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One patient does not a “game-changer” make in breast reconstruction release

New Breast Reconstruction Technique Provides Better Outcomes, Less Discomfort for Women Recovering From Breast Cancer

Our Review Summary

game changerIt’s hard to ignore a news release that claims a reconstructive breast surgery technique is “innovative” and “has the potential to be a ‘game-changer,'” as does this one from The Valley Hospital in Ridgewood, New Jersey.

The release focuses on the outcome of one 43-year-old woman who received the hospital system’s first attempt at the surgery and is quoted extensively in the release. The procedure in question is available to some women who get a mastectomy following diagnosis, yet want an implant to recreate the appearance of their breast or breasts. After the breast tissue is removed, a balloon-like sac is temporarily placed in the void left behind and gradually filled with fluid. This prepares the skin and muscles nearby for a permanent implant, which is typically inserted a couple of months later for “an excellent aesthetic outcome.”

This all sounds wonderful, but our review team (which includes a breast surgeon) thought the release was nearly devoid of crucial context. It doesn’t adequately discuss costs, risks, evidence, or alternatives, and it doesn’t make clear how this procedure differs from similar, more common implant techniques. It also trumpets the outcome of one woman, whose experience with the procedure — while extremely positive — may not hold true for many women who elect to have mastectomies.

At best, this release is an incomplete advertisement.

 

Why This Matters

Electing to have breast surgery is often an extraordinarily difficult decision: Every patient’s cancer, her risks, and her needs are different. And while it’s nice to have options for reconstructive breast surgery — a topic that’s important to women affected by breast cancer — the advantages or disadvantages of one procedure over another seems to become less clear as more techniques become available. That’s why it’s increasingly important for medical institutions that promote the latest-and-greatest cosmetic procedure make clear its place in a cornucopia of alternatives, and adequately discuss the risks of surgeries that may have little or no bearing on survival or other critical outcomes.

Criteria

Does the news release adequately discuss the costs of the intervention?

Not Satisfactory

No dollar signs here. However, not including a mastectomy (anywhere from $15,000 to $55,000 or more), tissue-expander breast surgeries typically cost about $40,000 per breast. But if there are any complications, those costs can skyrocket due to additional surgeries and other medical costs.

Does the news release adequately quantify the benefits of the treatment/test/product/procedure?

Not Satisfactory

The benefits are described — “diminished post-operative pain, quicker recovery time, improved mobility, and an excellent aesthetic outcome” — but not quantified, neither alone nor in comparison to other options.

How much is pain reduced by this procedure? How much faster is the recovery time? How much better can women get around? What constitutes “excellent” when it comes to the look of a reconstructed breast? We aren’t told.

Even if the release had quantified the results or made a comparison to other techniques, this is a report of one procedure in one patient. It is not possible to make general statements about the benefits of a procedure when only one procedure has been performed.

Does the news release adequately explain/quantify the harms of the intervention?

Not Satisfactory

As a 2013 New York Times Well blog post highlights, about one-in-four nipple-sparing surgeries (promoted by this release) lead to dead tissue “in the areola or in nearby skin” — and additional surgeries to remove that dead tissue.

The risks or necessity of mastectomy and reconstructive breast surgery aren’t mentioned, either. Mastectomies (as compared to lumpectomies or avoiding surgery altogether) may not lead to better outcomes for many women. Also, implants can leak, cause infections, and lead to other complications. We’re also not told how radiation and chemotherapy — two extremely common treatments in conjunction with breast cancer surgeries — affect results.

The one saving grace of this release is its last word, which makes a case for approaching each woman’s diagnosis and treatment on an individual basis.

Does the news release seem to grasp the quality of the evidence?

Not Satisfactory

Throughout the release, we get an earful about cause-and-effect relationship: If you do get tissue expander before, then you’ll heal faster, suffer less, and look better.

But all we get is a vague mention to “ongoing research.” What and where are these studies? At the very least, how are outcomes measured? Who is this procedure appropriate or inappropriate for?

The lack of key details that support the release’s claims is a major oversight. This is a procedure not commonly performed, and more study is needed to identify best candidates for the procedure as well as to evaluate the complications and long term results.

Does the news release commit disease-mongering?

Satisfactory

Descriptions of pain and long recovery periods are found in this release. But that seems essential to the nature of this procedure, which aims to reduce these and other problems.

Does the news release identify funding sources & disclose conflicts of interest?

Satisfactory

The Valley Breast Center is listed at the end of the release. But due to the overwhelmingly positive comments from the patient who received the procedure, it would have helped to make clear whether or not she was compensated in any form by the hospital system.

Does the news release compare the new approach with existing alternatives?

Not Satisfactory

Options for reconstructive breast surgeries are as numerous as they are nuanced, depending on the needs of the patient. However, none of them — one-stage implant surgeries, muscle flap surgeries, etc. — get even a passing mention.

In the context of this procedure, it would have been helpful to clear up the alternatives, including the more-common procedure of getting an implant beneath the chest muscle (where it’s less likely to cause complications).

It should always be stressed that there is no one-size-fits-all approach to breast cancer reconstruction. Factors taken into account include the patient’s constitution, other medical problems, location of the cancer in the breast, type of cancer, need for preoperative or postoperative chemotherapy, need for radiation therapy, and patient preferences for cosmetic outcome. In addition, extensive discussion needs to be held regarding the potential complications of each reconstructive approach.

Does the news release establish the availability of the treatment/test/product/procedure?

Not Satisfactory

We’re told The Valley Hospital performed this surgery, and — by implication of going through the effort of issuing a news release — we have to assume the hospital plans to perform this surgery again for patients who qualify. However, that isn’t made clear.

Does the news release establish the true novelty of the approach?

Not Satisfactory

This is definitely not a new technique. However it needs to be stressed that there are very good reasons why it is not commonly performed, and this release does not discuss any of them. The novelty is essentially lost in this release — the most we’re told is that this is a “variation of a standard technique.”

Almost all tissue-expanding breast surgeries place a balloon-like sac beneath chest muscles and on top of the ribs, where they’re better held in place (and less likely to protrude through surgical cuts).

The procedure described here places the implant on top of the chest muscles — right below the skin. Breast surgeons typically avoid this because the breast skin alone might not be able to support a saline-filled sac after an aggressive surgery, even if filed gradually over weeks.

And as much as this release tries to make the procedure seem new, it’s not; it just appears to be new within this particular corner of New Jersey.

Does the news release include unjustifiable, sensational language, including in the quotes of researchers?

Not Satisfactory

Hyped terms like “innovative” and phrases such as “has the potential to be a ‘game-changer'” are found throughout this release — and there’s almost nothing to back them up.

Total Score: 2 of 10 Satisfactory

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