Sunday, December 28, 2008

Breast Reconstruction article in the NYT - there's really nothing "hidden" about it

Being someone who did advanced fellowship training in breast reconstruction, I was interested in the article in today's New York Times, "Some Hidden Choices in Breast Reconstruction".

I came away somewhat disappointed. The article tangentially discusses the issue of some advanced breast reconstruction techniques and how they aren't always offered or discussed by surgeons. It mostly centers around some of the more advanced microsurgical breast reconstructions using what are called "perforator flaps", which are much more laborious then traditional muscle flap surgeries or implant based reconstruction techniques. Those operations are very elegant, lengthy, and complex cases whose "true value" is hard to demonstrate either in outcome data or to bean counters (who just pay attention to how much things cost). The editorial tone is basically suggesting that there's some conspiracy to not talk about these procedures to patients and that these advanced procedures are the most ideal reconstruction.

I have a few thoughts on this

1. I touched upon the resources and cost to the system of demanding the most exotic types of surgeries for all comers last October 2007 entitled "A Breast Reconstruction Lawsuit - Can We afford Cadillacs for all?" which involved a patient suing her insurer for NOT covering a redo operation with one of the perforator microsurgical flaps discussed in the article.

I asked the question then:
In a scenario like the one involved here (lawsuit over non-coverage), 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

We just cannot afford the most exotic procedures and technologies for every indication in every patient. Complicating this issue with breast surgery is that these types of procedures are arguably cosmetic procedures rather then functional surgeries (ie. a reconstructed breast reproduces a secondary sex characteristic but does not lactate). As a society in the US, we've come treat this topic differently through legislation guaranteeing breast reconstruction after mastectomy. This did not however, promise funding however, and the savaging of reimbursement for the long procedures and large amount of aftercare have functionally served to ration patients access to breast reconstruction.

2. Surgeries involving your own tissue have significantly more morbidity up front then tissue expander/implant procedures. They are not appropriate for everyone, particularly the very fit, smokers, obese patients, or the elderly. The complications from these operations can be MUCH more spectacular then expander procedures.

In general, I think TRAM, DIEP, and other described flaps are best reserved for young patients with small-medium breasts who are only having one sided mastectomies. The benefit in them is the natural "aging" of the flap more like the remaining breast. For bilateral mastectomies I (and most surgeons) think it is an absolute no-brainer to use tissue expanders in most patients in terms of recovery, cost, and symmetric result of the reconstruction. The improvements in implant designs that we should have available this winter make this an even stronger recommendation for most patients. Surgeon's who

I'm trained in just about everything, but I do implant based reconstruction on probably 7 or 8 out of ten patients as it's the best choice for most people. Keep in mind, that's coming from someone (me) who's favorite operations are TRAM's and Latissimus breast reconstruction. IF you look at the rest of the world, similar % of patients are reconstructed in this fashion which I think represents a collective pragmatic balancing of costs and benefits.


Tuesday, December 16, 2008

The economic meltdown for dummies (via Rick Ferri)

No Plastic Surgery today!

If you've watched the chaos in the financial markets and wondered how in the heck this happened, I'd like to point you a conference call by the investment management company, Portfolio Solutions. I have no money invested with this company per se, but I do admire one of the principals there, one Rick Ferri. Mr. Ferri is an accomplished author of financial books like the super, "All About Asset Allocation" and a regular contributor on the Boglehead Forum (a site concerning index investing as advocated by Vanguard Investments founder, John Bogle).

Mr. Ferri's discussion of the mechanics of how we got to where we are is really interesting and Ferri is an excellent communicator, even for "dumb skin doctors" like me.

Click here to go to the archived speech.


Sunday, December 14, 2008

Another one (, two) bite the dust! The body count rises in aesthetic medicine.

Artes Medical and Rhytec Inc. are the latest notable cosmetic medical companies to fold.

