Q. Should I get silicone or saline implants? Is there a price difference?

A. We believe that saline breast implants are safer than silicone gel implants.

All breast implants have risks. The most common is when the breast gets hard and painful, known as capsular contracture. Many women with implants have that problem after a few years, but it appears to be more common with silicone gel breast implants than saline implants.

Implant surgery usually costs between $5,000-8,000, including the implants and one follow-up visit. Silicone gel breast implants cost about $1,000 more than saline implants.

However, there are a lot of extra expenses that you need to be aware of.

For example, saline implants and silicone implants both have a high complication rate, and almost half the women will need additional surgery to fix implant problems within 3-4 years. That additional surgery often costs $5,000 or more. That is why we suggest that women considering breast implants make sure they have at least $5,000 in their savings that they will save and not spend until they need it for their next implant surgery.

All breast implants will eventually break, but when saline implants break it is obvious (they deflate quickly) and when silicone gel breast implants break, there are often no symptoms at first. Having no symptoms might seem like an advantage, but it is really a disadvantage because silicone can leak out of the tear in the implant, and get to parts of the body where surgeons can’t remove it. Leaking silicone can cause pain and allergic or auto-immune reactions. When it is removed, the breast may be deformed.

Because of concerns about leaking silicone, the FDA warns that women with silicone gel breast implants need to get an MRI to check for leakage after 3 years, and then every other year after that. Unfortunately, breast MRIs cost about $2,000 each, sometimes more. That may seem very expensive, but it is the only accurate way to know if your implants are broken or leaking. If they are leaking, it is important to have them removed immediately.

Given the expense and the risks, why would any woman get silicone gel breast implants? There is one advantage: they feel more like a real breast. Saline implants may not feel as warm as the rest of the body in cold weather. (A figure skater told us they were painfully cold!) And, women with saline implants sometimes say that they make swooshing water noises. Most plastic surgeons prefer silicone gel implants because they tend to look and feel more natural. However, many women tell us that does not make up for the added risks and added costs.

The bottom line: all breast implants will break, all breast implants are likely to cause complications that require additional surgery, and some women will have a bad reaction within a few weeks or months of getting their breast implants. But some implants are safer than others, and since all silicone gel breast implants are more likely to leak as they get older, we believe that saline implants are safer.

For examples of women who had less pain and other symptoms after their implants were removed, see the personal stories on our website at http://www.breastimplantinfo.org/personal-stories/. You also might want to check out www.explantation.com to hear from women who have had their implants removed and not replaced. Many felt healthier, happier, and more attractive afterwards.

We hope this information is helpful. For more information, check out http://www.breastimplantinfo.org/breast-reconstruction/surgical-alternatives/ or feel free to write to us at info@center4research.org / info@stopcancerfund.org

The comments and statements of the National Research Center for Women & Families are believed and intended to be accurate, and where applicable, based on scientific literature. NRC’s statements do not constitute medical diagnoses, medical advice, plans of treatment, or legal opinion, and we are not responsible for the use or application of this information. All medical information should be reviewed with your health care practitioner.

We hope that the information we’ve provided is helpful. In order to maintain this free service to all women and their families, we invite your tax-deductible contributions to NRC (see http://www.center4research.org/contribute/ )

Diana Zuckerman, PhD and Patricia B. Lieberman, PhD, Cancer Prevention & Treatment Fund

Although the Institute of Medicine’s report on breast implants is now very outdated, there are still plastic surgeons and other breast implant advocates that quote it.  The purpose of this article is to explain what that report did and did not include.

At the time the Institute of Medicine report was published in 1999, the major controversy about breast implants was whether it could cause connective-tissue diseases or autoimmune diseases.  There were only 17 studies on the subject at the time, but the conventional wisdom was that these studies proved that breast implants are safe.  However, a careful review of the results paints a different picture.

• • These studies do not provide a comprehensive evaluation of diseases among breast implant patients. Most evaluate a few connective-tissue diseases, including such rare diseases as scleroderma and lupus. The studies would have to be much larger to determine whether implants cause these diseases. They would have to include a wider range of health information, including cancer, breast pain, need for additional surgery, and other questions, to conclusively determine if implants are safe.
  • Even for the illnesses that they evaluate, the studies have limitations. In order to conduct an accurate study of implant patients’ health, patients should undergo a comprehensive medical exam. In contrast, most of these studies relied on medical records, which are likely to omit symptoms that the doctor considers less important. A few of the studies relied on self-reported illness, which were criticized because patients might exaggerate their health problems. However, the least meaningful studies were probably those that relied on hospital records; few implant patients would have been hospitalized for their symptoms, since connective-tissue disease, breast pain, and most other health problems that implant patients have reported do not require hospitalization.
  • The studies included women who had implants for a short period of time, such as a few months or years. If implants cause connective-tissue diseases, it would be expected that the disease would develop over a period of years. Diseases might also be more likely after an implant breaks. Therefore, a well-designed study would include women who had implants for at least 7-10 years, not an average of 7-10 years.
  • Most of the studies do not evaluate saline implants. Only one of the studies specifically evaluated the health of women with saline implants.
  • Many of the studies do not evaluate the safety of implants for breast cancer patients.

