E! talk show host Giuliana Rancic, recently diagnosed with breast cancer (and having failed an attempt to remove the cancer with a lumpectomy) has decided to proceed with bilateral mastectomies and reconstruction for her treatment. Her decision is similar to those made by actress Christina Applegate and comedian Wanda Sykes in recent years. This choice is likely the right one for a number of reasons IMO.

• at 37 years old and without children (she was actually undergoing fertility treatments when diagnosed with cancer), she possesses two significant independent risk factors for future breast cancer 1) personal history of cancer and 2) delay or absence of childbirth.
• She has had prior attempt at lumpectomy, which almost guarantees significant cavitary breast deformity, particularly on a thinner woman such as Mrs. Rancic with additional attempts
• She (being an American adult female in good health) has an estimated life expectancy of almost 95 years, and 6+ decades of future surveillance on a high risk individual treated with breast conservation strategies has not been studied. Mastectomy does seem to have an advantage of lower recurrence rates verus lumpectomy with radiation, particularly as you get decades out from the initial treatment.
• A breast treated with lumpectomy and radiation will progressively look worse and worse over time as it relates to bot appearance and asymmetry with the other breast.

Selecting or suggesting a treatment for a younger patient like Mrs. Rancic becomes as much a question of psychology as it is about treatment of the cancer. While it's likely that a more aggressive surgical treatment of localized cancer will pay dividends as you get farther out from the mastectomy, many women will never be comfortable with the breast cancer surveillance requirements going forward and select a mastectomy to simplify their care. It's telling that when women plastic surgeons have been surveyed on whether they'd undergo mastectomy or breast conservation with radiation, that almost all of them would choose mastectomy (and prophylactic mastectomy of the other breast).

Rob

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This is kind of a post I've been sitting on for about 7-8 months that I though would be kind of interesting. Last Fall there was an article in a New York business magazine about a small trend in some breast cancer surgeries being performed in plastic surgeon's offices in Manhattan. The article, "Mastectomies check out of the hospital" describes this phenomena and I found this quote interesting,

"Dr. Evan Garfein of Montefiore Medical Center was the driving force behind the new state law requiring that patients be informed of their surgical options. The breast surgeon says his effort was meant to correct a disparity: Poor minority women are less likely to get reconstructions because they often aren't told that federal law requires their insurers to cover the procedure.


But Dr. Garfein says he never thought the law's passage might drive a boom in office-based breast cancer surgery.“With the right doctor and the right patient, reconstruction can be safely done in an office,” he says. But not a mastectomy. “To me, that's the type of operation that should happen in a hospital.”

Dr. Garfein questions the motivation of plastic surgeons offering such procedures. The specialty has been hit hard by a drop in business during the recession. “When you look at the economics, you know that if a plastic surgeon owns his own operating room, it's [financially] better for him to do the surgery there,” Dr. Garfein says. “You have to ask, 'Why is this being done?' If there's a trend like this, it should be because patients are demanding it. Plastic surgeons shouldn't be driving a trend to get patients out of hospitals.” "

As someone with an interest in office based surgery, I found Dr. Garfein's comments kind of puzzling. Our office is equipped with a large hospital-grade operating room and is accredited for surgery by one of the same groups that reviews hospital and free-standing ambulatory surgery centers (ASC). We routinely do operations significantly longer and more difficult then breast cancer surgery (which is neither particularly long or difficult in most instances) at 1/2 the cost of the hospital with an infection rate close to 0% (our's is actually zero for over the 2 1/2 years we've been up and running). While there's a selection bias in outpatient surgery candidates towards younger, healthier patients there are many,many breast cancer procedures (both tumor removal and reconstruction procedures) we could absolutely do safely if we choose to.


