March 17th, 2013 Dr. Mele
A large portion of a Plastic Surgeon‘s day is spent sharing information. Whether it’s one-on-one in the office, or during a live television broadcast, my goal is the same. Knowledge is power, and the sharing of knowledge can be extremely powerful, but as the saying goes, a little knowledge….
Frequently Asked Questions About Plastic Surgery
Plastic Surgery Frequently Asked Questions
People come to my Walnut Creek Plastic Surgery office every day with questions about the procedures I offer. Whether cosmetic or reconstructive, the questions are the same:
- What can be done?
- How is it done?
- Where is it done?
- Who helps you?
- How many have you done?
- What is the recovery?
After a consultation, the answers are usually simple, but the answers will vary from patient to patient.
Specific Answers for Specific Patients
I try to give solid information about my San Francisco Bay Area Plastic Surgery practice on my web sites. Sharing information about the procedures I do is easy. Unfortunately, the information must remain somewhat generic. Answers to questions about a specific procedure will vary depending on your anatomy and needs. Sometimes, even the best procedure will change. The differences can cause confusion, but are also responsible for better results. So I spend a lot of time explaining. In person, it’s an interactive process, but explanations via email can be difficult, especially if we have not yet met.
Plastic Surgery Consultation Appointments
Even during a full consultation appointment, I cannot share every nuance. I did not learn everything I know about Breast Augmentation in an hour, but I can get the important questions answered. I can also tailor my answers to you, so that some of the unknowns are removed for the procedure. The goal is to make the reasons for the choices clear. It provides direction, fosters trust and removes some of the unknowns and worries from the process.
A Little Knowledge is a Dangerous Thing
We have all heard the expression, “A little knowledge is a dangerous thing.” It works both ways. If you don’t have enough knowledge about how to get the results you expect, you may pursue the wrong procedure or practitioner. If I don’t have all the information, I can’t make the best decisions for you. It is important to share with your plastic surgeon. I need to know not only what you expect from the procedure, but all other health issues, the medications you take, even something as simple as the best way to reach you can make a difference. Something as little as forgetting to mention you take a baby aspirin every day can be a big problem. Trust works both ways. To get the maximum benefit from our knowledge and experience, there needs to be trust.
Trust and Television
Television is a great medium. It provides sound and picture and the detailed descriptions of the story told are quite compelling. It works well for entertainment, where a certain suspension of belief is necessary; however, for describing plastic surgery, it is lacking. There is not enough time to describe every aspect of the decision making that goes into a Facelift. So instead, the answers are made to fit an imaginary patient, and the details necessary to provide better individual results as glossed over. The devil is in the details.
Zithromax
I think of the recent news stories about Zithromax causing arrhythmias. The tag line is “FDA warns Zithromax can cause fatal irregular heart rhythm.” It good information, but it’s also a little knowledge, without the benefit of tailoring that information to your specific needs. What is left out is the millions and millions of stories of people world wide who benefit from the simple effectiveness of a once a day Z-pack. Covering that would be fair and balanced, but also extremely boring and would likely be protested as nothing more than corporate influence. Now I’m not saying it is wrong to question your doctor if they prescribe Zithromax. In fact you should; however, after all the information has been shared (in both directions), at some point it comes down to trust. From your doctor’s viewpoint, every medication has the potential to do good and to do harm. We are trying to pick the best medication, with the best ratio of risk to benefit, for our patients specific situation.
New and Exciting Plastic Surgery Breakthroughs
I don’t prescribe a lot of Zithromax, but I do perform a lot of surgery, and the same rules apply. Surgery has the potential to provide great deal of benefit, but no procedure is perfect. When I tell someone that they have too much loose skin for me to do Liposuction, and that the better operation would be a Tummy Tuck, it’s not because I’d rather do a Tummy Tuck. It’s because, in that specific situation, Liposuction is not the best choice. Liposuction, whether it’s Smart-Lipo or Dumb-Lipo, cannot fully correct loose skin. When there is too much loose skin, Liposuction has less potential to do good, and more importantly, an increased risk of making things look worse.
There is little new about the Tummy Tuck. It is tried and true, with well defined benefits and risks. As a result, there is very little coverage about Tummy Tucks in the news. Over 150,000 women had a tummy tuck in 2012, but unless your name is Star Jones, Kate Gosselin or Shar Jackson, it didn’t make the news.