Mastectomy Patients and Implants

The studies are particularly unpersuasive regarding the health of mastectomy patients. Of the cohort studies, only eight included an analysis of mastectomy patients. Four of the eight studies showed higher rates of diagnosis or symptoms of connective-tissue diseases among women with implants, but in one the difference did not reach statistical significance. The remaining studies may have been too small or may not have followed implant patients long enough to detect significant increases in disease. The case-control studies contained too few breast cancer patients to be meaningful.

Cohort Studies

Cohort studies compare women with breast implants to a group of women who are similar in terms of age, race, and health who did not have breast implants.

Edworthy et al., 1998

• Does the study include mastectomy patients receiving implants? NO

Friis et al., 1997

• Does the study include mastectomy patients receiving implants? YES
• If so, how many? 1,435 of 2,570
• Diseases studied: Any classic connective-tissue disease, including lupus, Sjogren’s syndrome, rheumatoid arthritis, and scleroderma. Also looked at “other and ill-defined” rheumatic conditions.
• Were mastectomy patients analyzed separately from augmentation patients? YES
• Minimum length of time with implants included in study: To be in this study a woman could have had implants for less than one year.
• Average length of time with implants: 7.2 years for reconstruction group, 8.4 years for augmentation group.
• Additional notes: Rates of scleroderma, lupus, and Sjogren’s syndrome in mastectomy patients receiving implants was 30% higher than expected. According to the authors, the study had only limited power to detect an increased risk of any specific connective-tissue disease. Only women who were hospitalized were categorized as ill, not outpatients.

Gabriel et al., 1994, “Mayo Clinic Study”

• Does the study include mastectomy patients receiving implants? YES
• If so, how many? 125 of 749
• Diseases studied: Any classic connective-tissue disease, including lupus, Sjogren’s syndrome, rheumatoid arthritis, and scleroderma. Also looked at other disorders such as Hashimoto’s thyroiditis, cirrhosis, sarcoidosis, and cancer.
• Were mastectomy patients analyzed separately from augmentation patients? YES
• Minimum length of time with implants included in study: To be in this study a woman could have had implants for less than one year.
• Average length of time with implants: 7.8 + 5.5 years
• Additional notes: Women with breast implants had a 35% higher rate of arthritis, which was not statistically significant (relative risk: 1.35). Morning stiffness was 81% higher for implant patients, which was significantly higher than in women without implants (relative risk: 1.81). The authors estimated that they would need to have studied 62,000 women with implants for an average of 10 years to detect a 100% increase (or less) in rare diseases such as scleroderma.

Giltay et al., 1994

• Does the study include mastectomy patients receiving implants? YES
• If so, how many? Approximately 56 of 235
• Diseases studied: Rheumatic complaints, use of anti-rheumatic drugs, and medical consultations regarding rheumatic symptoms. For those reporting rheumatic symptoms, a rheumatologist made an assessment of the likelihood of a rheumatic disease.
• Were mastectomy patients analyzed separately from augmentation patients? NO
• Minimum length of time with implants included in study: Two years
• Average length of time with implants: 6.5 years with a range of two to 14 years
• Additional notes: Women with silicone breast implants reported significantly more rheumatic complaints than controls, but there was no evidence of increased prevalence of common rheumatic diseases, such as fibromyalgia, rheumatoid arthritis, or Sjogren’s disease. If mastectomy patients are more vulnerable to diseases than augmentation patients, the results may not accurately describe the health risks for mastectomy patients, since they were a small minority of the women in the study.

Hennekens et al., 1996, “Harvard Women’s Health Cohort Study”

• Does the study include mastectomy patients receiving implants? YES
• If so, how many? 18% of 10,830
• Diseases studied: Any classic connective-tissue disease including lupus, Sjogren’s syndrome, rheumatoid arthritis, and scleroderma. Also included mixed connective-tissue disease.
• Were mastectomy patients analyzed separately from augmentation patients? YES
• Minimum length of time with implants included in study: To be in this study, a women could have had implants for one year.
• Average length of time with implants: Not stated, but the authors analyzed the women in three groups; up to four years, five to nine years, and 10 or more years after receiving implants and showed no increased risk with increased duration of exposure.
• Additional notes: Implant patients had a 25% higher rate of connective-tissue disease, whether they were reconstruction or augmentation patients (relative risk: 1.25). This was statistically significant and the researchers concluded that there is a small increased risk of connective-tissue disease among women with implants.

Nyren et al., 1998

• Does the study include mastectomy patients receiving implants? YES
• If so, how many? 3,942 of 7,442
• Diseases studied: Hospitalizations for classic connective-tissue disease including lupus, Sjogren’s syndrome, rheumatoid arthritis, and scleroderma. Also studied hospitalizations for related diseases.
• Were mastectomy patients analyzed separately from augmentation patients? YES
• Minimum length of time with implants included in study: One month
• Average length of time with implants: Six years for reconstruction patients, 10.3 years for augmentation patients.
• Additional notes: Only women who were hospitalized for connective-tissue disease were categorized as ill, not outpatients. The authors acknowledge that the sample size was too small to draw conclusions about links between breast implants and rare diseases they studied, such as scleroderma.

