More mailbag questions!

Tom Fiala, a fellow plastic surgeon, asks "Do you think American women will make the switch to the Allergan Style 410 implants? Or does the required larger incision size, and un-naturally firm texture overwhelm the advantages of the non-collapsing shape? I read about lower capsule rates in the literature - but is that because they're so darned hard to start with? "

My prediction - there will be tremendous promotion of the form stable devices (the Allergan 410 & the Mentor CPG)upon approval with a signifigant backlash after people attempt to use them in the wrong patients. These devices demand a "virgin" pocket of tissue for tissue adherence and will not be a great choice for reoperative patients with the large pockets that smooth,round implants require. You will see a lot of rotational problems present as people experiment with these implants. These anatomic shaped implants are also a poor choice for patients with significant ptosis (droop).

If Allergan & Mentor are smart, they should be manufacturing a line of round, form-stable devices for the American market which will be what we gravitate towards I bet. The stiffness of these devices is also going to take getting used to. There exists a slightly less stiff cohesive 410-style device in Europe which might be a better fit for American tastes.

Underdog implant manufacturer, Sientra (aka Silimed) has had one of the softer cohesive gel "tweeners" in their lineup (which is still in FDA trials) that feels like it hits the sweet spot just right. They've also got some really sharp management in former Inamed execs Hani Zeini and Dan Carlisle. I haven't seen any of their implant performance data, but it will be interesting to see if the outstanding Allergan 410/Mentor CPG numbers in re. to rupture and capsular contracture are maintained when you soften the implant slightly like Sientra.

Snafu Suz also asked for news about the form stable (gummy bear) devices.

The million dollar question now is, "When will Allergan's & Mentor's devices be available?". You could go broke betting on how the FDA moves on anything. However, the data is so overwhelming that these type of implants dramatically reduce complications that it seems approval is likely this spring. I've heard thru the grapevine that major inservice meetings for the device reps. have been scheduled within the next few months which I take to mean that the FDA has communicated to these companies their endorsement of their PMA applications. Rupture rates of almost 0% and capsular contracture rates 60-80% less then current devices in recent studies seemed to have been persuasive.

Dancing Bev left this comment on a post re. to fat-grafting lumpectomy defects using a proprietary system by Cytori (see here) of which I was pessimistic on it's practicality. She writes "I recently heard a presentation of them stating that the costs for the whole reconstruction procedure (doctor fee, equipment, medical personal, energy...) would not surpass 8000$ of which the stem cell product itself costs roughly $2000. "

$8000? I'd counter that on planet earth it unfortunately costs more then $8000 to take somebody to the hospital O.R. to put a cast on for 10 minutes, much less perform a procedure taking several hours with several thousand dollars worth of disposable goods as is outlined in the description of that type of fat grafting. I sat through 5 lectures on fat grafting and 2 live surgeries this past weekend and the costs for those procedures was apparently between $30,000-50,000.

Don't take that to mean I'm not interested in this, I just don't understand the economics of complex fat grafting setups. A number of Europeans are presenting fairly simple ways of fat harvest and grafting irradiated breast wounds that can be performed in less then 30 minutes under local in your office. I was so impressed that I just bought some simple equipment to start doing fat grafts on radiation induced breast wounds in my procedure room.

Rob

Questions from the mail bag

Today is the innagural session of attempting to answer questions from the audience. I'd like to make this a regular feature.

Gorgeous black woman (what a great ID!) asks me to discuss "relatively new procedures (SmartLipo, Liposelection, surgery-free nose job, transumbilical breast augmentation)"

Everyone's always looking for "something for nothing" which describes most of those things you're asking about. My thoughts in order.

1. "Smartlipo" - this is a kind of liposuction machine which has a weak laser at the tip of the liposuction instrument which ostensibly breaks up fat at the end. It's promoted as having less edema, pain, etc... which is a claim that Plastic Surgeons have learned to be skeptical about. I'm withholding judgement on this particular device, but the track record of this kind of "laser assisted" liposuction is poor there are very experienced liposuction surgeons panning this. The fact that you will still need to extract the emulsified fat with traditional liposuction instruments makes some skeptical that it makes sense to buy a $100K+ machine to pretreat an area prior to suction.

