PORTAL and your Surgeon - The Cake is a Lie.

In October I wrote about spatial perception and the concept of being left or right brained as it applied to your surgeon. While generalities about artistic taste or surgical ability being associated with left/right dominant brained people and the like as it applies to individuals is a silly idea, I definitely think the ability to understand and intuit spatial relations is important.

Much like a pool hustler understands the geometry and physics of a bank shot without getting a compass and calculating force vectors, surgeons process symmetry, proportion, and volumetric relationships. With laparoscopic surgical techniques utilizing small cameras and long, remote instruments there are several studies suggesting that people who are good at video games tend to be better at laparoscopy. Researchers found that surgeons who spent at least three hours a week playing video games made about 37 percent fewer mistakes in laparoscopic surgery and performed the task 27 percent faster than their counterparts who did not play video games.

I think I've discovered a great video-game proxy for Surgery. Valve Software published the title PORTAL this Fall as a under-publicized throw-in for their blockbuster video game, Half-Life 2. Portal is a unique puzzle game that is a real mind-bender in the way you have to understand spatial relations, momentum, physics, and inertia. It is also a really, really creepy experience in artificial intelligence (AI) paranoia. The phrase in the title of this post, "The cake is a lie....", is a critical plot device in the story. You can read plot spoilers on Wikipedia's Portal Page.

So next time you go to surgery, forget those questions about their experience, training, or board certification. Rather, find out how good they are at Portal :)

Portal's trailer is visible below via YouTube.




Rob

More detail for those interested in the Tucson patient who had trouble finding care for her leg wound

There's an article in the Arizona Daily Star (click here) which goes into more detail on the events surrounding the patient in the MSNBC story I referred to in my last post, who could not find a Plastic Surgeon in the city of Tucson (pop. 946,362+) to take care of her leg injury.

The patient in this instance, Mary Jo McClure chronicled her experience with this episode on the web by starting a website "My Severe Wound.com". You can actually see photos of the wound during her treatment which required two surgeries to treat.

Rob

Emergency Room coverage by surgical specialties continues to worsen

Last summer I wrote a post "What's going to happen when you need a plastic surgeon in the E.R.?" about the worsening crisis in E.R. coverage among many specialists including Plastic Surgeons.

As we end the year, I've been seeing a number of articles referring to this come up again in our professional journals and on the news wires. MSNBC today highlights this again in a story "Emergency rooms find on-call specialists rare: Seriously ill suffer as relationship between physician and hospital unravels." Surveys of Emergency Room around the country have reported that as many as 75% have had issues about coverage for services like Orthopedics, Neurosurgery, Obstetrics, Hand Surgery, Oral Surgery, and Plastic Surgery.


In the MSNBC story, they profiled a patient who had trouble finding treatment from a plastic surgeon

Retiree Mary Jo McClure, 74, experienced the problem firsthand one Friday afternoon in January when she fell down some concrete steps, tearing large chunks of flesh from one leg. The plastic surgeon on call for Tucson Medical Center refused to leave her private-practice patients to come to the emergency department to treat McClure, who has health insurance. The doctor said instead she would see the injured woman in her office the next Monday.

But over the weekend, the specialist telephoned the family to say that she could not treat McClure after all because she performs only cosmetic procedures and is not trained to handle severe wounds, McClure said.

I can remember seeing this scenario multiple times during residency, and in this instance it is B.S.. This doctor may not want to or like to treat wounds but she is certainly over-qualified to. After examining it, she may determine that the extent of it requires surgical techniques she is no longer proficient in (eg. microsurgical techniques). This particular doctor is going to have to decide if staying on staff at that hospital is worth it to her for exposure to these issues from the ER. She may choose not to, but it looks real bad to behave like she did in this instance. Now for patients who present with hand issues, complex facial fractures, and mangled extremities I do feel it is more appropriate to defer treating if you don't do those types of procedures as the skill sets for treatment are more advanced and the resources required for their global care do not always exist at all hospitals.

I, for example, do not do any hand surgery (beyond smaller burns and occasional peripheral nerve procedures) in my elective practice and I do not take ER call for hand. Out of the nearly 40 Plastic Surgeons in my city, maybe 5 do any amount of hand surgery with most of those working at the University-affiliated level I trauma center. Outside the University, you may be SOL if you're trying to find a plastic surgeon doing hand injuries. As many orthopedic surgeons are following plastic surgeons out of the hand business, we're reaching critical mass for coverage of that specialty.

Traditionally, many specialists agreed to pull on-call duty in exchange for admitting privileges and use of a general hospital's facilities to perform operations and other procedures as part of their regular practice, O'Malley said. But the rise of physician-owned specialty hospitals and outpatient surgical centers over the past 15 years has reduced doctors' reliance on the general hospital.

"The historic relationship between physicians and hospitals is unraveling," O'Malley said.

I think that last sentence says it all. Surgeons en mass have reached a breaking point about being bullied by hospitals and insurers and now have some opportunities to walk away from uncompensated and unreasonable demands for ER coverage. In years past, the ER was a reliable practice builder for many plastic surgeons but in many instances it's now a reservoir of uninsured patients and offers less then cost reimbursement on insured patients with significant exposure of malpractice liability. What's not to like?

Much like I suggested when talking about specialty hospitals, the relationships between doctors and hospital ER's is going to have to be renegotiated. It's clear that hospitals will be having to pay stipends for ER coverage (which is perfectly reasonable to me) and that there will have to be increased medical malpractice tort reform for ER coverage to halt (if not reverse) this trend.


Rob

St. Louis Mesotherapy clinic chain (FIG) filing for bankruptcy

The first major casualty in the American experience with mesotherapy has arrived with reports that FIG, the first franchised mesotherapy clinic company, is closing it's doors in the wake of hundreds of complaints from unhappy clients.

FIG had operated over a dozen clinics in seven states that promoted a package of mesotherapy injections, costing almost $2,000 per body part, to reduce fatty deposits on the thighs, abdomen, buttock, and neck. Its clinics reportedly performed over 100,000 mesotherapy-style treatments across the nation.