Park et al., 1998

• Does the study include mastectomy patients receiving implants? YES
• If so, how many? 207 of 317 implanted women
• Diseases studied: Signs and symptoms of connective-tissue disease, such as a antinuclear antibodies, rheumatoid factor, joint pain, fatigue, Raynaud’s syndrome, etc.
• Were mastectomy patients analyzed separately from augmentation patients? YES
• Minimum length of time with implants included in study: Not specified
• Average length of time with implants: Six years for reconstruction patients, five years for augmentation patients.
• Additional notes: Because the sample size was so small, a health risk would have to exceed 320% for reconstruction patients and 1600% for augmentation patients in order to be statistically significant. In addition, approximately half of the women had implants for less than six years. Because of these shortcomings, this study does not provide useful information.

Sanchez-Guerrero et al., 1995, “The Harvard Nurses’ Health Study”

• Does the study include mastectomy patients receiving implants? YES
• If so, how many? 525 of 1183 for cancer or prophylaxis
• Diseases studied: Any classic connective-tissue disease, including lupus, Sjogren’s syndrome, rheumatoid arthritis, and scleroderma. Excluded women with milder or atypical cases of connective-tissue disease.
• Were mastectomy patients analyzed separately from augmentation patients? NO
• Minimum length of time with implants included in study: One month
• Average length of time with implants: 9.9 + 6.4 years
• Additional notes: According to the authors, the study does not exclude small health risks of implants that would be of public health importance. The study was designed to minimize “reporting bias” of health problems by implant patients by excluding any health problems diagnosed after May 1990, which was six months before the major media coverage of implant problems. They did not minimize bias in the opposite direction; for example, they included women who only had implants for one month. Also, they should have excluded women who reported receiving breast implants from 1952 to 1961, prior to the invention of implants. Including these women and their inaccurate statements increased the average years of implantation.

Schusterman et al., 1993

• Does the study include mastectomy patients receiving implants? YES, all were mastectomy patients.
• If so, how many? 250 implanted compared to 353 who had autogenous tissue transplants.
• Diseases studied: Patients were considered to have rheumatic disease if they had been seen by a physician who made the diagnosis on clinical grounds with corroborating laboratory evidence and had prescribed therapy.
• Minimum length of time with implants included in study: 10 months
• Average length of time with implants: Less than 2.5 years
• Additional notes: Length of follow up was too short to be meaningful. The authors state that the report must be considered preliminary because the onset of autoimmune disorders could occur 2-21 years after implantation.

Weisman et al., 1988

• Does the study include mastectomy patients receiving implants? NO

Wells et al., 1994

• Does the study include mastectomy patients receiving implants? NO

Case-Control Studies

Of the six case-control studies, only two specified that they included any women with mastectomies, and each included only one woman. Therefore, these studies are not useful for evaluating whether implants are safe for mastectomy patients.

Burns et al., 1996

• Design: Case-control study of women with scleroderma.
• Does the study include mastectomy patients receiving implants? YES, but only one

Englert et al., 1994

• Design: Case-control study of women with scleroderma.
• Does the study include mastectomy patients receiving implants? YES, but only one

Goldman et al., 1995

• Design: Case-control study of women with rheumatoid arthritis and other connective-tissue disease.
• Does the study include mastectomy patients receiving implants? Doesn’t specify

Hochberg et al., 1996

• Design: Case-control study of women with scleroderma.
• Does the study include mastectomy patients receiving implants? NO

Strom et al., 1994

• Design: Case-control study of women with lupus.
• Does the study include mastectomy patients receiving implants? NO

Williams et al., 1997

• Design: Case-control study of women with connective-tissue disease.
• Does the study include mastectomy patients receiving implants? NO

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

Diana Zuckerman, PhD and Anna E. Mazzucco, PhD, Cancer Prevention and Treatment Fund

In recent years, there has been a growing concern that annual mammography screening for breast cancer starting at age 40 may do more harm than good for many women. Mammogram screening recommendations mainly give advice for women of average risk. Average risk means that there is no personal history of breast cancer and no genetic mutation that is associated with increased risk of breast cancer. As you read this article, keep in mind that screening guidelines vary depending on different levels of risk.

The U.S. Preventive Services Task Force (USPSTF) is an expert group that reviews the latest research findings and is widely used as a gold standard for determining medical treatment and screening. Prior to 2016, their guidelines recommended annual mammography screening starting at age 40. However, the guidelines for most women, updated in 2016, now recommend mammography screening once every two years starting at age 50.^[1] These USPSTF recommendations are the same as those suggested by the American College of Physicians. Women of average risk who are ages 75 or older, as well as women with a life expectancy of 10 years or less, should consider discontinuing breast cancer screening if they have no symptoms and no previous history of breast cancer.^[2]

For many years, the American Cancer Society (ACS) recommended annual mammograms starting at age 40, but in October 2015, they issued new recommendations that moved in the direction of those of the medical experts. Since 2015 they have recommended that women at average risk of breast cancer start mammography at 45, that they undergo annual mammograms from 45 – 54, and continue to undergo mammography every other year after that, indefinitely, as long as they are in good health and expected to live at least 10 more years.  Those guidelines are still in place in 2022.^[1]

In contrast to these other experts, the National Comprehensive Cancer Network^® published new guidelines in July 2022, urging that all women of average risk start annual mammography at age 40.^[3] NCCN is an alliance of cancer centers with clear expertise; however, research has indicated that NCCN guidelines are developed by many physicians with financial conflicts of interest that could result in bias.^[4]

Some experts continue to emphasize that screening mammograms usually do more harm than good, because there is no evidence that they save lives or result in less radical surgery.^[5] Experts do not recommend MRIs for screening women of average risk, but clinical studies are being done to determine whether they should be.