Informercials offering magical belts, creams and exercise DVD’s, that claim to do what a Tummy Tuck can do, are broadcast just about any hour of the day. If they did work, I’d be offering them. I am all for using the simplest solution to a problem, but it has to work. A Tummy Tuck can cost $8000 to $10000, if an $80 cream worked, I’d be selling it, and a lot of it! But creams don’t work. Tummy Tucks, on the other hand, receive a 95% worth it rating on RealSelf by almost 4000 patients. So with that little bit of knowledge, who do you trust?
Cosmetic Plastic Surgery Consultations
Get Answers About Plastic Surgery.
If you are considering cosmetic plastic surgery, be certain to find a Board Certified Plastic Surgeon in your area who as experience in the procedure you need. Spend time researching not only your procedure, but also your doctor. Above all else, choose a doctor you can trust, who is willing to share more than just a little knowledge.
You may always ask me questions via the contact form on the left, but for specific questions, I will likely need to see you. The more information I have, the better the answer you get, and it’s hard to beat an in person consultation. Call (925) 943-6353 today, to schedule your Personalized Plastic Surgery Consultation Appointment.
Posted in Breast Augmentation, Facelift (Rhytidectomy), Home, Liposuction, Patient Safety, Tummy Tuck (Abdominoplasty) | No Comments »
March 12th, 2013 Dr. Mele
The American Society for Aesthetic Plastic Surgery (ASAPS) released the latest cosmetic plastic surgery stats today. In 2012. Americans received over 10 million nips, tucks, relaxations and plumps, representing a 10% increase from 2011. Here are the details:
Non-surgical Cosmetic Procedures
Five out of six procedures were non-surgical with the injectables in the lead again in 2012. The relaxers, Botox and Dysport (botulinum toxins), retain the number one position. Plumpers come in number two including the dermal fillers: Restylane, Juvederm, Perlane, Belotero, Prevelle, Elevess and Radiesse. Laser hair removal secured the number three spot, with microdermabrasion and chemical peels rounding out the top five.
Cosmetic Plastic Surgery Procedures
Cosmetic surgery procedures also increased from 2011 to 2012. Breast augmentation remains the number one American cosmetic plastic surgery procedure, followed closely by Liposuction. The other half of the Mommy Makeover, the Tummy Tuck (Abdominoplasty), comes in third. While cosmetic facial plastic surgery procedures, Blepharoplasty (Eyelid Lift) and Rhinoplasty (Nose Job), come in fourth and fifth, respectively.
Top Five Cosmetic Surgeries for Women
The top five cosmetic surgeries for women were:
Top Five Cosmetic Surgeries for Men
The top five cosmetic surgeries for men were:
Real-Self “Worth It” Ratings
For the first time, the ASAPS has included “Worth It” ratings from the popular plastic surgery consumer review web site RealSelf. The non surgical procedures typically receive worth it ratings from 60-70%, while the top five surgical procedures rank higher as follows: Breast Augmentation 93%, Liposuction 74%, Abdominoplasty 95%, Blepharoplasty 77% and Rhinoplasty 82%.
Considering a Cosmetic Procedure in 2013?
If you are considering a cosmetic plastic surgery procedure in 2013, give us a call at (925) 943-6353, or use the contact form to the left to arrange a private, personalized consultation appointment.
Posted in Patient Safety, Plastic Surgery Societies | No Comments »
February 9th, 2013 Dr. Mele
Dr. Mele is Board Certified by the American Board of Plastic Surgery
Any licensed physician can call himself or herself a Cosmetic Surgeon, so the importance of finding a properly trained and certified provider is paramount. The goal of this post is help patients looking for a qualified Plastic Surgeon know what to ask and how to check on their prospective doctor. I encourage everyone considering cosmetic plastic surgery to spend as much time researching their doctor as their procedure.
For Plastic Surgery Think PS
If you are considering cosmetic surgery there are three main goals that are mandatory, and the first two letters of Plastic Surgery can help. The three goals are:
- Proper Surgery
- Proper Surgeon
- Proper Setting
You want the most appropriate procedure performed by a qualified and experienced surgeon in a setting that provides for your safety.
Underground Plastic Surgery
Underground Plastic Surgery has grown along with the Board Certified variety. As Cosmetic Plastic Surgery has gained acceptance and popularity so has the quest for a bargain. There are no exact numbers, because those practicing cosmetic surgery illegally do not track or report their procedures to a national society like the American Society of Plastic Surgeons (ASPS) or the American Society for Aesthetic Plastic Surgery(ASAPS), but more about them later.