Now all this doesn't mean that mesotherapy can't or doesn't work, but it clearly shows what happens when you put the cart in front of the horse with new technology or techniques. It's to the credit of the Plastic Surgery Education Foundation that they've taken the lead in trying to study the safety and efficacy of standardized regimens for these injection lipolysis treatments. The inaction of other medical groups who have dabbled in this is disturbing.

Hopefully this will temper the enthusiasm for people experimenting with these kinds of injections until we have more information. Remember that the active components of all these treatments are cyto-toxic medications being used in a way far from their accepted indications.

Rob

Physician-owned hospitals - an unavoidable trend IMO

The issue of whether or not hospitals run better when the doctor's who work there own all or part of it has been a contentious issue. A provision ram-rodded into a 2006 deficit-reduction bill was a mandate that could put a moratorium on hospitals that are partly owned and run by doctors by denying eligibility for medicare/medicaid reimbursement for services (a condition that makes running a hospital impossible). There's compelling arguments on both sides of this.There are almost 130 physician owned hospitals in the United States versus approx. 5000 plus general hospitals.

"General Hospitals", who offer wide ranges of service and exist as either not-for-profit or for-profit hospitals, claim that doctor's face conflicts of interest over patient referral and will "cherry pick" healthier patients in higher-profit areas of medicine (usually cardiac medicine/surgery and orthopedic surgery) while eschewing medicaid patients and money losing endeavors (like emergency room services).

Physician investors in hospitals meanwhile argue that existing hospital corporations fear competition, and that they've built highly efficient facilities which have a tendency to have more nurses on patient floors, invest more in high-technology, and provides amenities and levels of service not available at general hospitals.

There's data from the feds which actually show both arguments to be true simultaneously.

My personal take is that physician ownership is both necessary and will become increasingly common unless prohibited by congress (as the hospital lobby has worked towards in Washington). As the margins of the economics of organized medicine become tighter, hospital-based physicians are going to demand a "piece of the action" to offset the savaging of their income by medicare and corporate medicine reimbursement. Hospital-Physician partnerships will be necessary for institutions to attract and maintain their medical staff in some profitable specialties. When doctors have a stake and more input into operating decisions, I can't help but think we'll all be better off at the end of the day.

Will this affect Plastic Surgery much? Not really I suspect. Our specialty has been marginalized for years by hospitals as we don't generate near as much revenue as other surgical specialties like orthopedics, cardiac surgery, or transplant surgery. With outpatient cosmetic surgery now the horse pulling the cart for the public face of our specialty, I think more and more Plastic Surgeons will feel like they don't have much of a stake in that fight. That may be kind of myopic and narrow-minded, but it's true. Except for outpatient surgery centers, I don't think there's a lot of doctor's going to be lining up to throw money at the full-service hospital business.

There's a great blog on WebMD, "Mad About Medicine" which has a number of related articles on the economics of medicine. Good stuff!

Rob

The "Squidworth's Nose" deformity : Does breast feeding make your breasts sag?

A study was presented at our major Plastic Surgery meeting in Baltimore which came to the conclusion that breast-feeding did not cause ptosis (drooping) of the breasts.

While I haven't seen the published manuscript yet, I find this conclusion somewhat implausible clinically and flawed based on the thumbnail descriptions of the methods of study used.

The researchers interviewed 132 women who consulted for a breast lift or breast augmentation. The women were, on average, 39 years old; 93 percent had had at least one pregnancy, and most of the mothers--58 percent-- had breastfed at least one child. Also evaluated were the patients' medical history, body mass index, pre-pregnancy bra cup size, and smoking status.

The results suggested no difference in the degree of breast ptosis (the medical term for sagging of the breast) for those women who breastfed and those who didn't. However, researchers found that several other factors did affect breast sagging, including age, the number of pregnancies, and whether the patient smoked.

Quantifying something as subjective as this is hard to do under most circumstances (and I give the doctor's credit for writing something interesting), but unless you study these women prospectively (rather then retrospective as was done here) and get better characterization of their baseline breasts size/shape, skin quality, body weight, and breast tissue tone (ie. firm vs fatty) then you really can make no valid conclusions about their hypothesis.

You get breasts that hang for a number of reasons including:

• gravity (no explanation needed!)


• thinning of the skin with age


• attenuation of the internal soft tissue support of breast tissue (aka Cooper's Ligaments)


• "tissue expansion" phenomena from weight gain or engorgement during lactation

Now in re. to ptosis and lactation, the tissue expansion effect is what I'd say predominates. Now as a lactating breast will be swollen for a longer time, it's pretty intuitive and obvious that it's going to affect the breast shape more. I'm skeptical from this intuitive POV plus an (occupational) observational basis on this idea that there's no difference after breast feeding.

One of the more common sub-groups in the breast augmentation or breast lift group are women in their early or mid 30's who present with "involutional ptosis" (our fancy words for saggy breasts after pregnancy). During my residency at the University of Louisville (KY), I can remember spending time with one of my favorite surgeons, Dr. Marc Salzman, who was kind enough to let me accompany him during his cosmetic surgery consults. There was a pretty girl ~ 33 years old who came in, and when describing what she did not like about her breast declared, "Dr. Salzman, after having my babies, my breasts now look like Squidworth's nose!". He was kind of puzzled by her comment, but I burst out laughing aware (due to having small children) that Squidworth is Sponge Bob Squarepant's boss on the popular cartoon show.

Pictured below is Squidworth. And you know what? Her breast looked exactly like Squidworth's nose. :)

Rob

It's hard to outsmart mother nature.

Just thinking about the human body today.....

Reports in the medical literature continually reinforce my belief that it's nearly impossible to outsmart mother nature in terms of the bodies inflammatory response. The inflammatory response is critical to your bodies compensatory mechanisms for stress or infection, but it has a tendency to go haywire and (apparently) make things worse. Billions of research dollars have been invested in characterizing (and manipulating) this cascade of biochemical processes. Every time we think we've figured out the big picture, eventually we are humbled by the bodies' "counter offensive".

