Category Archives: Medical Treatments with Cancer Risks

Allergan Recalls Textured Breast Implants Globally Due to Cancer Links

Sasha Chavkin, IJIC: July 24, 2019.


Allergan will recall its Biocell textured breast implants worldwide after United States health authorities requested that it remove them from the market due to their association with a rare cancer of the immune system.

The announcement, which reflects the most sweeping recognition to date of the serious health risks associated with breast implants, comes after the U.S. Food and Drug Administration obtained new data showing that Allergan implants were linked to most known cases of the cancer, breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).

“Once the evidence indicated that a specific manufacturer’s product appeared to be directly linked to significant patient harm, including death, the FDA took action to alert the firm to new evidence indicating a recall is warranted to protect women’s health,” said FDA Principal Deputy Commissioner Amy Abernethy, in a statement issued by the agency.

The company said the recalled implants, both saline and silicone, would no longer be distributed or sold in any market where they are currently available.

[…]

President of the National Center for Health Research Diana Zuckerman, who has called for stricter oversight of breast implants, said Allergan’s recall was a step in the right direction but did not eliminate the risks of BIA-ALCL.

“When women decide to get breast implants for reconstruction after mastectomy or for breast augmentation, they should not be putting their lives at risk for lymphoma,” Zuckerman said.

“This recall will reduce that risk but it won’t eliminate it, because the FDA has stated that not all women with BIA-ALCL had these specific types of implants.”

In its press conference, the FDA said that it was considering additional measures to protect patient safety.

The agency said it would soon announce updated labeling standards for breast implants, and that these might include a black box safety warning, which is reserved for products that pose the most serious health risks.

The FDA also said it might require a patient checklist, a document that briefly states the key health risks from breast implants which patients would sign before undergoing surgery. The agency is not recommending that women who currently have Allergan Biocell implants get their implants removed, unless they experience signs or symptoms of BIA-ALCL.

Read the full story here.

Allergan Recalls Textured Breast Implants Linked to Rare Cancer

Laurie McGinley, Washington Post: July 24, 2019.


Allergan announced a worldwide recall of textured breast implants Wednesday after the Food and Drug Administration found a sharp increase in a rare cancer and deaths linked to the products and asked the company to pull them off the U.S. market.

The Dublin-based company said it is recalling Biocell textured breast implants and tissue expanders from all markets in which they are sold. The devices had already been banned or recalled in several countries.

The FDA said the new data shows that 573 cases worldwide have linked the rare cancer to the implants since the agency began tracking the issue in 2011. The vast majority of those cases involve Allergan products. Thirty-three women have died of what’s known as breast implant-associated anaplastic large cell lymphoma, a cancer of the immune system. Of those fatalities, authorities identified the implant manufacturer in 13 cases — and it was Allergan in all but one.

In February, the last time the FDA had updated its numbers on implant-associated illness, it reported 457 cases and nine deaths worldwide.

The agency said Wednesday that the latest data indicates the risk of such disease is six times greater with Allergan Biocell textured implants than with other types of textured implants sold in the United States.

The FDA’s new stance against the Biocell product is a reversal of its posture a few months ago, when it said there was insufficient evidence to try to remove the devices from the market.

Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said on a news call the agency changed its position partly after seeing the sharp increase in reported deaths.

Allergan pulled the products off the European market last year. Canada banned them in May after finding an increased risk of cancer.

[…]

Diana Zuckerman, president of the National Center for Health Research, a nonprofit organization, welcomed the FDA’s decision to press Allergan to recall the implants. “We are very glad they have done it,” she said. “I think they could have done it months ago and I hope a lot of women have not been getting these implants in the meantime.”

The FDA said that in most cases, the rare lymphoma linked to the implants is found in scar tissue and fluid near the devices, but that sometimes it can spread throughout the body. The condition can be life-threatening if it isn’t diagnosed and treated promptly, the agency said. Most patients are treated successfully by surgery to remove the implant and scar tissue but some may require chemotherapy or radiation.

Scientists are not sure why certain textured implants might be linked to the rare cancer. “We don’t know what it is that might increase the risk,” said Binita Ashar, director of the FDA’s office of surgical and infection control devices.

The agency said its data on the rising incidence of illnesses and deaths related to the implants came from medical device reports and searches of medical literature.

See the full article here.

Allergan Recalls Textured Breast Implant Tied to Rare Cancer

Matthew Perrone, AP for ABC Action News; July 24, 2019


WASHINGTON (AP) — Breast implant maker Allergan Inc. issued a worldwide recall Wednesday for textured models because of a link to a rare form of cancer.

The U.S. Food and Drug Administration said it called for the removal after new information showed Allergan’s Biocell breast implants with a textured surface account for a disproportionate share of rare lymphoma cases. The move follows similar action in France, Australia and Canada.

The FDA is not recommending women with the implants have them removed if they are not experiencing problems.

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 Photo by: Matt McGlashen 

WASHINGTON (AP) — Breast implant maker Allergan Inc. issued a worldwide recall Wednesday for textured models because of a link to a rare form of cancer.

The U.S. Food and Drug Administration said it called for the removal after new information showed Allergan’s Biocell breast implants with a textured surface account for a disproportionate share of rare lymphoma cases. The move follows similar action in France, Australia and Canada.

The FDA is not recommending women with the implants have them removed if they are not experiencing problems.

[…]

The FDA said the latest figures show more than 80 percent of the 570 confirmed cases of the lymphoma worldwide have been linked to Allergan implants. The updated figures reflect 116 new cases of the cancer since the FDA last released figures earlier this year.

The new numbers still reflect a rare disease considering an estimated 10 million women globally have breast implants.

There is no firm agreement on the exact frequency of the disease, known as breast implant-associated anaplastic large cell lymphoma. Published estimates ranging from 1 in 3,000 patients to 1 in 30,000 patients.

Diana Zuckerman, a researcher who has studied breast implant safety, called the removal of the devices inevitable.

“Either the company would voluntarily decide to withdraw them from the market to protect from lawsuits, or the FDA would persuade Allergan to do so,” Zuckerman said in an email.

Read the full story here.

Radiation Therapy for Ductal Carcinoma In Situ (DCIS)

Diana Zuckerman, PhD, Cancer Prevention and Treatment Fund.