The big hold up here in Alabama is the dysfunctional Certificate of Need (CON) process and the reluctance of insurance carriers to upset the hospitals (who would lose some cases).  State's with CON's are essentially franchise cartels that try and protect their exclusivity of where surgery can be performed. Predictably, CON  states become a political quagmire of competing hospital systems suing each other to prevent the other from outmaneuvering their business model. In Birmingham we currently have 4 hospital systems in court trying to prevent the state CON board from either allowing a hospital to move from one area to another in town (see here) or building new hospitals in attractive demographic areas where none exists nearby. As a direct result of the CON fights here, we actually have a former Democratic golden boy and governor, Don Sielgelman,  sitting in federal prison for taking bribes to appoint a requested person to the CON board (that's a post for another day).

In an era where we're pinching pennies to come up with cheaper ways to deliver care, it's mind boggling to dismiss a simple (and safe) way to do many procedures. I take issue with Dr. Garfein's suggestion that it's a financial incentive on the surgeon's part as if you actually expense running an office OR like an accountant would, it's likely a break even proposition (at best) with better paying insurance companies and likely in the red for Medicare and other low-paying insurers. While it's certainly helpful to 1) my efficiency and 2) the patient's experience (as they much prefer the office to the hospital), the main beneficiary in all that is the system which is likely to see equal or better outcomes at reduced cost. What's not to like?

Rob

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The AP wire is reporting that the number of women opting for surgery to remove the healthy breast after a cancer diagnosis in one breast is rising, despite a lack of evidence that the surgery can improve survival. Sometimes this is presented as controversial, but I think this represents rationale behavior by many women choosing this.

There's the powerful slogan that's penetrated popular culture that women have a "1 in 8" risk of breast cancer. That's kind of correct but oversimplifies things. Biology is destiny with breast cancer and appears to overwhelm anything in your diet or the environment in terms of producing breast cancer. Like most cancers, risk of breast cancer increases as you get older. Taking all comers in the United States, a woman's chance of being diagnosed with breast cancer is about 1 in 233 when she's in her 30s which steadly rises to 1 in 8 by the time she's reached 85. However, there are women in that group who are at substancially more or substancially less risk.

Younger patients in particular would seem to benefit the most from prophylactic removal of the breast due to this increasing bias for later tumor development. The survival benefit for this surgery hasn't really been studied (as far as I can tell) in your breast cancer patients out for decades. It's assumed that you'd likely see a significant difference in that groups risk of breast cancer in the post menopausal group. Widely referenced studies (see here) suggest that after prophylactic mastectomy a woman's risk for later developing breast cancer is reduced by an average of 90% (some even suggest closer to 100%).

It's clear to me which way I'd suggest for all but the most favorable tumors in young women. Is it for you?

Rob

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That was a heck of the title, eh? My little pun on the "6 P's" ;)

Of all medical diseases, few are surrounded by as much politics as breast cancer. After all, who doesn't want to advance the treatment of breast cancer? The problems arise when feel good political ideas triumph over evidence based medicine and you end up with legislation which is almost sure to cause as many problems as it solves.

Enter the boldly titled "Breast Cancer Education and Awareness Requires Learning Young Act of 2009" (EARLY Act) introduced by Rep. Debbie Wasserman Schultz (D-Fl). For whatever reason, Rep Schultz is one one of the single most obnoxiously partisan members of congress and gets on my every last nerve when I come across her on television. Schultz's bill seeks to spend $45 million over five years to start educational campaigns that would include promoting regular breast self-exams to secondary school students, even though the this has been proven ineffective and quite possibly harmful in clinical trials.


Breast self-examination may seem an innocuous and intuitive way to assist the self-detection of breast cancer except for the fact that IT DOES NOT WORK when applied on large populations of non-selected women. All young women have dense lumps and bumps in their breasts tissue which represent fibrous breast tissue or benign cysts that become symptomatic with their menstrual cycles. Recommending breast self-exams to this group of women will cause fear, many expensive negative imaging studies, false-positive results of various screenings, and many unneeded biopsies.