In an international study (summarized awhile back here ) comparing bare metal versus the fancy new metal stents coated with medicines to inhibit re-occlusion of the artery showed dramatic increases in post procedural deaths as these patients were followed out from their procedure. When these drug-eluding stents were first introduced in 2003, they became the fastest-selling medical device in recent history despite being nearly 400% more expensive then the older bare metal stents.

We've witnessed a lot of similar outcomes in the trauma and septic response literature as multiple stages of the inflammatory cascade are suppressed or modulated, only to come back with a vengeance thru alternate "work around" pathways that must exist somewhere in the body.

When you see diagrams of what we think the immune response looks like, it is a frighteningly busy graphic. Despite millions of man hours in labor and billions of research dollars, complete understanding of these processes is elusive.

Rob

Give me you hungry, tired, and poor. Hold the fat, please!

Want to see a logical extension of federalized health care and the kind of rationing choices that will be made?

This story here is fascinating.

Richie Trezise, 35, a rugby-playing Welshman, lost weight to gain entry to New Zealand after initially being rejected for being overweight and a potential burden on the health care system.

His wife, Rowan, 33, a photographer, has been battling for months to shed the pounds so they can be reunited and live Down Under but has so far been unable to overcome New Zealand’s weight regulations.

Robyn Toomath, a spokesman for Fight the Obesity Epidemic and an endocrinologist, said the BMI limit was valid in the vast majority of people. She said she was opposed to obese people being stigmatised. "However, the immigration department’s focus is different," she said. "It cannot afford to import people into the country who are going to be a significant drain on our health resources.

"You can see the logic in assessing if there is a significant health cost associated with this individual and that would be a reason for them not coming in."blockquote>

The implications of this are interesting. Is it discrimination or is it making people take personal responsibility when you treat someone different based on what are (often) controllable health risk factors?

We've already clearly made this value judgement with smokers and we're moving that direction with obesity. It's clear that obesity (as opposed to be merely overweight), much like smoking, is a devastating drain on our resources from a systems level. This was federally recognized in this example from New Zealand. Expect to see some incentives for BMI parameters to more frequently appear in your health insurance policy or be sponsored by your employer, as they've clearly fingered this subgroup as an area for cost containment in their employee costs.

Rob

Happy Turkey Day!

Happy Thanksgiving to you and yours! I've got a lot of ideas floating around for some interesting (to me) writing coming up here on Plastic Surgery 101. 

Stay Tuned!

Rob

Why Doctors do not trust the government to administer health care?

Exhibit A: Wisconsin Democrat governor, Jim Doyle, is trying to do an audacious end run around the intent of a state-administered trust fund meant to control medical malpractice costs.

In 1975, the Wisconsin legislature set up a fund for physicians, hospitals, and other health professionals to contribute to called the Injured Patients and Families Compensation Fund. It was essentially a self-insurance "buffer" against rising med-mal costs and has been widely credited with stabilizing Wisconsin malpractice insurance premiums.

The assets of this fund are substantial, in excess of $735 million in 2007 (covering an estimated $685 million in potential liabilities). Such a large "pot of gold" has proven irresistible for Democrats in Wisconsin, and Gov. Doyle has proposed pillaging nearly $200 million to cover budget deficits the state is running up on their Medicaid program. While it's noble to fund a state's uninsured & under-insured, raping a successful program whose mandate and charter is very specific to the med-mal relief program is going to lead to a bitter court fight in Wisconsin between the Wisconsin medical association and Gov. Doyle.

In 2003 a state law declared the trust "for the sole benefit of health care providers participating in the fund and proper claimants. Monies on the fund may not be used for any other purposes of the state". Keep in mind that individual doctors have essentially been paying into this pool at somewhere between $8-10,000 annually for nearly 30 years. So in a nutshell, this Democratic proposal would turn an insurance program into a massive retroactive tax hike on providers while potentially causing the whole program to go insolvent (as assets would drop ~ $150 million below liabilities).

Gov. Doyle, you're the proud recipient of the inaugural Plastic Surgery 101 cheesehead award!

Vultures circling over Kanye West's mother's death after surgery

The tabloids are in overdrive digging up dirt on the surgeon who performed Kanye Wests' mother's surgery. The surgeon in question was kind of a minor media figure, having hosted some TV shows on plastic surgery. In an instant, this doctor's career has been reduced to "the guy who killed Kanye's mom" which is kind of sad.

Still to be determined is what exactly was the cause of death?

The implication being circulated is that she should not have been done as an outpatient surgery. That's a judgment call, but it's one that has to take into consideration her age, medical comorbidities, type of proposed surgery, and length of surgery. Her surgery was apparently almost 8 hours long, which while longer then you like, is certainly not outside the vague notion of "standard of care". Publicized cases like this tend to lead to reactionary measures, and I would not be surprised with some fallout in California as to how office surgery is regulated.

A woman her age (almost 60) who dies shortly after this kind of surgery would make me think of a few things

1. Did she have a post-operative heart attack( MI)?


2. Did she have hypovolemic shock from intra-operative or post-operative bleeding?


3. Could she have had toxicity from lidocaine (a local anesthetic) used in high volume liposuction?


4. Did she get nauseated, throw up, and subsequently go into respiratory arrest from aspiration?

There's a couple of less likely things that can happen, but they usually don't present quite like Mrs. West's case. Those would be pulmonary embolism (a blood clot which migrates to the lungs & usually happens a few days later), bowel perforation (usually has a more gradual onset of sepsis), and acute necrotizing infections (usually from Streptococcal group A or B bacteria).

Post operative deaths are rare, but tragic. They reportedly occur in only one of 51,459 cosmetic procedures, according to the journal Plastic and Reconstructive Surgery. It's been suggested that number may actually slightly under-represent the problem as not all deaths get reported accurately. For example, a study a few years ago by some dermatologists claiming no deaths from high volume office-based liposuction cases performed by dermatologists flew in the face of numerous anecdotal reports by General & Plastic Surgeons having to deal with major complications which showed up in the hospital from some of these same dermatologists.