The way we usually hear about illegal plastic surgery is when something goes horribly wrong. On January 3, 2013, a second person was arrested and charged in the death of a 37-year-old woman who died from pulmonary complications after receiving silicone-like injections to enlarge her buttocks. The patient was introduced to the unlicensed practitioner after paying $200 to an Internet referral source. The fact that the procedure was performed at home, rather than a medical facility, should have been a big red flag.
This unfortunate patient had the wrong procedure, performed by the wrong person in the wrong setting. While fat grafting has gained some traction as a viable way to provide buttock enlargement in selected cases, there are currently no FDA approved off-the-shelf injections available in the US for buttock enlargement. Anyone offering these types of injections, no matter how low the cost, is not doing you a favor, and is not practicing medicine within the current standard of care.
Licensed Plastic Surgery
As mentioned above, any licensed physician can call himself or herself a cosmetic surgeon. At one meeting. I met a doctor, not from the San Francisco Bay Area, who performs Breast Augmentation one day a week, and works as an Emergency Room doctor the rest of the week. The state of California finds this perfectly reasonable, because he is a licensed physician.
Plastic Surgery was born from a union of General and Head & Neck Surgeons, who had an interest in plastic and reconstructive surgery. There is a lot of overlap between Plastic Surgeons and other specialists like Otolaryngologists, Ophthalmologists and even Gynecologists. Each of these specialists receives specific surgical training in their discipline, but Emergency Medicine?
Trained Plastic Surgery
I knew early on that I wanted to be a Plastic Surgeon. As a result, I chose the most direct path available: Surgical Internship, General Surgery Residency and Plastic Surgery Fellowship. All along the way I had my eye on the prize, to become a Board Certified Plastic Surgeon. I did not start learning plastic surgery after completing some other discipline. My desire to be a plastic surgeon shaped my training from its inception. I was fortunate enough to be in a General Surgery training program that had Plastic Surgeons, but no plastic surgery residents. This gave me the opportunity to get a head-start on my Plastic Surgery Training well before my Plastic Surgery Fellowship.
After finishing my General Surgery Residency, I completed a three-year Plastic Surgery Fellowship. There I concentrated only on plastic surgery. I was fortunate to train in a program that not only provided a firm foundation in Reconstructive Plastic Surgery, but also was strong in Cosmetic Plastic Surgery. This depth and breadth of this training cannot be provided by a weekend course, or a few proctored cases. It’s the best way to learn plastic surgery, and it is why I chose to complete a Plastic Surgery fellowship as my path to becoming a Plastic Surgeon.
Board Certified Plastic Surgery
The San Francisco Bay Area is currently home to two Plastic Surgery Training programs: UCSF and Stanford, and for a long time was home to the oldest plastic surgery training program west of the Mississippi at Saint Francis Memorial Hospital. Additionally, the Bay Area is a nice place to live, so finding a well trained Plastic Surgeon in our area is pretty easy.
Board Certification is a process that occurs throughout the course of a Plastic Surgeons practice. Lifetime certificates where given out before I started my training, but currently certification requires continuous maintenance. The details for Plastic Surgery Board certification are available here: Certification by the American Board of Plastic Surgery.
The goal of Board Certification is to provide recognition for the most qualified practitioners in their discipline. It means they have the best training and have been vigorously evaluated by other Board Certified doctors to make sure their expertise is up to the standard of care.
The Three PS’s
PS #1 – Proper Surgery - Finding the proper procedure on the Internet can be difficult. While there are many sources of good information, there are a lot of claims that are too good to be true. While it is good to have an idea of what procedure will work, it is best to reserve final judgement until after an in-person consultation. A big part of my job is listening to what is bothering you, and finding the best way to fix it.
PS #2 – Proper Surgeon - Finding a Board Certified Plastic Surgeon is a good start in being certain you have the proper surgeon. For selected procedures, there is overlap with other specialties. Board Certified Ophthalmologist are well trained in Blepharoplasty and Board Certified Otolaryngologists are well trained in Rhinoplasty. What you will need is a well trained professional with experience. This helps assure that good skills are coupled with good judgement.
PS #3 – Proper Setting - Real surgery requires the correct setting. While Botox and Injectable Fillers, and minor surgical procedures can be safely done in an office setting, Breast Augmentation, for example, should be performed in an operating room. An operating room in an accredited facility is preferable. Placing a Breast Implant requires an FDA approved device and sterile technique; otherwise, you won’t be keeping it long.
