Breast Implants and Anaplastic Large Cell Lymphoma (ALCL): Should I be Concerned? —by Ryan Polselli

There are an increasing number of reports in the media lately about a new relationship between breast implants and an extremely rare form of cancer showing up in the breasts. Notice that I did not say breast cancer. That is because although this cancer is found in the breast, it does not appear to arise from breast tissue.

ALCL surrounding the breast implant in the right breast

This cancer, known as Anaplastic Large Cell Lymphoma and commonly referred to as ALCL, started showing up in cases of women that had persistent fluid accumulation within the fibrous capsule that the body forms when the implant is placed within the breast. Although fluid collections around the implant sometimes occur when the implant is initially placed, this fluid was showing up years after placement and seemed to persist despite typical treatment. As a result, some of these women underwent a second surgery in an attempt to correct the problem. When the fluid was sent for analysis, the cancerous cells were detected.

Reports of this phenomena started showing up in the literature until there were enough eyebrows raised to launch an official investigation by the FDA. Until recently, ALCL was known to be an extremely rare cancer that could involve the breast, but was better known for showing up in other areas of the body. Although it was known to occur in approximately 1 in 500,000 women each year, it only showed up in the breast 3 times for every 100 million women each year. The compilation of all the cases reported however, showed that it had shown up in the breasts of women with implants approximately 60 times worldwide when the total number of implants was estimated between 5 and 10 million.

So what has been concluded from these 60 cases worldwide? Only 34 of these cases had data reported that was deemed reliable enough to be included in the FDA’s study of cases from 1997 though 2010. From a statistical standpoint, there was not enough data to reliably determine any defining characteristics. ALCL occured in both implants with silicone and saline that had been placed for the purpose of reconstruction and augmentation.

There are some reports in the media stating that it is likely that the cancer is being caused by implants that are textured. This is because of the 4 cases of cancer in which the implant shell texture was known, they all happened to be textured. However, this could still be coincidence. We still don’t know what type of shell was involved in the remaining 30 cases.

Because more information is still needed, the FDA has formed a registry in association with the Society of Plastic Surgery to record all cases of ALCL. The FDA is requesting all confirmed cases of ALCL in women with breast implants to be reported to the FDA. The FDA has agreed to keep the reporter and patient’s identity confidential.

So what does all this mean for the average woman with breast implants. In short, don’t be alarmed. The incidence is so low and still so little definite information is known at this point that there is no need to run to your local surgeon to have breast implants removed. In fact, it is the official recommendation of the FDA at this point that implants should not be removed unless there is medical reason. The FDA continues to stand by the overall safety of breast implants when used appropriately.

Ryan Polselli, MD, Diplomate of the American Board of Radiology, Fellowship Trained Breast Imaging Radiologist

Note, this article is for general informational purposes only and is not intended to be medical advice

What is Breast Tomosynthesis and 3D Mammography?

Breast Tomosynthesis is better known by most patients and physicians as 3D mammography. However, the use of the term “3D” is a bit misleading. There are no 3D glasses to wear as one would typically expect when viewing a 3D image or movie and nothing “pops” out of the screen in the traditional “stereoscopic” sense.* The images actually appear as “flat” 2D images but are taken at multiple angles relative to the breast and then synthesized to appear as numerous thin traditional 2D images of the breast. This enables the radiologist to look at a single picture for essentially every millimeter of thickness through the breast. Depending on how thick the breast is when compressed, there can be 70 or more images for each view of each breast. In total, there can be 300 or more images created for each mammogram. The term 3D was initially introduced for the purpose of marketing directly to the consumer and to a lesser extent the medical community, but has since become so entrenched in our vocabulary that it’s here to stay.

2D mammogram and 3D mammogram from same patient. The 3D mammogram on the left shows the breast cancer more clearly.

A useful way to understand the concept is to imagine superimposing all the individual tomosynthesis images.  The resulting image would be very similar to the traditional 2D digital mammogram that has been the mainstream of mammographic screening for the last 10 years or so. The advantage of separating the images with tomosynthesis is that it allows the breast imaging radiologist to “see through” the normal breast tissue which can traditionally “overlap.” The image above is a good example. This traditional “overlap” causes 2 main problems. It can hide underlying cancer and it can occasionally overlap in such a way to look suspicious for cancer when there is actually no cancer present. These two problems with the traditional 2D mammogram result in decreased cancer detection rates and more patient recalls for additional imaging to look for cancer that is not there. In other words, 3D mammograms (breast tomosynthesis) detect more breast cancers and results in less false alarms.

