The niche market for outpatient plastic surgery technology & Ivivi in the news

One of my geeky interests is emerging technology. When this overlaps with Plastic Surgery all the better. Like I got into a little bit before (with my rant on what I thought was revolutionary vs. obsolete or dead-end the other day), we're in an era where we're bombarded with products, each claiming to have built a better mousetrap. Be it skin care products, the newest laser, or some 'magic' surgical technique or device to facilitate surgery everyone is trying to sell you something. In most cases you see that the results are modest & the costs are significant.

There's a big niche waiting to be filled in Plastic Surgery as I see it. As more and more procedures are done as an outpatient (increasingly in an office OR suite), things that can facilitate an easier recovery or lower cost for surgery are going to find a place in the market. Post-operative pain control and nausea prevention are two of the single biggest fears patients report on surveys when they're considering having surgery done.

I'm still a believer in pulsed magnetic field tech. for post-operative pain control in Plastic Surgery. A recent presentation studying the Ivivi device in Europe showed 80% acceleration in pain relief in breast augmentation patients treated with the active PEMF technology as compared to patients treated with placebo units. Another paper presented at a Neurology meeting showed improved nerve cell survival in a standard animal cell model of brain inflammation which is used to test treatments for diseases like Parkinson's, Alzheimer's, Lou Gerhig's disease, and other neuro-degenerative disorders.

Another real interesting thing out there is a drug called Emend (aprepitant). It's a new anti-nausea medicine that works different from other medications in that it actually blocks receptors in your brain that mediate the nausea response on a biochemical level. It must be given prior to anesthesia and is very effective (apparently) at preventing post-operative nausea and vomiting (PONV) for 48-72 hours. This drug is being used mostly for chemotherapy patients currently, but the potential for use in the outpatient Plastic Surgery patient group is obvious.

What's the catch with Emend? Well, currently it runs in excess of $80 per pill for a single dose. Merck received an approvable letter from the FDA in May so expect to see this promoted more and the price to slowly drift down. If it works as advertised, I bet it becomes routinely used preoperatively for many surgeries just as Zofran has been.

Rob

Ipods and the operating room plus free music

Unlike some of my old-school professors of surgery, I do not subscribe to the maxim that you have to be miserable and uncomfortable while performing surgery. For me this means having my IPOD hooked up providing background music. Up until a couple years ago music in the OR meant a stack of oft-scratched CD stacks that tended to accumulate in the OR.

The IPOD changed all that & I was a fairly early adopter back when I was training in Louisville,KY (all props to Drs. Marc Salzman & Steve Rowe who were the first people I saw doing this back in 2002-3). Prior to this I had a large CD collection and favored myself a bit of a hipster/music snob for alt-rock and singer-songwriter music. I've now got an Ipod with almost 4000 songs from all over which serves as my "virtual radio station" (WROB as one nurse called it).

I always get asked where my music comes from. Like I said, I had a large preexisting CD collection (which now sit unplayed) that I burned hundreds of songs from. I had discovered NAPSTER a number of months prior to it breaking big in pop culture during 2001 and amassed hundereds of songs before it was declared illeagle. Since then I've been a good citizen and bought a lot of songs thru the I-tunes store.

However, always one to look for bargins, I'm constantly looking for free & legal sources for MP3 downloads. My favorites:

1. PASTE Magazine - a great music magazine with monthly CD's featuring alternative/singer-songwriter types. It's a good source for discovering new artists.




2. Salon.com's Audio-file columns - a lefty media site, that despite (or in spite of) it's politics always is entertaining. Most colums have free download links to up and coming & and a few well-known artists.




3. iTunes store - the weekly download has a lot of really good artists with a free single each week.