Rob

Stripper Mistakenly Sent to School.....(Thanks, Mom!) and how stripper sales tactics mirror other business

From The Newsvault:

A teenage schoolboy in the UK was pulled around his classroom on a leash and spanked by a stripper after a birthday surprise mix-up. The teen's mother had ordered an agency to give her son a 'surprise' on his 16th birthday - and the teacher had also agreed to allow the surprise. But it all went wrong when the company sent a stripper dressed as a policewoman instead of a man in a gorilla suit - in what it called a booking error.

One student told Sky News: "She asked the lad to stand up, which he did, and told him he had been a very naughty boy because he hadn't been doing his homework."

"Then she put on some Britney Spears music and got out a collar and leash from her bag and told him to put them on." After walking the boy around the classroom and spanking him with a whip, the action got even more steamy.

"She took off some clothes until she was down to her bra and pants, pulled out some cream, put it on her buttocks and told him to rub it in," the student said. It was at that point the shocked teacher - who had not been told what the surprise was - called an end to the show. A spokeswoman for the school in Nottinghamshire said they were investigating how the incident happened.

What strikes me as so surreal is that up until the massaging cream on the butt, that the teacher was just watching this kid being lead around in a dog collar while being spanked with the rest of these 16 year olds. Too, too funny!

While doing "research" looking for a picture to frame this post with, I stumbled across something funny about how strippers and business tactics. It made me reflect that cosmetic surgery/medicine and strippers are alike in how sales are done.

From the Wise Camel Blog

Sales Technique #1 - Give them something for nothing One of the first things a stripper will do is come up to you and flirt with you. She will likely sit on your lap or do something to raise your excitement level. For this, you have to do nothing. But you do get a sample of the service and if it is a good one, your chances of buying the service increases. This also applies to the dances they do on the stage.
Sales Technique #2 - Understand your customers Strippers get to know their customers by asking questions. This allows them to develop a rapport and tailor the sales pitch…
Sales Technique #3 - Tailor the Sales Pitch Strippers will try different sales pitches to different people based on what she thinks they like. “I like to get dirty” or “Have you seen my great ass?” or “My tits are real”. Each pitch may be the one thing that converts the potential customer into a buyer. (Pointing out a tight ass works well for me). And she revises her pitch based on experience.
Sales Technique #4 - Make sure you are selling a great product/serviceShe knows she has to have a great product. If she put on 30 pounds or hadn’t showered for the past 4 days, she would likely not get as many customers. Regardless of how great of a salesperson you are, you can’t do much with a crappy product/service.
Sales Technique #5 - Provide Good Customer ServiceShe will make sure you are happy on your first dance or she won’t get repeat business or won’t be able to do what she ultimately set out to do…Upsell.
Sales Technique #6 - Upsell She sells the customer on a relatively cheap service, a lapdance, but then markets her other services to them. She tries to get them to the “champagne room” and sell an upgraded service, which is where the money is at. However, without the first sale, she would never get the larger sale. Customer acquisition is tough. Once she does it, she needs to get as much business as she can.
Sales Technique #7 - Closing Techniques. She will use a variety of closing techniques to get you to buy her services. There are a variety of closing techniques, but two popular ones used by strippers are the compliment close (usually flirting with you) and companion close (getting your buddies to push you into closing the deal).
Sales Technique #8 - Target your audience Strippers market to individuals that are interested in her service. First, she works in a strip club where guys go specifically for her service, that is obvious. But she also knows which guys to go after within a group or which groups will likely spend the most money. Spending time with cheap-asses only wanting to pay a dollar for a dance will not be a wise use of he precious time.
Sales Technique #9 - Persistence Even though the audience is qualified, she knows she will get rejections. Even so, she will go up to every guy and ask if they need a lap dance. She also knows that the more guys she asks, the more yes’s she will get.
Sales Technique #10 - Branding I don’t know any strippers that are named Ethel, Mildred or Agnus. Instead, you will get the pleasure to do business with Cookie, Destiny, Candy, or Raven.

Obesity- it's effect or mortality and can Plastic Surgery do anything about it

A real gauntlet was thrown down this past week with the publication reviewing the effects of excess weight and morbid obesity on our health. Dr. Walter J. Willett, a professor of epidemiology and nutrition at the Harvard School of Public Health, and 20 co-authors, compiled the 500+ page report, entitled "Food, Nutrition, Physical Activity, and the Prevention of Cancer: A Global Perspective".

Their meta-analysis of several thousand existing studies found that "excess body fat influences the body's hormones, and these changes can make it more likely for cells to undergo the kind of abnormal growth that leads to cancer." In short, "[t]he risk from excess weight begins at birth." Therefore, obese girls who begin menstruation earlier in life "will have more menstrual cycles. This extended exposure to estrogen is associated with increased risk for premenopausal breast cancer."

This staggering review, which took over five years to develop, indicates that "excess body fat increases the risk of cancer of the colon, kidney, pancreas, esophagus, and uterus as well as postmenopausal breast cancer."Obesity seems poised to become the number one risk factor for cancer in America, as obesity increases and the number of smokers decreases.

What can we do surgically about this?

Well, it appears the weight loss procedures, gastric bypass & gastric banding, can significantly reduce or eliminate many associated comorbidities including diabetes, hypertension, obstructive sleep apnea, and progressive osteoarthritis from excess weight load. In 2006, almost 180,000 patients underwent bariatric surgery of some type.

Last year researchers found that gastric bypass surgery patients were 40% less likely to die from any cause during a mean 7 years of follow-up, compared with the obese controls. It's kind of intuitive that there should be some risk reduction for some of these cancer risks associated with obesity, but I don't believe we have evidence to leap to that conclusion. It might be a very small effect statistically unless it was done on an obese adolescent in whom you'd have decades to track this.

I found a nice collection of review studies re. to Gastric Bypass here at Thinner Times if you're interested.

What about plastic surgery?

Unfortunately there is fairly poor evidence that plastic surgical treatment of weight, whether by resecting excess skin/fat or by liposuction, has an effect on any of these benchmarks. What we can do is cosmetic changes only. A paper from Washington University (St. Louis) published in the New England Journal of Medicine in 2004 found no benefit from high volume liposuction (as you''d expect from weight loss via other methods or diet), where as much as 20% of patients subcutaneous fat stores were removed via liposuction. There have been a small handful of lesser quality papers (like this) suggesting that large volume liposuction may improve glucose control in some type-2 obese diabetics, but the evidence is weak and the studies not really well done (it's a hard subject to study with any uniformity).