Numerous scientific studies have now demonstrated the benefits of 3D mammogram. Among them, a study published in the Journal of the American Medical Association (JAMA) in 2012 involving nearly half a million women demonstrated a significant increase in the breast cancer detection rate and the simultaneous decrease in the recall rate with breast tomosynthesis when compared to standard 2-D digital mammography.

In January of 2015, Medicare was the first insurer to begin reimbursing for breast tomosynthesis. More recently, in August of 2016, Cigna, inspired by the mammogram recommendations of the National Comprehensive Cancer Network (NCCN), became the first private insurer to begin reimbursing for breast tomosynthsis.  More recently, as of April 2017, Anthem and UnitedHealthcare have also reported that they will reimburse for 3D mammogram. Largely as a result of recent studies documenting cost saving and increased breast cancer detection rates, several states including New York, Texas, New Jersey, New Hampshire, and Maryland have introduced bills seeking mandated insurance reimbursement for patients seeking to undergo breast tomosynthesis in their states.  In the future, as the technology becomes more widespread, there will likely be an increasingly larger network of insurance companies that reimburse for breast tomosynthesis.

From the patient perspective, there is nothing noticeably different from having a 3D mammogram when compared with the 2D mammogram other than the “arm” which takes the mammographic “picture” will rotate slightly when obtaining the exposure. Unfortunately compression is still required and the experience is still uncomfortable. Patients that are pre-menopausal can minimize any discomfort by obtaining a mammogram approximately 1 week after a period or if medically appropriate, taking an anti-inflammatory before the procedure.

Ryan Polselli, M.D., Diplomate of the American Board of Radiology, Breast Imaging Radiologist

Please note, this is for informational purposes only and is not intended to be medical advice.

*Note, Fujifilm does market a traditional stereoscopic 3-D viewer, but the technology has not yet been adopted into mainstream clinical practice.

What Every Woman Needs to Know about Breast Thermography

Fluoridation of water exists to mask bad dental care to the poor. Vaccinations cause autism but the proof has been suppressed by a massive pharmaceutical company cover-up. HIV is an artifical disease created by the CIA. Condensation trails from aircraft represent the emission of biological and chemical agents into the atmosphere.

If you believe in any of the above or similar conspiracy theories, this article is not for you. However, if you believe in the scientific method and that properly applied scientific knowledge can improve health and prolong life, stick around.

 

There is an increasingly popular trend in the field of breast cancer screening. Many patients are turning to Thermography as an alternative to traditional mammography. Thermography is an older technology that uses a special camera to take infrared pictures of the breast looking for relative hotspots which are supposed to correlate with breast cancer. There is no ionizing radiation involved and it’s painless.

The theory being used to support it’s effectiveness is that tumors have increased metabolic activity and vascular recruitment which produces heat. This heat can then supposedly be detected in the form of a visual hotspot. While the gross concept is generally sound and it is true that some tumors produce more detectable heat than the surrounding tissues, many don’t.

But what do the scientific studies show? A complete review of the scientific literature demonstrates that Thermography does not reliably detect breast cancer or prolong life. In essence, Thermography is no more effective at detecting the important forms of breast cancer than throwing darts in the dark. The lack of effectiveness is likely due to the fact that breasts have a natural variation in background heat levels which mask or minimize any potential detectable heat difference between breast cancers, espeically when the cancer is small or slow growing.

So for those women wishing to improve chances of survival for a disease that shows up in 1 in 8 women, stick with traditional mammography and ignore the anecdotal stories of Thermographic success which can be found throughout the internet…along with the stories of chemtrails and vaccination cover-ups.

Note, this is post IS intended to be medical advice.

Ryan Polselli, M.D.

Diplomate of the American Board of Radiology

Fellowship Trained Breast Imager

Is it Time to Move on from the Preoperative Wire Localization?

For those unfamiliar, preoperative wire localization is the procedure performed on the overwhelming majority of patients undergoing lumpectomy or excisional biopsy prior to surgery. The general idea is that one or more needles and wires are inserted into the area in question before surgery with imaging guidance to assist the surgeon in removing the correct area of the breast that could not otherwise be felt or seen by the surgeon. The procedure remains essentially unchanged from its development in the 1970s and has been performed on millions of women and thousands of men across the United States. Although without question this method is cheap, reliable, and effective, it also suffers from some limitations.

One limitation is that the wire must be inserted on the day of the procedure, most often immediately before surgery. This not only creates an inconvenient rate-limiting step for all parties working the patient through the modern day surgical process, but more importantly it can become a safety issue. The pressure to rapidly move patients through the procedure on the day of surgery can be a source of latent errors. I have witnessed at least one sentinel event root cause analysis committee list an impatiently waiting surgical team and “time-crunch” as a reason for the wrong area of the breast being localized and subsequently removed.