4. SPIN Magazine - frequently has free MP3 downloads in the MUSIC section




5. Artists' web sites - many artists' websites will have some free songs. I'm a big fan of Richard Thompson who's website has a number of free things. Also check out the late,great Chris Whitley's homepage for some links to rare tracks. Other personal recs. include Adrian Legg, Chris Smither, Bruce Cockburn

Richard Thompson, Chris Whitley, Chris Smither, Bruce cockburn

ASPS launches campaign on hazzards of medical tourism and cosmetic plastic surgery

The American Society of Plastic Surgeons (ASPS) has launched a campaign to educate the public about the potential issues surrounding cosmetic plastic surgery procedures being performed in Latin America and Southeast Asia.

Three principal issues are raised by this education effort that all patients should be thinking about.

1. Is the physician qualified? Are the medical facility and equipment safe?
2. How will my post-operative care and any complications be handled?
3. Are travel and vacation activities compatible with surgery?

There certainly are first class operations performed in Mexico, South/Central America, and Southeast Asia. Many of the innovators in Plastic Surgery reside in Brazil, for instance. However, the quality of many of these "medical tourism" outfits seems dodgy at best. Doctors in states bordering Mexico report many anecdotes of scary medical practices they've seen where they had to end up holding the bag on serious surgical complications.

A group of Plastic Surgeons telling you not to go visit another group of Plastic Surgeons is always going to vulnerable to charges of slamming the "competition", or even charged with ethnocentrism or even racism when it involves Latinos locales in these PC times. However, this campaign is spot on in pointing out the practical problems with undergoing large operations without the safety-nets available in western countries.

The briefing summary of the ASPS patient information publication can be read here

Drive thru BOTOX and the marketing of cosmetic medicine products......not so great IMO

I'm on vacation this week which is why I've been so productive with the blog.

I saw this on FOX-News, but it's been picked up by the DrudgeReport as well. Entrepreneurs in New York have come up with "drive-thru" clinics to give BOTOX to walk-in clients. While this is convenient, I think this is a somewhat troubling trend.

Allergan, the parent multi-national conglomerate, who owns BOTOX, the Lap-Band weight loss surgical device, Juvederm skin filler, and other products has taken a page from the pharmaceutical industry in how they market. Allergan bought Inamed Corp. in 2006 to also become the world's largest breast implant maker and are now arguably the world's premier cosmetic medicine complany.

To these corporations, Doctors are an inconvenient middleman in their product distribution systems. Big pharma realized this years ago by slashing their budget for detailing physicians & concentrating it on print and media ads directed at consumers. What they want is for people to show up asking for their drug by name when they go to the doctor.

Allergan has thrust out it's formidable marketing team with huge media pushes for BOTOX & Juvederm (their hyaluronic acid filler aimed at knocking off market-leader Restylane), with TV ads on Grey's Anatomy and other popular shows featuring actress Virginia Madsen (co-conspirator Tony Youn mentioned this here last month).

From the Orange County Register, in an article titled "Allergan rethinks marketing of Botox, implants."

In its new breast-implant campaign, for example, Allergan's marketers imply that implants are artful, like designer clothing. Even though implants are basically plastic bags filled with silicone or saline solution, Allergan portrays them as sources of power, freedom, individuality and self-confidence.

That's a big change from last year, when Allergan bought Santa Barbara-based Inamed and its breast implants for $3.2 billion. Then, the implants were labeled "Style 68," "Style 101," etc.

The old labels were cold and clinical, so Allergan is giving them a new identity that sounds natural, feminine and artful. In a new marketing campaign, they're the "Natrelle collection of breast implants."

Write this down: Expect to see lots of feisty press releases from the anti-breast implant crowd over this for the wrong reasons (ie. a non-demonstrable auto-immune disease risk). The underlying concept of direct-marketing this type of surgery makes me uncomfortable as it will further trivialize what is an operation and aftercare that is anything but simple.

What's going to happen when you need a plastic surgeon in the emergency room?

There is a real crisis bubbling up through the American health care system in re. to how the Emergency Room is covered by surgical specialists. In 2006 the Institute of Medicine issued a report "Emergency Medical Services at the Crossroads" which highlighted this growing problem. I've been thinking about how to talk about this for months, but a few snap shots from articles in print this week speak louder then my words.