There's some math you need to think about with these younger women. The probability that a woman who is age 15 years will develop invasive breast cancer by age 40 years is less than one-half of one percent (0.497%). This can be compared to a 5% probability that a 50 year old woman will develop breast cancer by age 70 years (5.62%). The American Cancer Society reports that during 2000-2004, only 5% of new cases and 3% of breast cancer deaths occurred in women under 40 years of age. For women aged 20-24, there were only 1.4 cases per 100,000 women. The goal of an effective screening program is to find disease and save lives. Unfortunately, at the end of the day there is no effective method of detecting breast cancer in a healthy population of women under 40.

Other then family history, we're currently left with little other then some of the expensive genetic tests (like BRCA1 & BRCA2)to try and select out people for closer surveillance. Despite the strong association between BRCA mutations and breast cancer (where as many as 85% would be expected to develop invasive breast cancer), only 5-10% of all breast cancer patients have BRCA1 or BRCA2 mutations. This again gets back to the difficulty in effective screening.

Leslie Bernstein PhD of the City of Hope Hospital in California published an open letter to legislators considering this bill to explain why this is a poorly aimed directive and likely to cause more problems then it solved. The letter can be read here. A better public policy goal in my opinion would be to mandate insurers and Medicare to cover breast MRI for screening in high risk women.

Rob

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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.

Rob

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There's a paper this week in the Archives of Internal Medicine discussing the phenomena of some breast cancers possibly going away without treatment. As I do a lot of breast cancer related surgery, I know I'm going to get asked about this by a patient one of these days.

The paper is titled "The Natural History of Invasive Breast Cancers Detected by Screening Mammography" and can be read online here.

It opens with the observation that

...screening mammography has been associated with increased breast cancer incidence among women of screening age. If all of these newly detected cancers were destined to progress and become clinically evident as women age, a fall in incidence among older women should soon follow. The fact that this decrease is not evident raises the question: What is the natural history of these additional screen-detected cancers?

From autopsy studies of the elderly, we know we find many breast and prostate tumors which are clinically silent and that the patients died with rather then from. In an idealized world we could understand tumor biology enough that we could safely say some breast cancers could be watched, just as we already do with some prostate cancer.

This idea of "benign neglect" (no pun intended) for malignancies in regards to current standard treatments of surgery, chemotherapy, and radiation could potentially spare people significant morbidity and save the health system a great deal of money. One example of this would be the emerging idea that the drugs that block estrogen hormone metabolism (Arimidex) or estrogen receptors (Tamoxifen) may be just as effective as chemotherapy in post-menopausal women with estrogen receptor positive (ER+) tumors.

Now the study in question is taking some BIG leaps in logic making their conclusion. Much like financial analysts use "back casting" to test stock/bond buying strategies in the rear view mirror, these type of retrospective ideas can suffer from the fallacy of taking a result and looking back to make the data fit. This idea of watching these tumors would need to be done prospectively with very close followup. It would never be possible to do this trial in the United States due to internal review boards (IRB) and medical malpractice issues, but such an experiment might be possible in other countries (In the New York Times write up, Mexico is suggested for instance as a candidate. Gracias muchacho!)

Something to think about!

Rob

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Ok, I bit on the headline of some new "revolutionary" (their words) breast cancer technique written up on the UK's Daily Mail..... the "keyhole technique"

The article describes an endoscopic (lighted camera) assisted mastectomy done to preserve the nipple during surgery in breast cancer cases. As nipple sparing mastectomies have been done by plastic surgeons (and more recently breast oncologists) for about 50 years, officially color me skeptical that this technique adds anything other then complexity and or time.

For instance, in the last 2 weeks I did 2 nipple sparing mastectomies thru 3 cm incisions (one for male breast enlargement - gynecomastia, and one prophylactic for a woman with a history of breast cancer) sans endoscope in well under 45 minutes

Rob

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* Image at right spoofed from The Onion

One of the most serious claims in the class action lawsuits against Dow Corning Corp. during the "silicone crisis" involving breast implants in the late 1980's was that silicone breast implants caused breast cancer and/or delays in diagnosis of breast cancer. Despite there being no evidence for it actually happening, these were reasonable questions to ask. Over the last 20 years, we've been flooded with data that has been reassuring on these issues.