In recent years, ductal carcinoma in situ (DCIS) has become one of the most commonly diagnosed breast conditions. It is often referred to as “stage zero breast cancer” or a “pre-cancer.” It is a non-invasive breast condition that is usually diagnosed on a mammogram when it is so small that it has not formed a lump. In DCIS, some of the cells lining the ducts (the parts of the breast that secrete milk) have developed abnormally, but the abnormality has not spread to other breast cells.

DCIS is not painful or dangerous, but it sometimes develops into breast cancer in the future if it is not treated. If it develops into breast cancer, it can spread.  If that happens, it is called invasive breast cancer. The goal of treating invasive cancer is to prevent it from spreading to the lungs, bones, brain, or other parts of the body, where it can be fatal. Since DCIS is not an invasive cancer, it is even less of a threat than Stage 1 or Stage 2 breast cancer, which are the earliest types of invasive cancer.1  For more information, see our free DCIS booklet, and our other articles on DCIS.

Most women with DCIS will never develop invasive cancer whether they are treated or not.  Unfortunately, it is impossible to predict which women with DCIS will develop cancer and which ones won’t. That’s why treatment is recommended. A woman with DCIS does not need all the same treatments as a woman diagnosed with invasive breast cancer, but surgery is almost always recommended. Most DCIS patients will choose a lumpectomy (which removes the DCIS but does not remove the entire breast), and radiation therapy is usually recommended for those women to destroy any stray abnormal cells in the same breast.1

Is Radiation Necessary?

Doctors usually recommend radiation therapy for lumpectomy patients, but since it is inconvenient and has some side effects, many women prefer to avoid it.  In fact, some DCIS patients decide to have a mastectomy because they do not want to undergo radiation.  However, mastectomy is a much more radical surgery and is very rarely a good idea for DCIS patients. That’s because almost all women with DCIS live long lives, and undergoing radiation does not affect whether DCIS patients live a long life or not.

Instead, the main advantage of radiation for DCIS is to prevent recurrence of DCIS in the breast where the DCIS was removed. A study of more than 1,700 women with DCIS who underwent a lumpectomy evaluated different treatment options.  The women were randomly assigned either to radiation, tamoxifen, radiation plus tamoxifen, or no treatment after surgery.  Undergoing radiation had a very small benefit for women in general, and has little impact on your chances of living a cancer-free life.

In women treated with radiation, about 10% developed DCIS or breast cancer within the next 10 years after surgery, and it made no difference whether these women took tamoxifen or not. And while the vast majority of women were alive 10 years later, their chances of survival were no different whether they were treated with radiation, tamoxifen, both, or neither.4  

For women who did not have radiation therapy, tamoxifen reduced the chances of developing DCIS within 10 years in the same breast by about 3% and the chances of developing DCIS in the other breast by about 1%. Tamoxifen did not significantly decrease the chances of developing invasive breast cancer in the same breast, and only reduced the chances of developing invasive cancer in the opposite breast by about 1%.4

So why do doctors so strongly recommend radiation and hormone therapy for DCIS?  Doctors tend to focus on reducing “relative risk” rather than actual risk. So, if a  treatment decreases the chances of recurrence by about 50% that sounds impressive — but 50% of a 16% chance is 8%, for example, and that isn’t much of a difference. And 50% of a 6% chance of recurrence is even less meaningful.  Most important, it doesn’t affect survival so women can skip radiation now and choose it later if they have a recurrence. In contrast, if a woman has radiation after a lumpectomy and later has a recurrence anyway, she can’t undergo radiation again.

When is radiation most important for DCIS?  It is more likely to benefit younger women (especially women diagnosed before age 40), women with more serious types of DCIS (a high grade DCIS called comedo), and women with a family history of breast cancer.

What is the benefit of hormone therapy for women also undergoing radiation therapy?

Tamoxifen blocks the effects of estrogen on breast cells, which can stop the growth of cancer cells that are sensitive to estrogen. A study of more than 1,800 pre-menopausal and post-menopausal women with DCIS evaluated the benefits of tamoxifen for women who had lumpectomy and radiation treatment. These women were randomly assigned to take tamoxifen for 5 years or a placebo (sugar pill). The study found that after 5 years, women who took tamoxifen were about 5% less likely to develop either DCIS or cancer in the same breast, cancer in the opposite breast, or distant cancer spread.  The difference was 8 of women taking tamoxifen compared to 13% of women taking placebo. However, the vast majority of women survived and they did not live any longer whether they took tamoxifen or not.1

For postmenopausal women, aromatase inhibitors may be used instead of tamoxifen. Aromatase inhibitors block the body’s ability to make estrogen. A study of more than 3,000 post-menopausal women with DCIS evaluated the benefits of hormone treatment for women who had lumpectomy and radiation treatment. These women were randomly assigned to take tamoxifen or anastrozole for 5 years. The study found that after 5 years, compared to women taking tamoxifen, the women taking anastrozole were 2% less likely to develop either DCIS or cancer in the same breast, cancer in the opposite breast, or distant cancer spread.  The difference was about 8% of women taking tamoxifen compared to 6% taking anastrozole.  As in the previous study, the vast majority of women survived and those taking anastrozole did not live any longer than women taking tamoxifen.2

That was a very small benefit for anastrozole compared to tamoxifen, and another study of post-menopausal women with DCIS found no difference between the two hormone treatments.3

Bottom Line:  Radiation and hormone therapy both have benefits for most women who undergo lumpectomy, because they decrease the chances of DCIS returning after surgery.  However, the benefits are quite modest and neither of these treatments affect how long women live, because almost all women diagnosed with DCIS are still alive 20 years later.

References:

  1. National Cancer Institute. Breast Cancer Treatment PDQ. (Feb. 2018). Available online: https://www.cancer.gov/types/breast/hp/breast-treatment-pdq#link/_1576_toc
  2. Margolese, Richard G et al. Anastrozole versus tamoxifen in postmenopausal women with ductal carcinoma in situ undergoing lumpectomy plus radiotherapy (NSABP B-35): a randomised, double-blind, phase 3 clinical trial.The Lancet. 2016;387(10021): 849 – 856.
  3. Forbes, John F et al. Anastrozole versus tamoxifen for the prevention of locoregional and contralateral breast cancer in postmenopausal women with locally excised ductal carcinoma in situ (IBIS-II DCIS): a double-blind, randomised controlled trial. The Lancet.2016;387(10021): 866 – 873.
  4. Cuzick, Jack et al. Effect of tamoxifen and radiotherapy in women with locally excised ductal carcinoma in situ: long-term results from the UK/ANZ DCIS trial. The Lancet Oncology. 2011; 12(1): 21 – 29

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.1,,2  This unexpected and unprecedented drop in breast cancer incidence suggests that HRT has a more dramatic impact on breast cancer risk than previously thought.3

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.4  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. 5  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.

