factor v leiden Archives - Hormones Matter

Why Aren’t Women Tested for Factor V Leiden and Other Clotting Disorders?

Published on August 9, 2022

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When I had a stroke at age 28, my doctors did some tests and found that I have a fairly common clotting disorder called Factor V Leiden. They told me that this, combined with birth control pills, are what caused me to have the cerebral venous thrombosis (stroke). It didn’t occur to me then to ask what Factor V Leiden actually was. Or to ask why I hadn’t been testing for inherited clotting disorders before I was put on medication that increased my risk for blood clots. These things didn’t occur to me until much later, after I learned to walk again.

I spent most of the first two years after my stroke getting on with my life. It wasn’t until I was searching for a topic for my thesis that I revisited what happened to me. I had no idea that birth control pills could be so dangerous and I certainly didn’t know that I could have an inherited genetic condition which would make them exponentially more dangerous for me. “How many women have the same condition?” I wondered. “Why don’t we test them before they are put on hormones?” These are some of the questions I sought to answer with my research.

What is Factor V Leiden?

Factor V Leiden (FVL) is a 20,000-year-old mutation common in the general population and a major genetic risk factor for thrombosis. It’s the most common genetic clotting disorder, accounting for around half of all cases. It’s most commonly found in Caucasians (3-8%).

Patients with Factor V Leiden can be either:

Heterozygous: inherited one mutated gene from a parent

Homozygous: inherited two mutated genes, one from each parent

What Does It Do?

As my hematologist described, FVL doesn’t cause blood clots but once activated, it dangerously accelerates clotting. Researchers aren’t clear on why some people with FVL activate and others don’t but there is almost always a precipitating factor—surgery, trauma, immobility, use of hormones, etc.

According to a review in Blood, the journal for the American Society of Hematology, women with heterozygous FVL who also use oral contraceptives have an estimated 30 to 50-fold increased risk of blood clots, while women with homozygous FVL have a several hundred-fold increased risk.

It is the most common genetic cause of primary and recurrent venous thromboembolism in women.

We know that taking estrogen can increase the risk of blood clots, stroke, and heart attack in women. And estrogen, when taken by someone with FVL, can significantly increase the risk of blood clots. Whether women are taking synthetic estrogen in the form of oral contraceptives, or hormone replacement therapy or have increased concentrations of the endogenous estrogens due to pregnancy, they are at much greater risk of clotting.

FVL accounts for 20-50% of the venous thromboembolisms (VTE) that are pregnancy related. In the United States, VTE is the leading cause of maternal death. In addition to causing VTE in pregnant women, FVL has been linked to miscarriage and preeclampsia.

Perhaps the women most at risk for blood clots are those that have been placed on hormone replacement therapy (HRT). A recent review of data from several studies found that women taking hormone replacement therapy were at an increased risk of blood clot and stroke. Worse yet, women with FVL who are also on HRT were 14-16 times more likely to have a VTE.

Despite these risks, women are not systematically tested for FVL before they are prescribed oral contraceptives, before or during pregnancy, or before commencing HRT.

What Women Know about Birth Control and Blood Clots

Part of my thesis research included a survey to assess what women understand about the risks of birth control pills and clotting disorders. Over 300 women who had taken birth control pills participated. What I found was that most women do not understand the side effects of hormonal birth control, nor are they familiar with the symptoms of a blood clot.

As for clotting disorders, nearly 60% of the women surveyed had no knowledge of these conditions. When asked whether they knew about clotting disorders BEFORE they took birth control pills that number increases considerably.

Over 80% of women were taking a medication without the knowledge that they could have an undiagnosed genetic condition that would make that medication exponentially more dangerous.

This shouldn’t come as much of a surprise give that this information is not found in advertisements for birth control pills, on non- profit websites about birth control pills and their risks, or on literature provided with the prescriptions.

Why Aren’t Women Tested for Clotting Disorders?

The most common reason I found in my research for not testing women were cost-benefit analyses measured in cost per prevention of one death.

Setting aside the moral argument that you cannot put a price on a human life, because clearly the government and corporations do just that. (It’s $8 million in case you were wondering.) The cost of taking care of taking care of victims of blood clots is not insignificant.

Each year thousands of women using hormonal contraceptives will develop blood clots. The average cost of a patient with pulmonary embolism (PE) is nearly $9,000 (for a three-day stay not including follow-up medication and subsequent testing).

A hospital stay as a stroke patient is over twice that at nearly $22,000 (not including continuing out-patient rehabilitation, medications, testing, etc.). As a stroke survivor, I can tell you that the bills don’t stop after you leave the hospital. I was incredibly lucky that I only needed a month of out-patient therapy. Most patients need considerably more and will require life-long medication and testing. It’s important to note that due to the increasing cost of healthcare, the figures in these studies (PEs from 2003-2010; strokes from 2006-2008) would be exponentially higher now.