From US News & World Report comes "E.R. Help Needed Stat!" which gives some context to the problem. As the burden and liability of ER coverage by Doctors goes up while reimbursement has plummeted, you're seeing a predictable withdrawal of physicians willing to provide coverage. Most notably neurosurgery, orthopedics, and plastic surgery coverage is getting harder and harder to maintain for many hospitals.

"Emergency rooms depend on specialists to come in at any hour, any day, to, say, treat stroke victims or reattach fingers severed in an accident. But "specialists just don't want to cover emergency rooms anymore," says Dr. Loren Johnson. Earlier this month, he coauthored a study published in the online edition of the Annals of Internal Medicine reporting that nearly half of Oregon's hospitals cannot provide emergency on-call treatment around-the-clock in at least one specialty. A recent survey of emergency departments throughout the Southeast showed that 54 percent had to divert patients to another hospital because they didn't have the appropriate specialist on call....The Joint Commission, hospitals' major credentialing body, has cited lack of specialists as the cause of 21 percent of emergency department "sentinel events"—unexpected deaths or serious injuries due to slow treatment.

There were about 114 million visits to ERs in 2003, a 26 percent increase over the previous decade. During that same period, about 700 hospitals closed. But the number of surgeons in the country remained the same. "

These pressures have led to many specialists excluding areas involving trauma or emergent care from their practice to focus on elective surgical practices. These aren't "greedy" doctors, but they're frustrated caregivers who've watched the for-profit insurance industry strip-mine health care while recording record profits while simultaneously being squeezed by the feds who seek to contain health care cost with persist ant cuts in medicare fees. An AMA survey, released last week, showed that most doctors -- up to 77 percent -- would limit the number of new or existing Medicare patients they would accept if the cuts are made. The double whammy here is that private insurers, never one to leave money on the table, adjust their rates down to index medicare. You've also got the spectre of the malpractice free-for-all which affects both the economic & psychologic practices of medicine.

In Plastic Surgery the recusal from uncompensated ER call this has been facilitated by the increase in outpatient surgery which is flourishing outside of hospitals (which usually require some kind of obligation for ER call if you want to operate there. )

From the editorial page of the June 11,2007 Tampa Tribune titled "Running Doctors Out of the Emergency Room" which is discussing a recent med-mal case there when a woman who had a tummy-tuck nearly a month before, showed up with a late infection to the ER in septic shock which eventually required amputation of multiple extremities. A Plastic Surgeon (who wasn't her doctor) who was covering the ER and came in to drain her abdomen while calling in multiple specialists to try and save her life, got dragged into a $30 million plus malpractice verdict. Every report on this suggests appropriate care was given, but Florida's most notorious and successful ambulance chaser persuaded a jury that someone must pay for this unfortunate event, even when no clear malpractice is present.

I am writing this as a warning to readers who may at some time seek emergency medical care at one of our area hospitals. You may find that there are no doctors to treat your injuries from a car or motorcycle accident, a burn injury, head trauma or severe medical illness. Just as 'video killed the radio star,' plaintiffs' lawsuits filed when there are bad outcomes, rather than true malpractice, will keep qualified specialists from taking 'call' in emergency rooms.

My case in point is the recent decision by a jury to award Sally Lucia $30 million for the loss of her legs and fingers. Tragic, yes. A result of malpractice? I don't think so. I admit that I don't have all the facts presented by both sides, but I have spoken to Dr. George Haedicke, the surgeon on call, who was found to be 20 percent liable for a total of $6 million. Mrs. Lucia had a tummy tuck in early 2001 and had problems following surgery. Apparently, the plastic surgeon who did the original abdominal surgery told her to go to the emergency room if she had problems, which she did on Super Bowl Sunday in 2001.

The surgeon also happened to be in South Florida at the time she went to the ER.Dr. Haedicke was on call for Memorial Hospital and came in to see her. He evaluated her, drained her abdomen, ordered antibiotics and consulted four other physicians (who were also sued) to evaluate her condition. Her own surgeon returned to Tampa later that afternoon to assume care. Dr. Haedicke had seen her for a total of five hours.