Another thing to note is who is promoting these devices. By and large it's dermatologists, gynecologists, and the nebulous "cosmetic surgeon" types rather then Plastic Surgeons who actually have a great deal of body contouring training and experience. If you go to the manufacturers website the 3 physicians spotlighted are a family practice doctor and 2 gynecologists, one of whom claims "board-certification" by the American Academy for Cosmetic Gynecology of all things (color me impressed!). The 3 doctors in my state promoting this are a dermatologist and two ENT doctors BTW.

That's a big red flag to me that this is more sizzle then steak, but I am interested in seeing this hands on. I reserve the right to reevaluate this technology as it's techniques matures.

2. Liposelection (aka. VASER) this is a refined version of ultrasonic liposuction (UAL) technology. Despite initial enthusiasm, UAL has stiffed as it has been associated with higher complication rates with no clear advantage in results. VASER is a "kinder, gentler" UAL which has actually gotten fairly good reviews. The cost of the device ($50K+ I think) has killed wider usage, as it's really not clear that it offers any advantage over traditional techniques. Much like SmartLipo, the economics of it make no sense for most surgeons. If the price comes down it's use may increase somewhat. Think of it as an alternative to Smartlipo with a little better track record at this point.


3. "surgery free" rhinoplasty is not something I think you want to jump on board with. A number of referral rhinoplasty experts report that they are seeing serious complication from injectables in the nose with dramatic amounts of scarring/inflammation which make surgery very difficult. The picture at right is from Dr. Dean Toriumi, a rhinoplasty super(duper)star from November's "Cosmetic Surgery Times" feature on this practice.

Nasal skin is fairly specialized and can be pretty finicky in how it reacts to either defatting (to thin it out) or to augmentation with soft tissue fillers. Some defects can be camouflaged by fillers or more traditionally cartilage grafts (which have their own set of complications long-term). If I was going to be attempting correction with a filler it would probably be with something like the small-particle size Juvederm which should cause the least problems and wear off at some point.

The article by Dr. Toriumi clearly shows why if you are considering doing this, you need to have someone who actually knows nasal anatomy and surgery discuss this with you. This is not something your dermatologist or other cosmetic medicine provider she be dabbling with.

Anon, a breast cancer survivor, asks "I take tamoxifen. I exercise an hour a day - tough things like spinning and hiking. I keep gaining weight. Yes, I eat. But do I really need to starve myself? Is it the meds? The surgery? The menopause?"

Tamoxifen and other related drugs (Arimadex, Femora) literally induces a "chemical menopause" as they block estrogen receptors. It can play havoc with some people's metabolisms. At the end of the day though, all weight gain comes from taking in more calories then you're expending. If you're having problems with your diet, consider sitting down with a dietitian and they may have some relatively painless ways to cut back on high-cal/high-carb intake.

Anon #2 asks me to comment on the rumor that various insurance companies are cancelling or refusing to grant medical policies to women with breast implants.

I've yet to see this in writing anywhere, but I've heard it anecdotally from a surgeon in California. This should become less of an issue as we continue to produce better data on outcomes after breast augmentation. The longitudinal data that keeps churning out from the U.S. FDA data and from Europe looks better and better, particularly with the devices we're about to get wider access to in the United States.

Keep your questions & comments coming. I love this stuff!

Cheers,

Rob

Atlanta Breast Symposium 2008 - lots to digest!

Sorry for no posts since last week, but I've just returned back from the 2008 Atlanta Breast Symposium. Like I mentioned last year, Atlanta is kind of the "spiritual home" for plastic surgery of the breast in America, and this meeting is kind of the premier forum for discussing issues re. to breast surgery.

Lots of things buzzing around my head which I'll be writing about soon!

Expect forthcoming writings on:

• fat grafting of the breast
• controversies in breast reconstruction
• technical and safety advances
• the pending approval of form-stable "gummy bear" implants

Cheers!

Rob

Would you want to know? Testing your children for the breast cancer gene (BRCA)

*At right is a computer model of the BRCA-1 gene protein

The American Journal of Medical Genetics published a provocative paper this month titled, "Should genetic testing for BRCA1/2 be permitted for minors?" and reflected the surveyed opinions of adult carriers of the most defined "breast cancer gene" mutations, BRCA-1 & BRCA-2, about their feelings on having their children screened in adolescence.

