Category Archives: Breast Cancer

Can Girls Lower Their Breast Cancer Risk by Eating Peanut Butter?

Krista Kleczewski, Cancer Prevention and Treatment Fund

Peanut butter, a favorite food of so many kids and overwhelmed parents, may help ward off abnormal breast conditions linked to cancer, according to researchers from Harvard and Washington University School of Medicine. The study, funded by the National Institutes of Health (NIH) and the Breast Cancer Research Foundation, found that girls between the ages of 9 and 15 who regularly ate foods high in vegetable protein and fat had a significantly lower risk of developing non-cancerous (benign) breast conditions as young women than those who did not eat these foods.1 Peanut butter, peanuts and nuts were the main sources of vegetable protein and fat in the girls’ diets.

What is Benign Breast Disease and How is it Related to Breast Cancer?

Benign breast diseases are changes in the breast that sometimes have no symptoms and sometimes can cause pain or discomfort, but are not cancerous. Some benign breast diseases increase a woman’s risk of eventually developing breast cancer only slightly, while others can increase her risks more substantially.2<sup>,</sup>3 For example, women with simple cysts or fibrosis (scar-like tissue in the breasts) have almost the same risk of developing breast cancer as women who don’t have these benign breast conditions.<sup>4</sup> However, women who have fast-growing abnormal cells, called atypical hyperplasia, are 3-4 times more likely to develop breast cancer than women with normal breasts.4

Peanut Butter and Benign Breast Disease

The study enrolled 9,039 girls, ages 9 to 15, and kept in touch with them for 14 years. The girls regularly reported to the researchers what they ate and drank, and whether they had been diagnosed at any point between the ages of 18 and 30 with benign breast disease. Adolescent girls who ate peanut butter or any kind of nuts three times a week or more had a nearly 40% lower chance of developing benign breast disease.

Although all the girls who ate peanut butter and nuts were less likely to develop benign breast disease, the girls who benefited the most were those who had a family history of breast cancer. This is important because, in general, benign breast disease is riskier in women with a family history of breast cancer.

Many people think of peanuts as nuts, but they are actually legumes.  For that reason, it is not surprising that the researchers found that consumption of other legumes such as beans, lentils, soybeans, as well as corn, may help shield girls from these breast conditions. Although the researchers did not study the benefits of specific types of nuts, it is believed that regular consumption of most nuts, including tree nuts, such as almonds and walnuts, provide protection against benign breast disease. At least one study in 2011 found that a diet containing walnuts slowed breast cancer tumor growth in mice; more research is needed before we will know if this is true for humans.5

Should All Girls Eat More Peanut Butter, Nuts, and Beans?

Although this was a large study of over 9,000 girls living in all 50 states, 95% of the girls were non-Hispanic whites, primarily from middle and upper socioeconomic backgrounds. As a result, it is impossible to say whether the study’s findings would also apply to girls from other races, and ethnicities, or to girls of lower socioeconomic backgrounds.

The study had other limitations. Because the girls filled out questionnaires about their eating habits, the researchers did not observe what the girls actually ate, or how much. This means the researchers had to rely on the girls remembering and reporting their intake accurately.

Another important question is do these foods truly protect against benign breast disease and possibly even breast cancer, or do the girls who eat them eat fewer less nutritious foods that would increase the risk of cancer? Whichever the answer, it’s a good idea—particularly if you have breast cancer in your family— to eat snacks involving peanut butter or a handful of nuts instead of less healthy alternatives like cookies, candy, or chips. Nuts and nut butter are what nutritionists call “nutrient dense” foods. They are rich in protein and nutrients, but they are also high in calories. So eat them in moderation and don’t assume that the new study means you can eat Reese’s Peanut Butter Cups to your heart’s content! They are not a nutritious snack choice! Similarly, it is best to look for low-salt and peanut butter brands without added sugar or oils. Try peanut butter with an apple or banana, peanuts low in salt, or an old classic called “Ants on a Log,” which is a stick of celery with peanut butter and raisins sprinkled on top.

Spread the news, and spread the peanut butter (in moderation, of course)!

 

Can Aspirin Prevent Cancer and Cancer Deaths?

