birth control - Page 8

Can the Pro-Choice Community Embrace a Birth Control Dichotomy?

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In 2004, when I was executive director of Planned Parenthood Alberta, I gave an introductory presentation on fertility awareness for women looking for alternatives to hormonal birth control. One young woman who’d been on Depo-Provera for five years had been recently diagnosed with severe osteopenia. After quitting the drug, she said she realized in retrospect that for those five years she had felt like she was living “under the surface” of her life.

Another told the story of how she had struggled with serious mood issues while on the birth control pill. She would stop taking it, rely on condoms and emergency contraception for a while, then visit her doctor who would urge her to go back on the pill. After a few of cycles of on-off-on, she quit the pill once and for all. She said she decided to “just stop talking to this doctor about birth control.”

I’ve heard scores of stories like these over the past 30 years, and read hundreds more from women commenting on blog posts and online articles. For decades women have stopped using hormonal contraception to improve their health and well-being. Advocating on their behalf has been a major focus of my work as a pro-choice activist.

The Birth Control Dichotomy

I’ve been a pro-choice sexual and reproductive health advocate since I was 15 years old. Today I turn 60, celebrating a 45-year commitment to pro-choice values. But I mark the occasion with frustration and disappointment because the sexual and reproductive health (SRH) community to which I belong has failed to adequately–unreservedly–serve women who won’t, don’t or can’t use hormonal birth control.

I believe that what is keeping them from doing so is failure to acknowledge and embrace the dichotomy that exists within the pro-choice contraceptive framework.

A dichotomy is division of a whole into two mutually exclusive, opposed, or contradictory groups. If pro-choice contraception is the whole, two mutually exclusive groups are:

  1. women who use and like, or want to use hormonal birth control (HBC)
  2. women who use and like, or want to use non-hormonal birth control (NHBC).

Both groups deserve equal attention, support and services to use the birth control methods they decide are right for them. But this is not happening.

Just as we who hold pro-choice values don’t judge or hassle women for the reasons they choose to have abortions, we should not judge or hassle women for the reasons they choose not to use HBC, nor try to deter them. Yet anecdotal evidence abounds that women who want to quit the birth control pill, have their IUDs removed, or learn fertility awareness based methods (FABM) are often actively dissuaded from acting on their choices. It takes extreme self-assurance to do what one young university student told me she did when her doctor questioned why she didn’t want to use HBC. Her response: “My reasons are none of your business.” She said she knew the doctor would try to overcome her objections to the side effects she refused to incur.

I believe that pro-choice sexual health advocates and care providers can and must find a way to do their work effectively within this birth control dichotomy. We must acknowledge the right of women to choose HBC or NHBC depending on which best serves their health and contraceptive needs. And it’s our obligation to help them use their chosen method effectively and confidently, without persuasion or dissuasion.

This is not being done to the standard I believe it should.

Media, social media, and the blogosphere tell us that young women are ditching HBC, but not finding much information or support from their doctors or sexual health clinics for doing so. So why aren’t SRH organizations researching this identifiable “unmet need” or offering workshops on successfully transitioning from HBC to NHBC?

A one-size fits all diaphragm is in the works, and another silicone version is on the market but incredibly hard to find, as is the spermicidal gel required to use with it. So why don’t SRH clinics have programs in place to make them more accessible to women who want them? After all, the diaphragm was the contraceptive of choice for arguably the most influential sexual role model of the last 15 years – Carrie Bradshaw.

Evidence-based medicine proves that pro-choice FABM are as effective as HBC methods, and can be used with condoms to prevent STIs and emergency contraception if indicated, just as for HBC users. So why doesn’t every SRH clinic or organization provide certified FABM training on site or seek collaborative partnerships with certified, secular-based instructors?

Bottom line? The SRH community is failing to fully meet the needs of women who won’t, don’t or can’t use HBC. The current hoopla over LARCs – long-acting reversible contraception including copper and Mirena IUDs and hormonal implants – as the next best birth control “technology” is mere tangent, not solution. Other than the copper IUD, these are still drug-based methods many women want to avoid.