Another important limitation often overlooked is patient comfort. At best, following the procedure a wire (and sometimes needle) is left dangling out of the breast with an awkward tape-job which sometimes includes a styrofoam cup or other device taped to the patients’ chest in order to secure the wire and or needle in an attempt to keep them from becoming dislodged and out of site. In patients requiring more than one wire for surgical planning, it can leave the patient looking like some awkward form of radio-frequency receiver. Both cases leave the patient feeling uneasy, sometimes even grossly nauseated while looking at their breast with wires hanging out of it prior to surgery. Quite simply the look and feel from the patient perspective is “barbaric.”

Throughout the years there have been numerous devices and procedures to improve on the traditional needle localization, but none have ever taken root in mainstream clinical practice patterns. There is a newer method however, which appears in my mind to potentially hold enough promise to prompt change from years of habit it in the breast imaging and surgical community. Specifically, the new device implants special reflectors in the breast that allows for radar localization. This allows for placement many days before surgery if needed and does not make the patient feel as uncomfortable. This month, original research was published about this method in the journal of Radiology that examined the effectiveness of this method using the Scout device in 100 women over the course of a year. The results showed that it was effective for localizing breast lesions even when reflectors were placed closely together to “bracket” the lesions.

Beyond Wires and Seeds: Reflector-guided Breast Lesion Localization and Excision. 

Given this evidence and the above considerations, I think this is an excellent time for the breast imaging and surgical community to start seriously considering changes or at least alternatives to the traditional wire localization procedure.

Ryan Polselli, M.D.
Fellowship Trained, Breast Imaging Radiologist

What Really was Said at the Water Cooler in 2009: USPSTF Breast Cancer Screening Recommendations and Current Physician Practice Patterns

In 2009 the United States Preventative Services Task Force (USPSTF) updated their now infamous breast cancer screening recommendations. In their report, the so-called experts (many of whom had no direct affiliation with patient breast cancer screening) voted that a total of 12 mammograms throughout a woman’s lifetime should be enough to effectively screen women for a disease that is the second leading cause of death among women in the United States and kills an average of 40,000 women every year.

These new recommendations came at a time when studies throughout the world were repeatedly confirming annual screening mammograms reduce breast cancer deaths anywhere between 30-45% with newer advances in screening and treatment decreasing the death rate an additional 2.5% each year. In essence, the recommendation to cut back on screening mammograms was made by the USPSTF at a time when mammography was being hailed as the poster-child of a successful cancer screening program.

Not unexpectedly, when the report was originally released, most of the medical community and media gathered around the report like co-workers around the water cooler—everyone expected to discover the missing piece of evidence—perhaps there was some flaw in the system and perhaps mammograms were not as useful as we thought?

However, a review of the report still left most of the medical community scratching their heads. The report contained no evidence that mammograms were not doing their job or saving lives. There was actually evidence to the contrary. In fact, the USPSTF data even acknowledged that if their recommendations were followed, additional women would die. Some experts even estimated that up to 100,000 more women would die over time if the recommendations were adopted into mainstream clinical practice. Sure, most of the medical community understood the report was trying to make an argument for the potential harms that a woman could endure as a result of over-diagnosis from too many mammograms, but they couldn’t justify the lives lost. As a result, most in the medical community left the water cooler that day and returned to their desks unswayed from their decision to recommend annual mammograms. Most believed the task force simply voted the wrong way and that ultimately there was no more to the story.

But the story didn’t actually end there.

The majority of the media and a few impressionable souls in the medical community remained gathered around the water cooler that day. While the concept of mortality in the setting of breast cancer screening was perhaps the “real” news of the day, it wasn’t “exciting” news and quickly became overshadowed by discussion of the relatively new and intriguing concept of “over-diagnosis.” By 6 o’clock, all major networks became pseudo-educators for the masses and carried stories about the “harms of over-diagnosis” from annual screening mammography. In some circles, knowledge of the concept even became a surrogate marker for supposedly intelligent discussion of breast cancer screening. 

All of this occurred without significant mention of the fact that more of the women we love—wives, mothers, and friends would die if these recommendations were adopted.

This month, JAMA Internal Medicine published a research letter showing that most practicing clinicians continue to recommend annual screening mammograms contrary to the USPSTF recommendations. While that’s no surprise, you wouldn’t know it by the recent headlines. You would think most doctors have lost their minds. I even read one article that went so far as to suggest insurance companies should take the lead and quit paying for yearly mammograms. Think about that for a moment. In any event, it seems that now is a good time to remind a majority of the media and some in the medical community about the original takeaway from the “water cooler discussion” in 2009.

Ultimately and always—Do no harm.

Ryan Polselli, M.D.
Breast Imaging Radiologist

How Reliable is Breast MRI compared to Mammography and Ultrasound?