Nyedra W. Booker, PharmD, Tracy Rupp, PharmD, MPH, RD, Laura Gottschalk, PhD, and Danielle Shapiro, MD, MPH, Cancer Prevention and Treatment Fund

Doctors have prescribed aspirin to prevent heart attacks and stroke for many years. There is now good evidence that regular aspirin use can also prevent cancer. Experts already recommend an aspirin a day to prevent colon cancer, but aspirin may also “play a strong role in reducing death from cancer.”[1]  

Recommending Aspirin for Cancer Prevention

The U.S. Preventative Service Task Force (USPSTF), an independent group of medical experts, recommend  that people between the ages of 50 and 59 should take 81 mg of aspirin daily (which is the typical dosage of “baby” or low-dose aspirin) to prevent colon cancer. Since colon cancer develops slowly overtime, aspirin should be taken for at least 10 years.[2]

Daily aspirin is not for everyone between 50 and 59, however. For example, if you have an increased risk of bleeding because of other medication you are taking or because of a history of stomach or intestinal ulcers, kidney disease, or severe liver disease, the risks of taking aspirin daily may outweigh the benefits. 

The benefits of aspirin in preventing death from cancer are based in part on a 2016 study published in the prestigious Journal of the American Medical Association (JAMA), which looked at the rate of cancer in two large long-term studies.  The Nurse’s Health Study and the Health Professionals Follow-up study included almost 48,000 men and more than 88,000 women.[3] The study found that people who took aspirin regularly had a slightly lower risk for overall cancer and a 19% lower risk for colon cancer. These benefits were seen after just five years of use and are statistically significant, which means they are almost definitely due to the aspirin and not to other factors.

The new study results were presented at a national cancer conference in April 2017 and go beyond the results published in 2016.[1] Women in the studies who took aspirin regularly had a 7% lower chance of dying of any cause than women who did not take regular aspirin. Men who took aspirin regularly had an 11% lower chance of dying of any cause than men who did not take regular aspirin. Dying from cancer was 7% lower in women and 15% lower in men who regularly took aspirin. Women who regularly took aspirin had an 11% lower risk of dying from breast cancer. Men who regularly took aspirin had a 23% lower risk of dying from prostate cancer.  

Aspirin can have many benefits, but since it also has risks more studies are needed to examine who is most likely to benefit and who is most likely to be harmed. The study was observational, which means that it evaluated the health of people in the “real world,” rather than a randomized clinical trial.  Since it is not possible to know as much about all the health habits and other possible influences of the thousands of people in these huge studies as is possible in a clinical trial, the conclusions are considered less certain.

What You Need to do Before Starting Aspirin Therapy

Remember that aspirin is a drug, and it has risks even at low doses. You should talk about whether taking a daily aspirin is a good idea with your doctor, so that you can discuss:

  • Your medical history and all the medicines you are currently using, whether they are prescription or over-the-counter
  • Any allergies or sensitivities you may have to aspirin
  • Any vitamins or dietary supplements you are currently taking

Aspirin should not be taken with certain other over-the-counter pain medications such as ibuprofen (Motrin and Advil) and naproxen (Aleve) because they can increase the risk of internal bleeding. These medications are called NSAIDS.  Aspiring should also not be taken daily by those who regularly use herbs and nutritional supplements.  Vitamin E, fish oil (omega-3 fatty acids) and what’s known as the “four Gs”– garlic, ginger, gingko, and ginseng– can all increase your risk for bleeding when taken with aspirin and other blood thinners.[4]

If taking aspirin is not a safe option for you, there are other ways to reduce your chance of developing heart disease and cancer, without any side effects!  They include quitting smoking, eating a diet rich in fruits and vegetables, and getting up from your chair or couch regularly rather than sitting for hours without moving around. Walking or other exercising for at least 20-30 minutes each day is also helpful. However, for people at highest risk of heart disease or cancer, aspirin could truly be a lifesaver.

The Bottom Line

Regular aspirin use may prevent deaths from many causes including cancer, heart attacks, and strokes.

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

Footnotes:

  1. American Association for Cancer Research News Release. Regular Aspirin Use in Associated with Lower Cancer Mortality. April 3, 2017. Available online: http://www.aacr.org/Newsroom/Pages/News-Release-Detail.aspx?ItemID=1036#.Wib80kqnGM9
  2. USPSTF. Final Update Summary: Aspirin Use to Prevent Cardiovascular Disease and Colorectal Cancer: Preventive Medication. April 2016. Available online: https://www.uspreventiveservicestaskforce.org/Page/Document/UpdateSummaryFinal/aspirin-to-prevent-cardiovascular-disease-and-cancer
  3. Cao Y, et al. Population-wide Impact of Long-term Use of Aspirin and the Risk for Cancer. JAMA Oncol. Published online March 03, 2016. DOI: 10.1001/jamaoncol.2015.6396
  4. U.S. National Library of Medicine. MedlinePlus: Drugs, Supplements, and Herbal Information. Accessed December 2017. https://medlineplus.gov/druginfo/herb_All.html

Hormone Therapy and Menopause

Anna E. Mazzucco, PhD, Elizabeth Santoro, RN, MPH, Maushami DeSoto, PhD, and Jae Hong Lee, MD, MPH

 Do women need to “replace” hormones as they age? Millions of women struggle with the decision about hormones during and after menopause: should I go on, should I stay on, or should I go off?