Implants do make conventional mammograms harder to interpret by their "shadow", but the increased ease of doing manual exams by having the implant to push against to feel lesions compensates a great degree. An MRI mammogram can be used to supplement mammograms when needed for better imaging for screening.

One of the more interesting findings in several of the large series of women with implants was the observation of significantly lower (almost 40%) rates of breast cancer in the implant group versus a control population of women without implants. The intuitive reason for this has been that these women with implants were a self-selected (rather then "randomly selected") group who were likely to be healthier and have less breast tissue, which both should lowered their expected rates.

To really sort out a true "expected rate" for breast cancer, you'd have to do some herculean effort of better characterizing the individual risks with a tool like one of the "Gail Model's" of the study participants, which is almost impossible in such large trials. The suggestion that the presence of implants themselves was protective wasn't really taken seriously. There could however, be something that makes us look at this issue a little closer.

I came across a pre-publication in the journal Aesthetic Plastic Surgery entitled, "Breast Implants as a Preventive Factor" describing the differential temperature seen on thermography (a imaging technique that shows temperature) from experimental rats with silicone implants placed and the resultant affect that had on local circulating hormone levels and cellular abnormalities (both of which were decreased in the implant group). Now this was only an animal model mind you, but it immediately occurred to me that maybe part of that effect we were seeing was from this phenomena. Interesting stuff!

rob

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The Wall Street Journal profiled the concept of "Oncoplastic Breast Surgery". This is conceptually just lumpectomy or mastectomy done better. The concept uses rotating breast tissue to fill defects at the time of lumpectomy or larger "quadrantectomy" procedures. These are maneuvers we use with breast reduction and mastopexy procedures adapted to some of the cancer surgery procedures.



It's a nice concept, but the rate-limiting step here is getting general surgeons to change how they think about breast surgery. Trying to coordinate someone else during the resection with a reconstruction is difficult, as they don't "think" like plastic surgeons do. I'm skeptical that short courses to surgeons can teach much beyond the most simple techniques. It's like putting someone in front of Guitar Hero on the Wii or Playstation and expecting them to play guitar professionally afterwards.

I'm constantly evaluating blood supply, tension, and tissue quality in a way that you just don't get taught in other specialties. Weekend courses in this discipline just aren't the same as having doing hundreds of different possible reconstructive techniques all over the body and bringing that to bear on a given case. I had the pleasure of working with two of the leaders in this field during my breast surgery fellowship, in Plastic Surgeon Dr. Pat Maxwell and (an occasional basis) Breast Cancer Surgeon, Dr. Pat Whitworth in Nashville. I though I knew how to do mastectomies and whatnot before I saw these guys do their thing. They're incredible! Both do such anatomically sound breast procedures with no superfluous steps that it's really beautiful (for lack of a better word) to watch. Dr. Whitworth is quoted in the article BTW.

Rob

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There was a good article for the lay public a week ago in the New York Times "With a Tiny Bit of Cancer, Debate on How to Proceed" about the phenomena and controversy over breast cancer "micrometastasis" to lymph nodes. I do a lot of breast cancer related surgery and have this kind of discussion frequently with patients. I've tried over the years to come up with simple concepts for these women who often feel overwhelmed with ideas and terms that have been poorly explained to them.

If you're trying to keep things simple for patients with invasive breast cancer (meaning it has acquired characteristics on microscopic exam suggesting it has the potential to spread elsewhere), it's important to come up with a simple way to explain what their diagnosis really means. There's 3 things that really affect whether or not you're likely to do well when you're diagnosed with invasive breast cancer.

1. the size of your tumor


2. the presence or absence of cancer in your lymph nodes


3. the presence of Estrogen hormone receptors on the cancer cells

Tumor size and nodal status are proxies for metastatic potential. A larger tumor is more likely to have spread to the lymph nodes at the time of diagnosis. A tumor present in the lymph nodes is in turn more likely to have spread elsewhere and show up again down the road as systemic terminal disease. Breast cancer, like most solid tumors that spread via lymphatic tissue, is conceptually really only "cured" if you remove it surgically before it gets to lymph nodes. This basic fact is essentially unchanged despite steady refinement in radiation (XRT) and chemotherapy (CRT) treatments for 60 years. XRT or CRT do not cure anything, but rather decrease/delay recurrence or palliate symptoms. (I'm simplifying this greatly, but that's the skinny in a nutshell).

