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Women Ignored in Heart Device Studies

Women Ignored in Heart Device Studies

Heart devices on the market often don’t have adequate data on safety and effectiveness in women.

Devices like pacemakers, defibrillators, heart valves, and stents may act differently in women than in men, and there is a stunning lack of information about how safe or effective these devices are for women.

In spite of requirements for medical device makers to include women in studies submitted to the Food and Drug Administration (FDA) for device approval, most do not include enough women, nor do they adequately analyze how the devices work in women, according to according to research reported in Circulation: Cardiovascular Quality and Outcomes.

A news release from the American Heart Association quotes Rita F. Redberg, M.D., M.Sc., senior author of the study and professor of medicine and director of Women’s Cardiovascular Services at the University of California, San Francisco:

“Women and men differ in their size, bleeding tendencies, and other factors that are directly relevant to how the devices will work. It is likely that the benefits and risks of devices are different in women. Despite the directive to find out, it isn’t happening.”

FDA submissions for device approval are required to include a gender-bias statement, including such information as whether the proportion of men and women in the study corresponds to the proportion of men and women who have the condition, as well as information on differences based on gender.

Researchers found studies that didn’t bother to report gender of participants at all. For those who did, men made up an average of 67 percent.

A gender-bias statement was included in 41 percent of the studies. Of that 41 percent, 94 percent said they examined results by gender, and only 26 percent reported on differences in safety or effectiveness for women. There is no information available on applications which were not approved by the FDA.

About Heart Disease in Women

  • Heart disease is the number one cause of death among women 20 and older, killing about one woman every minute.
  • More women die of heart disease than the next four causes of death combined — including all forms of cancer.
  • Ninety percent of women have one or more risk factors for developing heart disease.

American women are being seriously shortchanged — giving our number one killer the upper hand.

The FDA mandated manufacturers of new medical devices to include gender statements in 1994. Why is this requirement not being enforced? And why are manufacturers, for the most part, still excluding women from important studies?

We deserve better than that.

Related Reading: Meet America’s Number One Killer

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photo: womenshealth.gov

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26 comments

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3:15AM PST on Mar 9, 2011

Actually, Lika, some biochemical differences recede after menopause, as estrogen decreases, but anatomical differences remain - on average, our arteries are smaller in diameter, for example, so stents need to be smaller.

2:31AM PST on Mar 9, 2011

Heart disease is still considered a man's disease, also. Even the signs and symptoms are different. I'm sure the devices are perfectly safe in women past menopause. Younger women are perpetually ignored in this category.

8:44PM PST on Mar 5, 2011

This doesn't surprise me. It's still a man's world. Also, since women typically have different symptoms than men do when suffering a heart attack, every women needs to be aware of those symptoms and be prepared to be her own advocate if she experiences any of them. Don't let your doctor or whoever answers the phone at his office dismiss any symptoms you might have! If necessary, go to your nearest emergency room or call 911.

1:07PM PST on Mar 5, 2011

The first heart studies, and for many years all haert studies were only done using men research subjects, because the male researchers believed that women did not have anything to worry about, thus would not have heart problems. When women were finally studied for the same heart problems, their rates were found to be similar to those of men, so, they had been dying undiagnosed, of heart failure, while men had been obtaining treatment and living through their heart attacks.
To Fred Hayward, your point is taking the question of male or female heart research patients out of context. The problem is that when a health issue affects both men and women, it is usually men who are studied in enough numbers to determine what the health problem actually is, thus, women may be wrongly assumed to have the same problems which is often not the case. With heart disease, women's symptoms are different than men's symptoms, and the precipitating factors are different. This was only found out about 30 years after the appropriate information was determined for men.

3:37PM PST on Mar 4, 2011

ty

11:21AM PST on Mar 4, 2011

This is still happening?

6:51PM PST on Mar 3, 2011

Sharon A - My God, how awful! The same thing happened to me; I could hardly get my breath. A visit to the ER, however, and I was admitted immediately for a pacemaker, or I'd be dead. Bless MN for having on-the-ball medical personnel.

Meanwhile, what is it with these anti-women right-wingers and law-makers? This is getting way out of hand. They had better remember that without women, there won't be anymore male babies to grow up into men for them to dote on. (I just had a horrible thought--unless they do it in bottles.)

5:01PM PST on Mar 3, 2011

Unbelievable!

2:42PM PST on Mar 3, 2011

I'd be curious to find out how many women scientist participated in each study and how many actually ran the trials. Next, how many women in each company had a impact on how it operated.

I'd almost bet the numbers are very very small.

11:47AM PST on Mar 3, 2011

Sharon A.,
I am so sorry about your experience that mimics the experiences of a number of women. Horror story.

Robert O.,
I think you're right about "minority" (and many would ask, in what context) but the folks we have chosen to call minority as this country began with primarily British Isle and German settlers, are forgotten and passed over in studies. With the infamous history of what has and hasn't been done to people of color in the past, it can be hard to convince people to join in studies too. Multi-faceted issue that still speaks to discrimination in our country. Thanks for your acknowledging this. Means a lot to those of us who are other. Or not.

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