Women who want to use NHBC effectively and confidently, or seek treatments for menstrual cycle problems that do not require hormonal contraceptives, are turning to care providers and information sources outside the SRH community. Is this what we want?

I don’t get it. If I can embrace the birth control dichotomy and retain my pro-choice commitment why can’t other pro-choice health-care professionals, non-profit organizations, and advocates do the same?

My pro-choice values have co-existed for decades with my advocacy for NHBC and menstrual cycle education. But I admit that because of my chosen focus, it is often wrongly assumed that I seek to deny options rather than to increase them, that somehow I cannot possibly be pro-choice.

Successfully using fertility awareness for birth control from age 27 through menopause (See p.4-5) did not keep me from serving 10 years on the board of Planned Parenthood Federation of Canada, or from bringing me back as a current board member of what is now the Canadian Federation for Sexual Health.

Promoting body literacy – acquired by learning to observe, chart and interpret our menstrual cycle events so that we become fully informed participants in health-care decision making – as a life skill that all girls and women should learn, did not keep me from being executive director of Planned Parenthood Alberta. The organization, which became Sexual Health Access Alberta and closed in 2010, distributed educational resources that included the most comprehensive Birth Control Demonstration & Sexual Health Promotion Kit still available for SRH professionals.

Sharing evidence-based medical information about the value of ovulation to women’s health and how to treat menstrual cycle disorders without the use of hormonal contraceptives, did not keep me from writing commentaries in support of abortion rights.

Within the pro-choice sexual and reproductive health community, I’ve chosen to focus on body literacy, menstrual cycle education, and advocacy for increased access to NHBC. At 60, I’m more committed than ever to promote a broader perspective within my community, one that will fully acknowledge and embrace the birth control dichotomy, one that will serve equally, without reservation, the contraceptive needs of all women.

About the Author: Laura Wershler, B.Sc., is a veteran pro-choice sexual and reproductive health advocate and women’s health critic who has worked for or volunteered with Planned-Parenthood-affiliated organizations in Canada since 1986. Laura graduated with a Certificate in Journalism from Mount Royal University in 2011. She has contributed columns on women’s health to Troymedia.com and blogs regularly for re:Cycling, the blog of the Society for Menstrual Cycle Research. Follow her on Twitter @laurawershler.

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Is Medical Abuse of Women the New Standard of Care?

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Over half a million hysterectomies are performed every year in the U.S. Up to 90% are considered to be medically unnecessary. Therefore, healthy hormone-producing sex organs are “routinely” removed. For this reason, removal of healthy sex organs is considered to be the ‘standard of care’ for women. If this doesn’t alarm you, it should. The U.S. leads the world in hysterectomies – not something to take pride in for sure.

I should note here that approximately 60% to 70% of hysterectomies include removal of the ovaries or “castration” which is linked to loss of sexuality, heart disease, Parkinson’s, Osteoporosis and other numerous mental and physical health problems. I wrote about my own story regarding unconsented hysterectomy and castration here. I also wrote about how our hormones animate us here and about how the loss of hormones resulting from castration can lead to severe depression and even suicide here.

Unnecessary Cesarean Births

Now, let’s talk about another alarming and often unnecessary surgery being performed on women daily in the U.S., the cesarean. Cesarean is the now number one surgery. The U.S. leads the world in C-sections rates. In fact, 15% of current in-patient surgeries nationwide are Cesarean deliveries. The following data may help shine a light on why so many C-sections are being preformed. The centers for Medicare and Medicaid have found that the average physician’s charges for uncomplicated vaginal delivery in the U.S. is just under $4,500. But for an uncomplicated cesarean delivery, it is $7,000. Hospitalization costs are doubled, going from an average of a little over $5,000 to over $10,000.

C-sections are necessarily exhausting hospital, surgical, and nursing services and as a result, they’re causing an increase in waiting time and nursing coverage for other needed procedures. Consider that for every 5% increase in U.S. C-section rates, there may be as many as 14 to 32 more maternal deaths and $750 million to $1.7 billion in health-care expenditures. Why then, do C-section rates keep rising? Could money be the incentive? You decide…

Unsafe Birth Control

Money is too often an incentive when it comes to unnecessary surgeries, medical devices, drugs, etc. and this seems to be especially true in reference to women. Birth control is something most every woman has to confront and manage in some way. Birth control pills are long associated with well-known risks such as blood clots, stroke, and heart attack, etc.