From the OC Register

Artes medical made a permanent dermal filler called Artefill which never gained much of a following. It was a gel based formulation of plastic "microspheres" made for injecting in deep layers of the skin. Most doctors have been reluctant to use these types of permanent fillers (like micro-droplet injectable silicone) as they are ruthlessly unforgiving for imprecise injections. If they're permanent and you have issues, then you have a permanent issue versus one that will regress as it's reabsorbed.

As hyaluronic acid fillers like Jevederm or Restylane are more user friendly and they go away after awhile, they are more of an attractive material. For a little longer lasting material for similar indications as Artefill, I think most people would use Radiess, which lasts closer to two years or so in duration. It's an extremely underated product IMO.

Rhytec's plasma based system was fairly novel and appeared at one time to have a lot of advantages. Compared to traditional laser resurfacing of the face with carbon dioxide or erbium lasers, it carried much less risk of pigmentation changes. I loved the candor of the Dermatologist quoted in the article who took some shots at other technologies that have been popular but have been panned off the record by many doctors.

Before Rhytec’s bankruptcy filing, Dr. Christopher Zachary, chairman of the UCI Department of Dermatologist, bemoaned the loss of a company with an innovative and effective therapy. He said, "Unlike companies that market laserlipo devices that are selling like hot cakes and are universally gimmicks and which have made companies like Syneron and Cynosure very healthy bottom lines, Rhytec, which makes a device that actually works, looks like it is in a major tailspin. Such is the cynical life of an aesthetic device manufacturing company."


Tuesday, December 09, 2008

Allergan "eyeing" FDA approval of new eyelash stimulating medicine Latisse

Allergan, maker of the popular Natrelle breast implants and BOTOX cosmetic is apparently poised to receive FDA approval of their next potential blockbuster. The new product, Latisse, is a topically applied drug which is effective for growing and thickening eyelashes. While that sounds like a superficial indication, there is expected to be a huge pent up demand for such a product.

From Seeking-Alpha

Allergan received an approval recommendation today from a FDA advisory panel for Latisse (bimatoprost solution 0.03%) as a cosmetic medicine treatment which would represent the first and only FDA-approved product to enhance eyelashes (making them darker, longer, and thicker). Latisse would be packaged with a special applicator to apply the drops on the edge of the eyelid as compared to the current use of bimatoprost as Lumigan, which is already on the market as a treatment for glaucoma to lower eye pressure.

Allergan estimates peak sales for Latisse of $500M, compared to trailing 12-month sales of $4.4B, with an expected FDA action date by mid-2009 on the pending NDA. Allergan is also a component in the ETFI Cosmetic & Reconstructive Medicine Index and could be a takeover target for big pharma after Johnson & Johnson (JNJ) agreed to pay $1.1B for breast implant maker Mentor (MNT) – although the market cap of Allergan is much larger at $11.7B with a wider range of businesses such as specialty pharma, medical devices, and cosmetic medicine.

Last Winter, cosmetic manufacturer, Jan Marini, was forced to pull a similar product off the market by the FDA because (as I understand it) they 1) didn't have FDA labeling approval to promote themselves for that indication, 2) didn't have any clearance to sell a prescription glaucoma drug (which was the active ingredient) over the counter, and 3) Allergan had patent rights on the substance that was the active ingredient. Talk about ballsy! A blurb last winter from the "Truth in Aging" blog about this can be read here.

I guess I must just have the "vision" thing for this sort of product as I kind of shrugged my shoulders when I heard about it before. However, pre-market surveys indicate there is a BIG market for it, and the price of this product is going to be fairly low. Expect every Tom, Dick, & Harry fringe aesthetic medical provider to be pushing it I predict.


Sunday, December 07, 2008

Breast Implant designer commits suicide from Yew seeds(!)

A South African man died who'd designed a novel type of silicone breast implant recently committed suicide by eating poisonous yew berries from a nearby graveyard of all things.

