS, and its certification program as overseen by the American Board of Medical Specialties (ABMS). The ABMS was originally developed through the Council on Medical Education of the American Medical Association and has 24 member boards.

Medscape: Aren’t there other agencies that offer certification?

Dr. Wells: It’s confusing because the term ‘board certified’ is used by many self-designated boards. There are organizations out there that offer certificates in various areas of medicine, and they create their own certifying agency that does not report to any central organization. When talking about board certification, people need to find out if it’s a legitimate board, and if it has a testing process that is recognized and acknowledged as a valid method for determining qualifications. There are over a hundred self-created boards that are not part of ABMS but provide some type of certification.

Medscape: What about the American Board of Cosmetic Surgery (ABCS)?

Dr. Wells: That is a self-designated board. It’s an organization whose members come from different training programs such as obstetrics and gynecology, dermatology, general surgery, and other areas of medicine, but who indicate an interest in cosmetic surgery. The ABCS created their own certification process, but are not members of ABMS.

Medscape: What’s the advantage of certification overseen by the ABMS?

Dr. Wells: The ABMS is recognized for its training and its educational process. It has a 75-year history and works with the Accreditation Council for Graduate Medical Education — which is the accreditation body for approval of residency training programs for the 24 recognized medical specialties. The Residency Review Committee reviews each training program and accredits each program. They can also disapprove a program for deficits in their training.

Medscape: Is it tough to get certification from the ABPS?

Dr. Wells: There are prerequisite training requirements to satisfy the ABPS testing process, such as completing a general surgery residency training program. Doctors need to have completed 3 years of general surgery or be certified by the American Board of Surgery to qualify for a 3-year plastic surgery training program. There are different venues, such as otolaryngology, to get into a plastic surgery training program. Once residents are finished with training they may sit for the written exam; if they pass that, they may sit for the oral exam. Certification is awarded upon successful completion of both the written and oral examinations.

Medscape: Can doctors also be certified to perform certain plastic surgery procedures through other specialties?

Dr. Wells: Yes. Some physicians do plastic surgery procedures coming out of other specialties that have a certain amount of overlap with plastic surgery training. For instance, ophthalmology has its own credentialing through the American Board of Ophthalmology.

Medscape: Are there issues related to the variety of people doing these procedures?

Dr. Wells: It comes down to, “Do I have the appropriate training, skills, and experience to do what the patient is seeking that I do?” Patients, on the other hand, need to spend time verifying that their doctor has that kind of training. The ABPS has a list of questions on their Website that patients should ask doctors when considering plastic surgery.

Medscape: What sorts of skills or knowledge does the ABPS-certified plastic surgeon have that others don’t?

Dr. Wells: ABPS training and testing covers the entire spectrum of plastic and reconstructive surgery of the entire body. A big part of the certification process is Maintenance of Certification, which means doctors stay up-to-date with changes in their particular specialty. Changes occur in medicine rapidly — new technologies, new approaches to treatment, new surgical techniques. It’s an evolutionary process, and tough to keep up with. If you maintain board certification, you’re more on top of things. If we’re really interested in the patients that we say we’re there to take care of, then it behooves us to be committed to lifelong learning.

Medscape: Are there data showing differences in outcomes between procedures performed by ABPS-certified people and ones who aren’t?

Dr. Wells: There is no reliable database that reports outcomes. The problem is each organization collects its own statistics. For instance, the ASPS and the American Society for Aesthetic Plastic Surgery both have databases showing the numbers of procedures done by their members. The ASPS statistics also overlap with procedures done in dermatology and otolaryngology. Plus, doctors can be members of more than 1 society, and may provide data to more than 1 group. Comparing statistics is difficult.

Medscape: Accredited facilities seem to go hand-in-hand with certification. What are the key issues there?

Dr. Wells: Facility accreditation is a voluntary process — except for ABPS members who are required to work in an accredited facility. In nonaccredited places, there are some safety issues. Are the people there appropriately trained? Are you using anesthesiologists who are appropriately trained and credentialed?

Accreditation of facilities may be done through the American Association for Accreditation of Ambulatory Surgery Facilities (AAAASF), which covers all ambulatory surgical facilities. Individual States also have accrediting bodies, for instance, there are four main accrediting organizations in California alone, including AAAASF and MediCare. The AAAASF has safety data that represents thousands of patients specifically from their facilities.

Medscape: Are there data showing problems with places that are not accredited?

Dr. Wells: I don’t know. The nonaccredited facilities are often not even listed, and there’s nobody following them per se. It’s an area for study.

Medscape: Nobody seems to really know what the risks are for patients going to nonaccredited facilities, nor of going to noncertified doctors practicing plastic surgery. Isn’t this of concern?

Dr. Wells: Yes, but a state agency has to be willing to try to accumulate that data. The logical party would be a medical board of a particular state. One would think that as a state organization, it would be in their interest to protect their citizens. Another possibility would be a national medical organization. The difficulty is how that information can be presented so it’s not perceived as defamatory against the individuals who may be cited. There are potential litigation issues.

Medscape: Do you have any key messages for doctors in general about these topics?

Dr. Wells: With physicians it’s often a push-back about another examination, more training, another testing modality. The process of certification and its maintenance is so patients know we are who we say we are. For doctors, it assures we have the training to take care of people and do things right. It’s about doing the right thing for patients for the right reasons. It lets us sharpen our skills, and gives us incentive to learn new processes. It behooves us to stay up-to-date and informed, and to make sure the public understands that we’re informed as well. The certification boards are, in reality, consumer protection organizations.

Martin Jugenburg,MD, FRCSC
Toronto, ON