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Cancer Prevention and Treatment Funds’ Comments On USPSTF Draft Recommendation Statement for BRCA-Related Cancer: Risk Assessment, Genetic Counseling, and Genetic Testing

March 18th, 2019


We are pleased to have the opportunity to express our strong concerns about the draft recommendations for risk assessment, genetic counselling, and genetic testing for BRCA-related breast cancer. The Cancer Prevention and Treatment Fund is a nonprofit program that conducts, analyzes, and reviews research, with a particular focus on which prevention strategies and treatments are most effective for which patients and consumers. We do not accept funding from pharmaceutical companies and have no financial ties to this issue.

We have concerns about the familial risk prediction methods and the baseline mutation probability threshold being used to refer large numbers of women for genetic counselling and potentially genetic testing.

According to the CDC[1], 1 in 40 Ashkenazi Jewish women have the BRCA mutation. Based on most of these models, most 30-year-old Jewish women with any first- or second-degree family history of breast cancer would likely be referred for genetic counseling, and yet 90% will not have a BRCA mutation.  This will clearly raise anxiety levels and we question whether the benefits outweigh those concerns.

Studies have shown that applying a seemingly universal mutation probability threshold of 10% for almost all risk prediction models will lead to a phenomenon called ‘over-dispersion.’  This means that those who are most likely to be carriers will have a very high probability prediction and those who are least likely to be carriers will have very low probability estimation.[2] Statistically, this often provides misleading and conflicting results to physicians.

Additionally, further research on the validation of risk prediction models has shown that the decision threshold should be derived from “diagnostic accuracy measures rather than defined directly by any breast cancer risk.”[3] Science has shown that tests in clinical settings with a high sensitivity are more likely to detect a higher number of carriers ultimately reducing the burden of unnecessary medical expense.3

Therefore, we urge the USPSTF to reconsider its assessment of the risk prediction models by employing a universal standardized sensitivity threshold instead of a universal standard mutation probability threshold. A universal sensitivity for all predication models will yield varying but statistically relevant mutation thresholds for different models. This will more accurately identify mutation carriers in need of genetic counselling and reduce the overall number of non-carriers who are sent for genetic counselling.

For questions or more information, please contact Dr.Varuna Srinivasan, MBBS, MPH at vs@center4research.org.

[1] Center for Disease Control and Prevention,  Jewish Women and BRCA Gene Mutations, www.cdc.org, https://www.cdc.gov/cancer/breast/young_women/bringyourbrave/hereditary_breast_cancer/jewish_women_brca.htm, November 5th 2018

[2] Lindor, N. M., Lindor, R. A., Apicella, C., Dowty, J. G., Ashley, A., Hunt, K., Mincey, B. A., Wilson, M., Smith, M. C., … Hopper, J. L. (2007). Predicting BRCA1 and BRCA2 gene mutation carriers: comparison of LAMBDA, BRCAPRO, Myriad II, and modified Couch models. Familial cancer, 6(4), 473-82.

[3] Schneegans, S. M., Rosenberger, A., Engel, U., Sander, M., Emons, G., & Shoukier, M. (2011). Validation of three BRCA1/2 mutation-carrier probability models Myriad, BRCAPRO and BOADICEA in a population-based series of 183 German families. Familial cancer, 11(2), 181-8.

NCHR Comments on USPSTF’s Draft Research Plan for Colorectal Cancer: Screening

National Center for Health Research: January 30, 2019

National Center for Health Research’s Public Comments on
the USPSTF’s Draft Research Plan for Colorectal Cancer: Screening

Thank you for the opportunity to share our views regarding U.S. Preventive Services Task Force (USPSTF)’s draft research plan regarding screening for colorectal cancer. The National Center for Health Research is a nonprofit think tank that conducts, analyzes, and scrutinizes research on a range of health issues, with particular focus on which prevention strategies and treatments are most effective for which patients and consumers. We do not accept funding from companies that make products that are the subject of our work, so we have no conflicts of interest.

The USPSTF last reviewed the literature in 2016 and provided an “A” grade for colorectal cancer screenings in adults aged 50 to 75 at average risk.1 It did not provide recommendations for particular stool-based, direct visualization, or serum screening tests, leaving the choice to be based on the balance of benefits, risks and preferences of the clinician and patient. However, recent studies based on the National Cancer Institute’s Surveillance, Epidemiology, and End Results (SEER) Program indicates that the rates of colorectal cancer are increasing among adults in their 40s.2  In response to that research, in 2018 the American Cancer Society released new guidelines recommending that adults at average risk for colorectal cancer begin screening at 45 years of age.3 In addition, the U.S Multi-Society Task Force on Colorectal Cancer supports screening African Americans for colorectal cancer beginning at age 45.4

We support the efforts of the USPSTF to carefully draft a research plan to guide the systematic review of available evidence for colorectal cancer screenings to reduce rates of colorectal cancer mortality. We also strongly support the efforts of the USPSTF to review the evidence regarding the harms and benefits of specific types of colorectal cancer screenings, and how they vary by age, sex, and race/ethnicity.

The draft research plan is specifically for average-risk adults, with adults at higher risk intentionally excluded. It is essential that the USPSTF always clearly specify whether recommendations are aimed only at individuals at average-risk.

We commend inclusion of the proposed contextual questions to determine what tools exist to assess the risk of colorectal cancer in the average-risk population. However, we strongly urge that these tools also be explicit regarding the impact of race/ethnicity, sex, and age, because those traits can affect the development of colorectal cancer as well as mortality.

While we understand that screening recommendations for high-risk individuals might differ from those for average-risk individuals, it is not clear why the draft research plan excludes all studies based on high-risk individuals.  Such studies could have important implications for the effectiveness or safety of screening methods for average-risk individuals.  This decision should be clarified or reconsidered.

We disagree with the plan to exclude the analysis of minor harms that affect screening behaviors and compliance with screening guidelines, such as physical discomfort and convenience.  Preparation for colonoscopy is the subject of considerable criticism and even derision.  As a result, it is essential to consider avoidance behaviors that result from minor harms.

We also urge that the analyses include studies of the potential harms of false positives that result in unnecessary colonoscopies or polypectomy.

We commend the inclusion of demographic subgroup analyses for screening program effectiveness, screening test accuracy, and harms.  We urge that these be analyzed in terms of whether the screening tests have benefits that outweigh the risks for each subgroup, rather than compare which subgroup has the best outcomes compared to other subgroups.  What matters to patients is whether the screening test is safe and effective for patients like them, not whether there are other types of patients for whom some tests are better.