A Shocking Diagnosis: Breast Implants “Gave Me Cancer”

Denise Grady, The New York Times: May 14, 2017

Raylene Hollrah was 33, with a young daughter, when she learned she had breast cancer. She made a difficult decision, one she hoped would save her life: She had her breasts removed, underwent grueling chemotherapy and then had reconstructive surgery.

In 2013, six years after her first diagnosis, cancer struck again — not breast cancer, but a rare malignancy of the immune system — caused by the implants used to rebuild her chest.

“My whole world came crumbling down again,” said Ms. Hollrah, now 43, who owns an insurance agency in Hermann, Mo. “I had spent the past six years going to the oncologist every three months trying to keep cancer away, and here was something I had put in my body to try to help me feel more like a woman, and it gave me cancer. I thought, ‘I’m not going to see my kids grow up.’”

Her disease — breast implant-associated anaplastic large-cell lymphoma — is a mysterious cancer that has affected a tiny proportion of the more than 10 million women worldwide who have received implants. Nearly all the cases have been linked to implants with a textured or slightly roughened surface, rather than a smooth covering. Texturing may cause inflammation that leads to cancer. If detected early, the lymphoma is often curable.

The Food and Drug Administration first reported a link between implants and the disease in 2011, and information was added to the products’ labeling. But the added warnings are deeply embedded in a dense list of complications, and no implants have been recalled. The F.D.A. advises women only “to follow their doctor’s recommended actions for monitoring their breast implants,” a spokeswoman said in an email this month.

 Until recently, many doctors had never heard of the disease, and little was known about the women who suddenly received the shocking diagnosis of cancer brought on by implants.

An F.D.A. update in March that linked nine deaths to the implants has helped raise awareness. The agency had received 359 reports of implant-associated lymphoma from around the world, although the actual tally of cases is unknown because the F.D.A.’s monitoring system relies on voluntary reports from doctors or patients. The number is expected to rise as more doctors and pathologists recognize the connection between the implants and the disease.

Women who have had the lymphoma say that the attention is long overdue, that too few women have been informed of the risk and that those with symptoms often face delays and mistakes in diagnosis, and difficulties in receiving proper care. Some have become severely ill.

Implants have become increasingly popular. From 2000 to 2016, the number of breast augmentations in the United States rose 37 percent, and reconstructions after mastectomy rose 39 percent. Annually, nearly 400,000 women in the United States get breast implants, about 300,000 for cosmetic enlargement and about 100,000 for reconstruction after cancer, according to the American Society of Plastic Surgeons. Allergan and Mentor are the major manufacturers. Worldwide, an estimated 1.4 million women got implants in 2015.

As late as 2015, only about 30 percent of plastic surgeons were routinely discussing the cancer with patients, according to Dr. Mark W. Clemens II, a plastic surgeon and an expert on the disease at the University of Texas MD Anderson Cancer Center in Houston.

“I’d like to think that since then we’ve made progress on that,” Dr. Clemens said.

Late last year, an alliance of cancer centers, the National Comprehensive Cancer Network, issued treatment guidelines. Experts agree that the essential first step is to remove the implant and the entire capsule of scar tissue around it. Otherwise, the disease is likely to recur, and the prognosis to worsen.

Not all women have been able to get the recommended treatment. Kimra Rogers, 50, a nursing assistant in Caldwell, Idaho, learned last May that she had lymphoma, from textured implants she had for more than 10 years. But instead of removing the implants and capsules immediately, her doctor prescribed six rounds of chemotherapy and 25 rounds of radiation. A year later, she still has the implants.

“Unfortunately, my doctor didn’t know the first line of defense,” Ms. Rogers said.

She learned about the importance of having the implants removed only from other women in a Facebook group for those with the disease.

Her health insurer, Blue Cross Blue Shield of Montana, covered the chemotherapy and radiation but has refused to pay for removal of the implants, and told her that her appeal rights were “exhausted.” In a statement sent to The New York Times, a spokesman said, “Cosmetic breast implants are a contract exclusion, as are any services related to complications of the cosmetic breast implants, including implant removal and reconstruction.”

Physicians dispute that reasoning, saying the surgery is needed to treat cancer. Her lawyer, Graham Newman, from Columbia, S.C., said he was planning a lawsuit against the implant makers, and had about 20 other clients with breast-implant lymphoma from Australia, Canada, England and the United States.

Ms. Rogers has been unable to work for a year. If she has to pay to have the implants removed, it will mean taking out a $12,000 loan.

“But it’s worth my life,” she said.

Insurers generally cover implants after a mastectomy, but not for cosmetic enlargement, which costs $7,500 or more. Repeat operations for complications are also common, and usually cost more than the original surgery.

Diagnosis and Treatment

Most of the cancers have developed from two to 28 years after implant surgery, with a median of eight. A vast majority occurred with textured implants.

Most implants in the United States are smooth. But for some, including those with teardrop shapes that would look odd if they rotated, texturing is preferable, because tissue can grow into the rough surface and help anchor the implant.

Researchers estimate that in Europe and the United States, one in 30,000 women with textured implants will develop the disease. But in Australia the estimate is higher: one in 10,000 to one in 1,000. No one knows why there is such a discrepancy.

What’s inside the implant — silicone or saline — seems to make no difference: Case numbers have been similar for the two types. The reason for the implants — cosmetic breast enlargement or reconstruction after a mastectomy — makes no difference, either.

Symptoms of the lymphoma usually include painful swelling and fluid buildup around the implant. Sometimes there are lumps in the breast or armpit.

To make a diagnosis, doctors drain fluid from the breast and test it for a substance called CD30, which indicates lymphoma.

The disease is usually treatable and not often fatal. Removing the implant and the entire capsule of scar tissue around it often eliminates the lymphoma. But if the cancer has spread, women need chemotherapy and sometimes radiation.

“In the cases where we have seen bad outcomes, it was usually because they were not treated or there was a major delay in treatment, on the level of years,” Dr. Clemens said. Doctors at MD Anderson have treated 38 cases and have a laboratory dedicated to studying the disease.

About 85 percent of cases can be cured with surgery alone, he said. But he added that in the past, before doctors understood how well surgery worked, many women were given chemotherapy that they probably did not need.