What was the result?
A strong majority felt they'd support more aggressive screening. No surprise there.

What's the controversy?
Is it right to burden teenagers with genetic information that they may not be able to properly understand or cope with. This topic of "genetic destiny" also predictably brings with it discussion of practical issues (Will I be discriminated against for getting a job or health insurance?) as well as discussion of ridiculous parallels (ie. Nazi eugenics).

I personally find the logic of not screening to be flawed. Carriers of the gene are predisposed to not only breast cancer, but also to ovarian, colon, prostate, and uterine malignancy among others. More aggressive screening tests and liberal use of prophylactic mastectomy would actually make a dramatic difference in cancer-specific mortality in this subset of the population.

Something to think about!

Rob

Florida, you deserve better then this from your state medical board

Today I feel like throwing some rhetorical grenades!

I'm reading today's New York Time health section when I came across another article about cosmetic medicine encroaching on retail environments, "Having a Little Work Done (at the Mall" when the photo below caught my eye.

The photo's caption reads "At the Sleek MedSpa in Aventura, Fla., Martha Mena undergoes a procedure to dissolve cellulite. Lorianne English, a nurse practitioner, gives the shots as Ms. Mena’s friend Erika Galan looks on."

THIS PICTURE AND THE PRACTICE DISPLAYED IS OBSCENE!

Let me get this straight: You have an unsupervised allied health provider (a nurse practitioner in this case) in the mall delivering off-label medications in an injectable form they're not approved for, which also have a track record of potentially serious complications.

Is the Florida State Medical Board asleep at the wheel? While Florida is liberal with scope of practice issues with their nurse practitioners and physician assistants, I'm taken aback that this is not being scrutinized closer. I got interested enough that I sent an email to the office of Quality Assurance in the state medical board asking for a position on this. I'm sure they'll get back to me el pronto. (snark!)

Rob

(Another Democrat) Govenor Ed Rendell tries to raid the Physicians' cookie jar!

Awhile back I'd written about (see here) the Democratic Governor of Wisconsin, Jim Doyle, raiding a trust fund set up (and paid for) by Doctors to stabilize medical-malpractice insurance costs in that state. Why? In order to avoid unpopular budget and spending cuts to balance his budget. That case is still being litigated.

Taking inspiration from his Democratic cohort, Pennsylvania's governor, Ed Rendell (D-Pa) has targeted their state's Medical Care Availability and Reduction of Error Fund to the tune of $400 million USD to cover deficits in their state's budget. A summary of this can be viewed in the AMA News, here.

This program known as "Mcare" has been successful in partially turning around Pennsylvania's climate for being a horrible state for doctor's to work in re. to med-mal conditions. MCare provides doctors with catastrophic coverage for medical malpractice. Doctors in Pennsylvania purchase $500,000 worth of insurance from a primary carrier and then another $500,000 worth of coverage from MCare. It was also a key component of limited tort reform in that state. On its Web site, the Pennsylvania medical society has posted the question, "Would you continue to practice in Pennsylvania if you no longer received relief (abatement) from MCare?" Nearly two-thirds of respondents said they would not.

FREE ADVICE: Ed, in a state struggling with access problems, I'm not sure that driving away health care providers is the way to go.

Governor Rendell has been progressive in trying to expand health care coverage in Pennsylvania (which is a good thing), but he has been unwilling to make hard spending cuts and unsuccessful in persuading his state legislature to fund his ideas thru taxes on tobacco and business not offering health insurance. He now is trying to play political hardball and quite willing to disrespect the health care providers in his state to do it. An article in today's Pittsburgh Post Gazette quotes the Governor as saying

"If I have to choose between taking care of doctors and taking care of someone who has cancer and doesn't have health insurance, it's an easy choice"

This is an unbelievably cynical "straw man" tactic (ie. setting up false alternatives to make a rhetorical point).

There's no plausible or logical link between Mcare and his political failures, but merely he sees a pot of "easy money" sitting around funding a successful program whose constituents (ie. doctors) don't have the resources to hurt him politically if he steamrolls them.