In conclusion, we strongly support the USPSTF’s efforts to update recommendations for different types of colorectal cancer screening for different demographic subgroups, as well as their broader efforts to improve the health of all Americans by making evidence-based recommendations about clinical preventive services.

Thank you for the opportunity to comment on this issue.

The National Center for Health Research can be reached through Stephanie Fox-Rawlings, PhD at sfr@center4research.org.

References

  1. Final Recommendation Statement: Colorectal Cancer: Screening. U.S. Preventive Services Task Force. June 2017. https://www.uspreventiveservicestaskforce.org/Page/Document/RecommendationStatementFinal/colorectal-cancer-screening2
  2. Siegel RL, Fedewa SA, Anderson WF, et al. Colorectal cancer incidence patterns in the United States, 1974–2013. JNCI: Journal of the National Cancer Institute. 2017. 109(8). https://doi.org/10.1093/jnci/djw322
  3. Smith RA, Andrews KS, Brooks D, et al. Cancer screening in the United States, 2018: A review of current American Cancer Society guidelines and current issues in cancer screening. CA: A Cancer Journal for Clinicians. 68(4):297-316. https://onlinelibrary.wiley.com/doi/full/10.3322/caac.21446
  4. Rex DK, Boland CR, Dominitz JA, et al. Colorectal cancer screening: Recommendations for physicians and patients from the US Multi-Society Task Force on Colorectal Cancer. The American Journal of Gastroenterology. 112(7):1016-1030. https://www.nature.com/articles/ajg2017174

NCHR Comment on FDA’s 510(k) Third Party Review Program Draft Guidance

National Center for Health Research: December 13, 2018


Comment of the National Center for Health Research Regarding the
510(k) Third Party Review Program:
Draft Guidance for Industry, FDA Staff, and Third Party Review Organizations.
OMB Control Number 0910-0375

The National Center for Health Research (NCHR) is a non-profit organization which conducts original research to better inform policy makers, health professionals, and patients.   NCHR accepts no funding from any entity which manufactures or distributes medical products.

We appreciate the opportunity to comment on this draft guidance.  We note that this draft guidance applies to low-to-medium risk medical devices, which concerns us because many Class II devices are permanent implants that have the potential to cause permanent harm to patients.  In fact, our research indicates that even Class I devices have been subjected to high-risk recalls by the FDA due to the potential for causing death or permanent harm.1 2 3

We have several serious concerns about the draft guidance.  First, Original Equipment Manufacturers (OEM) are accountable for the efficacy and safety of their medical devices.  FDA standards require that devices manufactured by OEM’s comply with relevant regulatory standards.  OEMs are required to track, monitor, and report product issues to FDA.  Overseeing the OEMs and their reporting are FDA’s responsibility to ensure patient safety.

Second, in the past FDA has had the opportunity to review the work of any third party reviewer, and reject it if deemed inadequate or shoddy.  In fact, the agency has often found problems with the third party reviews.  The proposed guidance would sharply reduce the agency’s oversight of third party reviews, which will clearly compromise safety.  Even if certified as qualified, third party review companies have an inherent conflict of interest: If their standards are too high, no device company will hire them and they will go out of business.  The system is similar to the EU regulation of medical devices, which has resulted in very harmful decisions, such as the clearance of the PIP breast implants that were found to use non-medical grade silicone.4  In addition, investigative reporters recently obtained CE clearance for a “surgical” mesh that was made out of a plastic mesh bag used for oranges.

Transparency is also a crucial factor.  Currently, third party review companies are not required to clearly label an OEM device indicating that a critical repair has been completed by someone other than the OEM.  Once that repair is made, the device is no longer the same device that was approved or cleared by FDA.  It is important that this chain of accountability is not broken or interrupted.

While we understand the desire of FDA officials to reduce medical device review times and reduce the burden on FDA staff and industry, the 510(k) program already is a quick way to get devices to market and the device industry has clearly benefitted from it.  The 510(k) pathway has been widely criticized by the Institute of Medicine, physicians, patients, and the media for its lack of clinical trials and lack of scientific evidence.5  Despite its weaknesses, the 510(k) pathway is considered superior to the EU regulatory system, however.  By reducing the “burden” for FDA staff and industry, the proposed guidance increases the burden on patients and doctors to figure out which devices are safe and which are not.  This would clearly put U.S. patients at greater risk.

FDA has not demonstrated that its proposed changes to the third party review pathway of Class I and Class II devices will benefit patients.  By definition, 510(k) devices only rarely are substantially superior to recent predicates.  Speeding up the process of clearance is not demonstrated to benefit patients.  Moreover, with registries, NEST, and other planned efforts to improve post-market surveillance still far from effectively implemented, any loosening of 510(k) regulations is very premature.

Finally, we note that Commissioner Gottlieb responded to recent media criticism of CDRH regulations by promising improvements to the 510(k) pathway to ensure patient safety.  The third party review program clearly moves in the opposite direction, reducing patient safety, rather than protecting patients from potentially harmful devices.   We strongly oppose it for that reason.

 

References

  1. Zuckerman, D.M., Brown, P, and Nissen, S.E.  (2011) Medical Device Recalls and the FDA Approval Process, Archives of Internal Medicine, 117, 1006-11.
  2. Zuckerman D.M., Brown P., Nissen S.E. (2011). In Reply, Archives of Internal Medicine, 171(11), 1045.
  3. Zuckerman D.M., Brown P., Nissen S.E. (2011). In Reply, Archives of Internal Medicine, 171(21), 1963.
  4. Zuckerman, D., Booker, N, and Nagda, S. (2012) Public Health Implications of Difference in US and European Union Regulatory Policies for Breast Implants, Reproductive Health Matters, 20 (40),102-111.
  5. Zuckerman D.M., Brown P. & Das A. (2014) Lack of Publicly Available Scientific Evidence on the Safety and Effectiveness of Implanted Medical Devices,  JAMA Internal Medicine, 174(11): 1781-1787.

 

After Years of Complaints, U.S. and U.K. Officials Say They Want to Reform the Medical Device Industry

Amy Martyn, ConsumerAffairs: November 29, 2018.


The official who oversees medical device safety for the Food and Drug Administration (FDA) recently said he wants the United States to be the “first” to approve medical devices, raising concerns among public health advocates that the agency isn’t taking efforts to reform the device industry seriously enough.