For decades, women were told that hormone therapy was like a fountain of youth that would protect them against many of the diseases and symptoms of aging that increase after menopause. Since estrogen alone was known to increase the risk of uterine cancer, doctors usually prescribed a combination of estrogen and progestin, unless a woman had a hysterectomy and therefore was at no risk of uterine cancer.

In addition to its proven effectiveness for decreasing hot flashes, night sweats, and vaginal dryness, in the 1980’s and 1990’s hormone therapy was thought to decrease osteoporosis, prevent heart disease, improve memory and concentration, reduce wrinkles, and improve mood. Women were encouraged to start hormone therapy before menopause started and to continue to take it for years, if not decades, in order to improve their health and their quality of life.

However, the research evidence is now clear: the risks of hormones outweigh the benefits for the vast majority of women.

What the Research Says

In December 2017, the experts at the U.S. Preventive Services Task Force issued a clear recommendation:  post-menopausal women should NOT take hormones to prevent chronic health conditions, such as increasing bone strength to avoid fractures. The reason is that the risks of these hormones outweigh the benefits.

This recommendation is just the latest evidence that taking hormones to “replace” those that are reduced in menopause if often bad for your health. Previous evidence came from the Women’s Health Initiative (WHI), sponsored by the National Institutes of Health (NIH), which included more than 27,000 women in three different trials to study the effect of hormones on women’s bodies. The 3 trials were: 1) the Estrogen Plus Progestin Trial, 2) the Women’s Health Initiative Memory Study, and 3) the Estrogen-alone Trial.

The researchers found that women taking a combination of estrogen and progesterone hormones were more likely to develop breast cancer, stroke, and blood clots, and at least as likely to develop heart disease, compared to women taking placebo. Those on estrogen alone were at an increased risk for strokes and at a significantly increased risk for deep vein, thrombosis.† The memory Study revealed that women taking a combination of estrogen plus progesterone were twice as likely to develop Alzheimer’s Disease and other forms of dementia compared to women on placebo.

All the three trials were stopped early for ethical reasons when it became clear that women taking hormones were more likely to be harmed than helped. While there are some short-term benefits to taking hormones, the researchers concluded that for most women, the risks of hormone therapy outweigh the benefits.

Following release of these findings, use of hormone therapy in the U.S. dropped significantly.  Since then, several large studies have pointed out that breast cancer incidence also dropped a few years after the decline inHRT use.6,,7  This unexpected and unprecedented drop in breast cancer incidence suggests that HRT has a more dramatic impact on breast cancer risk than previously thought.8

In 2009, a study found that hormone therapy increased the risk of dying of lung cancer among women who smoked or previously smoked, compared to smokers or former smokers who did not take hormone therapy. For more information click here.

In 2010 the University of California at San Francisco did a study of nearly 700,000 women. The researchers found that taking hormones may actually promote the growth of tumors in the breast which increases the incidents of invasive cancer and the risk of ductal carcinoma in situ (DCIS), a form of non-invasive pre-cancer. You can read more about that study by clicking here.

Experts who promote the use of HRT have criticized the WHI for enrolling women after menopause rather than just before or in the earliest stages.  So, it is important to note that in 2014, a study of 727 women in early menopause showed that hormone therapy did not prevent atherosclerosis (artery thickening), as had been claimed previously.  Following women on HRT for 4 years, the researchers from the Kronos Longevity Research Institute, a pro-HRT research institute, and other institutions, found no difference in artery thickening between the women who took HRT and those who didn’t.9  In 2015, the same group published an article admitting that hormone therapy also had no impact on “cognitive decline,” despite claims that it would prevent Alzheimer’s and memory loss. 10  Although the authors focused on a small improvement in mood related to using hormone pills for 4 years (but not found with hormone creams), they downplayed the more important finding: no impact on depression as measured by the valid and reliable Beck Depression Inventory.

What are the Risks and Benefits of Hormone Therapy?

To emphasize that lost hormones don’t necessarily need to be replaced, the term “hormone replacement therapy” has been changed to “hormone therapy.” Experts now advise women to use hormone therapy only for severe symptoms of menopause that reduce the quality of life, such as severe hot flashes, night sweats, insomnia, and vaginal dryness. Women are urged to take hormones at the lowest dose that is effective and for the shortest possible period of time. However, even short-term use (less than one year) increases some risks; for example, the increase in heart disease comes primarily from the first year of hormone use.

