…but Dr. Peter J. Normann, MD, was never a Plastic Surgeon. He was never a Surgeon and is now, thankfully, no longer a Doctor. Today, Peter J. Normann is a convict, a prisoner of the State of Arizona, convicted of multiple murderers.

My deepest sympathies to the families and friends of these three patients, and to others who have come forward since these tragedies. I have written several posts on the San Francisco Plastic Surgery Blog about how to select a Plastic Surgeon. I’m certain the jaded view these as self serving; however, I view these as part of my duty as a physician to do no harm. While this is but one case, there are too many others, and saying nothing, and ignoring the problem, would be harmful.

No one is perfect. Everyone makes mistakes, even well trained, experienced Board Certified Plastic Surgeons. The reason I spent eight years in training after graduating from the University of California, Davis, School of Medicine, was to reduce the chances of mistakes, to gain as much knowledge and experience as possible, and to prevent poor decision making. To not only learn how to operate, but how to provide patients with the best environment in which to operate and maybe most importantly, to know when not to operate. In this light, I present the following information, and three simple links that can help you have the safest possible plastic surgery. In fact, two of these links can help you, no matter what type of elective surgery you are considering.

How to Check Your Doctors Credentials – As Easy As 1, 2, 3

There are three places every patient should check before having any plastic surgery.

• American Board of Plastic Surgery
• American Board of Medical Specialties (ABMS)
• Your State’s Medical Board. In California check the California Medical Board.

Let’s use these simple online resources to check out Dr. Normann…

Dr. Normann – Didn’t Check Out

#1 – The American Board of Plastic Surgery

A quick check on the American Board of Plastic Surgery website reveals “No records found…” for Dr. Normann. This means he is not a Board Certified Plastic Surgeon.

#2 – The American Board of Medical Specialties (ABMS)

The ABMS website is the best way for you to determine what board has certified your doctor. Checking the American Board of Medical Specialties (ABMS) website currently reveals no certification by any board. According to healthgrades.com, he was Board Certified in Internal Medicine at some point in time, but this cannot be confirmed on the ABMS site. The reasons may be 1) He was never Board Certified in Internal Medicine; 2) He was Board Certified in Internal Medicine, but he did not pass recertification; or 3) His Board Certification was removed after his Arizona Medical License was revoked. The best case scenario here is that Dr. Normann was Certified by the American Board of Internal Medicine, but this not a Surgical Board.

#3 – The State Medical Board

A check of the Arizona Medical Board website reveals: one listing for Normann, Peter J. with a listed specialty of Emergency Medicine.

His detailed profile reveals that Peter J. Normann graduated Medical School on June 27, 1994, from St George’s University in St. Georges. The Caribbean Campus located in St. Georges, Grenada, West Indies, is perhaps best know from the October, 1983, invasion of Grenada. Part of President Reagan’s justification for the invasion was to rescue American medical students at St. George’s University endangered by the violent coup that had overthrown Grenada’s Prime Minister, Maurice Bishop.

The profile also states that Normann completed a three-year residency (06/24/1994 – 06/30/1997) in Internal Medicine at Roger Williams Medical Center in Providence, RI. At this time, it cannot be confirmed on the American Board of Medical Specialties (ABMS) website, and the ABMS website is the best way for you to determine what board has certified your doctor.

The Arizona Medical Board site also lists Normann’s License Status as Revoked. A revoked license means no license, and the practice of Medicine without a license is a crime. Call me Dr. Obvious, but this is worth knowing even if you are not having plastic surgery. For example, in November, 2004, Dr. Bach A McComb, DO, injected himself, his girlfriend and another couple with fake Botox leading to emergency room admissions for the resulting overdose and prolonged hospitalization for systemic paralysis. A simple check of Dr. McComb’s license prior to the incident, would have shown that his license was suspended for overprescribing painkillers. People convicted of bad judgement are likely to have recurrences. Dr. McComb couldn’t buy Botox without a license. His solution, additional bad judgement and the use of unregulated black market Botox.

Back to Normann. On the Arizona Medical Board’s Website, his areas of interest are listed as Emergency Medicine, Internal Medicine and Dermatology. His training however, was only in Internal Medicine, and at some point in time, he was ABMS Board Certified in Internal Medicine. While there is some overlap with Internal Medicine, Emergency Medicine and Dermatology are specialized branches of Internal Medicine with their own residencies, additional years of training and separate ABMS Board Certifications. Surgery is not a branch of Internal Medicine. After medical school, surgical training and medical training diverge. There is little overlap between Internal Medicine and Surgery, and even less overlap between Internal Medicine and the specialized procedures performed by Plastic Surgeons.

Too Many Red Flags

Normann’s credentials do not add up to excellent plastic surgery training. A quick Internet search reveals he was not a Board Certified Plastic Surgeon. He was an Internal Medicine doctor with no formal surgical training. He certainly did not complete a Plastic Surgery residency. During the course of the murder investigation, it was revealed that he had seven sessions of training in liposuction.

Your Federal and State Governments Cannot Protect You

Every state maintains a Medical Board. Their job is to check the training of all physicians and surgeons practicing in the state, and if qualified, the boards allows the qualified doctors to purchase a license to practice medicine. Each state has its own board, but the requirements are not widely varied. The federal government regulates prescription drug use, and licensed physicians can purchase a DEA certificate which allows them to prescribe drugs. Neither the state nor the federal government restrict the practice of medicine based on the type of training a doctor has completed. In fact, the MD degree is granted after completing Medical School, and a state license is granted in California after completing one year of internship and passing the required exams. With a state license, a DEA certificate can be obtained, before any specialized training is started.