One would think that after so many years, there would be a safer method of birth control, but that isn’t the case at all. Many women are undergoing irreversible sterilization every day in our country via a permanent method of birth control known as “Essure”. Hundreds of thousands of unsuspecting women have been coerced by their doctors into agreeing to having the Essure coil implanted. Sadly, this form of birth control is not the risk-free procedure that the gynecological community would have us believe. Instead, many women with the Essure coil in their body are now suffering unspeakable pain and serious medical conditions – some leading to hysterectomy.

The Essure coil intentionally causes an inflammatory response that encourages the growth of scar tissue, which then blocks the openings to the fallopian tubes – thereby preventing pregnancy. The problem is that the inflammatory response is intentionally chronic and the metals all too often evoke severe allergic reactions causing the coil to migrate, become misplaced, or even perforate the uterus, fallopian tube, and other organs. Obviously,  a variety of problems are likely to develop when a woman’s body begins the fight to reject the Essure coil. It’s estimated that over 800 women have filed reports with the FDA (Food and Drug Administration) regarding the adverse effects Essure has had on their physical health.

Morcellation

Let’s move onto another alarming issue in women’s health that has only recently come to light – at least for those of us who aren’t gynecologists or the maker of medical devices. In April 2014, the FDA issued a safety communication discouraging the use of laparoscopic power morcellators for the removal of the uterus and uterine fibroids. Based on an analysis of currently available data, the FDA cited a risk of the spread of unsuspected cancerous tissue.

The strange thing is that most women who undergo hysterectomy or myomectomy (removal of fibroids only) have no earthly idea that something called a morcellator is ever used. Most have never even heard of such a device. In other words, women are not giving their doctors consent to use this device to splice up their uterus or fibroids. When you consider that over 600,000 hysterectomies are performed every year (never mind all the myomectomies performed), the number of women who may have been subjected to morcellators could be quite substantial.

Transvaginal Mesh

Unlike the morcellator, transvaginal mesh is something that has been in the news a lot over the past couple of years. Most people have seen the advertisements on television regarding mesh-related lawsuits. The truth is that transvaginal mesh has been labeled a risky medical device by the FDA due to the high numbers of health complications associated with its use. Thousands of women have filed vaginal mesh lawsuits after suffering from the many complications related to transvaginal mesh surgery.

One urogynecologist, Dr. Richard Reid, told ABC news: “Since a mesh scar is quite fibrous and the bladder is very soft, it’s considered to be a compliance mismatch – which means the same as rubbing a piece of cheese over a metal grater.” In July 2011, the FDA issued a formal warning saying that transvaginal mesh was a “greater risk” with “no evidence of greater clinical benefit”. Johnson & Johnson removed its product from sale earlier this year and class actions are already underway in the U.S., Canada, and now Australia.

The HPV Vaccine

As alarming as all the information I’ve shared so far may be, there is even more alarming information regarding the medical abuse of young girls via an HPV vaccine known as “Gardasil”. As if targeting women wasn’t enough, many doctors are recommending the Gardasil vaccine to girls as young as nine and there’s no shortage of information regarding the many serious side-effects associated with this vaccine.

But, perhaps the most troubling thing about Gardasil is the negative effect it may have on the ovaries.  At least one Gardasil ingredient, polysorbate 80 is a known cause of ovarian deformities. Another Gardasil ingredient, L-histidine, carries significant risks as well. Because it’s a naturally-occurring substance in the human body, injecting it could have the effect of causing an autoimmune response. It would seem very probable that Merck -the maker of Gardasil- would almost have to have known that the vaccine would be putting young girls at risk for ovarian problems and even ovarian failure – leading to full blown menopause and all the associated health risks.

As of September 2013, there have been more than 57 million doses distributed in the United States, though it is unknown how many have actually been administered. There have been 22,000 Vaccine Adverse Event Reporting System (VAERS) reports following the vaccination.