Hormone therapy may be recommended in severe cases of vulvar and vaginal atrophy as well as for treating severe postmenopausal osteoporosis when non-estrogen medications or other strategies are unsuccessful or impossible. A decision to use any combination of estrogen and progestin should be discussed with a physician who is expert on the topic, and specific criteria for the indication, dose, and duration of these hormones must be met prior to their prescription and administration.

Risks:

Compared to women taking placebo, within 5 years the women who received estrogen plus progestinexperienced:
— 41% more strokes
— 29% more heart attacks
— twice as many blood clots
— 22% more heart disease of all types
— 26% more breast cancer
— 37% fewer cases of colorectal cancer
— one-third fewer hip fractures
— 24% fewer bone fractures of any type
— no difference in the overall death rate

It’s important to note that only 2.5% of the women in the study experienced health problems. So, while the percentage increase in some diseases was rather large, the risk for most patients remained relatively small. That does not mean these risks are not important however.

To provide a better sense of the additional risks that come with combination hormone therapy, the study data can be summarized more simply. Compared to a group of 10,000 women taking placebo, 10,000 women taking combination hormone therapy will experience:
— 7 more heart attacks
— 8 more strokes
— 8 more cases of breast cancer
— 18 more blood clots
— 6 fewer cases of colorectal cancer
— 5 fewer hip fractures

Research Evidence

The Women’s Health Initiative was a major 15-year research program to address the most common causes of death, disability and poor quality of life in post-menopausal women – cardiovascular disease, cancer, and osteoporosis. The WHI was launched in 1991 and consisted of a set of clinical trials and an observational study. The clinical trials were designed to test the effects of post-menopausal hormone therapy, diet modification, and calcium and vitamin D supplements on heart disease, fractures, and breast and colorectal cancer.

The hormone trial had two studies: the estrogen-plus-progestin study of women with a uterus and the estrogen-alone study of women without a uterus. (Women with a uterus were given progestin in combination with estrogen, a practice known to prevent endometrial cancer.) In both hormone therapy studies, women were randomly assigned to either the hormone medication being studied or to placebo. Those studies ended several years ago, and the women are now participating in a follow-up phase, which will last until 2010.

Estrogen plus Progestin Trial (stopped in July 2002)

Compared with women in the placebo those on estrogen plus progestin had:

  • Increased risk of heart attack
  • Increased risk of stroke
  • Increased risk of blood clots
  • Increased risk of breast cancer
  • Reduced risk of colorectal cancer
  • Fewer fractures
  • No protection against mild cognitive impairment and increased risk of dementia (study included only women 65 and older)
  • Increased risk of dying of lung cancer
Women’s Health Initiative Memory Study (stopped in May 2003)
  • Women taking hormones had twice the risk for developing dementia
  • Hormones provided no protection against mild cognitive impairment/memory loss
Estrogen-alone Trial (stopped in February 2004)
  • Estrogen increased risk for stroke
  • Estrogen decreased risk for hip fracture
  • No positive or negative effect on breast cancer

Compared to placebo women on estrogen alone had:

  • Increased risk of stroke
  • Increased risk of blood clots
  • Uncertain effect for breast cancer
  • No difference in risk for colorectal cancer
  • No difference in risk for heart attack
  • Reduced risk of fracture

Links to Research Information

Estrogen Plus Progestin Trial: July 2002
The Women’s Health Initiative Memory Study: May 2003
The Estrogen-alone Trial: February 2004

_______________________________________________

† Deep vein thrombosis refers to a blood clot deep inside the veins, usually in the legs.
‡ Symptoms include thinning and inflammation of the vaginal walls and changes in the vulva.

Question: My Silicone Gel Breast Implant May Be Leaking. How Do I Find out If It Is Leaking, and What Should I Do If It Is?


Q. My silicone gel breast implant may be leaking. How do I find out if it is leaking, and what should I do if it is?

A. We’re not doctors and we don’t provide medical advice, but I can tell you what we know based on research and from speaking with many experts and with women who have had breast implants.

The best way to tell if a silicone breast implant has ruptured or is leaking is to have an MRI with a breast coil. Unfortunately MRIs are expensive, but necessary because a mammogram can not accurately detect a rupture or leak. And, the squeezing from a mammogram can cause a broken implant to leak. A sonogram can be useful but only if the radiologist is specially trained to detect implant ruptures and leaks — and very few are. That’s why an MRI is the best strategy, although that also needs to be read by someone who has experience looking for a rupture or leak in a silicone breast implant.