Since a license is granted before specialized training is started, there are no restrictions on the type of medicine a license holder can perform. A doctor trained in Internal Medicine (diabetes, high blood pressure, lung disease…) can perform brain surgery, as long as they conform to the standard of care. This pushes the responsibility onto hospitals. Hospital medical staffs review qualifications within each specialty and grant privileges for specific procedures after a period of supervised proctoring. This peer review can help for hospital based disciplines like brain surgery, but most cosmetic surgery is outpatient surgery and is not performed in a hospital. The American Society of Plastic Surgery and the American Society for Aesthetic Plastic Surgery both require that all members have hospital privileges for all procedures they perform, even if they are normally performed outside the hospital.

Time for Restricted Medical Licenses

There has been much debate through the years for States to do more to protect their citizens from unqualified doctors practicing outside the scope of their training. Special interest money has made this is most impossible, and there is little interest in drafting this difficult legislation. While reviewing silicone breast implant leakage rates, the FDA noted that leaks occurred more often in the hands on non-Board Certified Plastic Surgeons, often in the operating room. Debate was had to restrict the use of breast implants to only physicians who are Board Certified Plastic Surgeons. It was decided that the FDA lacked the authority to enforce such a recommendation and, the subject was dropped. Until there is a public outcry for reform, it is unlikely that we are going to get this sort of assistance from our States.

Buyer Beware

So it is up to you to find the best doctor for the job. It is your body, your health and your life. Plastic surgery is elective surgery, and you have time to decide how to proceed and who to trust. Resources are available online to help you make the best possible decision. While the recommendations above cannot guarantee perfect results, they can certainly improve the odds.

Be certain to check the three resources above. If your surgeon is a member of the The American Society of Plastic Surgery and the American Society for Aesthetic Plastic Surgery, you can be assured that they are Board Certified Plastic Surgeons, with valid state licenses, who practice in Accredited facilities, and who maintain hospital privileges.

Bargain Basement Plastic Surgery

Bargain hunting is great, but not for Plastic Surgery. A low price might mean corners are being cut, and you may pay the ultimate price for it. I want the best possible outcomes for my patients, and this is reflected in everything I do. I completed eight years of residency after medical school, and maintain both the Board Certifications I have earned, one with the American Board of Plastic Surgery and the other with the American Board of Surgery. I operate only in accredited hospitals and surgery centers. I work with Board Certified anesthesiologists. I only use FDA approved products from reputable sources. I maintain membership in the most prestigious Plastic Surgery Societies. All of this costs more than cutting the corners, but it shows my patients that I take my responsibilities seriously, and that I am committed to achieving the best possible outcomes. A cut rate purse might look good, but low quality doesn’t last. You can always purchase another purse, but you cannot replace your face, your breasts, your tummy or any other part of your body. Why risk something irreplaceable? You are worth taking care of. While there can be no guarantee that you won’t meet a Dr. Normann, by taking a few precautions, you can increase your chances of walking away before the encounter ends badly. More details, and video coverage of the case, can be found here: ABC15 Phoenix, AZ.

Dr. Mele is Board Certified by the American Board of Plastic Surgery

How to Choose a Plastic Surgeon

The need for appropriate Board Certification has become increasingly important to educated consumers. Because of the confusion caused by Boards that sound the same, the state of California requires any physician advertising that they are Board Certified to explicitly state the Board they are certified by. While the term “Board Certified” applies to all physicians and surgeons, nowhere is the concept of Board Certification more confusing than in the field of Plastic Surgery.

The American Board of Medical Subspecialties (ABMS)

Any group can create an independent Board and define their own criteria for “Board Certification” without any outside intervention. To provide continuity within medical boards in the United States, the American Board of Medical Subspecialties (ABMS) was created. For over 75 years the ABMS has provided oversight for the certification of physician specialists in the United States. It is the recognized Certifying Body for Board Certification in the United States.

The ABMS provides valuable resources for consumers and physicians, including free online search that lets you check if you doctor is certified by a recognized board. To check your doctor click here -> Is Your Doctor Certified?

ABMS Recognized Boards

Board Certification means that your doctor has taken the appropriate training and passed both the qualifying and certifying exams. In the past, this was a one time deal. Once Board Certified, always Board Certified, but as the speed of advancement in medicine has changed, so has Board Certification. To maintain Board Certification, a doctor must also complete ongoing evidence of training yearly, including periodic recertification exams. This is termed Maintenance of Certification or ABMS MOC.

I am proud to maintain Board Certification by two ABMS Boards: The American Board of Plastic Surgery and the American Board of Surgery.

Here is a listing of all ABMS recognized boards:

• The American Board of Allergy and Immunology
• The American Board of Anesthesiology
• The American Board of Colon and Rectal Surgery
• The American Board of Dermatology
• The American Board of Emergency Medicine
• The American Board of Family Medicine
• The American Board of Internal Medicine
• The American Board of Medical Genetics
• The American Board of Neurological Surgery
• The American Board of Nuclear Medicine
• The American Board of Obstetrics and Gynecology
• The American Board of Ophthalmology
• The American Board of Orthopaedic Surgery
• The American Board of Otolarynology
• The American Board of Pathology
• The American Board of Pediatrics
• The American Board of Physical Medicine and Rehabilitation
• The American Board of Plastic Surgery
• The American Board of Preventive Medicine
• The American Board of Psychiatry and Neurology
• The American Board of Radiology
• The American Board of Surgery
• The American Board of Thoracic Surgery
• The American Board of Urology

The American Board of Plastic Surgery (ABPS)

The American Board of Plastic Surgery (ABPS) also maintains a free online search. If you are considering Plastic Surgery, check if your doctor is a Board Certified Plastic Surgeon. To check if your doctor is a Board Certified Plastic Surgeon, click here -> Certified by the American Board of Plastic Surgery.