Wall Street Journal joins the party on Mesotherapy

Apparently not wanting to be left out of the growing issue on the practice of mesotherapy, the Wall Street Journal chimes on today with a story "The Objections to the Injections Aimed at Fat" (who's rhyming quality sounds like Jesse Jackson).

This many stories from different sources profiling controversial aspects of mesotherapy seems likely to quickly force the FDA to step in and regulate this IMO.

From the story:

One fact isn't in dispute. There are no fat-busting injectables approved by the FDA. Practitioners use different recipes that are prepared by a compounding pharmacy or in a physician's office. Such custom mixes, using ingredients approved for other uses, fall into a regulatory gray area. One combination used by many practitioners is phosphatidylcholine and sodium deoxycholate, or PCDC for short.

Lipodissolve clinics say their injections are legal because states
regulate pharmacy practice, including compounded drugs. Some doctors, however, including Joel Schlessinger, an Omaha dermatologist and president of the American Society of Cosmetic Dermatology and Aesthetic Surgery, have written to
the FDA, urging the agency to halt "the practice of unapproved
medicine.".......The FDA says that "in virtually all cases," it "regards compounded drugs as unapproved drugs." The agency says it's evaluating lipodissolve, but "we do not discuss pending investigations or enforcement matters."

Rob

Mesotherapy in US News and World Report + Kansas bans mesotherapy!

Mesotherapy, off-label injections of soy lecithin & bile salts which are promoted to melt fat, is the focus of a story in this weeks US News & World Report entitled "A Shot to Melt the Fat?" which is a nice & sensible overview urging caution.

Several patients with disappointing results are quoted which is what I expect to see more of when this is more widespread. If you have big areas of fatty collection (lipodystrophy in doctor-speak) you likely won't do well with this. On the other hand, my curiosity is peaked with the effectiveness on smaller areas like under the chin and arm.

In other news re. to mesotherapy, the state of Kansas has apparently banned it for unrestricted use (story here from New Beauty magazine)requiring it be part of institutional studies. You may see that type of regulation spreading IMO.




Rob

Breast implant legislation neither "scientific" nor "fair"

As Reagan famously said to Carter in one of the 1979 presidential debates, "There you go again!"

Uber-liberal congresswoman, Rep. Rosa DeLauro (D-CT) (pictured at right), recently reintroduced her "FDA Scientific Fairness for Women Act" in the US Congress legislative docket. If you'll recall, last year Rep. DeLauro went out of her way (read here) to try and bully the FDA into ignoring both their own expert panels and unanimous international consensus when the final stages of FDA bureaucracy was being reached on reintroducing silicone breast implants (SBI) for cosmetic surgery indications in 2006. Now that Democrats have replaced Republicans as the crooks in charge and she has some actual political power, she apparently misses the irony when she claims her bill would take politics out of the FDA approval process?????

If passed, the bill would rescind the 2006 FDA approval for SBI's and create an impossible gordian knot standard for ever proving safety to her satisfaction. Keep in mind, the next generation of cohesive gel ("gummy bears") implants (which aren't even being debated about in this issue yet) are sitting poised for approval and would be even further from clinical use despite strong evidence of their superior performance and rupture rate data to currently used devices ("4th generation" implants).

Alexander cuts the Gordian Knot, by Jean-Simon Berthélemy (1743–1811)

Rep. DeLauro and the fringe cadre of anti-implant activists she associates with, live in a parallel bizarro-world universe in which SBI weren't (according to the FDA) the most extensively studied medical device in the history of the world. In contra-distinction to information contained in the text of the bill, we arguably know more and have more data about how SBI's (or silicone in any device for that matter) behave then any other implantable material in existence. Within the last few years, we have more then half a dozen studies (also here, here, here, here, & here) turning in outcome data on patients approaching two decades out in some cases from surgery with implants similar to what's currently manufactured.