Case reports on the F.D.A. website vary from sketchy to somewhat detailed and rarely include long-term follow-up. Some describe initial diagnoses that were apparently mistaken, including infection and other types of cancer. In some cases, symptoms lasted or recurred for years before the right diagnosis was made.

What exactly causes the disease is not known. One theory is that bacteria may cling to textured implants and form a coating called a biofilm that stirs up the immune system and causes persistent inflammation, which may eventually lead to lymphoma. The idea is medically plausible, because other types of lymphoma stem from certain chronic infections. Professional societies for plastic surgeons recommend special techniques to avoid contamination in the operating room when implants are inserted.

“It could also just be the immune system response to some component of the texturing,” Dr. Clemens said. The rough surface may be irritating or abrasive. Allergan implants seem to be associated with more cases than other types, possibly because they are more deeply textured and have more surface area for bacteria to stick to, he said. Allergan uses a “lost-salt” method that involves rolling an implant in salt to create texture and then washing the salt away. Other makers use a sponge to imprint texturing onto the implant surface.

Allergan is studying bacterial biofilms, and immune and inflammatory responses to breast implants, a spokesman said in an email. He said the company took the disease seriously and was working with professional societies to distribute educational materials about it.

Another possible cause is that some women have a genetic trait that somehow, in the presence of implants, predisposes them to lymphoma. Dr. Clemens said researchers were genetically sequencing 50 patients to look for mutations that might contribute to the disease.

Dr. Clemens was a paid consultant for Allergan from 2013 to 2015, but not for breast implants, and no longer consults for any company, he said.

A spokeswoman for Mentor said the company was monitoring reports about the lymphoma, and stood behind the safety of its implants.

[…]

Read the full article here.

Hormone replacement therapy and breast cancer

By 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

Research shows that, “replacing” the hormones women lose as they age is not only unnecessary, but it can bad for your health. The Women’s Health Initiative (WHI), sponsored by the National Institutes of Health (NIH), enrolled over 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 in HRT 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.

To learn more about the debate about hormone therapy for menopause, click here.

Risks:

Compared to women taking placebo, within 5 years the women who received estrogen plus progestin experienced:
— 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.

Does abortion cause breast cancer?

No. Although there has been a great deal of controversy on this topic, scientists have agreed that abortion does not cause breast cancer.

The world’s leading experts, including epidemiologists, clinical researchers, and basic scientists, have discussed the scientific data on reproductive events in a woman’s life that could affect her risk of developing breast cancer. They evaluated the research that has been done on this topic and concluded that abortion and miscarriage do not increase a woman’s risk of breast cancer.

Breast cancer is related to reproductive experiences such as age of puberty and age of motherhood, and for years anti-abortion activists have cited research showing a link between abortion and breast cancer. That research has been quoted by some politicians as evidence that should be provided to women to discourage abortions. A workshop was held in 2003 (during the Bush Administration) at the National Cancer Institute (NCI) as a result of this controversy, and despite political pressures it concluded that the research linking breast cancer and abortion is flawed and not as credible as research indicating that there is no link between breast cancer and either abortion or miscarriage.

A medical journal article published in 201511 evaluated 15 studies on this issue, which included 31,816 women with breast cancer from seven studies in the U.S., seven studies in Europe, and one in China, conducted between 1986 and 2013. The scientists only evaluated studies which used the most reliable research design (what is known as a “prospective study”) and concluded that the evidence does not show a link between cancer and abortion.

The fact that abortion does not increase the risk of breast cancer is also supported by, among others, the World Health Organization (WHO), the National Cancer Institute and the American Cancer Society, as well as many women’s health advocacy organizations, including the National Breast Cancer Coalition, the National Women’s Health Network and Our Bodies Ourselves.

For more information on the NCI workshop and early reproductive events and breast cancer, please see: http://cancer.gov/cancerinfo/ere.

 

Morcellation devices: a surgical tool that can spread cancer? What you need to know

By Anna E. Mazzucco, Ph.D.
2014

If you have uterine fibroids and are considering treatment or if you’ve heard about uterine morcellation in the news, this article will help you understand the issue.

What are power morcellation devices?

A power morcellation device is a small surgical tool which cut tissue into smaller pieces.  This allows organs or other tissues to be removed through smaller incisions, making surgery shorter and leaving smaller scars behind.  The front end of a power morcellator has a spinning blade that cuts the tissue into tiny pieces (pulverizes it), and the back end is connected to a tube which sucks the tissue through the device (see image below).

morcellator

Power morcellation devices were originally designed for removal of the uterus (or the womb), but are currently used for many different types of surgical procedures because they make it easier for a physician to perform surgery using smaller incisions.

What is the controversy about morcellation devices?

In 2012, two Harvard doctors had their lives tragically affected by these devices.  Dr. Amy Reed, an anesthesiologist at Beth Israel Deaconess Medical Center, which is affiliated with Harvard Medical School, had surgery in the fall of 2013 to remove her uterus due to fibroids.  After the surgery she was diagnosed with advanced (stage IV) uterine cancer, spread by the use of power morcellation during her surgery.  The morcellation left behind tiny pieces of tumor throughout her pelvic cavity, which allowed the cancer to spread.  While morcellation devices are sometimes used with a bag to contain the fibroid or tissue so that it won’t spread, the bags can be difficult to use so not all surgeons use them.   Dr. Reed was never told that morcellation would be performed during her surgery, or about the potential risks.

As a result of this surgical procedure with morcellation, a small cancer that could have been easily and completely removed through surgery has been spread and is now considered fatal.

Dr. Reed, who is now undergoing aggressive treatment for her metastasized uterine cancer, and her husband, Dr. Hooman Noorchashm, who was a surgeon at nearby Brigham and Women’s Hospital (also affiliated with Harvard), began a campaign to raise awareness of this issue and prevent other patients from being harmed.  As a result, Brigham and Women’s Hospital has since changed its policies on use of morcellation.  Since their story came out, other similar stories have surfaced, confirming that cancer has been spread by these devices, that it is not a rare event, and that it can have fatal results.  Moreover, many of these patients had not been told about these potential risks before their surgeries, and in some cases weren’t even told that morcellation would be used.  In May 2015, the Wall Street Journalreported that the FBI is investigating whether information about the risks of morcellation was not reported by hospitals, doctors, and device makers, as required by law.

What are uterine fibroids?