FDA scientists found that by the time women have implants for at least 10 years, at least one of them has usually ruptured. However, implants often break sooner, sometimes even within the first year. For women with saline breast implants, a broken implant is obvious because it usually deflates quickly. However, when silicone gel breast implants break, there are often no symptoms at all for a year or more. Years later, there are several symptoms that many women report: the breast changes shape or gets smaller, lumps or bumps may appear on the breast or nearby, some women complain of a burning pain, and some women experience symptoms of autoimmune disease, such as joint pain, memory loss, confusion, or chronic fatigue.

Many plastic surgeons believe that silicone is “perfectly safe.” However, experts who have read the research agree that a ruptured silicone gel breast implant should be removed as soon as possible, especially if it is leaking. The MRI can help the plastic surgeon know where the problem areas are so he or she can avoid leakage during removal. Removing broken implants soon means there is less chance that the silicone will leak outside the scar tissue that surrounds the implant. It is important to have the procedure performed by a plastic surgeon who is very experienced in removing leaking silicone implants. Old or broken silicone gel breast implants should be removed “en bloc,” also called an “en bloc capsulectomy.”  This means that the entire intact scar tissue capsule with the implant still inside it are all removed together. This makes it easier to remove any silicone that may have leaked from the broken gel implant and also helps remove silicone or other chemicals that may have seeped out from the silicone envelope into the scar capsule.

A study conducted by Dr Noreen Aziz from the National Cancer Institute and Dr Frank Vasey from University of South Florida found that most women who had rheumatological symptoms (such as joint pain) felt significantly better after getting their breast implants removed and not replaced. Those who didn’t get their implants removed usually got worse. Those who had them removed and replaced (with silicone implants or saline) implants did not get better.

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/. Many felt healthier, happier, and more attractive afterwards.

We hope this information is helpful. For more information, check out http://www.breastimplantinfo.org 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/ )

Question: Should I Get Silicone or Saline Implants? Is There a Price Difference?


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/ )

Are Breast Implants Safe for Cancer Patients?

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.

When Should Women Start Regular Mammograms? 40? 50? and How Often Is “Regular”?

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

In recent years, there has been a growing concern that annual mammograms starting at age 40 may do more harm than good for many women. That is why the U.S. Preventative Services Task Force, an expert group that reviews the latest research findings, recommends that mammography screening for most women start at age 50 rather than 40, and that the frequency be every two years (instead of annually) through the age of 74.

The Task Force is widely used as a gold standard for determining medical treatment and screening. In this case, they recommended raising the age to 50 after the American College of Physicians recommended the same thing, and they also recommended that women continue to undergo mammograms until age 74. They say that there is no evidence of what the benefits might be for women 75 and older.

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. They now recommend 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. In contrast, some experts point out that screening mammograms usually do more harm than good, because there is no evidence that they save lives or result in less radical surgery.[1] Experts do not recommend MRIs for screening women of average risk, but clinical studies are being done to determine whether they should be.

So What Is Best for You?

A key reminder: These recommendations are for screening mammograms. Mammograms are still needed at almost any age if a lump is found. The mammography recommendations also do not apply to all women, only for the average woman. 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 higher age– 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. In addition, if a woman finds a lump on her breast, a mammogram is still very important, regardless of the woman’s 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.

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.[2]

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 relatives had breast cancer at a young age, 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 Task Force 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 your doctor to recommend it because of your 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.

Which Kinds of Cancer Risks Can Help Me Decide?

A 2011 article by Dr. John Schousboe and his colleagues examined mammography for women at different ages and with different risk factors. They concluded that mammography screening once every two years (biennial) had health benefits and was cost effective for all women 40-79 with high breast density or with both a family history of breast cancer and a breast biopsy, regardless of breast density. Biennial mammography was also beneficial for women aged 50-69 with average breast density and women 60-79 with low breast density and either a family history of breast cancer or a previous breast biopsy. Annual mammography was not cost-effective for any group.

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 Task Force guidelines that women at an average risk of breast cancer can start biennial screening at age 50, and that women at a higher breast cancer risk should consider screening before age 50.[3]

The chances of getting breast cancer increase with age, and the disease is much more common after age 50. So, from a public health and cost-effectiveness perspective, annual screening mammograms do the most good after age 50. Earlier mammograms are less accurate and more likely to result in unnecessary anxiety or unnecessary biopsies. Unlike Schousboe and his colleagues, the Task Force did not recommend routine screening for women 75 and older, because there was not enough evidence to conclude whether or not the benefits outweigh the risks. However, the American Cancer Society recommends that screening every other year continue for older women whose health is good enough that they are likely to live at least 10 years. That is a difficult standard to implement: How many doctors want to tell their healthy older patients that they don’t need mammography because they are not likely to live at least 10 more years?