Dr. Jeffrey Shuren, the director of the FDA’s medical devices division under both the Obama and Trump administrations, earlier this year agreed to speak at a conference attended by medical device executives, according to a new report by the Associated Press.

At the conference, which cost executives $1,000 a head to attend, Shuren reportedly said that the FDA’s goal was to be “first in the world” to approve new devices. He also said he wanted the agency to remove “unnecessary burdens” for companies hoping to get their devices approved.

Such a goal may be at odds with what public health advocates say is a need to reform medical device regulation. Dr. Peter Lurie, a former FDA official who now heads the watchdog the Center for Science in the Public Interest, told the Associated Press that Shuren’s comments essentially offered device executives “an invitation to a race to the bottom for scientific standards.”

“Fatally flawed” system

The medical device industry already faces lower barriers for approval than the drug industry does, despite the fact that many medical devices are intended to be permanent implants or can leave lifelong impacts on a person’s body.

“If you’re going to have something implanted in your body for potentially the rest of your life, wouldn’t you like it to be really well-tested beforehand? Is that really too much to ask?” Dr. Diana Zuckerman, a health policy analyst and head of the National Center of Health Research, told ConsumerAffairs earlier this year.

Independent researchers for years have said that the medical device approval process in the U.S. is “fatally flawed.”

More recently, a Netflix documentary called The Bleeding Edge exposed the tragic, life-long effects that four failed medical implants had on nearly 70 patients interviewed for the film.

Looking for improvement

Regulators in the United States and abroad are now promising to put safety at the forefront of medical device regulation.

Shortly before Thanksgiving, FDA Commissioner Scott Gottlieb, who was portrayed in the Netflix film as being in the industry’s pocket, announced new plans for the agency to “create a more robust medical device safety net for patients through better data.”

A similar call to reform medical device regulations is also currently taking place in Europe. In the United Kingdom, the Royal College Of Surgeons recently called for “drastic regulatory changes” after an investigative report by a group of European journalists published yesterday linked 83,000 deaths and 1.7 million injuries to faulty medical devices.

But while medical devices face low scrutiny from European regulators, the socialized healthcare systems abroad are at least more hesitant about allowing such devices to actually be used in surgery, experts say.

“In Europe, it’s very easy to get something on the market, but the national health plans won’t pay for it if it’s not proven to be safe and effective,” Zuckerman of the National Center for Health Research previously told ConsumerAffairs.

It’s not that Europeans aren’t reporting injuries from faulty devices. However, those who do tend to be wealthier people who opted for private insurance over the public plans.

See the original story here.

Here’s What We Know About Breast Implants and This Rare Type of Cancer

Daisy Melamed Sanders, Survivornet: November 2018.

A series of new stories are examining the potential health risks that both silicone- and saline-filled breast implants may carry. The most serious of these is the possibility of developing a type of blood cancer. What’s not yet clear is if the evidence is significant enough for the government to issue a warning.

The blood cancer that implants may cause, called Breast Implant-Associated Anaplastic Large Cell Lymphoma or BIA-ALCL, is a type of non-Hodgkins lymphoma that is not breast cancer. It is rare, and symptoms include pain, redness and swelling around the implant or breast area.

And while getting breast implants certainly does not definitively mean you’ll definitely get this type of lymphoma, it’s a dangerous illness for those who do get it. “ALCL is rare, but for those who get ALCL from their breast implants, it is very frightening and potentially fatal,” says Diana Zuckerman, PhD, President of the National Center for Health Research.

Here’s what we do know: The Food and Drug Administration—responsible for regulating medications and medical devices—has acknowledged that it has known of a potential relationship between breast implants and increased risk of ALCL since 2011. The risk involves both textured and smooth implants but the FDA’s position is that the textured kind may have a higher likelihood of causing the disease. The FDA also notes that incomplete or inefficient monitoring of, and reporting on, these health issues on a national level has meant that many women do not know all the facts when choosing to have implants for either cosmetic or reconstructive reasons.

According to the FDA, “In most cases, BIA-ALCL is found in the scar tissue and fluid near the implant, but in some cases, it can spread throughout the body. Precise risks are difficult to determine due to lack of information about how many patients have received breast implants in the US and worldwide.”

In an interview conducted prior to recent news, Dr. Andrea Pusic, Chief of Plastic Surgery at Brigham and Women’s Hospital, told SurvivorNet that breast implants are generally considered safe—but they do require monitoring by a doctor. The FDA also states that breast implants are “not lifetime devices,” and that the longer a patient has them, the more likely they are to rupture or experience other complications.

With regards to the safety of implants, Dr. Darrick Antell, a private practice plastic surgeon in New York City, cites the rarity of these instances as part of the reason implants are not excessively dangerous. “Textured surface implants have rarely been noted to develop ALCL, at a rate of 1 in 30,000—I would even recommend them to a family member,” he says. “Multiple leading institutions from around the world have shown them to be safe.”

But, as Dr. Zuckerman urges, it’s important to discuss the risk with your doctor before getting implants, because some women felt blindsided and uninformed about the disease possibility. “We know women who, when they developed ALCL, felt betrayed because their doctors hadn’t warned them of the risks.”

Breast implants also have the possibility of causing other health or physical issues. These issues have not been fully studied, but Zuckerman and the NCHR recently released a paper that discusses some of the possible side effects.

The risks that come with implants are real for all women, Dr. Zuckerman tells SurvivorNet, but these risks increase with a personal or family history of autoimmune or connective tissue symptoms or diseases. They can happen soon after getting implants or years later, and are especially likely when a silicone gel implant breaks—most likely after three years. Another issue is that leaking silicone can migrate into the lymph nodes, and, “from there, the silicone can get into the lungs, liver, or other organs.” Broken saline implants, she continues, offer less risk when they leak, but can cause health issues from the silicone shell, other chemicals, as well as from bacteria, fungus and mold issues that develop over time.

This isn’t the first time instance of concern regarding breast implants and potential health risks. Throughout the 1980’s and early 1990’s, a company called Dow Corning was named in a number of class-action lawsuits claiming that their breast implants were the cause of a number of health issues.

In 1992, the FDA mandated that silicone implants be removed from the market, but they were re-introduced in 2006 following stricter regulations around tracking patients for at least 10 years after their surgeries. However, because monitoring the implants and patients with them is not always thorough nor properly reported, it is difficult to know for sure what side effects implants are having in the long term.