Uterine fibroids are non-cancerous (benign) growths on the uterus.  They are very common among women, especially during and after the reproductive years.  In many women, they do not cause any noticeable symptoms or problems.  But in some women, uterine fibroids can cause pain, discomfort during sex, and heavy bleeding.  To read more about fibroids and treatment options for them, read our in-depth article here.

What are the risks and benefits of using power morcellators?

Morcellation can allow surgeons to do shorter, less invasive surgeries.  This can reduce the chances of excessive blood loss and infection, and can reduce the amount of time spent in the hospital and result in an easier recovery afterwards.  However, in the case of fibroids, there is no way to rule out the chance of hidden cancer which could be spread by morcellation.  The Food and Drug Administration (FDA) estimates that 1 in 350 women receiving surgery for uterine fibroids has a hidden cancer that could be spread by morcellation. This is why the FDA released a warning in April 2014 recommending against morcellation for uterine fibroids.

On July 10-11, 2014, the FDA held a public meeting to discuss the risks and benefits of these devices.  Our testimony before the FDA panel on uterine morcellation, is here.

On November 24, 2014 the FDA announced that they were issuing an immediate change in the label for power morcellation devices, which will now include a black box warning as follows:

“Uterine tissue may contain unsuspected cancer. The use of laparoscopic power morcellators during fibroid surgery may spread cancer and decrease the long-term survival of patients. This information should be shared with patients when considering surgery with the use of these devices.”

These tragic events involving power morcellation devices raise questions about how medical devices are approved and monitored, and how a tragedy like this can be prevented in the future.  If larger studies had been done before the FDA allowed these devices to be used, and if cases of cancer being spread by morcellation had been reported to the FDA by doctors and companies, the FDA could have warned doctors and patients much earlier and prevented women from being exposed to these risks.

What do patients need to know?

If you are considering surgical treatment for uterine fibroids, be sure to discuss morcellation with your surgeon and make your wishes clearly known.  Depending on your particular situation, there are alternative surgical procedures, such as vaginal hysterectomy, which can be done without morcellation.  For any surgical procedure, make sure you have a clear and thorough discussion with your doctor about exactly how the procedure will be done, what choices you have, and what the risks and benefits of different options are.   If you feel that you are not getting enough information from your doctor, consider getting a second opinion.  Be sure to ask your doctor how often they perform the procedure you will have, because patients usually have a better outcome from surgery if the doctor performs the exact same surgery frequently.  If the physician does not have many years of frequent experience with the surgery, seek out a doctor who does.  For more tips on how to make smart decisions about medical treatments, especially use of medical devices, read our article here.

Everything you ever wanted to know about radiation and cancer, but were afraid to ask

Julie Bromberg and Laura Covarrubias

Click link to jump to section:

Radiation from the Environment
Medical Devices that Use Radiation
Other Manufactured Devices that Use Radiation
Table: Approximate Dose and Cancer Risk of Various Radiation Sources

When most people think of radiation, they think of manufactured devices such as the nuclear bomb or cancer treatments, which emit high doses of radiation.  In reality, however, radiation takes many forms and is always around us.  Some types are much more dangerous than others.12,13

Most researchers agree that there is no such thing as a dose of ionizing radiation that is so low that it will not have some effect on our body, such as damaging cells.  Usually, the damage is small enough that one dose does not lead to any health problems.  It is likely that the increased risk of cancer from low doses of radiation is so low that studies in the general population can’t detect it.14,15

It is important to note that each exposure to radiation builds up in our body and the risk of cancer increases with each radiation exposure.  So even though a single source of exposure to radiation is unlikely to cause cancer by itself, the combined exposures add up throughout our lifetime and increase our risk of cancer over time.16 This is why it is important to limit unnecessary exposures to radiation.  Radiation exposure during certain sensitive times of development, such as during childhood and puberty, also has more health risks than the same exposures in adults.17,18

Since radiation is always around us, we cannot avoid all radiation, but we can try to limit our exposures.  This article will explain the various risks associated with different sources of radiation and how you can avoid getting too much exposure to radiation.

Radiation from the Environment

Background radiation

Background radiation refers to radiation that naturally occurs in our environment and does not come from any manufactured devices.  Radiation is emitted from the earth, sun, our galaxy, and other galaxies.  Even the human body naturally contains some radioactive elements.19  People who receive few or no high-dose radiation medical tests usually get more exposure to radiation from the natural environment than from any manufactured device.20

This is because we are constantly exposed to a very low dose radiation for our whole lives, while devices such as x-ray tests expose you to radiation for a very short period of time.  On the other hand, one CT scan can be equal to several years of background radiation exposures, so many people receive much higher doses of radiation from medical devices than they do from the natural environment.

The risk of developing cancer from a lifetime exposure of background radiation is about 1 in 100, or 1% of the population.21It is impossible to avoid all background radiation, but the best ways to limit unnecessary exposure to radiation from the environment is to prevent your exposure to radon and repeated unprotected sun exposure.

Radon

Radon is a color
less, odorless gas that comes from decaying rocks and soil.  For the average person, radon accounts for over half their annual exposure to radiation.  Radon comes up from the ground and gets trapped in houses and buildings.

Exposure to a small amount of radon inside is normal, but high levels can cause lung cancer.  Radon is the second leading cause of lung cancer (smoking is the leading cause), and approximately 1 in every 15 houses have too much radon.  The only way to know if you have a safe level of radon in your house is to get it tested.22

Cosmic and terrestrial radiation

Cosmic and terrestrial radiation is radiation that comes from the galaxy and from the earth.  It makes up about 8% of our average yearly exposure to radiation.23 Cosmic radiation includes ultraviolet (UV) rays from the sun that cause tans and sunburns.  UV rays can also damage the DNA in our skin cells and lead to skin cancer.24 Although we cannot avoid UV rays all the time, limiting exposure to direct sun light can reduce your risk of skin cancer.  Tanning beds are also a common source of UV radiation and are just as dangerous as radiation from the sun.  For more information on tanning beds, please read: Tanning Beds: Safe Alternative to Sun?