Isn’t More Frequent Mammography Better?

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.[4][5]

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. Mammography rates more than doubled between 1987 and 1999, but more recently rates have decreased slightly.

The result of these important advances 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.[6] Have the survival rates improved because of mammography or because of better treatments?

This 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 important, 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 January 2017, the Annals of Internal Medicine published a Danish study which examined whether the use of mammography can prevent the number of bigger, more advanced cancers that are difficult to treat.5 Dr. Karsten Juhl Jorgenson 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 diagnosed breast cancer cases would never have caused noticeable health problems or death.

Other research indicates mammography may not be saving lives, except possibly for the highest risk women. Researchers estimate that for 1,000 40-year-old women who have annual mammograms, two fewer women will die of breast cancer.[7] During that time, approximately 600 of these 1000 women will have false alarms, and approximately 5 – 10 will have unnecessary surgical treatment that could be harmful to them. This latest 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 Task Force recommends against teaching women to do breast self-exams, because evidence suggests the risks outweigh the benefits. There are many “false alarms,” and by the time a cancer is large enough to be felt in a self-exam, it will soon be found anyway, in the shower or while dressing. The Task Force 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.

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. BMJ 2016;352:h6080
  2. 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
  3. 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.
  4. 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.
  5. 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.
  6. 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
  7. Welch G, et al. (2013). Quantifying the benefits and harms of screening mammography. JAMA Internal Medicine.

After Mastectomies, an Unexpected Blow: Numb New Breasts

Roni Caryn Rabin, The New York Times: January 29, 2017

After learning she had a high genetic risk for breast cancer, Dane’e McCree, like a growing number of women, decided to have her breasts removed. Her doctor assured her that reconstructive surgery would spare her nipples and leave her with natural-looking breasts.

It did. But while Ms. McCree’s rebuilt chest may resemble natural breasts, it is now completely numb. Her nipples lack any feeling. She cannot sense the slightest touch of her breasts, perceive warmth or cold, feel an itch if she has a rash or pain if she bangs into a door.

And no one warned her.

“I can’t even feel it when my kids hug me,” said Ms. McCree, 31, a store manager in Grand Junction, Colo., who is raising two daughters on her own.

Plastic surgeons performed more than 106,000 breast reconstructions in 2015, up 35 percent from 2000. And they have embraced cutting-edge techniques to improve the appearance of reconstructed breasts and give them a more natural “look and feel” — using a woman’s belly fat to create the new breast, sparing the nipple, minimizing scarring with creative incisions and offering enhancements like larger, firmer lifted breasts.

Read the rest of the article here.

Sientra’s Silimed Brand “Gummy Bear” Silicone Gel Breast Implants Pose Safety Questions

Mingxin Chen, MHS and Diana Zuckerman, PhD, Cancer Prevention & Treatment Fund

gummy-bear-bubblegum

In December 2012, the U.S. Food and Drug Administration (FDA) approved Sientra’s for its “Silimed silicone gel breast implants.” These implants are also called “gummy breast implants” because they are made of a thicker gel that is said to resemble candy gummy bears.

To gain approval, the company was required to submit the results of a clinical trial to prove that the implants were safe and effective. A 5-year study of these implants was published in the November 2012 issue of Plastic and Reconstructive Surgery, authored by three Sientra employees and several plastic surgeons who were paid by Sientra to conduct the research.[1] The study included 1,788 participants with 3,506 breast implants.

Re-operation, Rupture, and Capsular Contracture

The three major complications measured were need for a re-operation, rupture, and capsular contracture. They can occur at any time, and become more common as the implants age. Capsular contracture refers to the formation of scar tissues around breast implants which becomes hard and potentially painful as the patients’ immune system reacts to the implant. MRIs were conducted on 571 of the 1788 participants to assess rupture that has no obvious symptoms.

The study indicated that the overall risk of rupture during the five years of the study was 2%, but that is misleading because the rupture rate was higher when “silent ruptures” measured by MRI were counted. MRI is the most accurate way to determine if an implant is ruptured, and more than 4% of first-time augmentation patients had a rupture within 5 years, which is much higher than expected. The risk of capsular contracture was 9% overall, and did not vary much for the different types of patients.