I’m not a statistician but I can do some basic math and while I wasn’t able to find data for the United States (surprise, surprise), the health ministry in France recently conducted a study that showed that the birth control pill causes 2,500 blood clots a year and 20 deaths. The United States has 9.72 million women using the pill compared to France’s 4.27 million. This doesn’t include the patch, ring, injectable, or hormonal IUD, but for the sake of keeping things simple, let’s just use the pill. So we have over twice the pill-users as France, which means twice the blood clots (5,000) and twice the deaths (40). If we assume that half of the blood clots are PE and half are stroke, we come up with a whopping $77.5 million in hospital bills for these blood clots (not counting life-long treatment). Now adding the cost-of-life determined by the government (40 women times $8 million= $320 million) and we end up with nearly $400 million a year in damages caused by the pill. For the cost of only one year of damages, all 10 million women could have a one-time $40 blood test which would result in considerably fewer blood clots.

Furthermore, the research in my thesis shows that women would be willing to not only take these tests, but also to pay for them!

Of the 311 who answered the question, 82.3% (or 256) said they would be willing to take the test. Only 7.2% said no, with the other 10.6% “not sure.” More than 60% of respondents would be willing to pay for the test (up to $50).

In addition, the cost of a blood test is directly proportional to how frequently it is performed. An increase in testing will result in a decrease in the cost of testing.

Women Deserve Better

Putting aside the monetary costs for a moment, what about the emotional and physical toll for women who suffer these dangerous and debilitating blood clots? There is no excuse for women to suffer strokes, pulmonary embolisms, DVTs, multiple miscarriages, and still births because they have an undiagnosed clotting disorder.

That said, requiring a test before prescribing hormones to women would raise awareness of the dangers of these drugs and may reduce the overall number of women using them. Which leads one to wonder if the absence of testing for women is really just a public relations strategy.

Perhaps one of the most devastating cautionary tales of not testing for clotting disorders comes from Laura Femia Buccellato. Her daughter Theresa was 16 years old when she was killed from a blood clot caused by (undiagnosed) Factor V Leiden and birth control pills. Would Theresa be with us today if she had had a simple blood test? Would I have had a stroke? When we will demand better?

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Image by fernando zhiminaicela from Pixabay.

This article was first published in September 2016.

What Everyone Needs to Know About Hormonal Birth Control

by Laura Femia Buccellato

Published on May 23, 2016

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My only child, Theresa, came to me a month before her sixteenth birthday and told me she had sexual intercourse for the first time. I was not happy about it, but I was very happy we were close enough that she knew she could come to me about it. I spoke my mind about how I felt she was too young, but I also knew deep down my words would not prevent her from having sex again. Theresa asked about going on the birth control pill. I had been on the pill in my 20’s and had no side effects from it. I told her I would make an appointment with my OBGYN that also delivered her, and we would discuss the options with her first.

Starting the Birth Control Pill

Theresa had an exam by the doctor and then I joined them in the doctor’s office to discuss birth control. Our doctor mentioned the pill first. My first reaction was to ask about other contraceptives but the doctor felt the pill would be the best for Theresa. She said she would put her on one of the lowest dose pills, called Ortho-Cept. I was aware of some of the side effects of the pill like gaining weight, blood clots, and danger if you smoke (Theresa did not smoke). Our doctor did not go over any of the side effects with us or what to look for if something were to go wrong. I trusted my OBGYN because I have been with her for most of my life and she had four children so I never felt she would put Theresa in any kind of harm. She also was aware of my family medical history and that my mother had a stroke at 32 years old.

Theresa was on the pill for a month and a half and never complained to me about it. On August 15th, 2010, Theresa and I spent the whole day at the mall putting the final touches on her Mardi Gras Sweet 16 party. She was having her party in October instead of her birthday month in July because she wanted all her friends back from summer vacation so they could attend. Theresa always dreamed about her sweet 16 party; it was the day she felt she would be a princess and her start of becoming an adult. That night after shopping we stayed up all night ordering the masks for her Mardi Gras party. When I went to bed that night I had no clue our lives would end the very next day. That instead of watching my daughter’s dream party happen, it would be a memorial concert on her party date instead.

The Day that Changed our Lives Forever

August 16th, 2010 started out as a normal day. I woke up and got ready for work. Theresa was still asleep so I did not wake her to say goodbye. Around 1:00 in the afternoon she called me at work to ask if she could go out with two of her friends. I said yes and that her dad or I would pick her up at 9:00 PM. I told her I love you and we hung up. Those were the last words ever spoken with her.

Her dad decided he would pick her up that night. I remember just getting out of the shower when my phone rang. It was her dad telling me Theresa was sick and he had called an ambulance. I did not even wait for details; I got in my car and headed to the pizzeria he told me they were at. We later found out that Theresa had complained of a headache about an hour before the ambulance was called, and then became delirious, and vomited. I was there within 10 minutes and saw a huge crowd outside the pizzeria along with an ambulance. I rushed into the pizzeria and saw Theresa on the stretcher out cold. I remember looking around the pizzeria and it being packed with people. As soon as we got into the ambulance I saw the paramedics rip open Theresa’s shirt and start CPR. I was in a daze and in shock. I had no clue what was happening, but I knew I was losing my child.