To Governor Rendell, I ask you:

PLEASE KEEP YOUR HAND OUT OF THE COOKIE JAR!


Rob

Autopsy suggest cardio-pulmonary event led to Kanye West's mothers death

The autopsy report on Ms. Donde West, mother of hip-hop star, Kayne West has been released. You can read it here. On November 9th, 2007 Ms. West underwent breast augmentation/mastopexy, belt-lipectomy ("around the world" tummy tuck), and liposuction of her trunk.

Her autopsy report noted that West had moderate coronary artery disease (CAD), with blockage between 50 to 70 percent in her right coronary and left circumflex arteries. The 5-foot-2-inch, 188-pound woman also was moderately overweight and had developed several complications after surgery, including fluid in her lung. The investigation found nothing unusually high in the level of her narcotics and no signs of internal bleeding, infection, or pulmonary emboli.

According to West's autopsy report, she underwent cosmetic surgery on Nov. 9 and went home that day, "even though she was advised that she receive postoperative care at another facility." (That advice in her record may become very important for Dr. Adams defense when this is investigated)

Her first day home she was walking around and appeared fine according to the interviews with some of her care takers . She did complain of pain as you'd expect from such a huge series of procedures. The next day she developed mild trouble breathing and was found in full arrest when left alone for a short period of time.

A separate report by a coroner's investigator said it couldn't be determined whether West underwent any type of pre-surgical screening before her plastic surgery. She apparently had a stress test in January 2007 after experiencing vague chest and shoulder pain, but those symptoms apparently never returned and she seemed to be on only modest medications.

I'm 100% convinced after reading her full autopsy report that the explanation is pretty simple. It is very likely that she vomited and aspirated and then went into respiratory arrest. You see this frequently in hospitals and nursing homes in older and younger patients. I'm not sure why her pathologist was obtuse in his language about this. I take that back.... I know exactly why he is so guarded! He knew this case was going to be scrutinized and probably later litigated. This is defensive medical language 101 to me in all honesty.

To me, Dr. Jan Adams comes off a little better with this information in hand. This wasn't a surgical complication at all per se, and she apparently did not have any evidence of a heart attack (read the autopsy description of the heart itself - it was normal). Even if he'd kept her overnight in the hospital (which I think most people might do for this), it still would not have prevented this as it happened well after 24 hours post op. You can argue the wisdom of such a complex set of procedures as an outpatient surgery on a nearly 60 year old overweight woman with borderline hypertension, but I'm not sure that she would have been medically excluded from surgery all together by her internist. (Remember, she apparently had a fairly unremarkable cardiac stress test earlier in the year that did not trigger further work-up with a cardiac cath study.)

It will be interesting how this plays out. I will be surprised if the logic I'm outlining is not exactly how this plays out in front of the California Medial Board review of this episode.

Rob

Suggestion Box - What would you like to hear about?

If there are any topics that the audience would like to hear me wax poetic on, please feel free to throw ideas in the suggestion box I'll keep in the comments section of this post.

Cheers!
Rob

Catch of the day - things that make me go hmmm

Couple of things on my radar:

- Yet another study convincingly demonstrates the lack of relationship between thimerosol (a mercury-based preservative) in vaccines and links to autism. Read my blog entry, "Mad Science" to get up to speed if you're unfamiliar.

- One of the nation's leading Plastic Surgery groups that focuses on hand surgery in Houston,TX has published data suggesting nearly 4% suffer irreversible nerve damage from carpal tunnel symptoms that persist longer then 8 weeks, and that less then 2% of patients respond with traditional non-operative treatment demanded by insurance companies. This finding adds to the body of literature now suggesting we treat median nerve compression at the wrist (aka. carpal tunnel syndrome) much more aggressively.

- CNN news anchor, Glenn Beck, describes his experience after hemorrhoid surgery. Why is this a news story exactly? He's offended that he wasn't treated the empathy he feels he deserved after coming to the emergency room with post-operative pain (which is an emergency not an EMERGENCY!). He comes off looking a little crazy in his interviews and the infamous you tube video .