In contrast, the risk of reoperation varied considerably: 43% for first time reconstruction patients, 48% for reconstruction revision patients, compared to 17% for first time augmentation patients and 30% for augmentation revision patients. Revision patients are those whose previous implants were replaced with the Sientra implants.

Other Complications

There were many other complications affecting appearance and health. Most complications are highest for patients whose implants are for reconstruction after mastectomy; for example, 11% have asymmetry, 5% have an infection; 4% have breast pain, 4% of the implants are not in the correct position, and 3% have abnormal scarring. Complications are even higher for reconstruction patients who had earlier implants replaced by Sientra implants: 15% have breast asymmetry, 7% have implants in the wrong place, 5% have breast lumps or cysts, and 4% have breast pain.

For first-time augmentation patients, 3% have nipple sensation changes (either losing sensation or painfully sensitive) and 3% have sagging breasts. As noted earlier, reoperation, capsular contracture, and rupture are more common. Other complications, such as pain and swelling, add up, but each of these others complication is below 3%. Among revision augmentation patients, 5% have implants in the wrong position, 3% develop sagging breasts, 3% have wrinkling around the implant, and 3% have breasts that look asymmetrical.

Despite these high level of complications within only five years was high, the authors defended the implants. For example, they stated that over half of the patients who removed or replaced their implants did so for cosmetic reasons, predominantly patient request for style/size change. Regardless of the reason however, additional surgery is expensive and puts the patient at risk. And for breast cancer patients who chose mastectomy and implants so they would not have to think about cancer, these surgeries are a very unwelcome reminder.

The authors claimed Silimed is superior to the other two implant brands, Allergan and Mentor, in terms of risk of complications, as its risk of capsular contracture among first-time and revision augmentation patients within 5 years is 9% and 8%, in comparison with Allergan’s 13% and 17%, and Mentor’s 9% and 20%, both within 4 years.

Sientra, based in Santa Barbara, California, is the third largest global manufacturer of silicone implantable devices. The approval of the first gummy bear implants was welcomed by plastic surgeons, who pointed out that these implants had been manufactured and distributed outside of North America for 15 years.  However, the FDA approved the implants based on only 3 years of data, rather than the longer studies that would have been possible since the implants were on the market for 15 years.

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

Reference

Stevens, W. G., Harrington, J., Alizadeh, K., Berger, L., Broadway, D., Hester, T. R., . . . Beckstrand, M. (2012, November). Five-Year Follow-Up Data from the U.S. Clinical Trial for Sientraʼs U.S. Food and Drug Administration–Approved Silimed® Brand Round and Shaped Implants with High-Strength Silicone Gel. Plastic and Reconstructive Surgery, 130(5), 973-981.

Can Vitamin D Prevent Cancer?

Tracy Rupp, PharmD, MPH, RD and Mingxin Chen, MHS, Cancer Prevention & Treatment Fund

Although people all over the world can develop cancer, cancer patients are more likely to survive in areas of the world that receive the most sun.[1]  Since our skin makes vitamin D when exposed to sun, researchers wondered if vitamin D protects against cancer.  New research suggests that vitamin D may help women diagnosed with breast cancer to survive the disease.

The Evidence for the Role of Vitamin D in Breast Cancer

In November 2016, a study published in a major cancer journal looked at the association between vitamin D levels and survival in 1666 women with newly diagnosed invasive breast cancer in California. Among the participants, women with the highest vitamin D levels in their blood (the top one-third among the women in the study) were 28% less likely to die from all causes as compared to women with the lowest vitamin D levels (bottom one-third) in their blood. The association between vitamin D and survival was even stronger in premenopausal women: those with the highest vitamin D levels were 55% less likely to die from all causes and 63% less likely to die from breast cancer, as compared to premenopausal women with the lowest vitamin D levels.[2]

These results are similar to a study published in 2014, which also found that women with higher levels of vitamin D were more likely to survive breast cancer. This study used meta-analysis to pool the results from 5 previously published studies of the relationship between vitamin D levels and mortality from breast cancer. The study found that among 4443 breast-cancer patients, women with the highest vitamin D levels (about 30 ng/mL) were about half as likely to die from breast cancer as those with the lowest levels (less than 20 ng/mL).[3]

Since both studies found that women with higher vitamin D levels were more likely to survive the disease, we wonder: could the chances of improving survival really be so simple? Not necessarily. These two studies can’t tell us which came first: breast cancer or low vitamin D levels. For example, it’s possible that breast cancer causes vitamin D levels to drop. That’s one of the reasons it would be premature to recommend more vitamin D for women diagnosed with breast cancer.