Medical Abuse?

I’ll ask my original question I posed in my title: “Is medical abuse of women  the new standard of care?” While I’m not sure abuse has become the “new standard of care” exactly, I’m very sure that women cannot afford to simply trust that their doctor will do what’s best for them. That kind of blind trust is just not a good idea. The sad reality is that we must take charge of our own health. We cannot rely on doctors to do what is right for us. Doctors are under extreme financial pressure and it is just too easy for them to recommend expensive surgery or an unneeded medication for a condition that can be treated alternatively. Research in women’s health issues remains inconsistent, incomplete and often slipshod. Too often, women wind up being experimental “guinea pigs” for surgeons without ever being told of all the potentially life-shattering risks to which they are being exposed.

Essure® Sterilization Coils: The Good, The Bad, and The Ugly

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The Essure ® Fallopian tube coils were manufactured by Conceptus, Inc. as a means for “permanent” birth control (click here for pictures). There was a need for something new and different that was a non-hormonal, non-invasive, and uncomplicated method of sterilization that did not require anesthesia. The surgical option, bilateral tubal ligation (BTL), had been introduced by Dr. Blundell in 1823 before the Medical Society of London, and while useful, was a drastic measure that many women were unwilling to take.

In the 1960’s, as the Women’s Liberation Movement first desired decreased numbers of children, and then no children at all, the need for permanent sterilization was rapidly evolving. Women were getting blood clots, weight gain and strokes from the pill. The IUD that released progesterone was falling out of favor.

The “T-shaped” Intrauterine Device (IUD) Mirena ® was approved by the FDA in 2000. In December 2009, The FDA sent a warning letter to Bayer, complaining that its campaign had “serious misrepresentations” of side effects including life-threatening ectopic pregnancies, uterine or intestinal perforations, internal scarring, serious infections, risk of pregnancy, organ damage, post-operative surgical complications, Streptococcal sepsis, intensive care unit stays, and more.

Enter Essure: The Solution for Permanent Birth Control

On November 4 2002, Bayer acquired the Essure coil product from Conceptus and its use was FDA approved through a “preemptive” process called “Expedited Review”. Expedited Review usually means that the product has already been in use (e.g., in another country).  The expedited review relies on data gathered from product use in other countries. The data presented to the FDA Panel are supposed to confirm the product’s use, safety, and effectiveness. We will see in subsequent posts that this was not the case for Essure. There were minimal data suggesting either the sufficient safety or efficacy to merit an expedited review.

The Good: How Essure was Supposed to Work

In an effort to offer a vaginal approach to permanent sterilization without hormone therapy or IUD complications, Essure was approved by the FDA in 2002.

Components of each tiny Essure coil include a spine of stainless steel, covered by 24 coils of expanding and elastic outer coil of nickel titanium. It is covered inside and out with polyethylene terephthalate (PET) fibers, that are wound in and around the inner coil of stainless steel. The specific goal of the Essure PET fibers is to cause inflammation, induce scar fibers, and thereby block fertilization of the egg with the sperm.

The proper placement of the Essure Fallopian tube coil is such that it is screwed into the tube from inside the uterus, in a counter – clockwise fashion with no screwdriver needed. To do this, a surgeon uses a surgical instrument by hysteroscopy so that the coil fills the fallopian tube, dangling into the uterus. Next an ‘ejector’ shoots the coil in a little further; a quick ‘tug’ is supposed to ‘prove’ that it is correctly placed and will not migrate.

A hysteroscope is too fat to fit past the cervical os, where the sperm travel up, often times the doctor cannot see the two holes where the Fallopian tubes empty into the uterus. So the doctor inserts the hysteroscope under IV sedation or local anesthesia block, to make the uterus numb. The doctor then tries to find two little holes, one on each side of the uterus, where the Fallopian tubes empty into the uterus.

Once the coil placements are confirmed, the procedure is complete. But this is just the beginning. The insides of Fallopian tubes still need to undergo a process fibrosis, a local inflammatory response around the coils, so the Fallopian tubes are blocked off, or occluded (See Illustration 3). The blockage needs to be double-confirmed, so a special procedure is done after three months.