As guidelines change and vary from different experts, it may seem challenging to know what you should do. The goal of this article is to help you understand what recommendations are likely to be best for you.

What Is Best for You?

A key reminder: These recommendations are for screening mammograms, not diagnostic mammograms. Screening mammograms are scheduled to detect breast cancer whether or not you have a lump or other  symptom. Diagnostic mammograms are scheduled after finding some possible evidence of breast cancer, such as a lump or abnormal findings from a screening mammogram. Mammograms are recommended at almost any age if a lump is found. The mammography recommendations also do not apply to all women, but are meant for women with average risk of breast cancer. Experts agree that women at especially high risk of breast cancer, such as those with mothers or sisters who had breast cancer, may want to start mammograms between the ages of 40 and 50 or in rare cases, even earlier.

The bottom line is that mammograms have the potential to help detect breast cancer earlier. However, like most medical procedures, there are risks as well as benefits. Whether to start at age 50, age 40, or earlier or later or never depends on several different factors.

For most women who are not at especially high risk of breast cancer, regular mammograms do not need to start before age 50. Or, to be cautious, a woman can get one mammogram earlier (around age 45), and then if it is normal, wait until she is 50 for her next mammogram. This is the advice that the National Center for Health Research and their Cancer Prevention and Treatment Fund have been giving since 2007.

Women at higher risk of breast cancer should not wait until they are 50 to have regular mammograms. Please remember that the age of 50 is only a guideline (not a strict rule), and only for women with no symptoms and who are not at high risk of breast cancer. If a woman finds a lump on her breast, a mammogram is still very important, regardless of her age. For a woman at high risk of breast cancer because of her family history or environmental exposures, regular screening before age 50, or even before age 40, may be a very good idea.

Who Is At Higher Risk?

One study from 2011 examined mammography for women at different ages and with different risk factors. The study’s authors concluded that each woman’s decision about mammography screening should be based on the following risk factors: age, breast density, history of breast biopsy, family history of breast cancer, and personal beliefs about the benefits and harms of screening. This study supports the USPSTF guidelines that women at an average risk of breast cancer can start screening once every two years at age 50, and that women at a higher breast cancer risk should consider screening before age 50.^[6]

Women who are carriers of the BRCA genetic mutation were previously recommended to begin yearly mammograms between ages 25-30, since this mutation puts them at much higher risk of getting breast cancer. Newer studies have found that starting yearly mammograms before age 35 has no benefit and may instead be harmful. Women end up with higher exposure to radiation from mammograms over their lifetime, which increases their chance of getting radiation-induced breast cancer that they may not have gotten otherwise.^[7]

Most women who have a mother, sister, or grandmother who had breast cancer at the age of 50 or older, or who are at high risk of breast cancer because of obesity or other reasons, may want to have regular mammograms (every two years) starting between ages 40 and 50. If their close relatives had breast cancer before age 40, women may consider mammograms even before age 40. Unfortunately, younger women tend to have denser breasts, which often look white on a mammogram. Since cancer also shows up as white, mammograms are less accurate for younger women (and other women with dense breasts). For those women, a breast MRI is likely to be more accurate than a mammogram, and they are safer than mammograms.

Breast MRIs are more expensive than mammograms, costing an average of $2,000 (compared to about $100 for a mammogram). The USPSTF says there isn’t enough information to recommend for or against MRIs. For that reason, insurance may not cover the cost. If you want insurance to pay for an MRI, you probably need to be recommended by your doctor due to being high risk. Women with dense breasts are at higher risk, especially women with mothers or sisters who had breast cancer at a young age. It is logical that they could potentially benefit from regular breast MRIs, but research is lacking to draw conclusions.

The Big Debate: Do Mammograms Save Lives?

Between 1975 and 2000, dramatic improvements in treatments for breast cancer became available. Surgery options were improved, important chemotherapy agents were discovered, and tamoxifen, a hormonal treatment for estrogen-sensitive breast cancer, came into widespread use. At the same time, mammography became more popular. In 2000, about 70% of women 40 and over reported that they had a mammogram within the previous two years. Despite changes in guidelines increasing the recommended age to 50, in 2018, about 67% of women aged 40 and over reported that they had a mammogram within the previous two years.^[8]

The result of these important advances, as well as a decrease in the use of hormone therapy for menopause, has been a dramatic decrease in the number of breast cancer deaths, even while more cases of breast cancer were being diagnosed. The five-year survival rate for breast cancer increased from 75% between 1974 and 1976, to 91% between 2005 and 2011.^[9] Death rates, on average, have been falling by 1.4% a year from 2009 to 2018.^[10] Have the survival rates improved because of mammography or because of better treatments?