Plastic Surgery Professional Societies

The American Society for Aesthetic Plastic Surgery and the American Society of Plastic Surgeons require current ABMS Board Certification for membership. They also require that all members operate in only Certified Centers and adhere to a strict Code of Ethics. This is why ASPS and ASAPS members can’t give away Breast Augmentations as a raffle prize. Offering a procedure without a good faith medical history and physical examination is unethical. If the winner turns out to be a poor candidate for Breast Augmentation, this would be a problem.

These professional society memberships help ensure that your Board Certified Plastic Surgeon is held to the highest standards. I maintain active membership in multiple Plastic Surgery Societies including the American Society of Plastic Surgery (ASPS), one of the largest and most respected plastic surgery professional organizations in the world, and the American Society for Aesthetic Plastic Surgery, a subgroup of ASPS members dedicated to enhancing the cosmetic aspects of plastic surgery.

For more about my training click “Meet Doctor Mele” here or at the top of any San Francisco Plastic Surgery Blog page. Click here for more about my -> American Board of Plastic Surgery Maintenance of Certification.

The American College of Obstetricians and Gynecologists is Looking Out For You

Doctors are once again at odds with the government, but this time it has less to do with Obamacare, and everything to do with saving lives, possibly yours.

Mammograms Save Lives

We all know that Mammograms save lives. National Cancer Institute data show the US breast cancer death rate, previously unchanged for 50 years, has dropped 37 percent since mammograms became widespread in 1990. The US Preventive Services Task Force (USPST); however, doesn’t seem to get it.

Early Detection is Key

While a mammogram doesn’t treat breast cancer, it is the key to the early detection of breast cancer. Another key is routine monthly self-examinations. The combination is an effective way to detect breast cancer in its early stage. The earlier breast cancer is detected, the better the chance that treatment will lead to a cure.

Cure rates are greater than 90% for breast cancers detected early. Earlier detection means smaller tumors. Smaller breast cancers spread less often and are removed more easily. On the other hand, if breast cancer is discovery after it has left the breast, treatments rapidly become more complex and are dramatically less effective.

Doctors Fight Back For Their Patients

The American College of Obstetricians and Gynecologists (ACOG) recently issued new guidelines, joining a long list of physician lead professional societies strengthening the stand that early mammography saves lives. The new ACOG recommendations call for mammograms more frequently than the previous ACOG guidelines. The previous guidelines recommended mammography every one to two years beginning at age 40, and then annual mammograms after age 50. The new guidelines recommend:

• Mammography yearly beginning at age 40
• Monthly self-exams for women at high risk for breast cancer

The ACOG recommendations are in alignment with the American College of Radiology and Society of Breast Imaging recommendations, and both conflict with the government’s USPST recommendations of delaying mammography until age 50.

US Preventive Services Task Force (USPST) Recommendations Deemed Unacceptable

When the USPST recommended against routine mammography for women younger than 50-years-old, it was in direct opposition to the current standard of care. The Major Medical Organizations in the US where at first shocked and then adamantly vocal in their opposition. The recommendation would mean less money spent on mammograms upfront; however, the “savings” would be lost later in trying to treat larger tumors that are more likely to have spread. The ultimate cost; however, would be measured in lives not saved.

Thank you ACOG

Thank you to the American College of Obstetricians and Gynecologists for joining the long list of professional medical organizations, including the American Society or Plastic Surgeons, who disagree with the government’s suggestion to wait until age 50.

USPST WT?

When the American College of Radiology and Society of Breast Imaging made it’s recommendation that mammography should start at age 40, they used the USPST’s own data against them. After careful review, the USPST’s data did not support the recommendation of delaying mammography until age 50. I applaud the efforts made by organized medicine to bring this information to light. How this remains outside the main stream media is puzzling. With major health care “reforms” underway, this is an excellent topic for an investigative report, and early mammography will certainly save more lives than knowing where Casey Anthony is hiding.

You Are Worth It

Mammography, while not pleasant, is an effective screening tool. With 80% of breast cancer occurring in women without a family history, it is important for every woman to have access to the exam. If the government recommends delaying mammography a decade, the next step will be to stop paying for it. If government programs stop paying for the service, all insurance companies will follow.

Mammography allows us to detect and control the spread of breast cancer. If we allow a guideline delaying mammography to become law, it will be much more difficult for your doctor to order this simple, lifesaving test. If the USPST gets its way, unless you are willing (and able) to pay for your own yearly mammograms, you won’t be getting them. Your government may not think it is worth the documented reduction in breast cancer deaths, but your doctors do.

Please support your doctors in their efforts. We strive to practice effective medicine and protect our patients. The Hippocratic Oath mandates that we doctors do no harm. The USPST mandate delaying mammography until after age 50 would do harm, and allowing the recommendation to go forward unchallenged, would be just as harmful.

Silicone gel filled breast implants were introduced to the US in 1962, and after 50 years of use, they remain among the most scrutinized medical devices currently available in the US. In June, 2011, the FDA released their Update on the Safety of Silicone Gel-Filled Breast Implants.