When we got to the hospital the doctor on call continued CPR and made my ex-husband and I leave the room. A couple of minutes later the nurse came out to tell me to come in and hold her hand. I already knew Theresa was gone. The doctor then had me go out of the room and told us Theresa was gone. He said her pupils were not dilated, and there was no indication it was caused by any kind of substance. That I already knew: Theresa hated drugs and did not do them.

I remember walking back in the room to be with my daughter. She was lying on the table with her eyes wide open. I will never forget that picture. Theresa had the most beautiful green eyes and she was so proud of them. I remember blurting out I wanted to donate them. Everything after that is a total blur. My 16 year old daughter was dead and I had no clue why. She was a very healthy, athletic, young girl. I always thought we were blessed because if I took her to the doctor more than once a year for feeling ill, that was a lot.

I called our OBGYN the next day to tell her Theresa died. I still had no thought in my head that the pill had anything to do with her death. I actually thought she had an aneurysm because her friends said she complained about a headache an hour before she died. Two days after her death our OBGYN called me that the autopsy results were already in. She said Theresa died from a blood clot that burst in her leg and caused a pulmonary embolism.

Factor V Leiden, The Risk Factor that We Were Not Aware Of

I was then told Theresa had a blood clotting disorder called Factor V Leiden. Dr. Melgar told me that everyone in my immediate family and my ex-husband’s immediate family had to be tested for it because this disorder is genetic. She told me a simple blood test would determine if anyone in the family carries this disorder. I immediately went and had blood work done and found out I have Factor V Leiden also. Theresa got it from me, and I never even knew this disorder existed. My sister had her four children tested for it and two of her children turned out to be positive. My nephew has it and one of my nieces has it from both her parents, which is very serious.

I started doing research on this and that was when I found out the pill Theresa was put on was not the same kind of pills I was on in my 20’s. Hormonal contraceptives now have different types of progestins in them, and classified into second and third generation pills by the type of progestin. Women using third generation progestins have an even higher risk of developing a blood clot than women using second generation progestins. I also learned if Theresa had a blood test before she went on the pill, the doctor would have known about her having a blood clotting disorder, and she would have never been allowed on any kind of birth control.

After reading all this I drove straight to the doctor’s office to find out why the blood test was never mentioned. Dr. Melgar explained to me that the medical opinion is that blood clotting disorder is rare and insurance companies will not pay for the blood work so doctors do not mention it to their patients. She did not even give us the option to pay for it out of pocket. The insurance companies feel it is not cost effective to run this test on people going on birth control cause only 5-7 out of 10,000 die from it.

A simple blood test (that I would have paid for) would have saved Theresa’s life. Instead, she died from this. Theresa’s life, to the medical and pharmaceutical industry, did not matter. She is now just a statistic to them. For Theresa she lost her life, her future. She was a promising young woman that wanted to either become a veterinarian or work as a social worker with Project Children. She wanted to make a difference in this world.

As for her father and I, we might be living, but we are both dead inside. We lost the only important person in our life. We will not see our daughter graduate from college this year, get married, or ever have any grandchildren. The medical/pharmaceutical industry stole everything from Theresa and us, just by not mentioning a simple blood test.

Since Theresa’s death I have been trying to spread the word to others about this blood test. I am not against birth control at all, but I am against the facts not being revealed. I feel people need to know about this blood test. In Theresa’s memory I will tell people about this test over and over again. Many people I have talked to have had this test done after hearing of Theresa’s death. So many people have turned out positive for Factor V Leiden. I have come to find that this disorder is not as rare as the medical industry wants us to believe it is.

Actually talking to different doctors, I have found they are very ignorant about this disorder, and they have not been educated about it. It is up to us to fight for this blood test and make it mandatory for all females to be tested for it. Unfortunately a lot more people will probably die before it does become mandatory. I am hoping by telling Theresa’s story, this will bring awareness to others. Please insist on the blood test if you or anyone you know is going on any kind of hormonal birth control. Being a carrier (having one mutation, instead of two) also increases your risk of having a blood clot.

You need to watch all signs in your body for complications. Have you had many miscarriages? A swollen leg, that’s painful, red, and warm to the touch? Trouble breathing? These are all signs that you might have this disorder or a danger sign about your birth control. The number of people having strokes, pulmonary embolism, and dying have been increasing every year and the third generation birth control pills are contributing to this problem. The medical industry no longer cares about saving lives. They have teamed up with pharmaceutical companies to get as many profitable drugs on the market so they can benefit from it, instead of patients benefiting from it. They need to be stopped and only we can do that with our voice being heard.

Since Theresa’s death I have met many other parents that have lost their children to birth control and we are all trying to spread the word together. In conclusion, if one person’s life is saved from sharing Theresa’s story, then at least her death will not be in vain. I miss my child every second of every day. I lost my future, my best friend, my child and WHY? Because the medical industry felt she was not important.

Real Risk Study: Birth Control and Blood Clots

Lucine Health Sciences and Hormones Matter are conducting research to investigate the relationship between hormonal birth control and blood clots. If you or a loved one have suffered from a blood clot while using hormonal birth control, please consider participating. We are also looking for participants who have been using hormonal birth control for at least one year and have NOT had a blood clot, as well as women who have NEVER used hormonal birth control. For more information or to participate, click here.

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