This question became a full-fledged medical controversy in recent years. Two issues were at the root of the debate: 1) Was mammography simply uncovering more tiny, slow-growing abnormalities or cancers that would never have developed into a health threat even if they had never been discovered? and 2) Were we doing more harm than good by subjecting so many women to cancer treatment without knowing whether some of these breast abnormalities or very early cancers would really become dangerous? Since 2009, researchers have debated whether some tiny cancers disappear on their own without treatment. More importantly, experts agree that most ductal carcinoma in situ (DCIS) will never become an invasive breast cancer, even without treatment.

Regular screening mammography can possibly help diagnose cancer earlier, but the latest research suggests it may not have as much benefit for earlier diagnosis as expected. In March 2017, the Annals of Internal Medicine published a Danish study that examined whether regularly scheduled screening mammography can prevent the number of bigger, more advanced cancers that are difficult to treat.^[11] Dr. Karsten Juhl Jørgensen and colleagues looked at 30 years of data and compared women living in areas covered by screening programs to those in areas without the programs. Overall, mammography was not associated with fewer advanced cancers. However, in the areas with screening programs, diagnoses of non-advanced cancers increased. It is estimated that up to one third of the diagnosed breast cancer cases would never have caused noticeable health problems or death.

In 2021, a Swedish study published in the medical journal Cancer looked at data from 549,091 women, searching for breast cancers that were fatal within 10 years of being diagnosed, as well as advanced breast cancers. Data were collected on the type of breast cancer diagnosis, as well as the cause and date of death for each breast cancer case. The results showed that women who had participated in regular mammography (usually every 18-24 months) screening had a 41% reduction in their risk of dying from breast cancer within 10 years of diagnosis. When accounting for potential lead time (where an early diagnosis falsely makes it look like a patient’s surviving longer) and self-selection biases (when patients decide for themselves whether to participate in a research study), the estimate drops to a more conservative, but still statistically significant, 34% reduction in risk of dying within 10 years of diagnosis. The researchers compared women who received the same treatment, so the differences in survival are not related to any potential differences in treatment.^[12] However, keep in mind that even if women are less likely to die of breast cancer, they may die of other causes and therefore do not necessarily live longer than women who did not undergo screening mammography.

Other research indicates mammography may not save lives, except possibly for the women who have the highest risk of developing breast cancer. Researchers estimate that for 1,000 40-year-old women who have annual mammograms, two fewer women will die of breast cancer.^[13] During that time, approximately 600 of these 1000 women will have false alarms, and approximately 5 to 10 will have unnecessary surgical treatment that could be harmful to them. However, this research did not consider the benefits compared to the risks of regular mammography (every two years) after age 50. It is possible that starting less frequent mammography at 50 (and for women at high risk between the ages 40 and 50) could provide benefits that may outweigh the risks for most women. Although about 90% of worrisome findings from mammograms turn out to be false alarms — not cancer — many experts continue to believe that the overall benefits have been established for women over 50.

Having fewer women die of breast cancer does not, however, mean that fewer women die.  None of the studies that evaluate the impact of mammography do so in terms of lives saved. Instead, they evaluate the number of women who die of breast cancer specifically.

What about breast self-exams? The USPSTF recommends against teaching women to do breast self-exams, because evidence suggests the risks outweigh the benefits.^[14] Breast self-exams have low accuracy, leading to women experiencing “false alarms” and increased anxiety. In the cases that breast self-exams are accurate and positive, the cancer is large enough to be obvious. The USPSTF and the American Cancer Society no longer recommend that doctors do breast exams on their patients for the same reason. Nevertheless, women should be familiar with how their breasts normally look and feel and report any changes to a doctor right away.

The Bottom Line: How Often Should You Get Mammograms?

Remember that mammograms expose women to radiation, which can increase the risk of breast cancer. Increasing the age of mammograms to age 50 for most women, and reducing the frequency to every two years could save lives because it would drastically reduce radiation exposure. Experts believe that less frequent mammograms also means a lower false alarm rate, and that means fewer unnecessary tests, anxiety, and possibly fewer unnecessary surgeries.^[15][16] To summarize, women of average risk, aged 50 to 74, should get a mammography screening every two years. However, as stated earlier, for women who have higher risks of breast cancer, these recommendations do not apply, and more frequent screenings may be beneficial. For women 75 or older, the benefits of mammography screening are not clear.