A Brief History of Breast Implants

• 1962 – Silicone gel-filled breast implants were introduced in the US. Prior to 1962, breast augmentation was performed with fat grafting or polyvinyl sponges.
• 1976 – US Congress passes the 1976 Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act. Breast implants are classified as moderate risk (Class II) devices and required to comply with general controls and performance standards. The FDA reviews new breast implants through the 510(k) premarket notification process.
• 1980′s – Concerns are raised about associations between breast implants, particularly the silicone gel filled breast implants, and serious health issues such as breast cancer and systemic connective tissue disorders such as lupus, scleroderma and rheumatoid arthritis. The FDA reclassifies breast implants into Class III, higher-risk products needing premarket approval (PMA), and called for manufacturers to provide data demonstrating the devices were safe and effective.
• 1992 – The FDA decides that the manufacturers had not adequately addressed public concerns about certain complications. Rather than selecting the devices with a poor record, the FDA removes all silicone gel filled breast implants from the market, but only for elective cosmetic breast augmentation. The FDA continues to allow manufacturers to provide silicone gel filled implants for reconstruction after mastectomy, correction of congenital deformities, replacement of existing implants and for breast augmentation performed in conjunction with a breast lift. The Breast Implant Adjunct Studies were created, so that data could be collected about device performance and safety in these groups of women. In order to make breast implants again available for elective cosmetic breast augmentation, the FDA requires manufacturers to submit premarket approval applications that contained data on safety and effectiveness – like a new product. Europe follows the lead, but removes restrictions after 6 months, after reviewing the available literature and finding no links to serious systemic health issues.
• 1993 – The next generation of breast implants (Allergan Style 410 and Mentor Contour Profile Gel), textured, anatomic, highly cohesive (nearly form stable), silicone gel filled breast implants are complete, tested, and ready for submission for FDA studies in the United States and Europe … and Europe takes the lead.
• 1999 – The Institute of Medicine (IOM) releases a comprehensive report of the published literature and ongoing studies on breast implants, entitled Safety of Silicone Breast Implants. The study concludes that there is no evidence that silicone breast implants cause systemic health effects, such as cancer or autoimmune disease. Local complications (infection, bleeding, pain, deflation, capsular contracture, additional surgery) remain the primary safety issue with silicone breast implants.
• 2006 – The FDA approves Allergan’s Natrelle Silicone Gel Filled Breast Implants and Mentor’s MemoryGel Silicone Gel Filled Breast Implants. The FDA based its approvals on the manufacturers’ Core Studies. These clinical PMA studies followed hundreds of women with silicone gel filled breast implants for 4 years (Allergan) or 3 years (Mentor). The FDA determines that silicone filled breast implants are safe and effective and that the benefits and risks of breast implants were sufficiently well understood for women to make informed decisions about their use. As conditions of approval, the FDA requires both manufacturers to conduct six post-approval studies to investigate the long-term performance and safety of their silicone gel filled breast implants. From the FDA’s site these studies are:
  1. Core Post-Approval Studies (Core Studies) – To assess long-term clinical performance of breast implants in women that enrolled in studies to support premarket approval applications. These studies were designed to follow women for 10 years after initial implantation.
  2. Large Post-Approval Studies (Large Studies) – To assess long-term outcomes and identify rare adverse events by enrolling more than 40,000 silicone gel-filled breast implant patients and following them for 10-years.
  3. Device Failure Studies (Failure Studies) – To further characterize the modes and causes of failure of explanted devices over a 10-year period.
  4. Focus Group Studies – To improve the format and content of the patient labeling.
  5. Annual Physician Informed Decision Survey (Informed Decision Study) – To monitor the process of how patient labeling is distributed to women considering silicone gel-filled breast implants.
  6. Adjunct Studies – To provide performance and safety information about silicone gel-filled breast implants provided to U.S. women from 1992-2006, prior to approval, when implants could only be used for reconstruction and replacement of existing implants.
• 2011 – The FDA releases the Update on the Safety of Silicone Gel-Filled Breast Implants. The conclusion: breast implants, while not perfect, remain safe and effective. The most common problems associated with breast implants remain: capsular contracture, reoperation and implant removal (with or without replacement). Other frequent complications include: implant rupture, wrinkling, asymmetry, scarring, pain, and infection, among others. These observations are consistent with the local complications and adverse outcomes that were known at the time of approval, and there remains no apparent association between silicone gel filled breast implants and connective tissue disease, breast cancer, or reproductive problems.

What’s Next in US Breast Implants

A “new” breast implant has been available in Europe since 1993, and despite many years of experience, it continues to await US approval by the FDA. These from stable breast implants also are not perfect; however, they have a lower local complication rate than any breast implant currently available on the US market. San Francisco Bay Area Breast Augmentation patients and Plastic Surgeons alike, want to know, when will “gummi-bear” breast implants finally be approved? The date of approval remains anybody’s guess.

France Keeps Liposuction - Bans the Rest.

France Bans Mesotherapy as a “Serious Health Risk”

France, the birthplace of Mesotherapy, has banned the practice. Fifty years after inventing Mesotherapy, France has now made it illegal. The French government has made Mesotherapy, Carboxytherapy and Laser Fat Reduction treatments illegal because they pose a “serious danger to human health.” In fact, all non-invasive of fat treatments (ultrasound, lasers, infrareds, radiofrequency) have been banned.

Originally published on April 12, 2011, and effective June 13, 2011, the Ministry of Work, Employment and Health, Decree N° 2011-382, prohibits mesotherapy and most other forms of aesthetic lipolysis (fat destruction). This ban includes many of the methods of fat removal currently marketed in the United States as safe, cheap alternatives to liposuction.

Liposuction – Still Safe and Effective

It is important to note that the ban does not include Liposuction. Liposuction remains the most predictable and most effective means of liposculpture. Unlike weight loss, Liposuction can selectively remove specific deposits of fat, and works best if you are maintaining a weight near your ideal.

Mesotherapy – A Serious Danger to Your Health

The notice from the French High Authority of Health prohibits specific techniques of aesthetic lipolysis (destruction of body fat cells) presenting a serious danger. It also bans techniques using appliances for external application (ultrasound, lasers, infrareds, radiofrequency) presenting a suspicion of a serious danger for human health. The full decree translated to English is printed below, with a link to the original French.