The best idea, as always, is to discuss all the possible risks and benefits of implants with your doctor before any procedures, and be on alert for any symptoms that indicate a medical issue, suggests Dr. Zuckerman. “If a woman with implants starts to have any of the autoimmune symptoms that we’ve described in our report, she should consider having her implants removed.”

See the original story here.

Doctors, Patients Raise Alarms About Cancer Linked to Breast Implants

Lauren Dunn and Maggie Fox, NBC News: November 26, 2018.


When Michelle Forney’s breast started swelling and itching, doctors told her she had mastitis, a common infection, and treated her with antibiotics. When she discovered that she, in fact, had a rare form of lymphoma and that it was probably caused by her breast implant, she was both furious and frightened.

Forney is just one of hundreds of breast-implant recipients who have developed a rare blood cancer called anaplastic large cell lymphoma (ALCL). The Food and Drug Administration has been investigating reports linking breast implants with the cancer, and now has more than 400 reports about patients who developed ALCL after having a breast implant, including nine who died.

“I had my breast implants for about 19 years. And everything was fine for many of those years until about three years ago,” when she developed major itching and pain in her breast, said Forney, who is 46 and lives in Sacramento.

“Come December of last year, I woke up one day and my breast was the size of a volleyball. Within a day it grew and just engorged,” Forney told NBC News. “So I immediately went back to the doctor, saw my OB-GYN and she brought in a breast specialist. And they said: ‘Oh, breast mastitis. You have an infection.’”

But a 10-day course of antibiotics did nothing to help.

Cervical Cancer Screening Options: What Is Best For You?

Jared Hirschfield & Varuna Srinivasan, MBBS, MPH, National Center for Health Research


Smiling womenCervical cancer is cancer in the cells lining the cervix, the narrow passage between the uterus and vagina. This cancer is usually diagnosed in women between the ages of 35 and 44.1 Each year in the United States, approximately 13,000 women are diagnosed with cervical cancer and 4,700 women die from cervical cancer.1With regular screening and follow-up, however, cervical cancer is one of the easiest cancers to prevent and is highly curable if found early.

Almost all cases of cervical cancer are caused by the human papillomavirus (HPV), most commonly by two high-risk strains called HPV-16 and HPV-18.2 However, nine out of ten HPV infections go away on their own without treatment and do not result in cancer or any other health problems.

In addition to exposure to HPV-16 and HPV-18, there are other factors that put you at an increased risk for cervical cancer, including:3

  1.     Smoking
  2.     Multiple sexual partners and sexual intercourse at an early age
  3.     Obesity
  4.     In utero exposure to DES, a hormonal medication banned by the FDA in 1975
  5.     Long-term use of oral contraceptive pills
  6.     Multiple pregnancies
  7.     Other sexually transmitted diseases, such as HIV and chlamydia
  8.     Poor dietary habits or low consumption of fruits and vegetables
  9.     Family history of cervical cancer

Screening for cervical cancer

There are three screening methods to help detect and diagnose cervical cancer early when it is easy to treat. These include Pap smears, HPV tests, and a combination of both Pap smears and HPV tests (cotesting).

The United States Preventive Services Task Force (USPSTF) is a group of experts that recently updated its recommendations for cervical cancer screening.  They recommend no screening for women under 21 and a Pap smear every three years for women 21-29 years old. For women between the ages of 30 and 65, they recommend a Pap smear every 3 years or a high-risk HPV (hrHPV) test every 5 years.  As an “alternative,” USPSTF recommends Pap smear-HPV cotesting every 5 years. They do not recommend any screening for women over 65 or women who have had a hysterectomy.4

USPSTF Cervical Cancer Screening Recommendations (Updated August 2018)4

Women younger than 21 years
  • No screening of any kind
Women aged 21 to 29 years
  • Pap smear alone every 3 years
Women aged 30 to 65 years Preferred:

  • Pap smear alone every 3 years
  • hrHPV testing alone every 5 years

Alternative:

  • Pap smear-hrHPV cotesting every 5 years
Women older than 65 years
  • No screening of any kind
Women who have had a hysterectomy*
  • No screening of any kind

*with removal of the cervix

What is a Pap smear?

A Pap smear is used to evaluate abnormal cells in the cervix that can be diagnosed as pre-cancer or as cervical cancer. When a woman undergoes a Pap smear, a doctor or nurse collects cells from the outer layer of the cervix with a special stick, swab or a soft brush. The sample is then sent to a lab, where a pathologist checks for signs of abnormal cells. If the test is “positive,” the woman has abnormal cells, and those are graded, from least severe to most severe, as ASC-US (atypical squamous cells of undetermined significance), LSIL (low-grade squamous intraepithelial lesion), ASC-H (atypical squamous cells, cannot rule out HSIL), or HSIL (high-grade squamous intraepithelial lesion). Based on this grade, your doctor might recommend further testing, such as a colposcopy (a procedure in which the cervix is examined with a magnifying instrument) or a cervical biopsy.

What is an hrHPV test?

In a high-risk HPV test, also known as an hrHPV test, cells collected from the cervix are tested for the presence of HPV-16 and HPV-18, types of HPV that are most likely to cause cervical cancer. Keep in mind, however, that unlike the Pap smear, the HPV test does not tell you whether you have cervical cancer or are likely to develop cervical cancer.  Instead, it can only tell you if you currently have the virus that can be dangerous now or in the future.2

Which screening test is better?

The goal of both screening tests is to detect cervical cancer as early as possible while keeping the risks to women at a minimum. Pap smears and HPV testing accomplish this in different ways. Whereas Pap smears identify abnormal cells currently in your body, HPV testing indirectly measures your risk of precancer or cancer by identifying the presence of the virus.  HPV testing itself is not harmful, but testing for a virus that usually goes away by itself can lead to a very high rate of false positives.5 This means that people who may never actually develop cervical cancer may undergo expensive and painful invasive procedures to test for cancer and will experience the stress and fear of a cancer diagnosis.

Women with more than one sexual partner in recent years or whose sexual partner has other sexual partners are especially likely to have HPV. For that reason, the National Center for Health Research (NCHR) recommends a Pap smear every 3 years rather than an hrHPV test for these women. Alternatively, NCHR recommends combining a Pap smear and hrHPV test every 5 years.  In addition, we recommend that women over 65 who have recently had more than one sexual partner or have had a sexual partner who has had other sexual partners should continue regular Pap smears until age 75.

