Sunday, September 28, 2008

Oliver Plastic Surgery's new home (and name) - coming January 2009!

Sneak peak for today! 

My good friend and colleague, Dr. Jason Jack, and I are busy working on moving our practice to our new home in suburban Birmingham. Hopefully we're set to open in January 2009. What's exciting has been the chance to design from scratch, an office to accommodate a 21st century Plastic Surgery practice.

I've learned more about fire codes, environmental issues, work flow theory, electrical engineering, and architectural design ten I've ever wanted to know about.

One thing I'm particularly excited about is the ability to offer a state of the art office surgery suite which will offer us tremendous flexibility and convenience for our patients for cosmetic procedures. It also makes us less vulnerable to the random and often pernicious pricing patterns that hospitals and anesthesia groups have for cosmetic surgery in a hospital setting.


Wednesday, September 24, 2008

Britain's Plastic Surgeons ask for truth in advertising

A big Cheers(!) to our colleagues 'across the pond' who are encouraging more professionalism in the business of cosmetic Plastic Surgery.

The British Association of Aesthetic Plastic Surgeons (BAAPS) has made a position statement that digitally enhanced pictures of bikini-clad women in writhing poses should be banned in advertisements as they mislead patients about expected results. BAAPS has singled out one chain of cosmetic clinics for particularly egregious promotion, pointing to an ad by the West One Clinic franchise which used models in advertisements that are "anatomically impossible".

Below is the wasp-waisted model with gi-normous breasts that apparently started this discussion. It clearly looks to me like she's been "morphed" with Photoshop to narrow her waist in relation to her trunk.

A second promotion offers a £250 ($462.55 USD by today's exchange rate) discount to customers as an incentive to have the surgery quickly, while a third offers a "lunchtime facelift", which arguably plays a little fast and loose by with downtown and recovery for short-scar facelift procedures.

This education that BAAPS is not a call per se for limiting all cosmetic surgery procedures, but rather it is a desire to see a more safe, thoughtful, and informed process take place when someone is considering surgery. It is impossible to remove unrealistic body images from pop culture, as both men and women strive for whatever form is popular in their era. What we do owe patients are frank discussions about the limits and morbidity of surgery minus the "magic brush" function of computer photo editing.


Sunday, September 21, 2008

Another attempt by lawyers to get around tort limits on medical malpractice cases

This is getting real old, but the American trial bar is once again attempting to establish a game plan for circumventing liability protection that the FDA grants drug and device manufacturers after going thru the FDA approval process. An important legal precedent was upheld last winter which I wrote about in a post "Trial lawyers' ability to second guess the FDA on medical devices neutered" which refused a plaintiff's motion to allow layperson juries to essentially second guess the proceedings of expert FDA panels on medical devices. Medicines curently do not have that same level of insulation, and trial lawyers are contributing in record numbers to the Democrats for the fall election expecting favorable amendments to the law allowing expanded liability.

In a New York Times story this week, "Drug Label, Maimed Patient and Crucial Test for Justices" the case of a patient who had an inadvertent injection by a allied health provider (not a doctor)of a widely used anti-nausea medication (phenergan) into an artery in her hand and eventually suffered an amputation as a result of complications. This drug has been used for decades, and is both safe and cheap. The manufacturer of the drug is essentially being sued for a labeling issue where they claim that warnings about her particular complication were not prominent enough.

This type of action is embarrassing for our legal system, and demonstrates the great American legal tradition of finding the deepest pocket and suing the hell out of it. In this instance, the medical center already settled with this patient, but they're going for the big $$$$. While this individual had a terrible thing happen, it's not even clear that true malpractice even happened. Fines and putative damages on industry in these cases should be paid to the feds rather then individuals so as to remove the financial incentive for these ridiculous cases beyond economic damages.


Sunday, September 14, 2008

Does it make sense to screen asymptomatic breast implants with MRI?

One of the peculiarities of the USFDA process during silicone implant reintroduction in 2006 was the labeling on the devices recommending routine MRI surveillance of implants for rupture. When you step back and look at the proceedings and "unique" American history with breast implants, you can see that this was more a political concession to the anti-implant activist lobby then evidence-based medicine.

The FDA labeling currently suggests MRI's at 3 years post op and then every 2 years subsequently. It will be interesting with the coming form stable "gummy bear" implants whether or not this recomendation is still maintained.

Why 3 years for the first MRI?

That was the first data point with any ruptures reported in the FDA data during clinical trials. While there will be a certain failure rate associated with any manufactured device, it's likely that early failures of silicone devices were from missed trauma to the implant during insertion. Education courses on proper techniques for implant handling and insertion in recent years have emphasized ways to minimize this risk by suggesting larger incisions for gentler introduction and better visualization during closure.

But does it make sense to do this?

Clearly it does not. On this point, there's pretty much international agreement (USFDA excepted).

We've actually got a pretty good handle on rupture rates of 4th generation implants (conventional devices used for the last 15 years or so) up thru a decade, where it's pegged around 6-8% at 10 years based in two pretty solid studies on single devices by the two major implant makers Mentor & Allergan. If you take that and work backwards from the FDA recommendation, you're doing up to 4 MRI's during the first decade where the rupture rate is either almost nonexistent (years 3-7) or in the low single digits (year 9).

Whether you're screening an asymptomatic population for ruptured implants, colon cancer, breast cancer, or aortic aneurysms there's trade offs between costs and risk reduction. For tests to be effective for screening, they must satisfy both criteria. For a number of cancers, screening tests often fail this goal.

Take screening mammograms or breast self-exams for instance to detect breast cancer. In non-selected groups of women, both cancer detection modalities increase both cost and morbidity from unnecessary procedures without materially affecting death rates from breast cancer (arguably the whole point of screening). It's been persuasively argued when reviewing the data, that screening mammograms can be deferred to age 50 for low risk women (as opposed to the current recommendation for age 40) and perhaps discontinued altogether for women in their 70's with no affect whatsoever on breast cancer death rates. BTW, this same pattern of "dodgy logic" of routine screening also exists in regards to male prostate cancer and lung cancer screening in smokers.

Anyway, back to implants......

At the end of the day it's just hard to support screening implants for rupture in asymptomatic patients on either a cost basis or benefit basis. As it's been established that ruptured silicone implants (silent or otherwise) do not appear to correlate with systemic illness, the clear benefit of screening asymptomatic women is hard to establish. A team of doctor's from the world famous Sloan-Kettering Memorial Cancer Center agreed with this sentiment in a recent paper, Silicone Breast Implants and Magnetic Resonance Imaging Screening for Rupture: Do U.S. Food and Drug Administration Recommendations Reflect an Evidence-Based Practice Approach to Patient Care?