Decree N° 2011-382 Reads as Follows

• The Prime Minister, after report of the Minister of Work, Employment and Health, after the code of Public Health, especially of articles N° L.1151-3 and L.1152-2, after the advise of the High Authority of Health of December 17th 2010.
• Decrees:

  • Article 1 – The following techniques of aesthetic lipolysis are prohibited because of their serious danger for human health:
    • lipolysis using injections of hypo-osmolar solutions
    • lipolysis using injections of lipolytic solutions (phosphatidylcholine or sodiumdesoxycholate)
    • lipolysis using injections of mesotherapeutic mixture
    • lipolysis using Carboxy therapy(Carbon Dioxie or CO2)
    • lipolysis using transcutaneus Laser, without suction
  • Article 2 – Techniques of aesthetic lipolysis using appliances for external application are prohibited because of their suspicion of a serious danger for human health.
  • Article 3- The Minister of Work, Employment and Health is in charge of the execution of this decree, which will be published in the Journal Officiel de la Republique Francaise (<- click to read in the original in French).

American Plastic Surgery Societies Agree

The decree is in agreement with the advice given to its members by the American Society for Aesthetic Plastic Surgery (ASAPS) and the American Society of Plastic Surgeons (ASPS) task forces on mesotherapy. Both plastic surgery societies do not recommend their members use such methods as they remain unproven. The statement can be viewed on the ASPS website under Technology Briefs – Lipodissolve and Mesotherapy (Injection Lipolysis). Some of the devices included in the ban have previously been CE approved, so that will need to be sorted out by the courts.

How to Get Rid of Excess Fat

If you are near your ideal weight, and have stubborn disproportionate areas of fat that will not go away, liposuction can safely and effectively reshape your body. If you are significantly overweight, the safest method of weight loss remains a proper diet and regular exercise. Weight is likely to return after liposuction if not combined changes to your lifestyle to maintain the lower weight. If significantly overweight, liposuction is about as effective as a crash diet — once off the diet, the weight returns. If you are mobidly obese, bariatric surgery may be a viable option.

Liposuction Video

Stay tuned, this week I appeared on KRON4′s Body Beautiful with Vicki Liviakis and discussed liposuction. San Francisco Bay Area plastic surgery patients were able to call in and have their questions answered. In the coming weeks, I will post the liposuction videos here, on the San Francisco Plastic Surgery Blog. If you are interested and would like to take a trip to Walnut Creek, Liposuction consultations are available in my Walnut Creek Plastic Surgery office. Call (925) 943-6353 or use the contact form to the left if you have questions or would like to schedule your private cosmetic surgery consultation.

Stem Cells Facelifts, Stem Cell Breast Augmentation, Stem Cells in Plastic Surgery - Marketing Hype or Next Big Thing?

Stem Cells seem to be everywhere today: Stem Cell Breast Augmentation, Stem Cell Facelifts, Stem Cell Facial Creams, but what is it really worth? Does the marketing hype live up to the objective evidence? Are Stem Cells the panacea? First a little background.

ASPS and ASAPS Joint Stem Cell Task Force 2010

Last year, the American Society of Plastic Surgery (ASPS) and the American Society for Aesthetic Plastic Surgery (ASAPS) formed a Stem Cell Task Force to look into the safety and effectiveness of these Stem Cell Therapies.

What is a Stem Cell Anyway?

The idea of a Stem Cell is exciting: a cell that has the potential to change into any cell type you would want, placed where you want it. Sounds too good to be true, but science is marching towards exactly that. Currently, these types of results are reproducible under laboratory conditions, but are currently not as predictable in the patient.

Stem Cells Grafts and Stem Cell Injections

The original “Stem Cell” grafts were done for years, without doctors realizing that’s what they where doing. San Francisco Plastic Surgeons have been removing fat and transplanting it into patients’ wrinkles to reduce folds long before there was Restylane®, Juvederm®, Perlane®, Radiesse® or any other currently available prepackaged wrinkle filler. Fat grafting predates even the Bay Area’s own contribution to fewer wrinkles and larger lips, Collagen, and it turns out that fat grafts also contain stem cells.

Fat has More Stem Cells than Bone Marrow

I remember attending a presentation at the California Society of Plastic Surgery in Napa in 1995, during which the discovery of numerous and varying stem cells in liposuction aspirate was being discussed. It was at that time, we plastic surgeons began to realize that fat transplants contain more than just fat cells. Whether the fat is surgically removed and replaced as fat grafts, or is removed with liposuction and injected, stem cells are present.

Stem Cell Breast Augmentation

The first documented breast augmentation was done with fat in 1895. Surgeon Vincenz Czerny used a benign lumbar lipoma (fatty growth), to repair the breast asymmetry caused by removing a tumor. Larger volumes of fat could be used for primary breast augmentation; however, then as today, larger transplantations can be problematic:

• The volume of fat that lives can be variable leading to unpredictable amounts of augmentation.
• The area grafted can become lumpy and irregular.
• Nodules can develop.
• Calcifications can develop making it difficult to properly screen for cancer on a mammogram.
• As the patients ages and gains weight, so too do the grafts.

Stem Cell Facelifts

Part of the reason the face ages is that the fat on the face atrophies (goes away). Healthy babies have big fat round faces, and youthful faces maintain this padding. As we age, we lose the fat that adds volume to, and supports the skin. The result is a longer, narrower face, and skin that sags. Replacing this lost volume is one of the holy grails of plastic surgery. Facial implants, fillers, fat injections all have there place, and each can be helpful. Most stem cell facelifts are simply fat grafting to the face. While expensive machines are available to concentrate the stem cells in the graft, most practitioners do not use them, and there is simply no evidence that concentrating stem cells helps. This is one of the questions that the Stem Cell Task Form considered, and the answer still remains unclear.