Estrogen receptors (ER) are conceptually an "on/off" switch for normal breast tissue cells. A breast cancer cell that still maintains this normal regulatory switch offers a target for hormone manipulation. This "killswitch" provides the basis for medicines like Tamoxifen or Arimidex to show improvements in local recurrence after surgery by blocking these receptors or interrupting estrogen metabolism by essentially "starving" the tumor. We're increasingly seeing how important having this receptor is, particularly in post-menopausal women. It's looking more and more from tumor databases that many older women with ER+ tumors may be able to avoid chemotherapy altogether after surgery, and this observation is currently being tested in prospective trials. A breast cancer that's ER- (missing the receptor) suggests a more "primitive" tumor that's lost some of it's normal regulatory mechanisms and implies a worse prognosis. I found a really nice primer on this for people over at "Cancer Geeks"


BACK TO THE TIMES ON "MICROMETS"
Complicating treatment options now is our increasing ability to detect infinitesimal amounts of cancer cells (micrometastasis) in some lymph nodes that would have been labeled normal just a few years ago. Do we treat this the way we traditionally did positive nodes or are we over treating? We just don't know. It has played a little havoc with interpreting some breast cancer data that was suggesting we were doing better with our treatment.

Why? Well if you suddenly take these micromet positive patients and up the stage of their diagnosis like you would normally with positive nodes, you make both the node - and node + groups look like things are getting better. Nothings really changed except you're removing people who do worse from one group and putting them into a group of node + cancer patients where they will do better then their peers. (I cannot for the life of me think of the name for this statistical phenomena....)

Anyway, read the article (click here) as it's interesting.

Rob

Rob

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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

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*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

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Today's entry is kind of an "inside baseball" thought that occured to me reading an article on medicine.

There was a breathless article on the news wire "Participants Left Uninformed in Some Halted Medical Trials" (syndicated from a New York Times story) earlier this week about the fate of patients who were enrolled in clinical trials for devices or drugs that had been discontinued. In many instances these patients (and occasionally their doctor) were apparently unaware of this fact. They used two medical devices as examples - vascular stents used to treat aortic aneurysms and a type of breast implant used in cancer reconstruction.

The stents are a potential big problem in that if they don't perform as designed, the patient will die. The breast implant patients (two women in south Florida) seem to be having much less an urgent issue. From the thumbnail description it sounds like the women were having some degree of capsule pain, which is not terribly uncommon especially in breast reconstruction patients who've been radiated. Capsular contracture is also the way some silicone implant ruptures present.

Implied in the NYT article is the implication that these women are "sitting on a time bomb" with their implants which is really silly and makes the juxtaposition from the stents scenario kind of ridiculous. In this instance, I'm not sure you'd do anything at all different for these women other then checking for rupture. No one would recomend "prophylactic" removal of those implants in the abscence of documented rupture, particularly if the implants were less then 10 years old. We have plenty of information about the treatment of silicone breast implant ruptures, and it's well established that the problems you get are local issues to the chest wall. A capsular contracture or ruptured implant is it's own issue, but to hold it up next to potential life-threatening device failures misses the real serious problems with medical devices and their surveillance.

They don't really go into much detail other then identifying the implant manufacturer, Allergan, and that the particular implant had been discontinued recently (~2005). If I had to guess, it's probably the Inamed "Style 153" implant these women had, which was an anatomically shaped silicone gel device that preceded the more advanced Style 410 "gummy bear" implants. Those implants, which were voluntarily pulled from the market by the manufacturer during their approval process negotiations with FDA for their conventional type of silicone gel breast implants.

