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Recap of new surgical device for breast lesions skips all evidence

Using Radar to Make Breast Surgery Easier for Women

Our Review Summary

This news release claims a newer procedure called the Savi Scout device which uses radar to locate and mark a tumor in the breast prior to surgery has many advantages over the traditional procedure that uses a hook wire — but offers not a single concrete example. The availability of the new localizing technology may be an important step forward for patients as well as for institutions, but we need evidence in addition to positive marketing copy.

No numbers are provided to back up the claims despite the fact that there is a limited amount of information available about the device on the manufacturer’s website that could be referenced. In an entry on ClinicalTrials.gov, the manufacturer informs that the device is currently being tested for long-term (beyond 30 days) placement prior to surgery, and that the FDA cleared the device for commercial sales in August 2014. Under the approval, the manufacturer was not required to conduct clinical trials to prove the device’s safety and effectiveness.

 

Why This Matters

The commonly used process for localizing a non-palpable breast lesion prior to surgery involves the insertion of a thin wire hook into the tumor using ultrasound or mammography. Once the lesion has been located to the satisfaction of the radiologist, the patient then is transported to the operating room for removal of the mass. This process can be inefficient, resulting in delays in the operating room. Operating room time is an expensive and rare commodity in busy medical centers. For the patient, having a wire extruding from her breast can’t be a comfortable or comforting experience.

The Savi Scout device offers an interesting and potentially valuable alternative.  It may well be more cost-effective for hospitals due to reduced downtime in the operating room and it seems reasonable that it would be preferable to women. Unfortunately, there is little in the way of data offered in this news release to support its claims of superiority over standard methods.

Criteria

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

Not Satisfactory

The cost of new technology is an important consideration in its evaluation by patients and by institutions. The news release neglects to mention that some insurance companies view the Savi Scout device to be experimental despite its FDA approval. In that case, some patients may have to pay out-of-pocket.

It’s likely that the real savings comes from reducing the amount of time a woman is in the operating room, leading to decreased down time, but there’s no data on that here either.

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

Not Satisfactory

Although there are theoretical advantages to the Savi Scout device, the news release takes that speculation one step further suggesting not just convenience for the patient but also implying superiority: “…surgeons can target the affected tissue within 1 millimeter of the reflector,” and “…the more precise localization of the surgical site enable surgeons to plan the procedure better. That advantage may lead to less tissue needing to be removed and a better appearance of the breast after surgery.”

Since the Savi Scout has not been compared to the standard approach these are unvalidated statements.

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

Not Satisfactory

The release did not mention any potential harms from inserting the radar reflector. It mentions that it is performed on a day separate from the surgery, in a procedure similar to a needle biopsy.  Uncommon but potential complications of a needle breast biopsy procedure include pain, syncope (fainting), bleeding, and infection.

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

Not Satisfactory

The news release provides no evidence to support the claims made. This is quite unfortunate since the manufacturer’s website does provide a modest amount of information on the early experience with the system.

Does the news release commit disease-mongering?

Satisfactory

The release doesn’t engage in disease mongering.

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

Not Satisfactory

Since there’s no study involved we rate the first half of this criterion (Funding Sources) Not Applicable. But the news release is silent on potential conflicts of interest either institutionally or with individuals mentioned. Is Dr. Madrigrano, who speaks favorably about the device, a paid consultant to the company that makes it? We would have liked some information on any institutional or individual potential (or lack thereof) for conflict of interest.

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

Satisfactory

The news release does provide comments on the current standard of care and places the Savi Scout in a positive light in comparison.  But since no clinical trials have been conducted comparing the two,  readers should be reminded that the advantages stated are theoretical.

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

Satisfactory

It is clear from the release that Rush Medical Center is now making the device available to its patients. Beyond that facility, it’s unclear if the device is widely available.

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

Satisfactory

The news release claims that the Savi Scout is novel and that Rush is the first institution in Illinois to deploy the technology.

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

Satisfactory

The release doesn’t rely on sensational language. The benefits claims are carefully worded and provide a positive view of the technology. Statements such as: “Ultimately, this wireless technology has the potential to reduce surgical delays, and more importantly will benefit patients by increasing comfort and satisfaction during a stressful time,” are technically correct when viewed as a potential. However, the release is consistent in its suggestion that the technology is a clear advance over existing methods, without offering any comparisons or data.

Total Score: 5 of 10 Satisfactory

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