ASPS and ASAPS Joint Stem Cell Task Force 2011

I was in Boston this week for the annual ASAPS meeting, and on Monday, the ASPS and ASAPS joint position paper on Stem Cells and Fat Grafting was released. While the data looks promising, there is nothing currently in the literature to support the marketing claims you are currently hearing, and there is concern that these unsubstantiated claims will harm patients and tarnish the reputation of Plastic Surgery. The following is from the above referenced paper:

• Terms such as “stem cell therapy” or “stem cell procedure” should be reserved to describe those treatments or techniques where the collection, concentration, manipulation, and therapeutic action of the stem cells is the primary goal, rather than a passive result, of the treatment. For example, standard fat grafting procedures that do transfer some stem cells naturally present within the tissue should be described as fat grafting procedures, not stem cell procedures.
• The marketing and promotion of stem cell procedures in aesthetic surgery is not adequately supported by clinical evidence at this time.
• While stem cell therapies have the potential to be beneficial for a variety of medical applications, a substantial body of clinical data to assess plastic surgery applications still needs to be collected. Until further evidence is available, stem cell therapies in aesthetic and reconstructive surgery should be conducted within clinical studies under Institutional Review Board approval, including compliance with all guidelines for human medical studies.
• The collection and reporting of data on outcomes and safety by any physician performing stem cell therapies is strongly encouraged in order to advance the knowledge and science of stem cells.
• Stem cell based procedures should be performed in compliance with FDA regulatory guidelines. If devices are employed that are subject to regulation by the FDA, surgeons should use these devices with appropriate approval in place, especially when used for investigational purposes.
• Patients are advised to seek consultation for aesthetic procedures by a surgeon certified by the American Board of Plastic Surgery. These physicians are able to properly evaluate a patient’s concerns and offer a wide range of safe solutions. Extreme caution should be exercised when a physician is promising results from any treatment that sound too good to be true.

Buyer Beware

I continue to follow the debate, and as much as I want stem cells to be the next greatest thing, I also don’t want my hopes to cloud my judgement. Even among the tight knit aesthetic plastic surgery community, there is vigorous disagreement about the methods, safety and efficacy of fat grafting and the use of stem cells. At least a frame work for discussion has been defined, and the research is under way.

For now, buyer beware is still the best advice I can give. We all know that when something sounds too good to be true, it is probably not true, but we want to believe. Just because something claims to be new, it does not mean it is new, and being new has nothing to do with being better. We all want the greatest improvement with the least down time and no scars; however, there is something to be said for the tried and true. The older the procedure is, the longer it has survived, the more it has stood the test of time as a safe and reliable option.

What follows is a video segment from my recent television appearance on the Bay Area’s Local News Station, KRON4. I was originally scheduled to talk about Tummy Tucks (Abdominoplasty), but we kicked off the show with this important late breaking news update for women with breast implants. The (415) phone number in the video was for the live broadcast only. If you have questions about abdominoplasty, feel free to call my office directly at (925) 943-6353, or use the contact format the bottom of the column to the left.

This ALCL (Anaplastic Large Cell Lymphoma) update video includes:

• Information from the January 2011 FDA White Paper
• Why is it called a lymphoma?
• Why ALCL is not breast cancer?
• What are the symptoms of ALCL?
• How is the diagnosis of ALCL made?
• How rare is ALCL (34 cases in 10 million breast augmentation patients)
• How is ALCL treated?
• Do my implants need to be removed?

The important points to keep in mind:

• ALCL is very rare.
• ALCL presents with symptoms.
  • increasing size
  • swelling
  • discomfort
  • fluid around the implant.
• ALCL is not breast cancer.
• ALCL treatment is available.

If you have concerns with your breast implants, seek advise from a Board Certified Plastic Surgeon in your area. If you have the symptoms above, don’t panic, it is still unlikely that ALCL is the cause, and your local Board Certified Plastic Surgeon can help.

I will get the rest of the show up shortly for all of you interested San Francisco Bay Area Tummy Tuck patients. Once the tummy tuck videos are uploaded, I will place links below. In the interim, if you have have questions, or would like to schedule a consultation, please give me a call at (925) 943-6353 or use the contact form on the left.

The 2010 Plastic Surgery Statistics are out. The American Society of Plastic Surgeons released statistics on America’s consumption of what plastic surgeons had to offer. Here is the recap for 2010:

Americans spent 10.1 billion on 18.4 million plastic surgery procedures last year. Here is how it breaks down:

• 13.1 million cosmetic procedures were performed, up 5% from 2009. This includes:
• 1.6 million cosmetic surgical procedures (up 2%) and
• 11.6 million minimally-invasive procedures (up 5%).
• 5.3 million reconstructive plastic procedures were performed (up 2%).

While teen plastic surgery continues to make headlines, people aged 13-19 had the least plastic procedures (cosmetic and reconstructive) last year, accounting for 2% of the total. The largest age group continues to be 40 to 54 year-olds, who make up 48% of all plastic surgery procedures.

2010 Top 5 Cosmetic Plastic Surgery Procedures

• Breast Augmentation 296,000 (up 2%)
• Nose Reshaping (Rhinoplasty) 252,000 (down 1%)
• Eyelid Surgery (Blepharoplasty) 209,000 (up 3%)
• Liposuction (Lipoplasty or Liposculpture) 203,000 (up 2%)
• Tummy Tuck (Abdominoplasty) 116,000 (up 1%)

2010 Top 5 Cosmetic Minimally Invasive Plastic Surgery Procedures

• Botulinum Toxin Type A (Botox, Dysport) 5,400,000 (up 12%)
• Soft Tissue FIllers (Dermal Fillers – Restylane, Juvederm, Perlane, Radiesse) 1,800,000 (up 3%)
• Chemical Peel (Glycolic, TCA, Phenol)) 1,100,000 (unchanged)
• Laser Hair Removal 203,000 (up 2%)
• Microdermabrasion 116,000 (up 1%)

2010 Top 5 Reconstructive Plastic Surgery Procedures

• Tumor Removal 4,000,000 (up 2%)
• Laceration Repair 390,000, including 33,000 Dog Bites (up 7%)
• Scar Revision 161,000 (down 6%)
• Hand Surgery 106,000 (down 4%)
• Breast Reconstruction for Breast Cancer 93,000 (up 8%)

If you, or your loved ones, are considering plastic surgery, be certain to consult with a Board Certified Plastic Surgeon. All members of the American Society of Plastic Surgeons and the American Society for Aesthetic Plastic Surgery are required to be Board Certified. Certification can be easily checked on the American Board of Plastic Surgery web site. Check your Plastic Surgeon’s Certification here. Apologies for how bland the American Board of Plastic Surgery site is. I’ve been trying to get them to rejuvenate the site for years.