Being at higher altitudes, such as flying on a plane or living in a “mile high” location, will exposure you to higher levels of cosmic radiation than being at sea level.  While there is technically no “safe” dose of ionizing radiation, the chances of getting cancer from frequent plane trips is very slim.  Studies of airline crew members have not found a significant increase in risk of cancer after many years of working on airplane.25

In addition, living in Denver or other high altitude locations that receive higher doses of cosmic radiation has not been shown to increase the risk of cancer.26

How to Reduce Radiation Exposure from the Environment

Radon:  Test the level of radon inside your house to make sure it is not too high.  You can hire a professional to do this or you can purchase a “do-it-yourself” radon testing kit.  It generally takes only a few minutes and is easy to do.  If there is too high a level of radon in your house, people usually install an active soil depressurization (ASD) system, which is basically a ventilation system.2

UV Radiation: Some of the best ways to reduce your exposure to harmful UV rays are to:

  1. Wear sunscreen (at least SPF 15) year-round in all areas of your body that are exposed to the sun. (However, it is good to get vitamin D from the sun for 15 minutes each day.)
  2. Stay in the shade, especially when the sun is at it’s strongest (between 10am and 4pm)
  3. Wear protective clothing, such as broad-brimmed hats and tightly-woven clothes that cover your hands and legs.

Medical Devices that Use Radiation

X-rays

X-rays use ionizing radiation and are used for many types of diagnostic tests such as CT scans, mammograms, fluoroscopy, and simple x-rays.  These tests allow your doctor to see potential problems inside your body and choose an appropriate treatment.  They can help doctors make life-saving decisions, but some doctors are performing unnecessary scans or are using doses of radiation that are too high.27  Since x-rays use ionizing radiation, they can cause damage to our cells and DNA. X-ray tests can lead to cancer, but several common tests (such as mammograms and bone x-rays) use very low doses that have not been shown to cause a significant increased risk of cancer when administered properly.

Over the past few decades, the average level of radiation that Americans are exposed to has increased rapidly due to increased use of medical diagnostic tests such as x-rays (including dental x-rays and mammograms) and CT scans and cancer treatments.  Diagnostic tests and treatments can help improve patients’ quality and length of life, but there are also risks.  Usually, the benefit of receiving one of these tests outweighs the risk, but patients and doctors need to be wary of performing unnecessary tests, particularly if the test uses high doses of radiation.

Not all imaging tests use radiation that has been linked to cancer. Magnetic Resonance Imaging (MRIs) and ultrasounds do not use x-rays.  Instead, they use non-ionizing radiation and have not been found to increase the risk of cancer or other health problems.28

MRIs and Ultrasounds are a safer alternative to diagnostics tests that use x-rays or other ionizing radiation.

Children, young adults, and fetuses of pregnant women should be particularly careful about getting any x-ray tests.  Children, young adults, and fetuses are more sensitive to radiation, and their young age also allows a longer period of time for cancer to develop.29,30,31

Pregnant women should avoid any x-ray exposure, particularly when they are less than 20 weeks pregnant, since radiation exposure in the womb can lead to mental retardation, growth retardation, leukemia, and other cancers later in life.32  If it is necessary for a pregnant women to be x-rayed, the American College of Obstetricians and Gynecologists states a single x-ray test does not harm the fetus, but a protective lead apron should be used to cover the abdomen.33  However, high-dose, multiple-dose, or x-rays of the pelvic region should be avoided for pregnant women, whenever possible.

Many people get simple x-ray tests, such as an arm, leg, chest, or dental x-ray that look for broken bones or other problems.  Simple x-ray tests use very low doses of radiation,34  and studies have not found an increase risk of cancer among humans who have received a very low dose of radiation.35 Although the dose of radiation used to x-ray different parts of the body will vary, most simple x-rays use less radiation than other types of x-ray scans (such as a mammogram or CT scan).

Mammograms

Mammograms are an x-ray test that is used to detect breast cancer.  This test uses a higher dose of radiation than a simple x-ray, but less than a CT scan or Fluoroscopy.  According to the U.S. Preventative Services Task Force, a woman above age 50 who is at average risk of breast cancer should get a mammogram test once every two years until age 74.36 These new guidelines would expose women to less than half the amount of radiation from mammograms than following previous recommendations (which included annual mammograms starting at age 40 for women at average risk).

While these doses of radiation could cause new cases of breast cancer, the appropriate use of mammograms has resulted in lives saved, and the benefits of getting regular mammograms are likely to be even greater than the risks when the frequency of mammograms is reduced to every other year.

Women who are carriers of the BRCA genetic mutation were previously recommended to begin yearly mammograms at age 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 to these women and may instead be harmful.  They end up with higher exposure to radiation over their lifetime, which increases the chance of getting radiation-induced breast cancer that they may not have gotten otherwise.37

Fluoroscopy

Fluoroscopyis an x-ray test that allows doctors to see a continuous x-ray image of your body (like a movie, rather than just a picture as with other x-ray tests).  Fluoroscopy uses an x-ray absorbing dye that is either drunk or injected into the body, which allows doctors to see a better outline of the organ.  This procedure is used to view the digestive system (such as stomach, kidneys, or colon), arteries, or joints.38

Since this test sends x-ray beams over an extended period of time (usually 20-60 minutes),39 it exposes people to much higher doses of radiation than a simple x-ray test, although the doses vary widely depending on the test.

Fluoroscopy and CT scans both use high doses of radiation and pose the greatest and most avoidable risk of radiation-induced cancer.  Limiting the number of CT and fluoroscopy tests you receive is one of the best ways you can avoid getting cancer from radiation.  In addition to increasing cancer risk, this test can damage the skin and cause burns.40

Computed Tomographic (CT) scans

CT Scans are a relatively new type of diagnostic imaging technology that allows doctors to view 3-dimentional pictures of various organs in your body.  CT scans use higher doses of radiation than most other types of diagnostic test and are likely to cause new cancers in some patients, compared to their risk if they had not received a CT scan.

Today, an American’s average lifetime dose of radiation from diagnostic procedures is six times higher than it was in the 1980s.41  This is largely due to the increased use of CT scans. Everyday, 19,500 CT scans are performed in the U.S. and this number continues to climb. Each CT scan is equivalent to 30 – 442 chest x-rays, depending on the dose used for the CT scan.42 One study projected that CT scans performed in the U.S. in 2007 alone will result in 29,000 new cancer cases and roughly 15,000 deaths that would not have occurred if they had not received a CT scan.43 These risks would increase with each additional CT scan a person receives.  Low-dose CT scans, which expose patients to less radiation, are now being used to screen for lung cancer, with concerns about whether the benefits outweigh the risks.  For more information on low-dose CTs, click here.