The style 153 implant had an innovative "double lumen" core that had an apparent higher failure rate when you studied them on MRI scans (the best test for rupture). Confusing the issue is the resemblance of the double shell for some of the described signs of intracapsular implant rupture which is well described in this full text American Journal of Radiology article. There are a great many surgeons who strongly believe MRI's (or at least the radiologists reading them) have a tendency to over-estimate ruptures, particularly with this specific implant. At the end of the day Inamed made the decision in 2005 to "cut bait" on such a minor product to better their chances of FDA approval for their other products. The style 153 was a good implant for it's time, but it really was just a transitional model to the form-stable devices like the 410.


* Below is an MRI showing the characteristic "double lumen" sign confused for rupture occasionally with style 153 device

Rob

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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

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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

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From Japan comes the F-Cup brand cookie containing nearly 50mg of that "miracle" breast enlarging herb Pueraria Mirifica. This product packaged in the form of a "cute" cookie gives me reason for pause.

What's this herb Pueraria Mirifica anyway?

It's a plant found in Thailand and SE Asia whose root contains phytoestrogens, plant derivatives that can mimic the effect of estrogen in the body. As with many herbal products, god knows how much of the product is actually in an individual cookie. Quality control for most such things is notoriously poor.

Will products like this make my breasts grow?

Possibly, as estrogen makes ductal tissue (the non fatty component of your breast) proliferate. Something like this would likely produce gynecomastia (man boobs) in males.

Should people be taking this without talking to your doctor?

Hell no! These types of herbs are apparently associated with similar risks as estrogen containing birth control pills or hormone replacement. There is literature suggesting (see here) these can make estrogen-responsive breast cancers proliferate or interfere with Tamoxifen (a common medicine used to reduce the risk of breast cancer recurrence that works by blocking estrogen pathways). Estrogen products can also make you more likely to spontaneously develop blood clots in your veins which can cause lethal pulmonary emboli.

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There's an article in the today's (Sunday) New York Times "Cancer Patients, Lost in a Maze of Uneven Care" that hit home to me. It lays out the difficulty for patients in finding the right doctors and the correct treatment when you have cancer.

The article highlights some consensus statements on general principles of cancer treatment by the National Comprehensive Center Network. This information is useful to get your feet wet on learning about cancer treatment and can be found here. Several specialists at super-tertiary cancer programs comment on the "shocking" lack of standardized care in many instances in how common cancers are treated. Implicit in some of these statements is the notion that you have to go to some super-duper place like Memorial Sloan-Kettering (MSK) in NYC or MD-Anderson in Houston,TX for cancer treatment.

This is an absolutely ridiculous idea to me in most instances, except for certain surgical procedures which are only done commonly by a handful of super tertiary specialists. Post-operative morbidity & mortality for some of these procedures seems to directly correlate with volume, and volume tends to accumulate in small numbers of hands. However, I work commonly with community surgeons (a number of whom trained at places like MSK) who do higher numbers of these cases then the local super sized University-based teaching hospital.

Cancers of the liver, stomach, esophagus, pancreas, brain, and advanced head and neck tumors are the ones where I think you may be better off finding one of these specialists. For breast or colon cancer it's asinine to suggest you get better surgical treatment. For chemotherapy or radiation therapy the same "cookbook" for standard treatment exists whether you're in Manhattan or Mobile,AL and you shouldn't need to travel for it. Certain investigational trials (which again aren't standard and weren't the focus of the NYT article, may require you to go to regional cancer centers)

There's a patient in the article with aggressive stage IV colon cancer with liver spread who was (appropriately I think) counseled on the futility of extra aggressive chemotherapy and suggested a palliative regimen. She's used as an example of "under treatment" when she visits a referral center in Seattle that later used more then twenty cycles of chemotherapy to likely extend her life by less then a year and subsequently went to Johns Hopkins in Baltimore for what sounds like an ill-advised radical liver resection. Ironically my little brother is actually an oncology fellow at Johns Hopkins.

Even more ironic, is that last week I authored a section about surgical treatment of liver metastasis in the colon cancer entry on Wikipedia. Small world, eh?