Membership Counts
To be an ASPS Member Surgeon, a physician must meet these rigid requirements:
- Board certified in plastic surgery by the ABPS
- Graduate from an accredited medical school
- Complete a combination of at least five years of general surgery and plastic surgery residency training
- Pass comprehensive oral and written exams
- Operate only in accredited medical facilities
- Adhere to a strict code of ethics
- Fulfill continuing medical education requirements, including standards and innovations in patient safety
An easy way to be certain you have the PS’s covered is to seek an ASPS member. If you are considering cosmetic plastic surgery, a subset of the society, the ASAPS, are ASPS members dedicated to the cosmetic side of plastic surgery.
You Owe it to Yourself
It takes dedication, persistence and effort to maintain Board Certification, and so does being a Plastic Surgeon. You owe it to yourself to do the research and check your plastic surgeon before having any procedure. The Internet makes it easy. The following links, will make it even easier. Just click on what you want to do:
Check if your doctor is Board Certified by the American Board of Plastic Surgery.
Check if your doctor is Board Certified by another American Board of Medical Specialties board. You will need to register to use this site, but it is safe, free and fast.
Check if your doctor has an unrestricted California Medical License. Read the disclaimer and click “Continue to Search” at the bottom. If you are not in California, Google your local medical board for a link.
Posted in About Dr. Mele, Patient Safety, Plastic Surgery Societies | No Comments »
June 16th, 2012 Dr. Mele
I’ve spent a lot of time reporting about the newly FDA approved highly cohesive, high-strength silicone gel breast implants by Sientra, but what does FDA approved really mean?
The FDA (U.S. Food and Drug Administration) makes distinctions for approval depending on what is being approved. Since the FDA reviews everything from tongue depressors to artificial hearts, it makes sense that different levels of review exist. It also means that “FDA Approved” means something different for different medical devices, pharmaceuticals and medical equipment.
It may surprise you to know that breast implants are one of the most investigated medical devices in the history of the FDA. Since their introduction half a century ago, the FDA has mandated several large studies, involving tens of thousands of women. These studies have proven the efficacy and more importantly the safety of the current and the next generation breast implants, and the work is ongoing. Large scale investigations of both saline and silicone breast implants continue today. We are over half way through ten-year studies on the currently available breast implants. I am a primary investigator in these studies, and many of my patients have volunteered to participate in order to provide up-to-date safety data for the next generation of breast augmentation patients.
FDA Approved Breast Implants
Breast implants are classified as a medical device. When FDA review is needed prior to marketing a medical device there are two levels of approval:
- FDA Clearance - The FDA will “clear” the device after reviewing a premarket notification, otherwise known as a 510(k) (a section in the Food, Drug, and Cosmetic Act), that has been filed with the FDA. To acquire clearance to market a device using the 510(k) pathway, the submitter of the 510(k) must show that the medical device is “substantially equivalent” to a device that is already legally marketed for the same use.
- FDA Approval - The FDA will “approve” the device after reviewing a premarket approval (PMA) application that has been submitted. To acquire approval of a device through a PMA application, the PMA applicant must provide reasonable assurance of the device’s safety and effectiveness.
When it comes to breast implants, FDA approval means a lot. For the three companies currently FDA approved to sell breast implants in the US (Allergan, Mentor and now Sientra), the process was long, involving years of research and thousands of women. The process allowed the FDA to identify several quality control issues with the French manufacturer PIP, before their breast implants were allowed to be marketed in the U.S. PIP did not receive FDA approval, and sale of these adultered breast implants was blocked. The FDA single-handedly protected U.S. women from the problems PIP breast implants are causing around the world. Providing, the women did not go outside the U.S. for their surgery.
FDA Approved Radiation-Emitting Electronic Products – Huh?
I consulted the FDA web-site for the definition. A radiation-emitting electronic product is any product that uses electricity to power an electronic circuit that gives off any kind of radiation. Radiation means energy traveling across space. X-rays, microwaves, radiofrequency (RF) waves, laser, visible light, sound, ultrasound, and ultraviolet light are a few examples of the many types of radiation that may be produced by an electronic product. These devices include many of the latest fads in non-invasive, non-surgical cosmetic rejuvenation. But “FDA Approved” does mean the same thing for these devices, despite what is implied by the glossy adds featuring women too young to need the procedures.