The patient is instructed not to have unprotected sex for three months. Over these three months, an alternative form of birth control must be used.

At the end of the three-month period, a confirmation test must be done to show that the coils have done their job by fully occluding and blocking the Fallopian tubes. There is no other way to do this than to perform a  procedure called a hystero-salpingogram (HSG). The HSG uses dye injected past the vagina and cervix, past the uterus, and then hopefully it stops there, without going into the Fallopian tubes.

If the dye stays in the uterus and is blocked from going up both of the Fallopian tubes, the procedure is deemed a success and the patient is instructed that she can have unprotected sex now, because she can no longer have children.

If the contrast dye shows up inside the fallopian tube(s), however, then the patient can still get pregnant, and the coils have not finished doing their job at sclerosing the tubes shut. The doctor – patient relationship dictates what happens next; usually it is awaiting more time and then rechecking with another HSG at a later date. Although an area of controversy, removal of the coils is a possible choice.

The Bad: Side Effects of Essure

On the day of surgical placement, the most common side effects are: abdominal cramps, pain, and nausea/vomiting. Since the egg will still continue to be released each month at ovulation each month, the patient will still have her monthly period. The egg is simply reabsorbed into the body.

In 2013, Essure became a controversial procedure, with thousands of women complaining of complications leading to surgical removal, miscarriages with coils in babies’ ears, body hives, immune disease, coils breaking up into fragments, perforating the fallopian tubes, perforating the uterus, perforating the colon, pregnancies, severe abdominal bloating, pain on intercourse, general malaise, and even cancer. The first lawsuit against Bayer has been filed in 2014. Campaigner Erin Brockovich has taken Essure up as a cause, hosting her own website in the hopes of banning the product. Patients’ individual stories can be found here. Bayer continues to stand by its product, its safety, effectiveness, and reassures the public that it has a primary concern for public safety but that may not be enough.

If we look more closely at the Essure side effects, one thing becomes abundantly clear, they were predictable had anyone looked beyond the promise of ‘non-invasive’ sterilization. From the beginning, controlling the placement of the device within the Fallopian tubes was problematic and depended heavily on the surgical skill of the physician. Several studies indicate that correct placement occurred in only 84% to 98% of the cases. With perforation a likely outcome of a misplaced device, in a market of potentially millions of women, even a 2% failure rate is unacceptable. A 16% failure rate should give anyone pause; but it didn’t.

As difficult as that may be to accept, it seems that perforation may have been the least of the possible side effects. The chemical coating of the Essure device, meant by design to induce inflammation and scar tissue, was a toxicant itself; one that was inserted directly into the body.

The Ugly: Essure Chemical Coating

The Essure coils were coated in polyethylene terephthalate or PET fibers. PET fibers are plasticizers used in all sorts of commercial products. We recognize them by their brand names like Dacron (in the US), Terylene (in Briton) and Mylar under different conformational states. While these products are fantastic as outer coatings of materials to repel stains or water, as plasticizers that will degrade if exposed to heat and over time their usage in products that come in contact with food and/or are internalized is problematic to say the least.

The by-products of PET degradation, are acetaldehyde, a toxic intermediate in the metabolism of alcohol responsible for much of the liver disease in chronic alcoholics and antimony, a semi-metallic chemical element that is deleterious to health. Acetaldehyde is pervasive in airborne environments as a by-product wood smoke and other thermal reactions. Whether by inhalation or ingestion, acetyladehyde is a carcinogen. Should pregnancy occur in the presence of acetaldehyde exposure, it does cross the placenta and induce skeletal malformations, reduced birth weight, and increased postnatal mortality. Given its placement in the Fallopian tubes, follicular acetylaldehyde exposure could be predicted to induce changes in follicular morphology and perhaps even germ cell health for subsequent generations. Acetaldehyde is not something one wants leaching into the fallopian tubes, particularly when device placement is incorrect and pregnancy prevention nowhere near 100%.