However, there is some rationale for a mechanism of how it could work. Large areas of lipodystrophy (fat deposits) are essentially your bodies "batteries" for energy storage. Obese people have a resistance to the effect of insulin mediated in part by their excess fat. In more than 80% of patients who are severely obese and have diabetes and then have gastric bypass surgery, the diabetes is cured. So remove the fat, remove the diabetes, right? Well it turns out it's not quite that simple. It appears the visceral fat (fat inside your abdomen and liver) may be the bigger culprit then the fat outside that you remove with excision or liposuction.

Below is a photo of a visceral fatty deposits in a mouse liver in two different species of mice involved in obesity research. The upper photo shows an "obese mouse", while the lower photo shows the "fit mouse" liver. You can clearly see the "marbling" of the fatty liver.

Rob

Patients in clinical trials - a footnote to the breast implant patients in the New York Times article

Today's entry is kind of an "inside baseball" thought that occured to me reading an article on medicine.

There was a breathless article on the news wire "Participants Left Uninformed in Some Halted Medical Trials" (syndicated from a New York Times story) earlier this week about the fate of patients who were enrolled in clinical trials for devices or drugs that had been discontinued. In many instances these patients (and occasionally their doctor) were apparently unaware of this fact. They used two medical devices as examples - vascular stents used to treat aortic aneurysms and a type of breast implant used in cancer reconstruction.

The stents are a potential big problem in that if they don't perform as designed, the patient will die. The breast implant patients (two women in south Florida) seem to be having much less an urgent issue. From the thumbnail description it sounds like the women were having some degree of capsule pain, which is not terribly uncommon especially in breast reconstruction patients who've been radiated. Capsular contracture is also the way some silicone implant ruptures present.

Implied in the NYT article is the implication that these women are "sitting on a time bomb" with their implants which is really silly and makes the juxtaposition from the stents scenario kind of ridiculous. In this instance, I'm not sure you'd do anything at all different for these women other then checking for rupture. No one would recomend "prophylactic" removal of those implants in the abscence of documented rupture, particularly if the implants were less then 10 years old. We have plenty of information about the treatment of silicone breast implant ruptures, and it's well established that the problems you get are local issues to the chest wall. A capsular contracture or ruptured implant is it's own issue, but to hold it up next to potential life-threatening device failures misses the real serious problems with medical devices and their surveillance.

They don't really go into much detail other then identifying the implant manufacturer, Allergan, and that the particular implant had been discontinued recently (~2005). If I had to guess, it's probably the Inamed "Style 153" implant these women had, which was an anatomically shaped silicone gel device that preceded the more advanced Style 410 "gummy bear" implants. Those implants, which were voluntarily pulled from the market by the manufacturer during their approval process negotiations with FDA for their conventional type of silicone gel breast implants.

The style 153 implant had an innovative "double lumen" core that had an apparent higher failure rate when you studied them on MRI scans (the best test for rupture). Confusing the issue is the resemblance of the double shell for some of the described signs of intracapsular implant rupture which is well described in this full text American Journal of Radiology article. There are a great many surgeons who strongly believe MRI's (or at least the radiologists reading them) have a tendency to over-estimate ruptures, particularly with this specific implant. At the end of the day Inamed made the decision in 2005 to "cut bait" on such a minor product to better their chances of FDA approval for their other products. The style 153 was a good implant for it's time, but it really was just a transitional model to the form-stable devices like the 410.


* Below is an MRI showing the characteristic "double lumen" sign confused for rupture occasionally with style 153 device

Rob

Another landmark comprehensive review of silicone breast implants now on the books from Vanderbilt. GO 'DORES!

The November issue of the journal, Annals of Plastic Surgery, features an up to date comprehensive review article on the state of research involving issues of safety surrounding silicone gel breast implants. Researchers from the Vanderbilt University Medical School-Ingram Cancer Center review several hundred related studies to produce this magnum opus. A story interview the lead researchers can be read on the Vandy News Service here.

This "snapshot" is the most thorough review of this topic since the landmark 1999 Institute of Medicine report and addresses the ongoing epidemiology studies thru the Fall of 2007. The body of literature continues to be remarkably consistent in that the weight of the epidemiological evidence does not support a causal association between breast implants and breast or any other type of cancer, definite or atypical connective tissue disease, adverse offspring effects, or neurological diseases.

From lead author, Dr. Joseph McLaughlin,

“Few implantable medical devices have been investigated for safety hazards more extensively than silicone gel-filled breast implants,” said McLaughlin. “For almost three decades researchers around the world have been conducting in-depth studies on the health of women with implants to determine if there are significant health risks. The evidence is clear that implants are not linked to serious disease.”

An increased suicide rate from patients implanted 20-30 years ago has been the only consistent finding across several large follow-up studies. I've touched on that issue before on Plastic Surgery 101 (read here) on how inferring causation is likely incorrect as epidemiology suggested significantly higher psychiatric co-morbidity among women in those studies from the 1960's to early 1990's (so you'd expect higher suicide rates/attempts). I cannot imagine how you could ever effectively study this subject prospectively, particularly in the United States where medical records aren't centralized. Confusing things even more I'd submit is the recent rise in the United States of pharmacological treatment with mood-altering drugs (Prozac, Daypro, Xanax, anti-depressants, ADHD drugs, weight-loss medicines, etc...) for people who don't have classic or formally diagnosed depressive disorders. I see women (and men) all the time on such medicines prescribed by their family doctor or internist who would not meet strict medical criteria for what they're medicated for.

It would seem to me at this point that the most important issues left to characterize about existing silicone implants would be:

1. Late rupture rates - what can we expect durability-wise at 12-15+ years out?
2. Suicide rates - how to most effectively screen out unstable patients?
   
   

Spatial Perception - Is your surgeon left or right brained?