The Evidence for the Role of Vitamin D in Melanoma

A study published in 2016 found that low levels of vitamin D may result in worse outcomes for patients diagnosed with the type of skin cancer called melanoma.[4] In this study, melanoma patients who had vitamin D levels less than 20 ng/mL were more likely to have larger tumors and more advanced disease than melanoma patients with higher levels of vitamin D. The researchers also examined inflammation and found that low vitamin D levels predicted poor outcomes for patients regardless of their levels of inflammation.

This result may seem very surprising, since sunlight exposure increases vitamin D and also increases the risk of developing skin cancer. A study is ongoing in Belgium to see whether vitamin D supplements will reduce the chances of skin cancer returning or worsening.[5] While it’s too early to recommend widespread vitamin D supplements for skin cancer, it’s reasonable to check vitamin D levels in patients with melanoma or who have been treated for melanoma. If their vitamin D levels are low, a supplement is an easy way to try to bring levels into the normal range.

What Is Vitamin D?

Vitamin D helps the body use calcium and phosphorus to make strong bones and teeth. Our bodies make vitamin D when our skin is exposed to direct sunlight. We can also benefit from the vitamin D that is added to milk and cereals.

How Much Vitamin D Is Recommended for Healthy People?

Approximately one-third of children and adults in the U.S. (over 1 year of age) do not get enough vitamin D.[6] The Institute of Medicine recommends the following daily amount of vitamin D for average healthy adults:[7]

  • For those between 1 and 70 years of age, including women who are pregnant or lactating, the recommended dietary allowance (RDA) is 600 IU per day.
  • For those 71 years or older, the recommendation is 800 IU per day.

Experts agree that just 15 minutes of sun at mid-day in the summer is enough. Of course, this varies based on how much skin is exposed (darker skinned people may need more time), the time of the day (mid-day is best for vitamin D), altitude (the higher the altitude you are at the more vitamin D your body can make). It is also more difficult to get enough make enough vitamin D from the sun during the winter. If you live anywhere north of Los Angeles, then you really can’t get much vitamin D from November to March when the sun is very low in the sky. Thus, we have to rely on the vitamin D we were able to store up during the summer or the vitamin D we can take in through our diets and supplements.

How Much Vitamin D Is Too Much?

Given the possible link to reducing cancer, you might wonder if you should take vitamin D supplements even though the results of these studies are not conclusive. It is important to remember that too much of any nutrient, including vitamin D, can be unhealthy. The safe maximum of vitamin D for adults and children older than 8 years of age is about 4000 IU per day.[8]

Dietary supplements are more likely than foods to provide too much vitamin D.  Although too much sun exposure is dangerous because of skin cancer, it will not cause vitamin D toxicity.

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

Reference

  1. Grant WB. Ecologic studies of solar UV-B radiation and cancer mortality rates (abstract), Recent Results Cancer Res. 2003;164: 371-7.
  2. Yao, S., Kwan, M. L., Ergas, I. J., Roh, J. M., Cheng, T. D., Hong, C., . . . Kushi, L. H. (2016). Association of Serum Level of Vitamin D at Diagnosis With Breast Cancer Survival. JAMA Oncology.
  3. Mohr SB, Gorham ED, Kim J, et al. Meta-analysis of vitamin D sufficiency for improving survival of patients with breast cancer. Anticancer Research. 2014;34:1163-66.
  4. Fang S, Sui D, Wang Y, et al. Association of vitamin D Levels with outcome in patients with melanoma after adjustment for C-reactive protein. J Clin Oncol. 2016;34:1741-1747.
  5. Vitamin D supplementation in cutaneous malignant melanoma outcome. ClinicalTrials.gov Identifier: NCT01748448. https://clinicaltrials.gov/ct2/show/NCT01748448?term=Vitamin+D+supplementation+in+cutaneous+malignant+melanoma+outcome&rank=1 Accessed January 19, 2017.
  6. National Center for Health Statistics. NCHS Data Brief: National Health and Nutrition Examination Survey, 2001–2006. Available from: http://www.cdc.gov/nchs/data/databriefs/db59.pdf. Accessed September 21, 2015.
  7. Institute of Medicine Committee to Review Dietary Reference Intakes for Vitamin D and Calcium. Dietary Reference Intakes for Calcium and Vitamin D. Washington, DC: National Academies Press; 2011.
  8. Institute of Medicine Committee to Review Dietary Reference Intakes for Vitamin D and Calcium. Dietary Reference Intakes for Calcium and Vitamin D. Washington, DC: National Academies Press; 2011.