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New technique for breast reconstruction in older women sounds promising but questions remain

Direct-to-implant breast reconstruction provides good results in older women

Our Review Summary

The motivation for this study, in the words of the authors, seems to be: “half of all breast cancers occur in women over 65, yet only four to 14 percent of these women undergo reconstruction.” Most existing studies on breast reconstruction in older women focus on a technique involving gradual tissue expansion, followed by a breast implant. The authors wanted to see if going from mastectomy directly to implant in a single procedure — called ‘direct-to-implant,’ or DTI — had similar complication rates and outcomes.

This news release would have benefited from being more explicit about the nuts and bolts of how different breast reconstructions differ, as well as being more clear about costs and availability.

 

Why This Matters

Age is a major risk factor for developing breast cancer. The proportion of women age 65 and over is expected to increase in the near future. That means more women are likely to be diagnosed and treated for breast cancer. Whether reconstruction will follow suit remains unclear.

However, if reconstructive surgery does become more popular, surgical approaches that promise to be more convenient and less risky for women, need to be comprehensively studied. The study mentioned in this news release is a very small step in that direction.

Criteria

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

Not Satisfactory

This news release doesn’t mention the cost of either the new approach being studied (direct-to-implant, or DTI, breast reconstruction) or the widely used tissue expander/subsequent implant approach to which it’s compared.

It also made no mention on whether Medicare would cover either procedure.

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

Satisfactory

Multiple follow-up benefits (measured at 30 days and 1 year) are cited, with the DTI group having fewer readmissions, fewer days with a drain in place (13 vs 23), fewer days in hospital after the procedure, and fewer follow-up office visits (6.5 office visits vs 12 visits for the non-DTI group.)

The news release highlights the following benefit: “avoiding some of the inconvenience and risks of staged approaches to breast construction.” So, It would have been helpful to clarify for readers what the staged approach with tissue expanders involves; mainly inserting an inflatable expander in the space left by the removed breast, gradually filling the expander with saline over weeks or months, and eventually placing an implant once the area can safely and comfortably accommodate it.

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

Not Satisfactory

In framing this emerging technique as “safe and effective,” as well as highlighting complication rates that are no different from the standard approach, this news release may be minimizing the very real complication rates. The release states, “Complication rates were similar between groups, including blood and fluid collections (hematoma and seroma), infection, unplanned surgery, and failed reconstruction.”

The rates may not have been any different between the groups but that does not mean harms can be dismissed. It’s not hard to find disquieting statistics on the rate of complications after mastectomy with reconstruction, for instance this study showing a 10.3% overall complication rate after mastectomy with implant — and 6% of implants being removed within 60 days.

The published study mentioned previous research had found greater complication rates with the direct-to-implant approach. These contradictory findings are not mentioned in the news release.

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

Satisfactory

The news release does well in reminding us this is a retrospective chart review of just one hospital’s experience. The size of the study — comparing 24 breasts reconstructed by DTI in just 19 patients, with 109 breasts with expander-implant approach in 98 patients — also limits the generalizability of these findings. With just over 100 patients the study is quite small.

We appreciate mention of the fact that DTI is not an appropriate choice for all women (breast size, shape, and other factors come into play).

The study mentioned that many of the DTI reconstructions necessitated the use of acellular dermal matrix (a soft tissue substitute that is derived from donated human skin tissue) which has to be considered with regards to risk profile of the patient and whether this is a suitable procedure.

Does the news release commit disease-mongering?

Satisfactory

There is no disease mongering in this news release. However, the assumption of the release is that there is something wrong with the fact that most women older than 65 choose not to have breast reconstruction. And the implication is that these women would opt for reconstruction if it were more convenient than the current procedure. Maybe that is the case, but we don’t know why they choose what they choose.

Reconstruction requires being under anesthesia for a long time and there are known risks associated with implants. It also takes a while before the implants feel “normal.” None of these potential reasons for not having reconstruction surgery over age 65 were addressed in the release. That omission could suggest that women not opting for reconstruction is somehow a problem that needs to be remedied. And that’s concerning if those women are simply making a sensible choice to forego a procedure that lacks medical need but carries higher risks.

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

Not Satisfactory

The funding sources for the study are not disclosed.

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

Satisfactory

The point of the study was comparing two options for breast reconstruction.

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

Not Satisfactory

Although the release does mention that the tissue expander approach is more established and widely used, it could have been more explicit — as the authors of the study were — in letting us know “this is relatively new technique.”

We’re told  that DTI “has emerged as a single-stage approach to immediate breast reconstruction after mastectomy” and we get this quote from one of the lead authors:

The DTI approach is a powerful tool for breast reconstruction in elderly patients.

Taken together these two quotes could give readers an erroneous sense that this is an established and proven option. It’s not.

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

Not Satisfactory

It’s never really fully explained how the direct-to-implant approach differs from the tissue expander approach. But it is made clear that DTI is better studied in younger women than older ones.

Total Score: 5 of 10 Satisfactory

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