Bottom line: What is the best screening option for screening and how can cervical cancer be prevented?

The USPSTF recommendations are based on assumptions about the sexual activity of women at different ages. On average, women over 30 tend to have fewer sexual partners and more monogamous relationships than women under 30, and women over 65 have even fewer.  However, the National Center for Health Research recommendation is focused more on the number of sexual partners, and the fact that women in a monogamous relationship do not necessarily know if their sexual partner has had any other sexual partners. For that reason, we recommend Pap smears every 3 years or Pap smear-hrHPV cotesting every 5 years as the preferred methods of cervical cancer screening for most sexually active women aged 30 to 75. Pap smears directly determine the presence of cancerous or precancerous cells in your body. Cotesting can provide the added benefit of identifying high-risk HPV infection and allow for more vigilant follow-up if HPV-16 or HPV-18 is diagnosed.

In addition to monogamous relationships, women can reduce their chances of cervical cancer by using condoms. Other ways of reducing the risk include regular screening and follow-up with your physician, exercising, maintaining a healthy weight and balanced diet, and avoiding tobacco products.

 

[1] American Cancer Society. “Key Statistics for Cervical Cancer.” 04 January 2018. https://www.cancer.org/cancer/cervical-cancer/about/key-statistics.html.

[2] Centers for Disease Control. “Cervical Cancer.” December 2016. https://www.cdc.gov/cancer/cervical/pdf/cervical_facts.pdf.

[3] American Cancer Society, What Are the Risk Factors for Cervical Cancer?, www.cancer.org, https://www.cancer.org/cancer/cervical-cancer/causes-risks-prevention/risk-factors.html, October 3rd 2018

[4] US Preventive Services Task Force. “Screening for Cervical Cancer US Preventive Services Task Force Recommendation Statement.” JAMA2018;320(7):674–686. doi:10.1001/jama.2018.10897

[5] Rebolj, M. et al. “The Problem of False-Positive Human Papillomavirus DNA Tests in Cervical Screening.” Current Pharmaceutical Design(2013) 19: 1439. https://doi.org/10.2174/1381612811319080011

The Dangers of Juuling

John-Anthony Fraga, National Center for Health Research


What is Juuling? Is it safer than smoking?

A new type of e-cigarette called “juul” has become so popular that it is now about 68% of the $2 billion e-cigarette market. The “juul” is especially popular among children and young adults due to its sleek and discreet design, its ability to be recharged on a laptop or wall charger within one hour, and its liquid-filled cartridges that come in popular flavors like cool mint, creme brulee, and fruit medley.

As a result, “juuling” is now very common at teenage hangouts and even at school. Medical professionals are very concerned because juul delivers higher concentrations of nicotine than other e-cigarettes. Not only is nicotine highly addictive, but it is also toxic to fetuses and is known to impair brain and lung development if used during adolescence.[1] It is not replacing cigarette smoking but rather encouraging it: A 2017 study found that non-smoking adults were four times more likely to start smoking traditional cigarettes after only 18 months of vaping, which includes “juuling.”[7] For more information about e-cigarettes in general, check out our article here.

How does the Juul Work?

According to Juul Labs, the company that owns and sells the juul e-cigarette, the device uses an internal, regulated heating mechanism that creates an easily inhaled aerosol. This mechanism prevents the batteries in the juul from overheating and exploding, which has been a problem for other brands of e-cigarettes. Juul is easy to use because there are no settings to adjust or control. All that is required is a non-refillable juul pod cartridge that clicks into the top of the juul and contains a nicotine e-liquid formula. This e-liquid is heated and converted into vapors that are inhaled by the user. One of the reasons it is so popular among youth is that it is so easy to use – no prior experience or knowledge required. All they have to do to intake nicotine is to put a juul to their mouth and inhale.

What makes Juuls different from other e-cigarettes?

The increased harm of juuls compared to other e-cigarettes is due to the concentration and contents of its juul pods. The e-liquid is 5% nicotine by volume, which is more than twice the concentration of nicotine in similar devices like the Blu e-cig cartridge (2.4% nicotine). This increases the risk of addiction; in fact, a study done by the UK’s Royal College of Psychiatrists showed that nicotine is about as addictive as cocaine and even more addictive than alcohol and barbiturates (anti-anxiety drugs).[2]

The impact on the developing brain is also of great concern. Brain imaging studies of adolescents who began smoking at a young age had markedly reduced activity in the prefrontal cortex of the brain, an area critical for a person’s cognitive behavior and decision making, leading to increased sensitivity to other drugs and greater impulsivity.[3] The amount of nicotine in one juul pod is equivalent to a pack of cigarettes. Since teens often use multiple pods in one sitting, they can unknowingly become exposed to unsafe levels of nicotine that can have immediate and long-term health consequences. In 2016, the Food and Drug Administration (FDA) was given the authority to regulate e-cigarettes such as juul but has allowed e-cigarette manufacturers to postpone their applications for FDA approval until August 2022. Meanwhile, these harmful devices can remain on the market and continue influencing adolescents to become addicted to nicotine.[8]

Another reason why the juul is a unique threat to teens is its patented formula of nicotine. While other brands use a chemically modified form called “freebase nicotine,” juuls use “nicotine salts” that more closely resemble the natural structure of nicotine found in tobacco leaves. This makes the nicotine more readily absorbed into the bloodstream and makes the vapor less harsh so that it is easier to inhale more nicotine for longer periods of time.

In addition to this patented formula, juul pods contain a greater amount of benzoic acid, 44.8 mg/mL, compared to other e-cigarette brands, which are in the range of 0.2 to 2 mg/mL. According to the Center for Disease Control and Prevention (CDC), benzoic acid is known to cause coughs, sore throat, abdominal pain, nausea, and vomiting if exposure is constant, which is the case when using a juul.[4] This is due to how juuls utilize the properties of benzoic acid to increase the potency of the nicotine salts in its e-liquid.

What makes Juuls popular among children and teens?

Since juuls are small, discreet, and closely resemble a USB drive, they can be easily hidden and used in a wide variety of settings, such as the classroom. Teachers and school administrators across the nation are finding students juuling when their backs are turned: Students can take a hit, blow the small, odorless puff of smoke into their jacket or backpack, and continue their school work in a matter of seconds. Compared to other forms of teenage rebellion, juuling is especially dangerous as middle and high school students are unknowingly becoming addicted to nicotine at an alarming rate.

