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.
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.
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.
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.
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.
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.
The release doesn’t engage in disease mongering.
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.
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.
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.
The news release claims that the Savi Scout is novel and that Rush is the first institution in Illinois to deploy the technology.
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.
Systematic, Criteria-Driven
We will not display your name or e-mail address on the site, nor will we share your e-mail address with any third parties.
Thank you for joining the HealthNewsReview.org mailing list. It’s a good way for you to stay up-to-date on what we’ve published, even if you forget to come to our website every day or every week.
-Gary Schwitzer, Publisher, HealthNewsReview.org
By submitting this form, you are granting: HealthNewsReview.org, University of Minnesota , Minneapolis, MN, 55455, United States, https://www.healthnewsreview.org permission to email you. You may unsubscribe via the link found at the bottom of every email. Emails are serviced by Mailchimp. (See their Email Privacy Policy for details.)
Just a reminder of one of the most valuable resources available on the Internet for #journalists & #consumers
Produced by a good friend & superb thinker, @garyschwitzer & his crew @HealthNewsRevu
https://t.co/bULz7llqdy
I can't tell you how many times I recommended this to staff.
Comments
We Welcome Comments. But please note: We will delete comments left by anyone who doesn’t leave an actual first and last name and an actual email address.
We will delete comments that include personal attacks, unfounded allegations, unverified facts, product pitches, or profanity. We will also end any thread of repetitive comments. Comments should primarily discuss the quality (or lack thereof) in journalism or other media messages about health and medicine. This is not intended to be a forum for definitive discussions about medicine or science. Nor is it a forum to share your personal story about a disease or treatment -- your comment must relate to media messages about health care. If your comment doesn't adhere to these policies, we won't post it. Questions? Please see more on our comments policy.
Our Comments Policy
But before leaving a comment, please review these notes about our policy.
You are responsible for any comments you leave on this site.
This site is primarily a forum for discussion about the quality (or lack thereof) in journalism or other media messages (advertising, marketing, public relations, medical journals, etc.) It is not intended to be a forum for definitive discussions about medicine or science.
We will delete comments that include personal attacks, unfounded allegations, unverified claims, product pitches, profanity or any from anyone who does not list a full name and a functioning email address. We will also end any thread of repetitive comments. We don”t give medical advice so we won”t respond to questions asking for it.
We don”t have sufficient staffing to contact each commenter who left such a message. If you have a question about why your comment was edited or removed, you can email us at feedback@healthnewsreview.org.
There has been a recent burst of attention to troubles with many comments left on science and science news/communication websites. Read “Online science comments: trolls, trash and treasure.”
The authors of the Retraction Watch comments policy urge commenters:
We”re also concerned about anonymous comments. We ask that all commenters leave their full name and provide an actual email address in case we feel we need to contact them. We may delete any comment left by someone who does not leave their name and a legitimate email address.
And, as noted, product pitches of any sort – pushing treatments, tests, products, procedures, physicians, medical centers, books, websites – are likely to be deleted. We don”t accept advertising on this site and are not going to give it away free.
The ability to leave comments expires after a certain period of time. So you may find that you’re unable to leave a comment on an article that is more than a few months old.
You might also like