- A Catholic hospital in California is being sued as it is refusing to allow a transgender man to get breast augmentation surgery on it's campus. This kind of political grandstanding against traditional Catholic teachings (which is what this case is) by the gay/lesbian/transgender activists is noxious. There are many places nearby where this surgery could be performed without issue, and this is just another kind of "lawsuit abuse" that's substituted for the political process in America.

- Many hospital systems are formally adopting policies of not charging patients or insurers for costs associated with treating "never event" complications like wrong site surgeries or cases where surgical instruments or sponges are left in patients. This is a good thing! Still to be determined however are complication costs more related to patient age or preexisting medical conditions like urinary tract infections, pressure sores, or falls. This is an unworkable policy penalizing hospitals for these last 3 things, and definitely falls into the V.A. LOGIC (see here & here) realm of bureaucratic insanity.



Rob

"VA Logic" in re. to plastic surgery - German style

It's always amusing to hear the United States Veteran's Administration (VA) hospital system celebrated by advocates of universal health care as a model system. If you've ever worked in one, you quickly learn it's a quagmire of competing impenetrable bureaucracies with insane regulations relating to everything. These regulations combined with a unionized workforce can make simple things (like taking care of patients for instance) not so simple. Illogical rules and regulations, and the irrational thinking behind them is what we used to call "VA logic".

VA logic has metastasized to private hospitals in the form of rules like the Federal Emergency Medical Treatment and Active Labor Act EMTALA, the Health Insurance Portability and Accountability Act HIPAA , and the growth industry of "nurses with clipboards" (NWC), nurses who aspire to have no patient contact, but serve vague administrative roles in hospitals harassing everyone. Each of these things started off with the best of intentions, but have spiraled out of control and now serve non-contributory bureaucratic roles.

A recent case from the German military comes to mind, where enforcement of an outdated and illogical regulation on cosmetic surgery led to the dismissal of a female soldier from her position after she'd had a breast augmentation surgery. From the report

A 23-year old female recruit who underwent breast implant is appealing to military authorities for reinstatement after she was booted out of army training in Germany for have boob job. Alessija Dorfmann, who has cup D after the operation, claims she was devastated after being kicked out of the army training as it has it been always her dream to be a soldier with a great figure. "And now my fake boobs have cost me my job," said Dorfmann adding she earned the money for the boob job by working as in an OAP's home before joining the army. "I could not stop crying when they told me. I wanted to work as an army medic and help save lives."However, military chiefs have vowed to review the Dorfmann's plight. "The rule that was brought in because of the increased risk of an injury is under review," said Army spokesman Harald Kammerbauer. "It was introduced more than a decade ago and it may be that it is no longer relevant in the modern army. In future we may be prepared to make exceptions."

Dorfmann will, however, apparently be allowed to join the Navy (go figure). With great pain, I will refrain from any jokes about floaties.

The rationale for this old policy doesn't make much sense, particularly if she had her surgery done when she wasn't on active duty or while on vacation. When done well, the down time after breast augmentation can be fairly modest. One of these days, I'll write down some thoughts on my take the evolution of surgical techniques for breast augmentation which I think we'll be interesting for the lay audience here.

Nurses get breast implants fairly frequently and are usually able to return to work within a week with only mild restrictions. Most breast augmentations in Europe are now done using textured form-stable silicone ("gummy bear") anatomic implants placed over the muscle, which has much less recovery time then the submuscular (partially under the pec muscle) placement that we do more here in the United States (another good topic for another day). Those kind of implants are so solid that they literally cannot physically rupture, although they can "fracture". If this woman was not in a front line position, it's fairly ridiculous to assert she's endangered herself or increased her risk of injury by her surgery.

As an interesting aside, while looking for some information on German nursing, I came across this old World War II propaganda poster from Great Britain which was trying to stir passion among the Brits over the German nurses' reputation for not treating captured wound allied soldiers.

P.S. Warning - Don't do an image search on Google using the term "German nurse" with children or your spouse around, as apparently there is a thriving porn-fetish industry around the theme :)

P.S.S. "French nurse" image searches are even more risque as you end up with both nurses and French maids ;)


Rob

Doctor's who are part of the tort problem

Many of the major product liability cases of the last 30 years involving occupational exposure and medical devices have served as the poster-children for what's wrong about the way the United States legal system sorts these issues out. Class-action plaintiff's attorneys have repeatedly exhibited some of the most jaw-dropping acts of dishonorable behavior in the pursuit of settlements that pay themselves ten's or even hundreds of millions of dollars in legal fees and compensation.

