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As countless studies have shown us, early detection of breast cancer is one of the most effective tools we have in helping improve outcomes. New techniques are constantly driving improvements in detection and ultimately, outcomes. As a result, the last American Cancer Society biennial update on female breast cancer statistics in the United States showed that mortality rates have fallen significantly in the last 30 years.
However, one group of patients who have not seen similar improvements are women of color, particularly Black and Hispanic women. In fact, the mortality rate for breast cancer remains 40% higher in Black women than in white women despite a slightly lower incidence of breast cancer among Black women than white women.
To understand why, we can isolate a number of factors.
Women of color may come from more challenging socioeconomic backgrounds, and as a result, have difficulties accessing quality primary care, where early detection often takes place. They may have had negative experiences with the health care system that make them reluctant to seek out an examination. Also — and this is particularly true of Black women — their breast tissue may have greater density, making it more difficult to identify a tumor in the earlier stages as well as a higher prevalence of triple-negative breast cancer, which has a poorer prognosis.
On a standard two-view screening mammogram — which is the most common diagnostic test used to identify breast cancer — dense breasts appear white, making it very difficult to discern a tumor (which also appears white) from healthy tissue. It’s a bit like trying to find a snowball in a snowstorm. Compounding the situation is the fact that this condition is very common. In the United States, about half of women who are 40 years old or older have dense breasts.
So, another diagnostic option is clearly called for.
Mammography is the current gold standard in breast imaging, but it is not the only option available. There’s also digital tomosynthesis. Like mammography, tomosynthesis uses low-dose X-rays to create an image of the breast. The key difference is that with tomosynthesis the image is three-dimensional. In just seven seconds, the X-ray device circles the breast and takes eleven images, which are then digitally assembled by a computer algorithm to produce one complete image of the breast tissue, viewable from multiple angles. This gives increased visibility to tumors that may have been missed in denser breasts examined by mammography.
Other advantages over mammography include a reduction in obscured tumors. It also reduces the rates of false positives and the subsequent need for a biopsy. Since its introduction a decade ago,digital tomosynthesis has shown in studies, including one published in Radiology in 2020, its advantages over digital mammography. Findings that include increased cancer detection and fewer false-positive findings were maintained over multiple years and rounds of screening. In addition, research showed that digital breast tomosynthesis screening helped detect a higher proportion of poor-prognosis cancers than digital mammography.
So, it’s clear that digital tomosynthesis is a powerful tool in meeting patient needs. However, a 2019 study of its adoption in clinical practice noted that it has “more rapid uptake in areas of the country with greater socioeconomic resources, including higher income and educational attainment.” So more needs to be done to improve access to this technology for the populations it would most benefit.
Hopefully, with time and further attention, that’s exactly what will happen. Providing new tools to benefit those who most need them is an important part of what has driven me and my team throughout our careers, and what drove us to found MOLLI Surgical, and deliver for patients an alternative to breast cancer treatment that has moved patients (literally) out of the 20th century.
When it was first introduced in the 1970s, wire-guided localization (WGL) was the standard in marking breast cancer lesions. The method involved inserting one or multiple wires into the breast adjacent to the abnormal tissue. This approach has changed very little over the past 50 years, as care teams, hospitals and patients have continued to face the same challenges and drawbacks associated with the technique.
WGL has also proven to be challenging and inconvenient for patients. The technique requires the lesion to be identified on the same day as the surgery, which can result in a long day spent waiting at the hospital between the two procedures, a situation that is far from ideal. The protruding wire also carries the risk of displacement or transection during surgery, which can lead to the potential for inaccuracy and additional procedures, or migration. And all of this is happening while the patient is fasting from the night before.
We heard about these issues directly from patients and their families through a patient and family experience advisory group at Sunnybrook Hospital in Toronto. The VP of the cancer center challenged our team to create a wire-free method of locating lesions for surgery.
We founded our company, MOLLI Surgical, as a direct result of that advocacy.
Wire-free localization involves implanting a small marker in the breast which can be detected using a wand and visualization tablet during surgery. The localization procedure takes approximately five minutes, and then the patient is able to leave the hospital and return within 30 days to remove the abnormality. Clinical trials have verified the effectiveness of this approach, and other studies have shown reductions in cost and increases in patient satisfaction.
By decoupling localization from surgery, physicians can change their respective workflows, which helps ensure efficient and timely care for patients. Wire-free techniques have been shown to be as effective as WGL standard technique, with the substantial benefits of being much easier to use, more precise and offering flexibility that helps achieve the cosmetic results patients often desire.
With new tools earning FDA clearance amid an industry expected to grow by 7.5 percent by 2025, administrators and oncologists are facing a rapidly expanding lesion localization market. It is incumbent upon hospitals and administrators to explore various options to not only improve the effectiveness and efficiency of surgical procedures, but also the experience of patients.
Choosing the correct option will depend greatly upon the goals of each provider and their patients, but regardless of the selection, wire-free techniques and their benefits represent the future of better lesion localization and improved breast cancer care.
In the course of my work, I have met with many women at various stages of their breast cancer journey. I have seen a health care system that at times meets their needs well, but at other times does not.
What drives me and my colleagues is the belief that we can do better. As we’ve seen with the progress made in digital tomosynthesis, women who have challenges around dense breast tissue – which occurs disproportionately in women of color – should have greater access to an alternate diagnostic tool that would make a difference in diagnosis and outcomes. In my own work, and that of my team, we’ve seen a huge impact in the experience of patients about to undergo breast cancer surgery and who need one less thing to worry about when it comes to locating their tumor.
This work matters. Our team is grateful to be a part of it, along with so many other innovators who have come before us, and will follow after.
Fazila Seker, PhD
President & CEO, MOLLI Surgical
Fazila Seker is passionate about women’s health and social disparity issues in healthcare. She is the CEO and co-founder of MOLLI Surgical, a company that develops devices to guide precision surgeries for a better patient experience. Fazila hosts a weekly Facebook Live show called “Breast Practices” where experts and patients discuss topics in patient-centered care. She is also a frequent author and blogger on issues in women’s health.