Similarly problematic, Antimony leaching; antimony is a toxicant when applied topically. It induces local necrosis (cell damage and death). Systemically, continuous exposure to small amounts of antimony leads to an array of symptoms from cardiac to hepatic diseases similar to arsenic poisoning. Due to its very a very long half-life, antimony can induce reproductive disorders and chromosome damage. Antimony is toxic to reproduction with mutagenic and oncogenic potential.

Both degradation compounds have been found to leach into drinking water from plastic bottles exposed to heat (>65 degrees). Imagine how they might leach from a device placed into the Fallopian tubes where the temperature is ~98 degrees. There are no data regarding the degradation rate of the Essure coils or regarding the rate or risk of chemical exposure to women who used the device.  Even when the device is placed appropriately and skillfully, and sterilization reached, the potential local and systemic exposure to PET degradation products should give anyone pause, but it did not.

Adventures in Natural Family Planning

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Ten years ago, I began researching fertility and natural alternatives to achieving and avoiding pregnancy. The more research I did, the more I realized that there was a decided lack of current, accurate information on the internet. After becoming pregnant with my first child, I focused my research to learn how to space my children without using birth control. Though my family has a long history of breastfeeding and childbirth, they did not provide me with any information that I could use. I didn’t want to use hormones while breastfeeding but neither did I want to get pregnant again immediately. While there has been significant research validating ecological breastfeeding, at the time it had not caught on. There was very little information on the internet about practically applying it in everyday life. Needless to say, using the information on the internet, I was soon pregnant with my second child and then my third child.  At that point, my forays into natural family planning were not working.

Natural Family Planning and Physicians

I was desperate to find a way to space my children without artificial hormones or invasive devices; I looked to my OB/GYN and the local health department. My OB and the health department could not provide me with any information about natural family planning, and in fact I was openly mocked by the doctors and nurses. The health department tried giving me Cycle Beads with very little instruction. I refused them, knowing that they would be completely ineffective as I was breastfeeding and didn’t yet have a menstrual cycle. It seemed that I knew more about managing my fertility than they did.

Do-it-yourself Natural Family Planning

Discouraged and outraged, I obtained as much information as I could and assembled my own version of natural family planning. It worked for two years until I found myself pregnant with child number four. When my family and I relocated to another state, I was soon able to find a natural family planning instructor. I learned the Billings Ovulation Method. I cannot stress enough how important an instructor is when using natural family planning. This system taught me what I had been doing wrong all these years (I will write more about this and other methods in subsequent posts). I was able to successfully navigate breastfeeding my fourth child without getting pregnant.

However, my hormones started acting up in very obvious ways shortly after giving birth. None of the doctors I spoke to about it could give me an answer. I was experiencing what is known as “tail-end brown bleeding” from the end of my menstrual cycle on up to and including the day of ovulation. I went to two OB/GYNs and a hematology specialist. The answers I received ranged from “it is normal” to “there is nothing wrong.” Not one of them could explain this very obviously abnormal symptom. They all seemed unconcerned even though I knew that something was up.

I continued my research of the female reproductive system, as I realized that neither the Billings Ovulation method nor the Sympto/Thermal Method did anything to help the women who had health problems such as PCOS, endometriosis, infertility, or in my case abnormal bleeding.

Natural Family Planning With Irregular Cycles

My continued search for answers led me to another method of natural family planning called the Creighton Model FertilityCare System.  The Creighton Model is considered the gold standard of the natural family planning world. Creighton has been able to research and document in a woman’s chart hormonal irregularities and how they relate to her overall fertility and health. Finally, I had a method of not only diagnosing but also treating the abnormality I experienced. With the use of the Creighton Model and NaPro Technology it is possible to work cooperatively with a woman’s cycle to help seek treatment for health problems like my abnormal bleeding pattern.