No mention is made of exactly how gruelling this kind of therapy is, nor is there any perspective of the costs of treatment to the system. This was over $400,000 of dollars more expensive then what was recommended by her first oncologist. In an aside to the debate over "Sicko" and government health systems, you can bet that this treatment would not be subsidized by universal health care systems in most of the rest of the world.

As part of the food-chain of the oncology system, most often for breast and skin cancer, I see this all the time. One of the frustrations of breast reconstruction is trying to read the tea leaves about what kind of chemotherapy, radiation, and mastectomy a patient will receive. Variations in any of these can dramatically affect the quality of reconstruction, which is more of a tertiary concern from an oncology perspective but is often the most important from the patients perspective.

I'm just a "dumb skin doctor" these days but in scanning the NCCN recommendations on breast cancer treatment, I found a number of statements I thought either wrong, misleading, or at least up for debate. In particular they seem to be rather eager to irradiate people (for little or no benefit) and still wedded to the idea of "lumpectomy for all". When younger women, whom generally have aggressive tumor characteristics, are made to understand that (at approaching two decades follow up) between 15-19% of people treated with lumpectomy and radiation may have local recurrence of their invasive breast cancer, the rationale and enthusiasm for breast conservation diminishes sharply.

Plastic surgeons are particularly tuned in to the problems of radiation as we inherit them for reconstruction. By and large, if you considering a lumpectomy with radiation, you do not want to ask a Plastic Surgeon's opinion of it as we disproportionately see the complications. That's a post for another day.

Rob

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Fat grafting the breast is a controversial topic. A biotech firm claims to have come up with a feasible model for immediate reconstruction of lumpectomy defects involving injecting stem cells from fatty liposuction aspirate of a patient's abdomen. The process from Cytori Therapeutics is called Celution™ . The San Diego Times-Union featured this a few months ago here.

From Forbes Magazine:

In the technique, adipose (fat) tissue is taken from the patient, using a minor liposuction-like procedure. The tissue is then placed into the Celution system, and processing begins. An hour or so later, a dose of regenerative cells is delivered back to the patient, injected in the breast. Fat tissue contains many types of cells, (Thomas) Baker said, but the stem cells and regenerative cells are the "stars" that make the reconstruction possible

Now it's unwise to blow off the wisdom of a guy like Dr. Tom Baker, the Miami plastic surgeon of historic contributions to our field (particularly in face-lift surgery & by virtue of him literally inventing the first effective chemical peel in the late 1950's), but I have some doubts about this. It's going to take at least 10-15 years of incredibly close follow-up to make any kind of conclusion about the effect of stem cell fat-grafting a breast with cancer. The premise of injecting pleuripotent (cells which can "turn" into other cells in layman's terms) stem cells into an organ that's cancer-prone sets off lots of alarm bells. Like "regular" fat grafts, you presumably are going to create mammogram artifacts, which is something you have to approach carefully in someone with a personal history of breast cancer. The American Society of Plastic Surgeons has come out on the record in 2006 against fat grafting of the breast for just such concerns.

Also, on a more practical level, who is going to pay for this?

Most lumpectomy sites don't require any treatment for starters. As I understand this kind of stem-cell "transplant", it takes several hours to harvest and prepare the cells which is expensive time in an O.R. In an era where reimbursement for surgeons performing breast cancer reconstruction has fallen nearly 75-80% since 1990, I cannot imagine this being adopted by Medicare or other 3rd party insurance payers and if they do it will not be economically feasible to perform it. This is what happened to surgery using your own tissues (ie. TRAM flaps), the congress mandated coverage for breast cancer reconstruction in legislation, but Medicare and insurers subsequently made it difficult to earn a living doing it, particularly in the case of muscle flaps or microsurgical reconstructions.

The stem-cell potential of this kind of technology seems to have much more practical potential in areas like ischemic heart disease and neurodegenerative processes IMO then reconstructive Plastic Surgery. If the price comes down, use for cosmetic injections in the face might also be an interesting indication.

Rob

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Last week I talked about the recent literature re. the new recommendations by the American Cancer Society on breast MRI's for cancer screening. I touched on both the financial considerations as well as the potential for increased screening to cause more problems then it solved.