Unfortunately, there is no established guideline for how much radiation should be used for each procedure.  Different scans require different levels of radiation in order to get a clear image, but some doctors are using more radiation than is necessary.  One study found that different medical facilities had huge variations in the dose of radiation used for the same procedure.  On average, the highest dose given for a CT scan was 13 times higher than the lowest does given for the same type of scan.44 The researchers found no pattern in why this dose variation occurred, and no scientific justification.

Children’s exposure to radiation from CT scans is particularly worrisome because children have many more years to develop cancer than adults receiving CT scans and are more sensitive to the effects of radiation.  A June 2012 study found that children receiving higher doses of radiation — through multiple CT scans– were more likely to develop brain tumors and leukemia than children who had only one CT scan.45  However, brain tumors and leukemia are very rare conditions and the increased risk due to CT scans was relatively small: for every 10,000 CT scans performed on children under 10 years-old, there will be one additional diagnosis of leukemia and one additional diagnosis of a brain tumor. The researchers concluded that the benefits of children having necessary CT scans outweighed the risks of later developing cancer.

A study published in May 2013 looked at children from infancy to 19 years of age in Australia and compared those who had undergone CT scans to those who had never had any.46  Ten years after getting scanned,  there were 24% more cases of cancer among  the 680,000 children and teenagers who had CT scans than among the 10 million children and teenagers who did not undergo CT scans. Young people who had CT scans during the 12-month period before being diagnosed with cancer were not counted because the decision to scan them may have had to do with cancer symptoms.  Children 4 and under had the highest increased risk in cancer, and risk for all increased with the number of scans. The researchers concluded that for every 1,800 people under 20 who had a CT scan, there was 1 additional case of cancer that would not have occurred without the radiation from the CT scan. The CT scans in this study took place between 1985 and 2005 when radiation doses where generally higher than they are today.

Parents should make sure that CT scans ordered for their children are medically necessary and ask their doctors if lower-radiation alternatives exist. While parents should not stop their children from receiving a necessary CT scan because of radiation concerns, they should think about keeping the number of scans below age 20 to a minimum.

The FDA and investigative journalists have also released warnings about occurrence of extreme accidental overdoses of radiation from CT scans.47,48

 In January 2010, the FDA reported that over 250 patients at 4 facilities had received as much as 8 times the amount of radiation that they were supposed to receive.49 Accidental radiation overdoses can result in skin redness, hair loss, increased risk of various cancers and cataracts in the future, and death.  While extreme overdoses of radiation are rare, these avoidable mistakes have lead many health professionals to call for more standardized and comprehensive methods of overseeing medical radiation.50

(Click here for more information on heart CT scans and cancer risk).

Positron Emission Tomography (PET) scans

PET scans differ from other types of diagnostic imaging in that they allow doctors to see how an organ or system is functioning rather than just seeing the structure.  This test works in a very different way than other tests and does not use x-rays-rather, it uses gamma rays, which usually have a higher level of energy than x-rays.

PET scans work by injecting (or swallowing) small amounts of radioactive material, which then spreads throughout the body. The PET scanner is then used to detect the radiation that is emitting from the radioactive material in your body. Procedures that use radioactive material to diagnose and treat patients is referred to as “nuclear medicine.”51

The dose of radiation from a PET scan is similar to CT, and therefore exposes people to a relatively high dose of radiation in comparison to other types of scans.

Using Radiation to Treat Cancer:

Radiation therapy

Radiation therapy uses high doses of radiation to treat various types of cancers.  Beams of radiation are directed at the cancer to kill off cancerous cells.  This can save lives and prevent recurrence of cancer, but healthy cells that are exposed to radiation may develop into a new cancer.  Fortunately, new cancers caused by radiation therapy are not thought to be very common since radiation technology can precisely irradiate a small part of the body that contains cancer, minimizing the amount of healthy cells that are exposed to radiation.52

Another concern about radiation therapy and diagnostic tests are errors in using this technology. Although relatively uncommon, some patients will accidently receive doses that are too high.  In addition to being at increased risk of developing cancer in the future, the incorrect doses can cause serious wounds to the skin, bone, and other organs, as well as death.53,54

Between 1950 and 2006, the frequency of diagnostic radiation increased 10-fold.55 As health professionals continue to find new uses for medical devices that use radiation, people will be exposed to radiation more often. For example, many radiologists have recently started promoting the use of CT scans to screen for colon cancer (known as a virtual colonoscopy), although the FDA has not approved CT scans for this purpose.56

Although many patients would prefer this non-invasive procedure over the traditional direct examinations, it would expose people to high doses of radiation that is roughly equal to 100 chest x-rays (or 3 years of background radiation.57 This means more people are likely to be diagnosed with cancers that are caused by radiation than they would not have gotten otherwise.

Other Manufactured Devices that Use Radiation

Airport and Building X-ray Scans

Backscatter and millimeter scanners have begun replacing metal detectors and are designed to scan a person to determine what weapons or explosives they may have beneath their clothing. Currently, there are about 250 backscatter and 264 millimeter wave scanners in the United States. The TSA hopes to have 1,800 scanners of either type installed by the end of 2014 – which would mean that nearly every airport in the country will have one.

Backscatter scanners look like two large blue boxes:

(Source: Transportation Security Administration)
(Source: Transportation Security Administration)

People raise their arms and stand sideways between these two boxes when they are scanned.

In contrast, millimeter wave scanners look like circular glass phone booths, and the person being scanned stands with their arms raised while part of the scanner rotates around them:

(Source: Transportation Security Administration, from http://www.tsa.gov/videos/travel-tips-advanced-imaging-technology)
(Source: Transportation Security Administration, from http://www.tsa.gov/videos/travel-tips-advanced-imaging-technology)

If you are not sure which scanner is in use at your airport, ask a TSA official at the security checkpoint.

While metal detectors and millimeter scans both use non-ionizing radiation, which until recently was assumed to be safe (see our article Can Cell Phones Harm our Health?), backscatter scans use ionizing radiation, which is used in x-rays and known to potentially increase the risk of cancer. Backscatter scans work a little differently from x-rays. X-rays work by sending high-energy radiation to the body and recording the radiation that passes through the body. Dense parts of the body (like bones) block some of the radiation, resulting in lighter areas on the recorded image.  Backscatter scanners also send radiation toward the body, but at much lower energy than an x-ray. Because it is not as strong as the radiation used in x-rays, the radiation does not pass through the body. Instead, the outer layers of the body “scatter” the radiation, which bounces off the body and back toward the machine. People receive most of the radiation that is absorbed by the body is deposited in the outer layers (like the skin and ribs), although a 2012 study showed that radiation from these scans may penetrate to other organs.58  Because the radiation is concentrated in the skin, there are concerns that this could cause skin cancer.