For more information:

 U.S. Preventive Services Task Force, Breast Cancer Screening Final Recommendations, http://screeningforbreastcancer.org 

For information about insurance coverage for free mammograms: http://www.hhs.gov/blog/2016/01/11/bottom-line-mammograms-are-still-covered.html

 Related Content:

Should I “upgrade” to digital or 3D? A mammography guide

Breast implants and mammography: what we know and what we don’t know

DCIS: Mostly good news

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

References:

1. 1. Breast Cancer: Screening (2016). U.S. Preventative Services Task Force. https://uspreventiveservicestaskforce.org/uspstf/recommendation/breast-cancer-screening#:~:text=The%20USPSTF%20recommends%20biennial%20screening,aged%2050%20to%2074%20years.&text=The%20decision%20to%20start%20screening,should%20be%20an%20individual%20one.
   2. Qaseem A, Lin JS, Mustafa RA, Horwitch CA, Wilt TJ; Clinical Guidelines Committee of the American College of Physicians. Screening for Breast Cancer in Average-Risk Women: A Guidance Statement From the American College of Physicians. Ann Intern Med. 2019 Apr 16;170(8):547-560. doi: 10.7326/M18-2147. Epub 2019 Apr 9. PMID: 30959525.
   3. Darwin, R. (2022). NCCN Publishes New Patient Guidelines for Breast Cancer Screening and Diagnosis Emphasizing Annual Mammograms for All Average- Risk Women Over 40. News Comprehensive Cancer Network (NCCN). https://www.nccn.org/home/news/newsdetails?NewsId=337
   4. Desai, A., Chengappa, M., Go, R., & Poonacha, T. (2020). Financial conflicts of interest among National Comprehensive Cancer Network clinical practice guideline panelists in 2019. National Library of Medicine. https://pubmed.ncbi.nlm.nih.gov/32497271/
   5. BMJ 2016;352:h6080
   6. Schousboe JT, Kerlikowske K, Loh A, and Cummings SR. (2011). Personalizing Mammography by Breast Density and Other Risk Factors for Breast Cancer: Analysis of Health Benefits and Cost-Effectiveness. Annals of Internal Medicine, 155:10-20.
   7. Berrington de Gonzalez A, Berg CD, Visvanathan K, and Robson M. (2009). Estimated Risk of Radiation-Induced Breast Cancer From Mammographic Screening for Young BRCA Mutation Carriers. Journal of the National Cancer Institute, 101(3): 205-209. doi:10.1093/jnci/djn440
   8. Centers for Disease Control and Prevention. FastStats – Mammography. CDC.gov. https://www.cdc.gov/nchs/fastats/mammography.htm. Updated March 26, 2021.
   9. Siegel, RL, Miller, KD, & Jemal, A (2016). Cancer statistics, 2016. CA: A Cancer Journal for Clinicians, 66(1), 7-30. doi:10.3322/caac.21332
   10. National Cancer Institute. Cancer Stat Facts: Female Breast Cancer. Cancer.gov. https://seer.cancer.gov/statfacts/html/breast.html. Updated January 27, 2021.
   11. Jørgensen KJ, Gøtzsche PC, Kalager M, Zahl PH. Breast Cancer Screening in Denmark: A Cohort Study of Tumor Size and Overdiagnosis. Ann Intern Med. 2017;166(5):313-323. doi:10.7326/M16-0270
   12. Duffy SW, Tabár L, Yen AM, et al. Mammography screening reduces rates of advanced and fatal breast cancers: Results in 549,091 women. Cancer. 2020;126(13):2971-2979. doi:10.1002/cncr.32859
   13. Welch G, et al. (2013). Quantifying the benefits and harms of screening mammography. JAMA Internal Medicine.
   14. Siu AL; U.S. Preventive Services Task Force. Screening for Breast Cancer: U.S. Preventive Services Task Force Recommendation Statement [published correction appears in Ann Intern Med. 2016 Mar 15;164(6):448]. Ann Intern Med. 2016;164(4):279-296. doi:10.7326/M15-2886
   15. Hubbard RA, et al. (2011). Cumulative probability of false-positive recall or biopsy recommendation after 10 years of screening mammography: a cohort study. Annals of Internal Medicine, 155(8):481-92.
   16. Braithwaite D, et al. (2013). Screening Outcomes in Older US Women Undergoing Multiple Mammograms in Community Practice: Does Interval, Age or Comorbidity Score Affect Tumor Characteristics or False Positive Rates? Journal of the National Cancer Institute,105(5):334-341.

Diana Zuckerman, PhD, Brandel France de Bravo, MPH, Jae Hong Lee, MD, MPH, and Sophia Lee, Cancer Prevention & Treatment Fund

For several decades, women have been told that regularly scheduled mammograms for midlife women can help detect breast cancer early and save lives. However, there have been controversies; for example, two Danish scientists concluded in 2001 that using mammograms to screen for breast cancer did not save lives.[1][2] One of those scientists has continued to publish articles questioning the benefits of mammogram screening for breast cancer and arguing that women are not sufficiently warned about the negative effects of screening.[3][4][5][6][7][8] As a result of the media attention to those concerns, some women are wondering whether they should undergo regularly scheduled mammograms. While the Danish researchers have highlighted some important issues, we say the answer to “Should midlife women undergo mammograms?” is YES.

First, it is important to understand that mammograms serve two different purposes: Screening mammograms are the ones regularly scheduled (usually every year or two) regardless of whether there are any lumps or other symptoms. Diagnostic mammograms are the type that are scheduled specifically to learn more about any potential lumps or other signs or symptoms.

There is no controversy about diagnostic mammograms: Experts agree they are important. The controversy is about screening mammograms.