Before (Left) shows localized fat of the chest (gynecomastia) and abdomen. After (right) reveals improved contours and better muscle definition with tumescent liposuction.

How Much Fat Can be Removed With Liposuction?

To improve patient safety, the American Society of Plastic Surgeons and the American Society for Aesthetic Plastic Surgery released a joint statement recommending an upper limit on the volume of fat removed of 5 liters. This is not to say that more fat cannot be removed safely. This recommendation was made for patients undergoing elective outpatient liposuction, on a come-and-go basis. In others words, if you are having liposuction and going home that same day.

Five liters is about 10 pounds, so you can see that liposuction is not a good method of weight control. Liposuction is best if you are near your ideal weight, and have localized, disproportionate accumulations of fat. Unlike weight loss, liposuction can remove fat from the areas you choose, this makes it ideal for stubborn areas that won’t leave. The selective nature of liposuction has lead some to use the term liposculpture.

Over the last few years, as the demand for liposuction increased, a large number of different liposuction techniques sprung up like weeds. All claim to better than every other technique, and most have no or an insignificant amount of proof to back their claims. The best technique remains the tumescent technique, under the guidance of a well trained professional. Ultrasound Liposuction (VASER, Liposelect) and Laser Liposuction (SmartLipo) both piggy back onto Tumescent Liposuction. As a result they get the same benefits of Tumescent Liposuction, but with increased cost and the chance of getting burned.

Before (left) localized fat collections of the inner and out thighs. After (right) tumescent liposuction provides smoothed contours, improved appearance and enhanced fit of clothes.

Can Liposuction Tighten My Loose Skin?

Loose skin is a contraindication for liposuction. While all techniques claim to shrink skin, none can significantly tighten loose skin. Studies comparing tumescent liposuction and other liposuction techniques have been done. In a well controlled study, in which tumescent liposuction was performed on one side of a patient, and laser liposuction was done on the other side, neither patients, nor surgeons, could not tell which side was which. Significant skin tightening remains a problem from all liposuction. You will find examples where the skin seems to dramatically tighten, but these lucky people would tighten with any modern technique. Unfortunately, they are the exception rather than the rule.

Liposuction Safety

The most important aspect of any elective cosmetic surgery is safety. It is surgery, and should be performed by a qualified surgeon in an accredited facility, with proper monitors, excellent anesthesia, meticulous sterile technique and with proper equipment.

How to Choose a Liposuction Specialist

As a Board Certified Plastic Surgeon trained in a program well known for cosmetic plastic surgery, I am biased, and with good reason. As a group, plastic surgeons receive the best surgical training available specific to plastic surgery. The San Francisco Bay Area has been home to three world class training programs, and as a result, you have many excellent professionals from which to choose. While there are some unique individuals, trained in other disciplines, who can get good results, if you are considering Cosmetic Plastic Surgery, considering seeing a Board Certified Plastic Surgeon.

At a minimum, your surgeon should be a member of the American Society of Plastic Surgeons (ASPS), and even better, a member of the American Society for Aesthetic Plastic Surgery (ASAPS). ASAPS members are plastic surgeons who specialize in cosmetic plastic surgery. ASAPS members are required to be Board Certified Plastic Surgeons, members in good standing of their local societies, operate only in certified facilities and allow periodic review of their results. More about these organizations can be found by clicking on their names.

Screening mammography, an important part of breast cancer diagnosis.

Remember when the revised US Preventative Service Task Force (USPSTF) recommendations for breast cancer screening were released in November 2009? Like the recent FDA White Paper and Advisory Statement on Anaplastic Large Cell Lymphoma (ALCL) in women with breast implants, the USPSTF caused quite a stir. A the heart of the controversy was the USPSTF’s advice against the long time recommendation for routine screening mammograms for women beginning at age 40. The USPSTF recommended delaying routine screening until age 50.

Immediately, cash strapped county health organizations and large HMO organizations alike, debated cutting dollars to fund screening mammograms for women under 50. Meanwhile, a large number of US health care organizations, including the American Society of Plastic Surgeons (ASPS), the American Cancer Society (ACS), the American College of Radiology (ACR), and the American College of Obstetricians and Gynecologists (ACOG), recommended that physicians and patients continue to follow earlier guidelines. They recommended to continue screening mammography for patients aged 40 to 49, despite the government committee’s recommendation to start at age 50. The recommendation to continue screening at 40 was based on all previous studies showing a benefit to finding early breast cancer.

40 is Still the Right Age for a Screening Mammogram

Two years later, the advice to continue screening mammograms at age 40 seems to have been right on the mark. I don’t think this comes as a surprise to anyone who cares for women with breast cancer; however, a study published in the American Journal of Radiology, which analyzed the same data as the USPSTF concurs with the earlier guidelines. According to the analysis, women who receive annual mammograms starting at age 40 can significantly reduce the risk of dying from breast cancer by 71 percent. This is in stark contrast to women who follow the USPSTF recommendations, who had only a 23.2-percent reduction in mortality.

What Have We Learned?

The lesson here is not that government is bad, but that science is good. The practice of medicine is based on the odds of something helping more than it hurts. While studies may at times seem to offer conflicting advice, carefully analyzing the details can often resolve the issue. In this case, the data used in the USPSTF study was used to prove the point. So ladies, if you are 40, it is time to get your mammogram.