Because a person must be at least 21 to purchase a juul or juul pod, a juul black market is the source for many teens, through eBay or Craigslist. In response, the FDA contacted eBay to raise concerns about listings of juul products on its website, resulting in the removal of the listings and the creation of measures to prevent new listings from being posted.[5]

In April 2018, FDA Commissioner Scott Gottlieb announced that he was creating a Youth Tobacco Prevention Plan aimed at stopping the dramatic rise in the use of e-cigarette and tobacco products among youth. The FDA specifically asked Juul Labs for documents related to product marketing and research on the health, toxicological, behavioral, or physiological effects of their products in order to understand why youth are so attracted to them.[6] Additionally, Juul Labs is currently facing lawsuits in several states claiming that its products were deceptively marketed to youth under the legal smoking age. The FDA now plans to create enforcement policies for e-cigarette manufacturers, including juul, that are marketing their products to children and teenagers.

The Bottom Line:

The popularity of juuls among adolescents exposes them to large amounts of nicotine that can have adverse health risks for their physical and emotional development. While juuls are called e-cigarettes, they look nothing like them, making it easy for children and teens to secretly use them without a parent, guardian, or teacher noticing. This may be just a temporary trend, but if the FDA does not quickly do more to restrict flavors that appeal to adolescents and to educate the public about the risks, it is likely to create an enormous increase in young people addicted to nicotine.

All articles are reviewed and approved by Dr. Diana Zuckerman and other senior staff.

References:

  1. England, L., Bunnell, R., F. Pechacek, T., Tong, V., & A. McAfee, T. (2015). Nicotine and the Developing Human (Vol. 49).
  2. Nutt, D., King, L. A., Saulsbury, W., & Blakemore, C. (2007). Development of a rational scale to assess the harm of drugs of potential misuse. The Lancet, 369(9566), 1047-1053. doi:https://doi.org/10.1016/S0140-6736(07)60464-4
  3. Musso, F., Bettermann, F., Vucurevic, G., Stoeter, P., Konrad, A., & Winterer, G. (2007). Smoking impacts on prefrontal attentional network function in young adult brains. Psychopharmacology, 191(1), 159-169. doi:10.1007/s00213-006-0499-8
  4. Centers for Disease Control and Prevention. Safety Material Data Sheet: Benzoic Acid. Accessed July 30, 2018. Available at: https://www.cdc.gov/niosh/ipcsneng/neng0103.html
  5. “Statement from FDA Commissioner Scott Gottlieb, M.D., on new enforcement actions and a Youth Tobacco Prevention Plan to stop the youth use of, and access to, JUUL and other e-cigarettes. ” FDA News & Event. FDA, April 24, 2018. Accessed: July 30, 2018. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm605432.htm
  6. “Official Request of Information for JUUL Labs.” FDA Rules and Regulations, FDA. April 24, 2018. Accessed: July 30, 2018. https://www.fda.gov/downloads/TobaccoProducts/Labeling/RulesRegulationsGuidance/UCM605490.pdf
  7. Primack, B. A., Shensa, A., Sidani, J. E., Hoffman, B. L., Soneji, S., Sargent, J. D., . . . Fine, M. J. (2018). Initiation of Traditional Cigarette Smoking after Electronic Cigarette Use Among Tobacco-Naïve US Young Adults. The American Journal of Medicine, 131(4), 443.e441-443.e449. doi:10.1016/j.amjmed.2017.11.005
  8. “FDA’s Comprehensive Plan for Tobacco and Nicotine Regulation” FDA Newsroom, FDA. August 6, 2018. Accessed: August 8, 2018. https://www.fda.gov/TobaccoProducts/NewsEvents/ucm568425.htm

Buy a Nice Sleep Mask! It’s an Investment in your Health

Jessica Becker, Cancer Prevention and Treatment Fund

Research shows that sleeping in total darkness allows your body to produce as much of the hormone melatonin as possible. This is good because when your production of melatonin drops, you are at greater risk of breast and/or colorectal cancer and other health risks.

What is Melatonin?

Melatonin is a hormone that is naturally produced in your body. It is secreted by the pineal gland, which is buried deep in the brain. Melatonin is only produced at night and only when it is dark, which means that melatonin production peaks between 3:00 a.m. and 5:00 a.m. for most people. This hormone helps to regulate your circadian rhythm, which is like your body’s natural clock. When melatonin and several other chemicals are released, you feel drowsy and your body temperature lowers. In addition to this sleep-cycle function, melatonin also works as an antioxidant. This means that it can help prevent damage to your DNA that can result from aging, exposure to cancer-causing chemicals, or harmful rays from the sun. Preventing damage to DNA is important because DNA damage can cause cancer.

Doesn’t My Body Produce Enough Melatonin?

There have been major advancements in technology over the last two centuries, one being the light bulb. Because of the light bulb (and electricity, in general), we are able to stay awake and active much later, so the night is not as dark as it used to be. Think of New York City: the city that never sleeps. Cities are so lit up at night that it can be hard to see the stars. This is referred to as “light pollution.” And, of course, even in the middle of nowhere, you can keep your lights on all night in your house.

Our ability to turn night into day has allowed for more night shift work, often called “the graveyard shift.” Even if you don’t work on the late shift, you may be working at home late at night or staying up late watching TV or using the internet. Unfortunately, this kind of schedule has many effects on your body, including reducing the amount of melatonin produced. But it is not just night owls or shift workers who suffer from a decreased production of melatonin. Sleep studies show that almost everyone wakes up at some point during the night, even if we do not remember it. Unless you have blackout shades on your windows, there is a good chance that some light is coming into your bedroom and that your eyes are registering this light during those wakeful periods.[2]

New technology is compounding the effects of light pollution. Early incandescent light bulbs that were dim and yellow and did not affect melatonin production very much. Now, artificial light emits more blue wavelengths. For example “Cool White” fluorescent bulbs are a very popular choice of light bulb because they are bright, moderately energy efficient, and relatively inexpensive. They also produce a lot of blue light which is why they have a “cool” effect. Maybe you have noticed while driving that certain people’s headlights appear to be very bright and have a blue tint to them. These new headlights produce blue wavelengths of light. Unfortunately, research shows that blue wavelengths of light are especially effective at reducing melatonin production in humans.[3] All types of computer monitors and television screens also emit blue light.

Why Is Having Less Melatonin A Bad Thing?

