Why is breast cancer reconstruction surgery with implants done in multiple stages? "Baby Steps"

From time to time you will get asked by breast cancer patients whether their reconstruction surgery can be done all in one stage at the time of mastectomy. The answer is you can, but there are a number of factors working against you for the best result, such that "baby steps" (planned sequential small procedures)

Typically, most implant reconstruction surgery involves placing a temporary implant called a "tissue expander" at the time of mastectomy that is later replaced by a permanent implant. As compared to a regular implant, a tissue expander is shaped different to maximize shape of the lower breast. It is decidedly more rigid and firm and then permanent devices, particular when silicone implants are later used. The advantage of such specialized devices is that they allow either 1) expansion of the skin by periodically adding fluid to them and 2) better resisting shrinkage of the skin following mastectomy.

Planned 2 stage surgery was popularized by Dr. Pat Maxwell (my mentor) and Dr. Scott Spears, and is well established as the most popular way to do breast reconstruction world wide. There has always been some interest in trying to skip the intermediate step, but doing it predictably is elusive. The big problem is tissue shrinkage of the skin, which as I mentioned is better resisted by the more rigid expander implant versus the softer permanent ones. The best candidates are those with smaller breasts who are having nipple-sparing procedures so that the native skin is 100% conserved. Even in that group, I find I'd be increasingly likely to go back and fat graft to camouflage the implant in a 2nd stage surgery. To my way of thinking, the benefit of single stage surgery just work enough to give up the benefit of the expander structural advantages.

Rob
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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.

Rob
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What's oncoplastic surgery?

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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Questions about breast reconstruction


I got a late question in the "mailbag" from a Plastic Surgery resident asking



"When I was applying to programs last year and traversing the country visiting programs, there were a few trends which enticed applicants, probably none more that microvascular breast reconstruction. I was curious whether you think this trend will persist, or do you think increased insurance skepticism and comparability of implant based reconstruction and rotational flap reconstruction will leave this procedure for the uber rich willing to pay the difference?"


One thing to understand with questions like this is that while quality in healthcare is applauded, it is not paid for in a vacuum. With rare exception, reimbursement for insurance will continue to be depressed as we creak towards some kind of "federal medicare for all". As the feds and 3rd party payers look at things, quality is measured in things like length of stay and total cost rather then measuring quality in terms of "Does this type of reconstruction look more like a breast?".

Microsurgical expertise is gradually being concentrated in fewer and fewer hands as it has become a financially unsustainable procedure for most surgeons. (you can witness the same phenomena in pediatric plastic surgery & increasingly, hand surgery btw) I don't think there exists a large population of "uber rich" to sustain the field in a robust fashion, and there really is no plausible stimulus pending (50% increase in RVU's for instance) for rekindling interest in free flap surgery when other options exist.


Rob
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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.
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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.
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Is fat grafting a Lumpectomy defect in the future for breast reconstruction?


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.


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Breast Implants and suicide redux


The correlation between patients with breast implants and slightly higher suicide rates is something I touched on previously (see here).

To most observers this is a fairly easy phenomena to explain: higher rates of psychiatric issues and depression among cosmetic surgery patients would expect to result in a corresponding suicide rate increase. An excellent review of this literature was published in the February issue of Plastic & Reconstructive Surgery, the world's flagship scholarly journal for Plastic Surgery.

Still, among the cadre of anti-implant activists , there lingers the suggestion that these observed suicide rates are from either psychic or physical pain from their implants. This was voiced recently by the actress/ant-implant crusader, Sally Kirkland (see photo), who speculated that Anna Nicole Smith's death by drug overdose was from her breast implants. (As opposed to her reported history of depression, psychiatric problems, alcoholism, and drug abuse/dependency.)

"Dr." Kirkland's observations aside, an interesting addition to the literature popped up this week which asked the logical question of whether the increase in suicide rates was also seen in breast cancer patients. Surprising no one, the answer is no in a National Cancer Institute funded review of cancer registries. The skeleton of this study can be read here.

Hopefully this puts the stake in the flawed assertion that breast implants causes suicide, and redirects the attention towards more effective screening out of potential patients who would benefit from psychiatry rather then surgery.
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Atlanta Breast Symposium tidbits



I just returned this last weekend from the Atlanta Breast Symposium, one of the annual major meetings in Plastic Surgery. Atlanta is one of the places where many milestone advances in Plastic Surgery came from including flap based reconstructive surgery, the TRAM flap & latissimus breast reconstruction procedures, and endoscopic plastic surgery. At one point in the early-mid 1970's there existed a cadre of talent at Emory University's Plastic Surgery department that will never be rivaled.

A few observations from the meeting:

- the form-stable shaped "gummy bear" implants from Inamed (Inamed 410 implant), Mentor (Mentor CPG implant), & others (Silimed, Euro-Silicone) are going to dramatically affect our results for the better in breast reconstruction surgery. A number of international presenters showed results that cannot be achieved with round "normal" silicone implants as were just approved by the FDA.

- the silicone-istas are ready to pounce on any failure of compliance with the FDA instructions to demand that approval be withdrawn for silicone implants.

- we're struggling with how to address the increasing use of radiation in breast cancer patients when we plan reconstruction. There continues to be wide variability in different cities in who gets radiated and how much the side affects are.

- subglandular implant placement seems poised for a comeback. Contemporary "low bleed" implants appear to have significantly lower chance of capsular contracture as compared to older implants when placed above the muscle.

- using smaller implants continues to be identified as the single most important factor in reducing complications and reoperations.
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Breast reconstruction using own twin



In this weeks' PEOPLE magazine, there's a feature on twin sisters from Pennsylvania who underwent an unusual type of organ transplantation. After radiation treatments and a failed implant-based breast reconstruction, Naomi DeSalvo Whinnie turned to micro-surgeon extraordinaire Dr. Bob Allen in Charleston, SC for help.

Dr. Allen is the father of the "DIEP" flap for breast reconstruction, an operation that uses microsurgical techniques to transfer tissue from the abdomen to the chest and performs more then 100 hundred such reconstructions annually. The catch here is that the tissue in this case was provided from the abdomen of Mrs. Whinnie's identical twin sister, Nina DeSalvo Hildebrand. This operation can be performed on twins without intense immunosuppression because their immune systems do not recognize the tissue as foreign and reject it. This is the third such twin-twin DIEP flap Dr. Allen has performed in what is likely the largest personal experience in the world.

Seen below are the sisters shown recovering in a shared hospital room.

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