The emphasis for all device approval is safety. The main goal of the FDA is to be certain that the device, when properly used by a trained professional, is not likely to cause injury. Even a low energy laser pointer can cause you serious injury, if pointed at your eye. Like with implantable medical devices, the FDA does a good job in ascertaining device safety.
The efficacy side of FDA approval, for external medical devices like lasers, ultrasound and R-F devices, is much less strenuous. While thousands of women were enrolled in breast implant studies, most radiation-emitting electronic products’ studies have low numbers of enrollees (10 – 40 is not unusual). As long as no one is hurt, and one patient shows some improvement, the device is “FDA Approved.” So it’s still buyer beware, especially if you are promised something that sounds too good to be true.
The Tool vs. the Professional
FDA approval is very important for medical devices. As a Board Certified Plastic Surgeon, I appreciate everything the FDA does to provide me with the best tools of the trade. While the proper tools are important, the person holding the tool is even more important. If you are seeking cosmetic surgery, be certain to find a Board Certified Plastic Surgeon to be your guide. We are very fortunate in the San Francisco Bay Area to have some of the best training programs and professionals in the world. With the right tools, in the proper hands, great things are possible.
Posted in Breast Augmentation, Home, Patient Safety | No Comments »
April 27th, 2012 Dr. Mele
PIP founder, Jean-Claude Mas, arrested after French breast implant manufacturing scandal.
The arrest of Poly Implant Prothese (PIP) founder, Jean-Claude Mas, in January, brought 2 years of investigations to its logical, albeit protracted, conclusion. However, the story goes back much farther, and there is much more work to do.
Poly Implant Prothese – PIP
PIP was founded in 1991 as a manufacturer of silicone breast implants covered with a polyurethane foam. When the US FDA restricted the use of silicone gel breast implants in 1992, the silicone breast implant market shrank. In 1995, France too placed restrictions on silicone filled breast implants. PIP expanded its market through innovation, and began offering pre-filled saline breast implants in 1996. It was with these pre-filled saline implants that PIP moved into the US market. 1996 was the first time I heard the name PIP.
PIP’s Short Lived Stay in the US – Thank You FDA
After a few years of use, it became clear to US plastic surgeons that PIP breast implants where not the same quality that US Board Certified Plastic Surgeons were used to with Inamed (formerly McGahn and now Natrelle under Allergan) and Mentor (now Johnson & Johnson). In general, breast implant failure rates are low in the first year and are more likely to leak the older they get, but the PIP saline implants seemed to leak much sooner and more often. Moreover, all PIP pre-filled saline implants experienced volume loss, even without obvious holes. A study published much later, in 2006, confirmed this. PIP’s popularity wained.
The FDA Goes to France
In May 2000, a decade before the current PIP silicone filled breast implant crisis, the US FDA performed an inspection of the PIP factory in La Seyne-sur-Mer (Southern France). The finding led to the immediate halt of all US PIP breast implant sales. The FDA issued a warning letter to PIP owner, Jean-Claude Mas, declaring its saline implants “adulterated.” The report sited 11 questionable manufacturing practices that were outside industry recognized best-practices. Whether the French Health Authority (AFSSAPS) was informed about the results of the FDA’s inspection or not, is unclear. If only the AFSSAPS had taken action then…
Silicone Gel Breast Implants are Back
By 2001, France removed its restrictions on silicone filled breast implants. PIP was still in business in Europe, and was expanding into South America, so again PIP innovated. In 2002, PIP launched an asymmetrical silicone filled breast implant. Fortunately, for all US women, the FDA had already given PIP the boot.
The Center of the Problem
On paper, these new breast implants were filled with NuSil, manufactured in California by NuSil Inc., a company founded by McGhan breast implant founder, Donald McGhan. In reality, PIP was not using NuSil to fill its breast implants. Instead, Monsieur Mas had his own recipe for a silicone filler, which I will call PIP gel. PIP more often used PIP’s non-approved silicone gel to fill PIP breast implants. The main reason, price. It cost about $23 to fill an implant with NuSil, but only $3 if PIP’s gel was substituted. This saved PIP about two million dollars in 2009. But the cheaper implants were also inferior in quality. The real cost was to come to the women receiving PIP breast implants, because PIP gel is made with industrial grade silicone, rather than the required medical grade silicone. Moreover, the failure rate of the PIP silicone filled breast implants, like the saline filled breast implants, seemed to come sooner and more frequently.