Believe it or not, the International Agency for Research on Cancer (IRAC) classified shift work as a probable human carcinogen in 2007. There have been numerous studies showing a link between night shift work and an increased incidence of breast cancer. For instance, a study done in the Netherlands found that by working half a year at night, a person’s risk of breast cancer increased 150%.[3] A major study found that nurses who worked night shifts at least 3 times a month for 15 years or more had a 35% increased risk of colorectal cancer.[3] If you’re still unconvinced, a study conducted in 147 communities in Israel found that women who lived in neighborhoods where it was bright enough to read a book outside at midnight had a 73% higher risk of developing breast cancer than women living in areas without outdoor lighting.[2]

What Can I Do To Limit My Chances Of Getting Cancer Because of Light At Night?

The good news is that there are easy and inexpensive ways to limit the amount of light you are exposed to at night. For starters, if you have electronic appliances in your bedroom that produce light (like a clock radio or cable box), pick those that have red lights as opposed to green or blue lights. Walmart, Target, Best Buy, and many other stores all carry alarm clocks and radios that display the time in red numbers. These brands are not more expensive than their blue numbered counter-parts. Studies show that red lights don’t cause as much of a decrease in the amount of melatonin produced by your body.[4] Also, if you have a television or computer in your bedroom, turn it off before you go to sleep.

It is also a good idea to limit the amount of time you spend in front of a screen at night. If you spend a few hours a night in front of your computer, whether or not you’re not in your bedroom, you are decreasing the amount of melatonin that is being produced in your brain. Most screens today offer a “night mode” which reduces the amount of blue light used and creates an orange tint. This is a recommended setting to use before bed.

Also, since melatonin production is highest between the hours of 3:00 am and 5:00 am, make sure you’re in bed and asleep by 3:00 a.m., and if at all possible, sleep until at least 5:00 am. While you probably will not be able to petition your community to get the street light in front of your house turned off, you can buy blackout shades to block the light. Most department stores sell blackout shades, and they are relatively inexpensive. If you don’t want to invest a penny more in “window treatments,” consider using a sleep mask. Airlines sometimes give them away in travel kits, but you can also treat yourself to a nice one that is sold online or in a department store. Besides lowering the risk of getting certain cancers, sleep masks can also lower your stress and help you fall asleep faster. Now that’s a “three-for!”

All articles on our website have been approved by Dr. Diana Zuckerman and other senior staff.

  1. Navara J, Nelson R. The Dark Side Of Light At Night: Physiological, Epidemiological, and ecological consequences. Journal of Pineal Research. 2007, (43)
  2. Chepesiuk R. Missing the Dark: Health Effects of Light Pollution. Environmental Health Perspectives. 2009, (117)
  3. Pauley S. Lighting For The Human Circadian Clock: Recent Research Indicated That Lighting Has Become A Public Health Issue. Medical Hypotheses. 2003
  4. Reiter R. Circadian Disruption and Cancer: Making the Connection. The New York Academy of Sciences. 2009

DCIS, LCIS, and other Pre-Cancers: Are Women Getting Mastectomies They Don’t Need?

Susan Dudley, PhD and Diana Zuckerman, PhD, Cancer Prevention and Treatment Fund

Thanks to heightened awareness of breast cancer screening, women are being diagnosed earlier than ever before. However, that has also resulted in what some experts consider an epidemic of women diagnosed with abnormal breast conditions that are not cancer or may never develop into invasive cancer. Some of these conditions are not at all dangerous, and the others have survival rates near 99%; nevertheless, these diagnoses often sound very frightening. In fact, research shows that these women are often just as worried about whether they will survive as women with the much more dangerous, invasive forms of breast cancer.

There is a wide range of treatment for women with these “stage zero” conditions. Although mastectomies are almost never necessary or recommended by experts, many women undergo mastectomies nevertheless. Research suggests that this is especially likely in the South, Midwest, and Southwest parts of the United States, in certain types of medical facilities, and with older doctors.

Knowing the Facts Will Reduce the Fear

It can be extremely upsetting for a woman to learn that she has any condition that increases her breast cancer risk. Too often, such news leaves women feeling that they must rush into surgery. They agree to – or even insist upon – undergoing mastectomies that they do not really need, in hopes that it will increase their chances of survival. In fact, their chances of survival are already very high, and having a mastectomy will not make it higher.

The good news is that most women with “pre-cancerous” conditions or other non-cancerous breast conditions will never get invasive breast cancer. For example, only 1 in 12 breast lumps is cancerous, and 1 in 5 cases of micro-calcification (white spots seen on mammograms that alert doctors that follow-up diagnosis is needed) are related to cancer, so most women get good news after a breast biopsy. For many women, however, anxiety levels soar when they learn that they might possibly be at risk for breast cancer because of abnormal changes in their breasts.

This issue brief will describe two conditions that are often referred to as “stage zero breast cancer” as well as other non-cancerous abnormal breast conditions.

Ductal Cancinoma in Situ (DCIS)

In recent years, ductal carcinoma in situ (DCIS) has become one of the most commonly diagnosed breast conditions. It is often referred to as “stage zero breast cancer.” It is a non-invasive breast cancer that is usually diagnosed on a mammogram when it is so small that it has not formed a lump. In DCIS, some of the cells lining the ducts (the parts of the breast that secrete milk) have developed abnormally, but the abnormality has not spread to other breast cells. DCIS is not painful or dangerous, but it sometimes develops into invasive cancer in the future if it is not treated. That is why surgical removal of the abnormal cells, followed by radiation, is usually recommended.

What makes most cancers dangerous is that they are invasive, which means they are not restricted to one spot, but have spread to other cells within the organ where they arose. Once that happens, cancer can metastasize, which means that it spreads to other organs in the body. DCIS is not an invasive type of cancer and DCIS can not metastasize unless it first develops into invasive cancer.

The goal of treating invasive cancer while it is still confined to the breast is to prevent it from spreading to the lungs, bones, brain, or other parts of the body, where it can be fatal. Since DCIS is not an invasive cancer, it is even less of a threat than an early-stage invasive cancer (usually called Stage 1 or Stage 2 cancer).

Having DCIS means that a woman has an increased risk for developing invasive breast cancer in the future, unless she has treatment. With appropriate treatment, DCIS is unlikely to develop into invasive cancer. A woman with DCIS does not need all the same treatment as a woman diagnosed with invasive breast cancer, but she does need surgery to remove the DCIS, and radiation to ensure that any stray, abnormal cells are destroyed. This lowers the risk that the DCIS will recur or that invasive breast cancer will develop.