There's an excellent overview of this in the Washington Post which crystallizes many of these concepts more eloquently then I. Click here to read.

From the article:

...if you really want to find as much cancer as possible, we would suggest whole-body CT, MRI and PET scans every month. But that would be absurd. Why? Because the goal is not to find more cancer. The goal is to save lives. The two goals are not the same...Over-diagnosis is the reason that the number of people with cancer diagnoses is increasing much more quickly than the numbers dying from those cancers.

For breast cancer, MRI may (or may not) be the best test. We just don't know. The only way to know is to do a true experiment -- a randomized trial -- in which half the participants have MRI while half have mammograms, and determine how many die from breast cancer in each group. These experiments are a lot of work and they take a lot of time. But they are the only way out of what is beginning to appear to be a vicious cycle: more and more testing finding more and more cancer, with the assumption of benefit...Early detection is a strategy that turns many more people into patients. Its effect on how many people die is relatively small, at best. People will die from cancer, whether or not they are tested.

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There's another paper today challenging conventional wisdom on how effective screening studies are in the prevention of breast disease. In this instance it's computer-aided detection (CAD) mammograms, which were billed as a way to increase the effectiveness of interpreting mammograms. It uses advanced image recognition software to screen for abnormalities. Despite little data, this technolopgy was quickly adopted. Many mammography centers adopted this technology and were incentivized by medicare with additional payments ( ~ $20 per study) to use CAD. Note: When you do thousands of mamograms a year, this $20 per study can be serious money in someone's budget

CAD is apparently more sensitive then humans to abnormalities, but less able to distinguish malignant from benign. It also tends to identify a number of ductal carcinmona in situ (DCIS) lesions, which if left undiscovered may never turn into invasive breast cancer (aka. "real" breast cancer). Much like small prostate cancers in males, where many would die with it rather then from it, we as yet have no predictable way of tell patients that nothing will come of it and are forced to offer more aggressive surgical and medical treatments and their associated morbidity.




This report is the mirror image of the other large counter-intuitive finding we saw recently with screening CT scans for lung cancer. (ie. we find more disease but don't improve outcomes about death from cancer, while actually increasing morbidity and anxiety for patients.

While I'm off on this I'd like to dovetail on imaging studies for breast implants. With the 2006 FDA approval for silicone gel breast implants came a recommendation for routine screening by MRI of all implant patients starting 3 years post-op then every 2 years. This illogical and unenforceable (and unfunded) suggestion is surely going to widely ignored by patients and I'm not sure I'd blame them. For the period which would encompass the first 2 MRI's (five years out) the rupture rate of an implant in augmentation patients of "regular" silicone implants is likely under 1-2% while after 4 MRI's (10 years out)it's likely only 6 or 8%.

What drove this recommendation by the FDA? Most point to the highly charged political environment that still exists in America over this. One month prior to the FDA approval, Canada released the last of it's token restrictions on the devices and commented that while MRI screening was discussed, routine use was not evidence-based medicine. What do other countries do? They image implants selectively and usually start with ultrasound and reserve MRI for equivocal findings. As consequences of rupture tend to be confined to the breast and we know many woman may go years or decades with asymptomatic rupture, this is the position that makes the most sense to me. If you were to start MRI screen in asymptomatic women it would make sense to do this at 10-12 years when you sit and crunch the numbers.


The form-stable cohesive gel implants from Inamed
(picture below), Mentor, & other companies will make this topic be revisited when they are likely (you never know with the politics of the FDA)approved for general use later this year. When you have a device like Inamed's 410 implant with rupture rates so low as there are no data points to even do projections on rupture rates will the unsound MRI recommendation be attached to it as well? Keep in mind there has also been an issue of a number of false positive MRI's read out with the Inamed 410 and some of the dual-lumen devices (part saline-part silicone)in some of their clinical trials as they look somewhat different on MRI

Stay tuned!

Rob Oliver Jr. MD
www.oliverplasticsurgery.com

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