What evidence is there that mammograms save lives? Six large clinical studies performed by researchers over several decades, incorporating data from hundreds of thousands of women in three countries, have shown that using mammograms to screen for breast cancer helps to prevent deaths from breast cancer-with decreases in the number of breast cancer deaths ranging from 13% to 45%.[9][10]  Only one large study, performed in Canada, showed no difference in the number of breast cancer deaths with the use of mammograms.[11][12] Some scientists have criticized the design of the Canadian study because it compared mammography plus a physical examination by a doctor to physical examinations alone. This study design would tend to dilute the benefits of mammography since physical exams and mammograms will detect some of the same cancers.[13] However, numerous studies show that regularly scheduled mammograms help to catch breast cancer in earlier stages, when the chances of a cure are much better and when treatment might require less extensive surgery that conserves the breast.[14] That last point is important, because even if the Danish study were correct and mammograms do not save lives compared to physical exams, earlier detection combined with less extensive surgery would be a significant quality-of-life benefit.[15]

The bottom line is that either mammograms or physical exams will help detect breast cancer, but mammograms can detect much smaller, earlier cancers, and many women have mammograms more often than they would have physical exams. Overall, the research cited above indicates that the benefits of mammography generally outweigh the risks, as long as mammograms are performed in accordance with federal regulations (as outlined under the Mammography Quality Standards Act[16]). In 2021, FDA warned women that several mammography centers were found to have inaccurate results.[17][18]

What kind of a study did the Danish researchers conduct to come up with results so different from six out of seven clinical studies? For their 2001 study, Ole Olsen and Peter Gotzsche performed what is known as a meta-analysis. This type of study does not produce any new data, but instead reanalyzes previously published data-in this case, data from the seven large clinical studies already mentioned above. Meta-analyses have become increasingly popular, in part because they are inexpensive and relatively easy to perform: all that is needed are paper copies of previously published studies, a computer, and software. However, performing a meta-analysis also requires many subjective decisions by the scientists that can bias the results. For example, many researchers disagree with the decision by Olsen and Gotzsche to label certain studies “unreliable” because of small differences in average age between the groups of women receiving and not receiving mammograms.[19][20] Those researchers argue that differences of a few months in average age between patient groups are not relevant in judging the validity of a study. As you can see, it is very possible for two different teams of researchers performing a meta-analysis of the same data to reach completely different conclusions.

In a 2009 article, Gotzsche and his colleagues propose revising patient information materials about mammography screening to make the risks clearer to women.  Although he acknowledges that mammograms can save lives, he again emphasizes that it is “not clear whether screening does more good than harm” because mammography screening results in “overdiagnosis” and “overtreatment.”[21] False positives cause emotional distress and may result in additional unnecessary exposure to radiation. In addition, women with non-invasive breast conditions, such as Ductal Carcinoma in Situ (DCIS), may undergo medically unnecessary mastectomies. He concludes that instead of decreasing mastectomies, breast cancer screening with mammography leads to more mastectomies.

If six out of seven large-scale clinical studies show that mammography screening saves lives, could Gotzsche be correct that the risks outweigh the benefits? His articles have received a great deal of attention because he has worked with the prestigious Cochrane Collaboration and because the articles were published in two prestigious British medical journals: The Lancet and the British Medical Journal. Publication in such journals tends to lend weight to a scientific report, but that does not guarantee the quality or true importance of the work. In the case of the meta-analysis, some journalists could not critically evaluate the results from this type of study. Most journalists, including those who report on health issues, are not scientists and do not have extensive medical research experience. That may explain why the news media overemphasized the importance of the Danish meta-analysis, causing concerns among thousands of patients around the world.

How Overtreatment Affects the Risk to Benefit Ratio

Although the importance of the Danish meta-analysis may have been overemphasized, the authors did raise very important potential problems with breast cancer screening using mammograms: unnecessary biopsies or overaggressive treatment.[12] The use of mammograms to screen for breast cancer does result in more biopsies for lesions that look suspicious on mammograms but are not cancer. However, better training of radiologists and improved technology could reduce the number of unnecessary biopsies.[22] Overly aggressive treatment is a well-documented problem, and not only because of mammograms. Many breast cancer patients undergo mastectomies when they are eligible for less extensive breast-conserving surgery.[23][24][25] Women who have pre-cancerous conditions are often urged to have surgery even when experts believe “watchful waiting” or “active surveillance” is the more appropriate choice.[26][27] It is important for patients to carefully discuss diagnostic and treatment options with their physicians. A second opinion is always a wise option, especially if any type of surgery is recommended.

A final important issue is that at the same time that mammograms improve the chances of early diagnosis, they also expose women to radiation, which certainly can increase the risk of getting breast cancer. For example, the radiation from digital mammography screening is estimated to cause 2 to 11 deaths per 100,000 women. This estimate depends on factors like the woman’s age and how frequently she undergoes mammography.[28] For this reason, it makes sense to avoid unnecessary mammography, rather than assume that more mammograms are better than fewer. Women should not undergo mammograms more often than is necessary, and they should make sure that their exposure to radiation from mammography is as low as possible.