At right is the mind-bending work, Bond of Union, by M.C. Escher , who made a career of challenging his audience's spatial perception. I thought about this artist when I was thinking/daydreaming about how to make better incisions for tummy tuck operations on weight loss patients. The key to those operations is trying to figure out ways to equalize differing lengths of skin with your incision over a cylindrical object (your trunk) while compensating for it's movement and elastic properties.

I saw reference to spatial relations and how we percieve them on theFreakonomics blog. Freakonomics was a best-selling book in 2005 written by a University of Chicago economist who applies economic models to mundane things which will leave you thinking about things like you never did before.

The picture below links to an animation of a dancer rotating which is supposed to be a proxy for whether you're left or right brain "dominant".

Left brainers (who see the dancer rotating counter-clockwise)are supposed to be stereotypical logic-oriented, better at math and 3-d spatial relations, and overall more conservative.

Right brainers (who see the dancer rotating clockwise) are more intuitive, imaginative, risk-taking, and artistic-minded.

Click on the picture to start the animation in a new window.


They say you can make yourself reverse the spin you perceive if you concentrate properly (much like the state you have to get in to see those "magic picture" images). I see the dancer going clockwise most of the time, and I'm pretty convinced that the image reverses itself on some interval to see it the other way.

I'm dismissive of the right vs. left brain dichotomy, at least in a rigid view of it. There's philosophic debates in Plastic Surgery about measurements versus "artistic taste" when performing procedures. I find that argument tedious. Much like an artist, athlete, or even a pool hustler we actually do process these spatial and ma thematic relationships internally, so in some sense it's all about the math. Recording or marking that (when possible) seems likely to achieve reproducible, predictable, and quantifiable results. Complicating all that analysis is that in Plastic Surgery are the variables that are outside of our control - scarring, contracture, elasticity, gravity, atrophy, and motion.


Rob

Red Sox yes! Fat graft no! Stay far,far away from this Boston area Dermatologist's plan

The Boston Herald last week did a "gee whiz" piece on a dermatologist(!) promising to start performing breast enlargement via fat grafting despite the fact that there is no literature documenting it's either safe or effective. Over the last year I think I've mentioned this idea once or twice commenting on some of the technology evolving to better harvest stem cells from liposuction aspirate.

Irrespective of whether it's appropriate for your average dermatologist to do large volume liposuction (which is required for harvesting the graft material) and go anywhere near your breasts, there's a couple things that are really troubling with this.

1. Is it a good idea to out pleuripotent stem cells in a cancer prone organ like the breast?

2. What's the effect on mammograms from (inevitable) areas of fat necrosis?

3. Does fat grafting and the internal breast tissue scarring/distortion that will result, prohibit conventional techniques for breast surgery from being performed?

4. Can touch-up grafts be successfully done?

5. Can predictable volumes of graft be obtained in a material (fat) who's success rate traditionally hovers around 50%?

6. Has this doctor established an IRB (internal review board) protocol for this kind of human experimentation (which is what this is?)

Call me a cynic, but I find it unlikely that these kind of issues have really crossed the mind of this dermatologist from the rather flip quotes in the newspaper story. Fat grafting of the breast has a role in the armatarium of breast surgery and is being studied, but "cowboy medicine" like this article describes sticks in my craw. Fat grafts for primary breast augmentation is a subject that demands carefully designed multi-site studies.

Rob

PS 101's break from serious stuff - featuring Travis

I've got about a dozen half-finished blog-post drafts laying around. I;ve decided to take the easy way out today and do a quick hitter.

If you've never heard of the British band, Travis, you're missing out. It's ironic that prior to hitting the big time, Coldplay was considered too derivative of Travis to make it. The video for their single "Closer" is absolutely sublime and features a cameo appearance by actor, Ben Stiller.


Click on the image below to watch Travis' "Closer" via the magic of You-Tube.




This should have been a big hit stateside for Travis IMO. It really reminds of the wonderful Spike Jonze-directed video for Weezer's "Buddy Holly" from the mid-90's. To sample the body of work of Spike Jonez see Wax's "Southern California", Levi's jeans "Tainted Love" commercial, Fatboy Slim's "Weapon of Choice" (featuring a tap-dancing Christopher Walken)

Cities bringing a gun to the knife fight when they're sued for medical malpractice

Sorry for the dearth of writings! I've been in California all week.

An interesting and ironic story in the New York Times today "Rules to Collect Care Costs Are Coming Under Attack."

In summary, in a number of instances where complications involved with indigent medical care resulted in large medical malpractice judgements against municipalities, the cities have subsequently turned around and presented bills for their care to be subtracted from the judgement. I LOVE IT!

The case discussed in the article involved a psychiatric patient who's estate sued a city after he gauged his own eyes out in a treatment center (because obviously it must be the cites fault according to trial lawyer logic).

“This is a matter of fiscal responsibility,” said George Valentine, the Washington district’s deputy attorney general for civil litigation, explaining that city taxpayers deserved to be protected from expenses that could be shouldered by patients. Payment from Ms. Motley would have been due only if a jury found in her favor and the city would not have collected more than what was awarded, Mr. Valentine said."

Trial lawyers have complained that such attempts to re-compensate cities for free care gives too much leverage to the city when they're trying to negotiate settlements from them (and removes much of a potential windfall from their share of the settlement). This is just one more example of just how crazy our med-mal system has become.



Rob

Doctors flock back to Texas after tort reform. Well DUH!

The New York Times chronicles the massive success of Texas' tort reform efforts have had on the climate for medical practice in their state. They've answered one of those "Who's buried in Grant's tomb?" stupid questions about the real-world positive effects of tort reform on medicine. Since 2003, when sensible med-mal caps for non-economic damages were enacted, Texas has seen an increase of nearly 20% of Physicians becoming licenced there. This includes a disproportionate number of critical specialists including 186 obstetricians, 156 orthopedic surgeons and 26 neurosurgeons.

For pain and suffering Texas patients can sue a doctor for no more than $250,000 each. Plaintiffs can still recover economic damages, like the cost of medical care or wages, but the amount they can win was capped at $1.6 million in death cases. Those are numbers I think most people consider reasonable, especially when the primary goal of the med-mal system is not to be some punative wealth-redistribution process.