How Does Science Work?

The best scientific tool we have is the prospective, randomized, controlled, blinded study. But what does that mean?

• Prospective: the study is planned before the data is collected. In this way, data known to be conflicting can be accounted for, and will be less likely to distort the results. The opposite of a prospective study is a retrospective study, where data from the past, often not collected in the best way possible, is used to evaluate a treatment plan.
• Randomized: patients are randomly selected to enter the treatment groups. This is very important. This allows for equity in the treated and untreated groups. For example, patients with a family history of breast cancer tend to have a higher incidence of breast cancer. If all patients with a family history of breast cancer elected to have early mammograms, as one would expect them to, the incidence of breast cancer would be higher in the group that received early mammograms. Without additional information, it would be assumed that mammograms caused more breast cancer. This would not be true, but the data would support it, because of the way the study was designed.

  If patients are randomly assigned to the early and late mammogram groups, patients with a family history would be randomly (evenly) distributed between the two groups. The net effect would be the same expected incidence of breast cancer in both groups. In a randomized study, if the group with early mammograms had more breast cancer, it would indicate that the mammograms may be causing the problem. This is not what randomized studies show. We know that mammograms require radiation, and radiation can cause cancer; however, for all studies done, mammograms find and cure more breast cancer than they cause for women over 40.

• Controlled: A control group is a group that is compared to treatment under study. If you have a new treatment, and you want to prove that is provides a benefit, you need to compare a group of patients receiving the new treatment to a group receiving the current treatment. The current treatment group serves as the control group. Comparing a new treatment to no treatment, may show that the new treatment is better than nothing, but it will not prove that is better than the currently accepted treatment without the head-to-head comparison.
• Blinded: Blinded studies are designed so that the patients do not know which treatment they are receiving. Sometimes the doctors and health professional conducting the study are kept in the dark too. This is to prevent investigator bias, and to help randomize the placebo effect.

The Ideal Study for Screening Mammograms at Age 40

The mammogram on left is of normal glandular breast tissue. The white circle in the mammogram on the right is breast cancer.

So, the ideal test to prove the benefit of mammograms to screen for breast cancer between ages 40 to 49 would need the following under each of the categories described above:

• Prospective: Before the study is started, protocol is established. This would include who would be studied (women age 40) and what conditions would be excluded (men, women who already have breast cancer, women with other severe health problems). The number of women needed to prove statistical significance. Reasons for dropping out, and how to handle the data collected for those dropping out. It might be good to estimate the number expected to drop out, so that the remaining groups could still show statistical significance.
• Randomized: How women are selected to be in each group. Toss of a coin, even or odd days of birth, anything unrelated to the mammograms or breast cancer, so that the two groups will be as equal as possible in all the variables that are not being controlled.
• Controlled: A definition of the control group is established. In this case, the control group needs to be matched for age, family history of breast cancer, smoking, weight and all other variables known to contribute to breast cancer. This way the study group receiving the mammograms, and the control group not receiving the mammograms, will be as equal as humanly possible.
• Blinded: While not likely in this type of study, the best control group would do everything the study group does except get mammograms. A clever sham for the control group, would be to use mammogram machine, have it make a noise like a mammogram was done, but not use any radiation. No mammogram would be taken, but it would not be possible for the patient, and in some cases, even the mammogram technologist to know if a real mammogram was done. This way, if there was some other factor in the mammogram room that caused breast cancer, like the paint on the wall, that increased the risk of breast cancer, the exposure would be the same. Blinding can also prevent investigator bias. For example, if an investigator was truly convinced that there was a benefit to treatment, they would be less likely to allow someone with a family history of breast cancer to go into the control group and not receive treatment.

So the above study would have to run ten years to provide mammograms for the women from age 40 to 49, and to provide no mammograms for the control group. Then data will need to continue to be collected throughout every participants life to see if there was a benefit. Were tumors found sooner? Smaller? Once the diagnosis was made was the treatment for breast cancer easier? More effective? How many had recurrences? Were recurrences local, or were the recurrences to other organs like the lungs, liver, brain or bone? Did patients live longer in the screened group? The main question is, did fewer women in the screened group die of breast cancer?

Unfortunately, Compromise is Necessary

It might take 50 or 60 years to get the final results, and it would be very expensive to run this test. As a result, this type of testing, even though ideal, is never done. Often, new treatment protocols are unblinded early for ethical reasons. A separate group of investigators may be asked to review the unblinded results. This prevents bad treatments from doing more harm, and prevents good treatments from being withheld from the control group.

It is very important to keep the above principles in mind when reviewing data. Unblinded results can be dangerous if the investigator has a bias. Recent developments in the vaccine and autism controversy come to mind. It is important to remember that risk is always relative. Risks that occur often, but cause small problems may be acceptable. A cream that causes temporary burning, but clears a rash is acceptable. Even terrible consequences may be acceptable if they are very rare. An antibiotic that clears a particularly difficult and dangerous infection 99% of the time, but can lead to liver failure and death in 1 in a million treated with it, would be acceptable if they had a better chance of dying without the antibiotic.

Medicine and the Evening News

The evening news is not the best place to get medical information. While many reports are fair, most are sensationalized. Increased drama equals increased viewership, and that leads to more advertising dollars. The motivation to inform is in all reporters and producers, but if the story is not interesting, it will never air.

So in 2011, doctors are still recommending screening mammograms, beginning at age 40. For women with a family history of breast cancer developing at a young age, earlier screening may be recommended. The study by the American College of Radiology (ACR), is much more thoughtful, and certainly more objective, than the US Preventative Service Task Force (USPSTF) recommendations. But you won’t see the same prime time news coverage tonight for the ACR paper that we did in 2009 when the USPSTF made their announcement. The results are not as … interesting.