From Wikipedia on the Yew tree toxicity:
The major toxin is the alkaloid taxane. The foliage remains toxic even when wilted or dried. Horses have the lowest tolerance, with a lethal dose of 200–400 mg/kg body weight, but cattle, pigs, and other livestock are only slightly less vulnerable.[7] Symptoms include staggering gait, muscle tremors, convulsions, collapse, difficulty breathing, and eventually heart failure. However, death occurs so rapidly that many times the symptoms are missed.

Jonathon Hamilton a talented design engineer who had recently lost majority control of his an implant business he'd founded when he was forced to sell stock to cover his debts. His company "Smart Implant" has a proprietary design where the filler of an implant is composed of hundreds of solid silicone beads instead of a viscous silicone gel.

Having never seen one of these implants in person, I'm not sure there's much to this departure from conventional design that is much of an advantage but it's an interesting idea. These type of implants are not available in the United States and I'm not aware that they've even applied to the FDA to conduct clinical trials here.


Thursday, December 04, 2008

Kayne West's nurse cousin now being investigated in Donda West case

The death of Donda West, mother of hip-hop star Kanye West, the day after undergoing plastic surgery last year was big news. The surgeon involved in the case received a great deal of criticism and the implication was that he'd commit ed some horrible malpractice on Mrs. West.

I talked about this last Spring (see here), going over the autopsy report that was released online. The report vindicated Dr. Adams of some technical mishap, but was inconclusive on what actually caused her death. I speculated she vomited and aspirated with subsequent respiratory arrest, a not uncommon scenario we see in hospitals and nursing homes in elderly or infirmed patients.

A new wrinkle is being looked out apparently. Could Donda West's death be from an overdose of her pain medicine given by her cousin? I still think my aspiration idea is more plausible, but the role of pain killers could be a component in that mechanism (ie. narcotics can cause post-operative nausea/vomiting and a stuporous patient is more like to aspirate). I'm not sure that's a fair suspicion to throw on someone unless her toxicology had abnormally high serum levels of her pain medicine.

From the UK's Daily Mail

Police have now launched a probe into the possible role of her nephew, Stephan Scoggins, 46, a registered nurse who was allegedly supervising her post-surgery care.

A source tells American magazine People that investigators are looking into the alleged possibility that Scoggins administered too much of the painkiller Vicodin in a short period of time.

The insider also alleges that Scoggins left West in the care of a friend and Kanye's assistant to attend a baby shower prior to her death.

Last January, a Los Angeles coroner ruled that West died of 'multiple post-operative factors,' clearing West's embattled surgeon Dr. Adams of responsibility.

An investigator for the California Department of Consumer Affairs has issued subpoenas asking individuals 'to testify in the matter of the investigation of Stephan Scoggins,' a source tells the publication.


Monday, December 01, 2008

Breast implant maker Mentor Corp. now "augmenting" Johnson & Johnson's portfolio

Santa Barbara-based Mentor Corp., one of the the largest manufacturers of silicone breast implants, is in the news today with word of a takeover bid by Johnson & Johnson. If you're a shareholder in Mentor, you're going to be making some serious coin today. J&J is paying $31 for each Mentor share, a big 92% premium to Friday's closing price but well off its 52-week high of $40.82 about 11 months ago.

Mentor, and rival Allergan, have been locked in a real dogfight for market share of the American (and world) market in breast implants. Mentor today gets almost 90% of its revenue from breast implants, most of which are sold for cosmetic proposes. To survive, Mentor had been desperately broadening their portfolios to include dermal fillers, a BOTOX alternative ("PurTox") , an Alloderm alternative (NeoForm), and medical grade skin care lines. Their expansion to this point has run right into the teeth of the financial market downturns, and their earnings and stock price had been pummeled to this point. A real interesting transcript of the company's on the record discussions with institutional investors last week seemed kind of defensive. You can read it over at the excellent Seeking Alpha website of financial stories. They sure kept this deal under wraps!

This seems like an excellent opportunity to achieve synergy with some of J&J's research and development capability and distribution networks. It puts them on more equal footing with the large corporate entity Allergan.