Law professor, Lester Brickman recently estimated in the New York Times that “mass tort fraud” has cost at least $30 billion just in the last 15 years and cited "compelling evidence” that "many if not most of the medical reports supporting more than 700,000 damage claims filed in asbestos, silica, diet drug and silicone breast implant litigation are frauds

Many of these cases would have gone nowhere without the complicity of physicians from a number of disciplines who have either inaccurately or fraudulently testified in court, or those that have set up lucrative "diagnosis mills" based on referrals from trial lawyers to establish their claim.

From the Wall Street Journal:

Over one million potential litigants have been screened by agents for tort lawyers in asbestos, silica, silicone breast implant and diet drug (fen-phen) litigation. The lawyers sponsoring these screenings have paid over $100 million for medical reports to support the 700,000 or more claims generated by these screenings. There is compelling evidence, much of it reviewed in my published writings, that the vast majority of these medical reports, including chest X-ray readings, echocardiograms, pulmonary function tests and diagnoses are bogus.

The dimensions of this fraud are stunning. An asbestos screening of 1,000 potential litigants generates about 500-600 diagnoses of asbestosis. If these same occupationally exposed workers were examined in clinical settings, approximately 30-50 would be diagnosed with asbestosis. The total take for "excess" asbestos diagnoses is more than $25 billion, of which $10 billion has gone to the lawyers. More billions for bogus claims in the diet drug (fen-phen) and silicone breast implant litigations can be added to this bill.

A comparative handful of doctors and technicians are responsible for the vast majority of bogus medical tests and diagnoses. To indict and prosecute those responsible would require testimony from other doctors that the mass-produced diagnoses cannot have been rendered in good faith.

To be sure, doctors can differ in reading X-rays or making a diagnosis. But when a doctor has been paid millions of dollars to produce 5,000 or even 50,000 diagnoses in the course of mass-tort screenings -- and when panels of experts have found the vast majority of these to be in error -- the most compelling conclusion is that the diagnoses were "manufactured for money."

There's been a long overdue movement in medicine about better regulating the way Doctor's serve as expert witnesses. A number of specialty societies' have started to put forth registries for their members to enlist in for tracking and also allow peer review of expert testimony. Along with this are calls to put reasonable caps on how much a doctor should charge for their case review and testimony fees so as to remove the financial incentive to become a "professional expert witness". Predictably, the trial bar gets incendiary over this claiming doctor's want to intimidate their peers into not ever cooperating with tort or med-mal cases (a la the "blue line" about cops testifying on other cops).

Missiouri doctor, John Hagan M.D., wrote a blurb about the serial expert witness industry "testimony tart" in his blog saying:

For the right price these mendacious individuals will find malpractice in almost all of the cases they are asked to review. They serve exclusively the plaintiff’s bar. Known variously as “hired guns” or (my favorite) “testimony tarts”, they not infrequently earn millions of dollars per year.
Most are driven by base greed and avarice; a few are motivated by delusional standards of excellence and perfection that they think they alone practice and can determine. Their names and credentials are shilled in legal publications, over the web or through procuring agencies. Hometown physician colleagues are frequently unaware of the hired gun’s sordid and sub rosa activities.
What’s the going rate for a top testimony tart? Try $1000-1500/hour to review records, for trials or depositions $10,000-15,000/day, first class airline or private jet travel, limousine service, suite of rooms at the best hotel, expensive gifts at Christmas and, for the most egregiously corrupt, a contingency fee based on a favorable verdict and large judgment. Some allegedly guarantee their testimony will result in a big settlement or guilty verdict.

In doing some research on this, I found reference to this going back to a New York Times article in 1897 (!), which reported that The Committee for Remedial Legislation in Regard to Expert Testimony called for all physician witnesses to be paid by the county rather then lawyers or prosecutors so as to remove potential bias. It seems we're still trying to get our hands around this issue 110 years later.





rob