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