Knowing When to Duck
Although PIP was a French company, it was certified by TUV Rheinland in Germany. The approval came in 1997, and yearly inspections where performed in accordance to regulations. Unfortunately, guidelines also required TUV Rheinland to give PIP 10 days advance notice of their arrival. PIP used this time to hide all evidence of PIP gel. The paperwork was filed to look legit, and the regulators where none the wiser.
The European system had no requirements for unannounced inspection of the manufacturing facilities or even the breast implants. Once approved, the silicone filling of PIP implants was never retested.
More Acronyms – AFSSAPS
The AFSSAPS (Agence Francaise de Securite Sanitaire des Produits de Sante), does not certify medical products, but it can remove defective or dangerous products from the French market. In 2001, when silicone breast implants were reintroduced to France. The AFSSAPS tested the contents of PIP implants prior to approval. After that, private companies LEMI and LNE, to over. While strength and toxicity test were performed, no results are available about whether NuSil or PIP gel was used. The first random test was not performed until 2010, after PIP was under police investigation. The finding in the 2010 AFSSAPS report reads, “this one does not reach the degree of quality of a silicone gel intended for breast implants.”
European Regulators Blissfully Unaware
The FDA’s warning never reached Europe. Although the AFSSAPS watches the FDA site, it missed the PIP posting warning of problems in PIP’s breast implant manufacturing. There was, and still is, no system in place for sharing the information. Perhaps, this will now change, and countries can share information proactively. For a global economy, it makes sense.
It wasn’t until March of 2010, that two French health inspectors, acting on a tip, discovered six discarded plastic containers of Silopren along the outside wall of the PIP breast implant production facility. Silopren is a line of liquid silicone used mostly for industrial use, there are some medical uses for some of the Silopren product line, but externally for scar modification, and not as a filler for breast implants. PIP was not supposed to be using Silopren. Pip was supposed to be using NuSil. A week later, the factory was raided. It took another 8 months to track down Mas. The picture above is from the Interpol website.
European Regulators Under Scrutiny
French and European safety regulators now find themselves in an untenable position. European and South American governments are offering to pay for the removal of the estimated 300,000 defective PIP implants, before further harm is done. It is estimated that 10% of these implants have already leaked.
There is much to be learned from the PIP problems. Regulating medical devices is hard. It is a balance between allowing innovation and protecting from harm. In the elective surgery arena, the balance is tipped toward protection. However, in the case of PIP, there were many warning signs. Poor manufacturing, poor quality control, poor oversight and ignorance of the warnings from the FDA led to 10 years of inaction.
Low Price and Low Quality Often Go Together
Since in the US, PIP breast implants never achieved FDA approval, I never used them. I have not use the saline filled PIP breast implants either. I have, however, had to remove them. There were cheaper, but when it comes to enhancing one’s body cheaper is not better. Reputable, experienced and dedicated count, and this comes with a price. When it comes to plastic surgery, the lowest price is rarely the right answer.
What to do With PIP Breast Implants
If you had Breast Augmentation surgery in the US, with a reputable plastic surgeon, you do not have to worry about PIP silicone gel filled implants. However, if you had breast augmentation outside the US, you should check which implants were used. All PIP silicone breast implants should be replaced with new, FDA approved, breast implants, or at a minimum removed before they cause problems. If they have leaked, the sooner they are removed the better. If they haven’t leaked, it is recommended that you replace or remove them before they do. Either way, if you have PIP breast implants, find a Board Certified Plastic Surgeon today.
Posted in Breast Augmentation, Home, Patient Safety | No Comments »
September 25th, 2011 Dr. Mele
The headline reads…
Anthem Plastic Surgeon Gets 25 Years for the Deaths of Three Patients
…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.
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.
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September 9th, 2011 Dr. Mele
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 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.
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August 12th, 2011 Dr. Mele
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.
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June 23rd, 2011 Dr. Mele
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:
- 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.
- 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.
- Device Failure Studies (Failure Studies) – To further characterize the modes and causes of failure of explanted devices over a 10-year period.
- Focus Group Studies – To improve the format and content of the patient labeling.
- 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.
- 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.
Posted in Patient Safety | 1 Comment »
June 19th, 2011 Dr. Mele
Update: The French Supreme Court has issued an injunction against the decree listed below. The court found inconsistencies siting the broad range of exclusion which included some devices previously CE and FDA approved. For now the baby and the bathwater are safe.
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.
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