BioZorb marker implant. Image: Focal Therapeutics
The first study highlighted in this news release (and the focus of this review) describes the use of a three-dimensional bio-absorbable marker implanted surgically during breast cancer surgery. The purpose of the device is to aid surgeons and radiation oncologists in making breast cancer tumor removal more precise (without damaging extra tissue) and leaving a marker in place at the surgical area to aid follow-up examinations and radiation treatment.
The release would have been stronger with a mention of study limitations and added details on harms and quantification of benefits.
Breast cancer patients and physicians alike want treatment to be the most effective and least toxic possible. Reducing radiation damage and improving followup care are worthy of news coverage. There are, however, a number of inadequately covered issues in this news release.
The news release declares the cost of treatment will be cut “by approximately 25%” without indicating a starting cost for treatment without the implant.
But the release does go in to some detail on how cost savings were estimated: During the three-year span of the study, the marker facilitated many physicians to shift from traditional external beam radiation to the shorter course hypo-fractionated radiation therapy, which results in a cost savings. The patient outcomes remain similar, however.
Although there were numerous potentially useful benefits stated, there was no attempt in the news release to quantify them. Rather, the claims made were quite general: “less radiation,” “better overall cosmetic outcome,” “marker allowed physicians to be more confident in their targeting.” The release would have benefited from quantified measures of at least some of the benefits listed.
There was no indication of harms in the news release. However, the original article did note side effects that arose in two patients. It would have been good to note them in the release. The published study also acknowledged that skin changes and dermal lymphedema (swelling) were a concern among patients but were not specifically tracked. Again, a mention of that in the release would have been helpful to patients.
The news release gave a brief overview of the three-year case series that was published. The study focused on 108 patients with early-stage breast cancer, with the surgical device implanted during reconstructive lumpectomy.
The size of the study is considered reasonable for this type of device. It is not clear how long these patients were followed, but for the purposes of this study (to determine usefulness for radiation therapy) long-term follow up is not needed.
However, the release earns a Not Satisfactory for neglecting to point out the limitations of a case series with no control group. Without a control group, what basis is there to conclude that there were benefits such as a “better overall cosmetic outcome?” What were they comparing it with? The release doesn’t say.
The release didn’t engage in disease mongering.
The news is provided by Focal Therapeutics, maker of the implant. There is no mention in the news release of any potential conflict of interest, but the published study noted one of the authors had a financial arrangement with Focal.
This is a novel device and there aren’t any similar devices it can be compared with.
We aren’t told where the device is available or whether it’s covered under most insurance plans. It was noted that the implant has received clearance by the FDA.
The release states that the implant is the first and only device of its kind, and there do not appear to be any similar products on the market.
It should be noted that the surgical clips placed by the surgeon at the time of lumpectomy are helpful but do not always accurately reflect the area most at risk for recurrence, especially when oncoplastic surgical techniques are used.
The release doesn’t employ unjustifiable language.
Systematic, Criteria-Driven
The tale of two “negative” studies. Or, how spin is applied to make research findings look more impressive. A must read. https://johnmandrola.substack.com/p/the-tale-of-two-negative-studies
The @nytimes chose to interview one of the editors of the @AnnalsofIM (publisher of this paper) who "gushed with extraordinary glee: It’s huge! There are very few things that reduce your mortality by 30%."
Turns out coffee is not one of those few things despite all that glee. https://twitter.com/garyschwitzer/status/1533202075928215558
Comments (2)
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Vivianne Williams
June 8, 2017 at 8:09 pmI have had a BioZorb device in my right breast for over a year and have experienced pain every day since. I will have another surgery in a few days to have it removed!!
Diana Brown
August 28, 2017 at 11:09 pmThis biozorb was implanted in my right breast during lumpectomy on January 5, 2017. I am small breasted. This device should NOT be implanted in small breasted women. The implant is very close to the surface of my breast just underneath my skin and is causing notable discomfort. Due to the location, I expect absorption to be slow, I want it removed, but advised by radiation oncologist to wait until at least 6 months after radiation. Because of the discomfort, I do not think I can wait that long.
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