As a result of these, the average malpractice premium reduction physicians has seen is 21.3%, and I suspect for some of the surgical specialties it may in fact be much more then that. It's hard to argue against that as more evidence of the correlation between tort reform and the malpractice crisis unless you're a trial lawyer.

Rob

More on the "Cadillacs for all" post

I got a couple emails and posts about the last entry here on Plastic Surgery 101 on the lawsuit over breast reduction asking some questions about the cost of these procedures. Particularly, people (me included) feel this woman's lawsuit is sympathetic but feel the cost difference is indeed something that should be factored in, especially as it's over 15 years out from her original surgery.

A colleague pointed out some of the long-term costs associated with implants that you don't necessarily have with autologous (your own tissue) reconstruction (ie. need for replacing ruptured implants or the need for revision surgery for capsular contracture).

Here's my take.......

Trying to figure out the actual costs & morbidity of surgical procedures is difficult. There are tremendous variables all playing into this. A number of studies have compared the cost of different reconstructions at their institutions and come to different conclusions on long term costs. Implant based reconstruction is clearly cheaper up front, but over the course of many years (and further revision surgeries) this evens out assuming no major complications from flap-based surgery. These studies have never addressed scenarios like the one involved in this lawsuit.

It becomes silly at some point to try to translate the cost of these surgeries at a place like MD-Anderson or Sloan-Kettering Memorial (the most well-known cancer centers in the country) to how much it costs to do the surgery in some non super-tertiary center. Length of stay, routine post-op care, and operating times in these papers are all over the place and most Plastic Surgeons reading these analysis just don't believe the numbers reported (or at least don't believe those numbers are reproducible at their hospital).

In this case consider the up-front costs of the two proposed surgeries:

1. An hour-long outpatient bilateral implant exchange/minor revision prob. has a true cost (not what you'd seen on charges to an insurance company) between $5-10,000. I say "true cost" as I know what it would cost to do this as a cosmetic case where all fees are out in the open. For comparison of what an implant costs (not the surgery fee, but the price tag for just a single device): a saline implant is ~ $300, a traditional silicone implant is about $850, and the not currently available Inamed 410 "gummy bear" implant will be almost $1100

2. a traditional bilateral pedicled (where you keep the blood vessel attached) TRAM flap is a surgery that would likely take 5-7 hours for one surgeon to do and require closer to a week in the hospital. Charges for this might run closer to $100,000. Associated with harvesting both rectus muscles is a fair incidence of abdominal wall hernias requiring future surgery.

3. a microsurgical bilateral "free" DIEP flap could take 10 hours of surgery depending upon the difficulty of the microsurgery, require ICU admission for flap monitoring post-op, require a week in the hospital, and bring a bill over $150,000. This procedure spares the muscle harvest of a TRAM at the expense of a longer and more complex surgery with higher rates of flap loss.

Implant reconstruction brings some "legacy costs" which autologous reconstruction does not. Now modern implants life-expectancy is still a moving target, but 15 years is a reasonable expectation. (The gummy-bear implants still pending approval may extend that life-span indefinitely). Worse-case scenario, a young or middle aged-woman might have to have her implants exchanged 2-3 times over the course of her life. Reoperations from hardening (capsular contracture) are also going to add some number of reoperations to this figure.

From my crude estimate of costs in this case, even though immediate implant-based reconstruction may be more expensive in some cost-analysis decades out from surgery (when reoperation costs are figured in) then doing a TRAM or DIEP at the time of mastectomy, you can imagine that the costs in this particular scenario will never make sense from a cost perspective, especially when the system has already been hit once with the first reconstruction cost. It's for this reason I find it most compelling to expect the patient to self-finance part of this when other less expensive options are available.

Rob

Breast reconstruction lawsuit - Can we afford Cadillac's for all?

There's an interesting philosophic debate being played out in a lawsuit in New Jersey over an insurance companies refusal to pay for a patients breast reconstruction surgery. You can read the news wire story here.

Short Version: Patient has double mastectomies with saline implant reconstruction almost 15 years ago. One of her implants deflates, and her insurance company is refusing to now pay for a conversion to a reconstructive procedure using her own tissue.

Replacement of her implants with either saline or silicone implants (which they would agree to cover) would be able to be performed quickly and done as an outpatient surgery with little morbidity. The type of surgery she wishes to have covered, a DIEP flap (deep inferior epigastric artery perforator) is a complex microsurgical procedure (where tissue from her abdomen is transferred to her chest wall) which would involve a long, expensive operation and a number of days in the hospital.

Last fall I profiled a case in People magazine where such a DIEP flap was performed on identical twin sisters, with one twin's abdominal tissue transferred to the other's breast. You can see that story here "Breast Reconstruction Using Your Twin."

What are the issues involved with this as I see it:

1. Should breast reconstruction after mastectomy be covered?

Well that issue was settled a number of years ago via federal legislation, the Women's Health and Cancer Act (WHCA) of 1998, ensuring that reconstruction was a mandatory obligation of insurers.

2. Should all types of reconstructive surgery be covered?

Again, that's part and parcel of the WHCA, which includes reconstruction after mastectomy for benign disease, usually done for painful cystic breast tissue.

3. In a scenario like the one involved here, should someone have the right to demand complex and expensive surgery when less expensive options are available?

I'm conflicted here. It does not seem completely outrageous to me for this company to deny this request or at least ask the patient to pay part of the balance difference given the particulars as I understand them. She had an acceptable reconstruction with implants, and needs a quick & relatively inexpensive surgery to maintain her result.

In other countries with state-funded ("universal") health care programs, I suspect there's no way in hell this would be approved. In an era of cost-containment, all health care costs are going to be scrutinized and there will be hard choices to make. Luxuries like exotic breast reconstruction almost two decades after the initial surgery seem hard to justify in that context.

Rob

Dr. O in American Sexuality Magazine........ Mom will be so proud!

I was interviewed awhile back for San Francisco's American Sexuality magazine which finally came to print. The article "Plastic Surgery and the New Standard, Unnatural Beauty" can be read by clicking here.