DCIS does not need to be treated immediately. A woman can spend a few weeks after her diagnosis to talk with her doctors, learn the facts about her treatment choices, and think about what is important to her before she chooses which kind of treatment to have.

Treatment Choices for DCIS

DCIS patients have three surgery choices. They are 1) lumpectomy followed by radiation therapy 2) mastectomy or 3) mastectomy with breast reconstruction surgery. Most women with DCIS can choose lumpectomy.

Lumpectomy means that the surgeon removes only the cancer and some normal tissue around it. This kind of surgery keeps a woman’s breast intact – looking a lot like it did before surgery. Under most circumstances, mastectomy does not increase survival time for women with DCIS, and would only be considered under unusual circumstances, such as cases where the breast is very small or the area of DCIS is very large.

Radiation therapy is also recommended for almost all women with DCIS after lumpectomy. This type of treatment is very important because it could keep more DCIS or invasive cancer from developing in the same breast. DCIS patients who choose lumpectomy with radiation live just as long as they would with mastectomy.

Tamoxifen or another hormonal therapy is recommended for some women with DCIS to help prevent breast cancer. The benefit is that it can further decrease the risk of recurrence of DCIS or the development of invasive breast cancer. However, these medicines can have potentially dangerous side effects, such as increased risk of endometrial cancer, severe circulatory problems, or stroke. In addition, hot flashes, vaginal dryness, abnormal vaginal bleeding, and a possibility of premature menopause are common for women who were not yet menopausal when they started treatment.

Unlike women with invasive breast cancer, women with DCIS do not undergo chemotherapy and they usually do not need to have their lymph nodes tested or removed. Experts are not sure whether all women with DCIS would eventually develop invasive breast cancer if they live for a long time and are not treated. They do know that most women with DCIS who undergo surgery and radiation can put fears of breast cancer behind them.

Lobular Carcinoma in Situ (LCIS)

Lobular carcinoma in situ (LCIS) is also sometimes referred to as stage zero breast cancer. But we shouldn’t let the words “carcinoma” or “cancer” scare women. LCIS got its name many years ago, before doctors realized that it is not breast cancer at all.

Unlike breast cancer, LCIS does not form a tumor. Unlike DCIS, it does not form abnormal cells that can develop into invasive cancer. That is why no surgery is needed to remove LCIS. Instead, LCIS is one of several conditions that may indicate an increased risk for a woman to develop breast cancer in the future. Even though most women who have LCIS never develop breast cancer, a woman with LCIS should talk to her physician to evaluate all her risk factors and to set up a plan to monitor her breast health, such as regular mammograms. This will ensure that any changes in her breast health can be detected and evaluated very early.

How is LCIS different from breast cancer?
In LCIS, some of the cells lining the lobules (the parts of the breast that can make milk) have developed abnormally. LCIS is not cancer. It does not cause pain or produce a lump. In fact, by itself, LCIS is not a dangerous condition.

How does LCIS affect breast cancer risk?
There is no way for doctors to predict whether a woman with LCIS will develop breast cancer in the future. Most won’t, but if they do, it could be in either breast (not just the one where the LCIS was found) and in any part of the breast (not just in the area near where the LCIS was discovered).

What is the treatment for LCIS?

LCIS has no symptoms, and is first suspected because of an abnormal mammogram. A biopsy is needed to confirm the diagnosis. After a diagnosis is made, no more surgery or other treatment is needed, even if the affected area is large.

The abnormally developing cells that make up LCIS are often spread around in more than one location in the breast. It may even be in several areas and both breasts. If LCIS is diagnosed in one breast, it is not necessary to search for it or biopsy the second breast or to try to locate each area of affected lobules. That’s because no treatment is necessary regardless of the spread or location.

Women diagnosed with LCIS may question why no treatment is necessary, but experts agree that LCIS is a condition that should be managed rather than a disease to be treated. You can think of it like being overweight, which is a condition that puts a person at risk for heart disease but is not itself heart disease – and people who are overweight do not always develop heart disease.

Women with LCIS who are especially worried and want to “do something” can consider a low calorie or low-fat diet, as well as an increase in fresh fruits and vegetables to reduce their risk of future breast cancer. Although the research is not conclusive, those kinds of dietary changes may reduce the risk of breast cancer, and also have the potential to prevent other diseases. Hormonal therapy (with a drug such as tamoxifen) is also sometimes recommended to reduce the risk of future breast cancer, although it has the potentially dangerous side effects mentioned earlier, such as increasing the risk of stroke and endometrial cancer, and can cause unpleasant symptoms such as hot flashes and vaginal dryness. However, if a woman is very worried and does not feel comfortable without treatment, hormonal therapy is a less radical prevention method that bilateral mastectomies.

Other Non-Cancerous Breast Conditions.

Many women who find lumps on their breasts do not have cancer, DCIS, or LCIS. Non-cancerous lumps can be cysts that are filled with fluid, or fibroadenomas, which are smooth, and hard, often feeling like a marble under the skin. Thickened but harmless areas called pseudo-lumps also fall into this category. Cysts are sometimes but not always drained, but otherwise, these conditions usually require no further treatment. Fibrocystic breasts (also called mammary dysplasia, benign breast disease, or diffuse cystic mastopathy) feel bumpy or lumpy and sometimes painful. This condition used to be considered a pre-cancerous disease, but experts now realize that it is not a disease and does not increase the risk of breast cancer.

What About Mastectomy to Prevent Future Breast Cancer?

Ten or 20 years ago, when breast conditions like these were diagnosed, they were often treated with mastectomy, surgery which completely removes the affected breast. Sometimes a healthy second breast was also removed (prophylactic mastectomy), even when there was no sign of cancer or other abnormalities in the other breast.

Today, thanks to advances in scientists’ understanding of breast cancer and of these other conditions, along with the development of better diagnostic, surgical, and treatment techniques, mastectomy is often unnecessary. In fact, we now know that a less radical treatment (lumpectomy followed by radiation therapy for most DCIS or Stage 1 or Stage 2 cancers) or no treatment (for cysts, fibroadenomas, fibrocystic breasts, and LCIS) is just as effective. Except in unusual circumstances, mastectomy does not increase survival time for these conditions, and the risks of mastectomy usually outweigh any benefits.