This is one of the most important questions in the field of breast imaging today.

It is important to keep in mind that there are widely varied opinions about this question depending who you ask. As a breast imaging radiologist, my opinion may differ from physicians in other specialties. My opinion, however, is formed from all prior studies and current research, as well as personally interpreting hundreds of thousands of mammograms, tens of thousands of ultrasounds, thousands of breast MRI’s, and diagnosing hundreds of breast cancers each year.

I could spend significant time discussing the relative “reliability” of breast MRI in scientific terms of sensitivity (how likely breast MRI is to detect breast cancer when it is present) and specificity (how likely breast MRI is to be correct when it shows what looks like breast cancer), but I think the message would be lost, so I will do my best to answer the essence of this question based on my opinion in the simplest terms.

First, mammography saves lives. Independent studies in the United States and several countries throughout the world have demonstrated time and time again that annual screening with mammograms reduces the number of deaths from breast cancer anywhere from 20–48%. Recent studies have demonstrated that the newer 3-D technology is even better than the traditional 2-D mammogram in terms of detecting more cancers.

As a result, annual screening mammograms are generally recommended by the majority of major health organizations such as the American Cancer Society, The American College of Radiology and the Society of Breast Imaging, The National Cancer Comprehensive Network, the American Medical Association, and others. However, in addition to mammography, breast ultrasound and breast MRI are increasingly playing large roles in breast cancer screening.

Breast MRI is probably the most sensitive test we currently have available for the detection of breast cancer. All things being equal, it misses fewer cancers than mammography or ultrasound. While it is more common that a breast cancer cannot be seen on mammogram but shows up on breast MRI, it occasionally happens that a breast cancer cannot be seen on breast MRI which shows up on a mammogram. For this reason, breast MRI and mammogram are considered to be complementary tests.

It is currently recommended by the American Cancer Society, the American College of Radiology and other organizations that women with high risk for breast cancer undergo annual breast MRI in addition to annual mammogram. If you want more detailed information about breast MRI see this recent article I wrote for SW Florida Health and Wellness Magazine:

What Every Woman Should Know About Breast MRI 

Recent research however, is demonstrating that breast MRI may even be useful for women at average lifetime risk of developing breast cancer. If you want more information about this research see this article from one of my earlier posts here:

Screening MRI Benefits Women at Average Risk of Breast Cancer

Although breast MRI is extremely powerful, one of the criticisms is that it can occasionally be difficult to differentiate some forms of active but normal breast tissue (and other findings) from certain forms of breast cancer (usually low grade breast cancers). This becomes more of an issue when someone who does not have extensive experience reading breast MRI attempts to interpret a study, or when the facility performing the study, does not do a sufficient number of breast MRI’s to produce consistent or high quality images.

Breast ultrasound can also be a useful supplement to mammography, but is highly dependent on the ultrasound technologist and equipment and can be a worthless test in the wrong hands. It will undoubtedly miss more cancers than breast MRI, but occasionally demonstrates cancers that cannot be seen on mammogram. However, there are several forms of breast cancer which are not seen on ultrasound and therefore ultrasound should never be substituted for a mammogram.

I could go on and there are many other complex considerations to this question, but I feel these points are some of the most important considerations at the present time. With the amount of confusion there is out there regarding this question, I like to take the time and educate where I can. Hopefully, this has been helpful.

Ryan Polselli, M.D., Breast Imaging Radiologist

This answer is for general informational purposes only and is not a substitute for professional medical advice. Always seek the advice of your doctor before starting or changing treatment.

Should I Have a Mammogram Yearly or Every Other Year

I have written about this before, but I receive so many questions about this on a daily basis that I want to revisit the question.

There are organizations that advocate both.

Organizations such as the United States Preventative Services Task Force (USPSTF) advise mammograms every other year. They acknowledge that many cancers will be missed with this model, but they believe the number is “small” (it is estimated an additional 100,000 women will die as a result of the recommendations) but they believe this is outweighed by the anxiety, additional biopsies, and the potential for misdiagnosis that can occur by yearly mammograms.

Organizations such as the American College of Radiology (ACR), still recommend yearly mammograms because they believe the number of lives that will be saved by yearly screening far outweighs the anxiety, the extra biopsies, and the potential for misdiagnosis.

I personally want every important woman in my life to have a mammogram every year because I am more concerned that they could end up as one of the 100,000 women that will die from a missed cancer than I am that they could experience some anxiety, an extra biopsy, or misdiagnosis.

But this may not be the right decision for everyone and most importantly I believe in patients being given all the facts…and the freedom…to make their own choices.

-Ryan Polselli, M.D.

Fellowship Trained Breast Imaging Radiologist