When considering whether the benefits of mammography outweigh the risks, it is important to weigh the risks and benefits of mammography as a technology separately from the risks of overtreatment. Overtreatment can be reduced if physicians are more cautious in their treatment recommendations and do a better job of communicating with their patients.

Should women younger than 50 and older than 75 get mammograms?  Every year or every 2 years?

The risks and benefits of mammography vary depending on a woman’s age.  In November 2009, the U.S. Preventative Services Task Force (Task Force) changed their recommendations for mammography.  The new recommendations raised the year of regular screening for most women from 40 to 50, and changed the frequency from every year to every two years through the age of 74. In 2019, the American College of Physicians also recommended screening mammography every 2 years for average-risk women between the ages of 50 and 74.[29]  For more information on the most recent mammography screening guidelines, click here.

Over the past decade, the recommendations for mammography screening have changed several times.   Prior to 2002, the Task Force screening mammograms recommendations were similar to current recommendations: women under 50 were not recommended for regular screening, because cancer is less common in that age group, and mammograms are less accurate for younger women because their breast tissue tends to be denser. Screening mammography was not recommended for women over 69 either, because the costs appeared to outweigh the benefits: older women tend to face many life-threatening illnesses other than breast cancer. A study funded by the National Institute of Health (NIH) followed Medicare patients for eight years to see if there was a difference in breast cancer mortality between women who underwent annual mammography screenings and those who did not. In women over the age of 75, researchers found that annual screenings did not make a statistically significant difference in the percentage of women dying of breast cancer.[30]

Consistent with these research results and the recommendations of the U.S. Preventive Services Task Force, the American College of Physicians also recommends that mammography should be discontinued in average-risk women aged 75 years or older, or in women with a life expectancy of 10 years or less.[30]

Between 2002 to 2009, the U.S. Preventive Services Task Force issued mammography screening recommendations that broadened the age range beyond women 50-69,[31] even though 50-69 is still the age group for which the evidence of benefits and reduced mortality is greatest. These guidelines recommended that women 40 and older undergo a mammogram every 1-2 years. The Task Force made this change based on evidence that screening women 40 and older could possibly reduce breast cancer deaths by 20-25% over a ten-year period; however, they also point out that on average, the risks and benefits of screening mammography between the ages of 40-49 are relatively even.

In 2009, the Task Force retracted these guidelines as further evidence revealed that screening mammograms before 50 has little benefit for most women, and may even be harmful.  At this point, there is a general consensus supporting regular screening with mammography for women 50 and older, but some debate still exists as to whether women 40 to 49 should routinely be screened. The associated risks of screening-false positives, unnecessary anxiety, biopsies, and exposure to radiation-outweigh the benefits for some women, but for others the risk of cancer is great enough to override those risks.  It is important to note that both the Task Force and the American College of Physicians acknowledge that certain women would benefit from earlier screenings (such as women who have a high risk for breast cancer).  Both groups encourage an individualized approach to determining whether a woman’s risk of cancer between the ages of 40-49 justifies regular mammograms.[31][32]

An alternative to mammograms is magnetic resonance imaging (MRI). Breast MRIs are, on average, more than 10 times as expensive as mammograms, but they are more accurate at detecting breast cancer in high risk women and do not expose patients to radiation. Research suggests that they may be an especially good option for young women who carry the BRCA1 or BRCA 2 gene mutation, which puts them at very high risk for breast cancer. For women under 35 years of age with BRCA1 or BRCA2, the harms of annual mammograms outweigh the benefits.[34] MRIs show great promise but because of the expense and high number of false positives, they are not likely to be used for regular screening anytime soon, except among those women at greatest risk. A 2012 study of women under 30 years old with BRCA1 and BRCA2 mutations showed that the radiation they were exposed to from early mammography increased their risk of breast cancer. Women with the most radiation exposure had the highest risk of breast cancer. This research indicates that young women who carry these genes should be screened using methods that don’t use radiation, including magnetic resonance imaging (MRI) techniques. According to a 2004 article in the Journal of the American Medical Association, “…MRI-based screening is likely to become the cornerstone of breast cancer surveillance for BRCA1 and BRCA2 mutation carriers, but it is necessary to demonstrate that this surveillance tool lowers breast cancer mortality before it can be recommended for general use.”[35]

The Danish study stirred controversy more than a decade ago and some experts continue to be highly critical of mammography screening, but scientific evidence still supports the use of mammograms every 2 years for women ages 50 and over. Similarly, there is widespread agreement that women younger than 50 who are at a higher risk of breast cancer because of gene mutations or other risk factors should be screened regularly, but the risk of mammography can be reduced for them by using screening devices with reduced radiation, or with MRIs.  We now know that women who are carriers of the BRCA genetic mutation are likely to be harmed more than helped by yearly mammograms starting at age 25-30, because the higher exposure to radiation over their lifetime increases their chance of getting radiation-induced breast cancer that they may not have gotten otherwise.[34]

For women between the ages of 40-49 who are not at high risk, the benefits and risks of mammogram screening are close to even, which is why there are differences of opinion among health care providers. On average, for women between 50 and 74, mammograms every other year contribute to early detection, which can translate into less aggressive treatment and fewer deaths from breast cancer.

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

References

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