In point of fact, there are already existing FDA clinical trials collection long-term outcome data on the issues Rep. DeLauro is demanding answers to. However, the activists she has allied herself with have no wish to actually let prospective information continue to accrue and be analyzed (We already have mountains of retrospective data on these issues which do not support their POV) . They are so convinced that SBI are toxic that they will use any means neccessary to achieve their political agenda.

There are legitimate issues still to be better characterized with SBI's

1. What's the rupture rate in modern implants beyond a decade? (we have a good idea at around a decade it's ~ 6-8% with contemporary devices)



2. How do you reduce reoperations relating to complications (not cosmetic issues)?



3. Are there things we can do to reliably reduce capsular contracture (hardening of the implant)?



4. What is an evidenced-based way to recommend MRI studies to screen for rupture? (Currently the FDA's "cover their ass" position of frequent MRI's is illogical)



5. Is the superior performance of 5th generation cohesive gel SBI's compelling enough to abandon older device styles? (softer, round, & smooth surfaced)

Rob

Pete Burns Plastic Surgery adventures in his own words

In February, I wrote about former Dead or Alive singer, Pete Burns', horrific problems from a series of procedures for lip augmentation (see "Adventures in Lip Augmentation") . There's a really interesting show from the UK where he candidly talks about his plastic surgery history. Surprisingly, he really struck me as a very likable guy despite his odd looks with some real insight into his obsession with surgery.

I found it striking how impulsive he seems to have been with a number of major surgeries. He tells the anecdote of his trademark eyepatch, which as it turns out was an attempt to draw attention away from a radically overdone rhinoplasty (nose job).



Rob

Beautiful People.net -....You're so vain, you probably think this website's about you.

It seems that there are even "velvet ropes" beyond the club-scene to keep out the riff-raff in online dating these days.


Beautiful People.net purports to be a dating service catering to the "special needs" of the beautiful. How do you get deemed as such? You submit your picture to the sites members who vote you candidacy for membership up or down, with results on full display.

As an experiment, I've decided to test the exclusivity of this club this using myself (who's happily married BTW) as the guinea pig on the application. After looking at some of the guys on the site, I'll defer the stock glamour-shot picture male picture of me topless, oiled-up and flexing, chest hair-less, and mugging my best Zoolander "blue steel" stare (pic. at right) for my plain old professional portrait thumbnail. If I can get voted in, then you know it's not a club you'd want to join as Mark Twain (or is it Groucho Marx?) used to quip.

I'll keep everyone posted on just how savaged I get with the Internet voting! Currently I'm not polling so well (????), so I guess I need to get my mother and wife to vote :)

Also from BeautifulPeolple.net comes the results of an international survey of "attractive people" which can be viewed here.

• 61 Percent of attractive English men would prefer their partners to have surgically enhanced breasts.



• UK people surveyed claim to have between 10 and 15 different sexual partners per year.



• 66 Percent of attractive UK inhabitants admitted to cheating on their significant other



• 65 Percent of attractive UK inhabitants & a startling 81% of attractive Swedes expect to have sex on the first date



• 66 Percent of attractive British & 85% of American one's believe their physical appearance has aided their success in life.



• 75 Percent would not opt for a relationship with someone who had personality but was not extremely attractive.

Rob

USA-Today on limited health insurance plans

USA Today's cover story today, "Is a little medical coverage that much better than none?" revisits the issue of "limited benefit" health insurance which I talked about in April's Plastic Surgery 101 post, "Tennessee's experiment in (slightly less than) universal healthcare coverage".

The philosophic issue is whether crappy health coverage is better then no coverage. On balance I'd say no for most people, as it will only encourage employer's to give fewer benefits and leave more people under-insured. This is a bumpy transition period towards Universal Healthcare I believe, and these type of plans were well-intentioned band-aids on a failing infrastructure. However, an approx. 15% annual growth rate in enrollees in limited benefit plans has the insurance companies scrambling to make a buck, which is now catching regulators attention. As a Doctor, I can promise you that anything insurance companies rapidily try to co-opt is going to bit you in the ass at some point.