My contribution to this had to do with the question of:

1. Whether we're becoming a society of have & have-not's for plastic surgery along class lines




2. Whether we're in an era of unprecedented beauty standards

I made two observations.

One - that rather then becoming more exclusive, the access to cosmetic plastic surgery has never been more readily accessible to the masses. Decades ago, there were only a handful of providers who catered mostly to the very well-to-do. Now we have many different kinds of doctors doing "cosmetic medicine" of all types at historic discounts with low-interest financing available from multiple sources. The cost of theses procedures is historically low and are frequently offered in convenient retail-like environments.

Two - "unnatural" standards of beauty have always existed and I'm not so sure that what passes now (BOTOX'd foreheads, laser "Brazilian" hair removals, breast implants, etc...) are more radical things that have been done since time immemorial (infant head molding, feet binding, corsets ("wasp waists"), neck stretching, tattooing, ritual scarring/piercing). In fact, there's kind of been some pushback towards less radical surgical and non-surgical treatments towards less obvious and more natural results.

Rob

The best breasts (?)

In what I guess passes for peer-reviewed literature in the UK, a London surgeon has proclaimed to have identified the perfect breast. The model mammary has a nipple that points slightly up, and an upper breast pole just a bit smaller than the bottom half. Apparently UK surgeon, Dr. Patrick Mallucci, spent many hours "poring over photos of topless models in lads magazines and tabloid newspapers" to come up with this theory.

While observing the "ideal" (as defined by cultural norms) is an ok way to make some general observations about beauty, I'd take issue that "laddie mags" (STUFF, Maxim, etc....) and pornography are the best reference point. A disporportionate number of models in those mediums have had breast augmentations which changes your whole frame of reference for comparison. The ideal augmented breast should approach the ideal un-augmented breast, which most (don't flame me here) would point to as the symetric nulliparous (prior to childbearing) breast with little ptosis (droop) that possesses some degree of upper pole fullness. This is pretty much what Dr. Mallucci describes, but I take some contention to his methods and conclusions. Most women will never have this kind breast naturally, but "good" breast surgery can move someone closer to it. The ideal breast shouldn't be pointed to one that does not and cannot exist in nature, ie. Baywatch circa 1996.


Who has the "best breast" according to this doctor? The "why exactly am I famous again?" model/singer/personality, Caprice Bourret

And the worst? The world's most famous soccer mom, Victoria (Posh Spice) Beckham

I'd agree that Ms. Beckham's result isn't the best, but thin women have a hard time hiding all but the most modest implants. She would have done better with smaller and narrow implants, and would have been ideal for the anatomically-shaped gumy bear devices (form-stable high cohesive silicone gel devices like the Inamed 410 or Mentor CPG).

But picking 36 year-old Caprice Bourret as the best "natural" breast shape (as described by this doctor in the article)? She's got a classic over-sized, over-round result you get from big implants (again that Baywatch thing). She's claimed in the past not to have had extensive plastic surgery, but I find that implausible.

Do you?



While it may in fact be a result that both earns Ms. Bourret a great deal of attention and be one that many women think they want, it's a setup for multiple future complications. That tissue just won't maintain that result for any length of time.


Rob

Urban legend debunked: Can you donate skin from your tummy tuck to the Shriner's burn center for skin grafting?

I do a good bit of surgery on people after the two most common weight loss operations, gastric bypass and gastric banding (the "lap-band"). Every few months I get an email from someone asking about a rumor they've heard that if they donate their excised skin from their tummy tuck (panniculectomy) surgery that they will get the cost of their surgery covered by the Shriner's, the charitable social organization whose endowment funds many of the largest burn units across the country.

The idea that that skin could be used easily always sounded fishy to me, as post weight loss skin is "damaged goods" and would seem like poor material to be considered for use as it tends to be very thin and attenuated tissue.

Cadaver skin has been harvested for a long time for use as temporary wound coverage. If you try grafting it on someone else, their body ultimately mounts an immune response and rejects it. Still, it can make an effective temporary closure for very large burns. A number of companies turn cadaver skin into commercial products like Alloderm by removing the proteins from it that trigger your immune system. Alloderm (usually processed from the very thick back skin) is a very strong material I increasingly use during breast reconstruction.


Anyway, back to busting the urban legend thing.............

From the Shriner's Hospital website:



Q: Can skin from gastric bypass surgery be donated to children for skin grafts?


A: No, the only donor skin that can be used at the burn center is cadaver skin processed through a skin bank. Only skin from cadavers is used for skin grafts, because cadavers give the greatest amount of surface area – up to 10 sq. feet of usable skin for a burn patient. Skin that could be taken from a person who had excessive weight loss would not generate the amount of skin or quality skin needed to treat burn patients.

Rob

Redefining indications for breast reduction

In this month's Plastic & Reconstructive Surgery, our profession's flagship journal, there's a study about the symptomatic relief woman receive after breast reduction who fall below the minimum threshold insurers require for coverage. To no one's surprise, even reductions less then half of the average weight removed showed dramatic symptomatic improvement at over 1 year out from surgery.

Most health insurance plans require a minimum of 500 gm (~ 1.1 lbs) of tissue to be removed per side for coverage in addition to documentation of symptoms related to their breast size. Occasionally you get some asinine form letter asking for proof of "conservative" treatment of large breasts prior to surgery, whatever the hell that is!

The authors of this study call for review by insurers of their criteria for coverage. Good luck! Insurers haven't been recording record profits by dramatically expanding their potential exposure for surgical procedures. This study doesn't really offer much that hasn't been presented to these companies for years. They're not interested in the close to three dozen papers with similar findings in the published literature.

The catch-22 here is that when coverage is expanded usually the reimbursement for the surgeon is cut. Breast reductions are long and physically hard procedures which can take 3-4 hours when you do it by yourself on large reductions. What we get paid for these is about 20-30% of what is commanded for mastopexy (breast lift) surgery, a closely related procedure which often may involve a small reduction component. It's gotten to the point for many surgeons that they just won't do it anymore as (depending upon the insurer) these hover right at the break even point for their practice when all the costs and follow-up care are figured. If you don't believe me, try finding a list of providers who will accept Medicaid assignment for these.

Rob