All data on backscatter scans are provided by TSA, a government agency that does not allow independent researchers to examine the machines they use.59 Researchers must therefore make educated guesses using data provided by the TSA, or they must make models of the scanners based on information that the agency releases.

The TSA states that backscatter scans use such low doses of radiation that estimating the potential effects of the scan is extremely difficult.60,61 A 2011 report using information from the TSA found that these backscatter scans expose people to the same amount of radiation that they receive from 3 to 9 minutes of normal daily life or from 1 to 3 minutes of flight.62 To put this into perspective, we would expect only 6 of the 100 million airline passengers each year to develop a cancer in their entire lives due to the backscatter scans.

Dr. David Brenner, a researcher at Columbia University, produced a different estimate based on the risk that the scanners are to the entire population, not just to an individual.63 Dr. Brenner multiplied the risk associated with one scan by the number of scans conducted each year to estimate the number of people who may develop cancer in one year because of the scanners. Because up to one billion scans may be performed each year, Brenner estimated that each year 100 people would develop cancer because of their exposure.

In April 2010, a group of scientists from the University of California, San Francisco wrote a letter of concern to Dr. John Holdren, the Assistant to President Obama for Science and Technology, about the backscatter scans. These researchers pointed out that because backscatter scans only penetrate outer layers of the body, it is possible that these layers receive a higher concentration of radiation than previously believed.

The scientists also expressed concern that sperm may mutate because the testicles are close to the surface of the skin and are exposed to radiation during these backscatter scans. In addition, they noted that the effects of radiation on the cornea (the outer surface of the eye) and the thymus (a part of the immune system located in the chest) have not been studied. While this letter only outlined concerns of the scientists and did not present new data, it called for further testing of backscatter scans.  The scientists called for more rigorous and independent studies to ensure that the scans are safe for the entire population, as well as for all parts of the body.

In a joint reply with the TSA, the FDA stated that the radiation exposures from the backscatter scans were within established legal limits, even for frequent fliers.64 In reply to the scientists’ concerns that the radiation dose to the skin would be higher, the FDA wrote that their calculations showed that a person would have to pass through the scanner 1000 times in a year in order to begin to absorb the annual limit of what is considered safe.65

Not everyone agrees with the FDA, and some people have pointed out that TSA agents operating the scanners may improperly manage the devices or that mechanical errors may occur, either of which could cause the machines to emit more radiation than they are supposed to. From May 2010 to May 2011, there were 3,778 calls for mechanical problems on backscatter machines, but only 2% of those machines were evaluated for radiation safety.66

For a more in-depth look at airport security and radiation, read here.

Microwaves, Cell Phones, and Other Manufactured Devices

There is still much debate among scientists about whether non-ionizing (low-energy) radiation such as microwaves can increase your risk of cancer or other health problems. The concern is not about microwave ovens, but rather the long-term exposures to microwaves from other sources, such as communication towers and cell phones.67 Cell phones emit very low doses of microwave radiation, which was long assumed to be safe.

Although generally safer than ionizing radiation, the much longer-term exposure could make these products potentially dangerous. There are studies indicating that long-term exposures to low doses of non-ionizing radiation can damage DNA and may cause cancers and neurological and reproductive harm.68,69

The rapid increase in use of cell phones and other wireless devices intensifies the need for further research on potential health effects of these non-ionizing radiation sources.  Click here to get more information on cell phones and health.

Tobacco, fertilizer, welding rods, smoke detectors, and several other consumer products also contain some radiation, but radiation from these sources is generally very low (approximately 3% of our yearly radiation dose.[10]

APPROXIMATE DOSE AND CANCER RISK OF VARIOUS RADIATION SOURCES: How does it compare to natural background radiation? What is the lifetime risk of cancer death from one exposure to this radiation source?

Type of Radiation (dose in mSv)† Equivalent Period of Natural Background Radiation‡ Estimated Lifetime Risk of dying from cancer that results from a single exposure§
Airport Security x-ray scanner23 (~0.0001mSv) less than one hour Almost (less than 1 in 100,000,000)
7 hour airplane flight9 (~0.03 mSv) a few days Almost 0 (1 in 1,000,000 – 100,000)
Chest x-ray6 (~0.1 mSv) ~ one week Almost 0 (1 in 1,000,000 – 100,000)
Mammogram (~0.4 mSv) a few months (~2 months) 1 in 100,000 to 10,000
CT of chest27 (~7 mSv) a few years (~2.3 years) 1 in 10,000 to 1,000
Fluoroscopy: colon (barium enema)27 (~8 mSv) a few years (~2.7 years) 1 in 10,000 to 1,000
CT of heart (angiography)27 (~16 mSv) a few years (~5.3 years) 1 in 10,000 to 1,000
PET scan, whole body5 (~14 mSv) a few years (~4.6 years) 1 in 10,000 to 1,000
Fluoroscopy: kidneys, ureters and bladder5 (~15mSv) a few years (~5 years) 1 in 10,000 to 1,000
Whole-body CT scan5 (~22.5 mSv) several years (~7.5 years) 1 in 1,000
Nuclear Medicine: Cardiac stress-rest test (thallium)27 (~40.7mSv) many years (~13.6 years) ~2 in 1,000
Transjugular intrahepatic portosystemic shunt placement27 (~70mSv) many years (~23.3 years) 1 in 100 – 1,000
Lifetime risk of cancer death NOT caused by radiation§§ 1 in 5

†Dose is based on a normal effective dose for that type of scan.  Actual doses used for a specified scan vary widely depending on the medical institution, the individual, and other factors.70

‡Natural background radiation is equal to about 3mSv per year.71

§ Risk of developing cancer is based on EPA cancer risk estimates: “…health physicists currently estimate that overall, if each person in a group of 10,000 people exposed to 1 rem [10mSv] of ionizing radiation, in small doses over a life time, we would expect 5 or 6 more people to die of cancer than would otherwise.”[33]

§§ “In this group of 10,000 people, we can expect about 2,000 to die of cancer from all non-radiation causes. The accumulated exposure to 1 rem [10 mSv] of radiation, would increase that number to about 2005 or 2006.”[33]

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


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