Also illustrated in the USA-Today story is just how far patients have become removed from the cost of delivering health care as one of the people in the article seemed surprised (and indignant) that he'd actually received a bill from the Doctor!

Rob

Britain's NHS tells smokers they're SOL.

see today's Daily Mail

In a move that makes tremendous sense and also foreshadows the growing influence of the government that will accompany any universal health care plan adopted here, the United Kingdom's National Health Service (NHS) is planning on refusing any elective surgery in smokers until they "pee in a cup" (to test for nictine metabolites) to prove they've quit prior to an operation.

When the feds own the purse string here in the United States (as they clearly are moving towards with some kind of Universal Heal Coverage), expect to see a lot of actuarial data and cold outcome data end up driving health care spending. It's not necessarily a bad thing, but Americans used to having an awful lot of discretionary health care spending (elective surgery, doctor visits, imaging studies, prescription drugs, etc..) will be in for a shock the first time they get scolded, are told to wait, or told flat out NO.

In this instance, the NHS has hit the nail on the head by asking people to take some personal responsibility for their behavior whose cost will ultimately be borne by everyone.

There (generally speaking) are 4 major risk factors for surgical wound complications.

1. Diabetes
2. Obesity
3. Peripheral Vascular Disease
4. Tobacco use

It's is hard to realistically make a dent in #'s 1-3, but smoking cessation is an easy target for interventions. It's not really the "smoke" per se, but rather the effect of the break down metabolites of nicotine, which have effects on micro-circulation in tissue. How you get the nicotine is irrelevant be it cigarettes, cigars, snuff, chewing tobacco, or nicotine patches and gum. It takes weeks for nicotine to clear you system and have your blood vessels react normally (ie. not spasm with normal stimuli).

In plastic surgery the effect on circulation can be profound as many common procedures (breast lifts/reductions, tummy tucks, face lifts among others) require many of the collateral sources of blood flow to be divided. This can put you at much,much higher risk of having skin slough or fat necrosis.

I have little sympathy for smokers who feel like they're being discriminated against in this instance. In a nutshell, if you don't care enough about yourself to quit smoking, why should the doctor (or health system in this case) be willing to make your problem their problem.

Rob

Today's highly recomended FREE STUFF!

From time to time I like to point my audience out some free swag. Today I'd like to point you to Open-Office.

If you don't want to shell out several hundred dollars for various versions of Microsoft Office, the ubiquitous software bundle of word processor (MS-Word), spread sheet (MS-Excel), and slide show maker (MS-Powerpoint), there is a great alternative. Even better it's free!

the "Professional" version of Office 2007 is listed for $419 at Newegg.com Newegg is the world's greatest computer store for mail-order stuff BTW. They have everything send orders out almost immediately, have at or near the best prices, and have great return policies. I order from no one else in most cases! I hope my check is in the mail for the free PR :)

Open Office is a free-ware office suite contributed to by programmers around the world. It's extensively tested by users prior to release of it's updated version and uses the same file formats as MS Office so things produced in Office are able to be edited or displayed in OpenOffice and vice versa. It can effectively replace MS-Office for most users. I have it installed on a few of my computers that I was too chinchy to spring for Office on.

OpenOffice 2.2, the current version, can be downloaded from here at http://www.openoffice.org/

Rob

Pretty Pills (?).....

People are always looking for "something for nothing" in terms of their appearence, but nothing in life is free.

In May, the FDA gave the green light to Glaxo Smith Kline to sell their weight-loss drug Alli over the counter.

Alli, in the form of Xenical or Orlistat, has bee around for awhile as a prescription drug. It works by blocking the absorption of fat in the small intestine so that about 30% of the fat you eat is passed through the body undigested.

When taken along with a low-fat diet, it has the potential to be a modestly useful drug for weight loss. It's success has been tempered by patient compliance with their diet producing "GI upset". Look for many people rushing out to try this medicine without a doctor's inservice to thereafter be running for the toilet frequently.

Rob