I fell in love with this method and went through the extensive training course to become a presenter and promoter for the Creighton Model. I originally set out to become a practitioner for this method so that I could help other women get the education they needed. I soon learned about the politics that surround natural family planning.  We’ve all heard the jokes. “You know what you call a woman who uses natural family planning?……….. Pregnant.”  Well, that pretty much sums up what most people think of natural family planning. Teachers are abundantly available for those interested in learning any method of natural family planning; but there is much more work to be done to change our culture’s current paradigm surrounding natural family planning

Luckily, we have come pretty far over the last decade. There is ever more press and discussion these days about the side effects of hormonal birth control (I will add a few links here). More and more women are deciding against hormonal birth control. Though, there is still much work to be done,natural family planning is becoming a viable alternative to the pill and other devices.

A New Approach: Fertility Awareness

Fertility Awareness is catching on as the new bias free catch phrase for a concept that has been around since the beginning of the birth control explosion. I have dedicated my life to spreading and sharing the wonder that is natural “organic birth control.” What we women really need is more voices who advocate for, and promote today’s modern Fertility Awareness Methods (FAM).

Over the coming weeks, I will be writing articles about the various methods of Fertility Awareness; the pros, the cons and my personal experiences with each. If you’d like learn how to navigate pregnancy naturally or if you have been diagnosed with a women’s health problem that you are currently treating with birth control, follow me on Hormones Matter. If you’d like to share your own experiences with natural family planning and fertility awareness, click Write for Us and send us a note.

The Yasmin Chronicles: Bad Medicine, Big Money and Bayer

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Perhaps you’ve heard of the Yasmin line (Yaz, Ocella, GIanvi, Loryna, Beyaz, Safyral and Zarah) of birth control pills. For a while they were some of the most highly promoted, highly prescribed on the market. Indeed, they were so highly promoted, Bayer, the manufacturer was slapped with not one, not two, but three warning letters by the FDA for mismarketing this contraceptive, specifically suggesting the drug could be used to treat PMS and acne, when it had been approved for neither. Bayer was also cited for downplaying and failing to communicate the risks of these contraceptives. Though Bayer eventually changed their lifestyle ads promoting Yaz and Yasmin, the damage was already done. The perception that these pills were safer and more effective than older birth control pills was cemented in the minds of physicians and patients worldwide and Bayer had garnered 18% of the coveted birth control market share. A mere 100 million women worldwide use oral contraceptives daily. With the Yasmin line, however, there is 3-fold increase of thrombo-embolitic events over the already high risk associated with the older birth control pills. Compared to women not taking oral contraceptives, the risk for these side effects is 6-fold higher; risks not to be taken lightly.

What Makes the Yasmin Line so Dangerous?

The Yasmin line of contraceptives contain the fourth generation progestin, drosperinone. Unlike previous generations of synthetic progestogens (progesterone-like compounds) derived from testosterone, drosperinone is a completely different animal. Drosperinone is analog for a common drug called Spironolactone (Aldactone),an aldosterone receptor antagonist that tells the kidneys to remove water and salt from the body. It’s a diuretic used to treat hypertension, congestive heart failure, kidney disease and cirrhosis of the liver.

Spironolactone comes with a serious list of side effects, including a condition called hyperkalemia or high potassium levels. Unregulated potassium levels, either too high or too low can cause serious heart rhythm irregularities leading to death, and so, physicians are advised to monitor potassium levels in patients using Spironolactone. Have any young woman using either Sprionolactone or Yasmin ever had potassium levels measured? Nope.

Additional side effects of spironolactone include: GI bleeds and gastritis, agranulocytosis, urticaria, maculopapular or erythematous cutaneous rashes, anaphylactic reactions, vasculitis, mental confusion, ataxia, headache, drowsiness, lethargy, renal dysfunction and Stevens Johnson Syndrome; perhaps not something one wants to give to otherwise healthy young women. Indeed, sprironolactone was prescribed for young women with acne, before becoming a birth control pill and then prescribed along with its analog, Yasmin, rather cavalierly.

Drosperinone is a spironolactone analog, meaning drosperinone binds to and blocks the aldosterone receptor just as spironolactone. In fact, binding affinity studies comparing Yasmin to the older generations of contraceptives, showed that it has 500X the anti-mineralocorticoid (aldosterone receptor) binding affinity of the other contraceptives and is equivalent to the 25mg dose of spironolactone. So, from that information alone, one might prescribe this pill a little bit more judiciously, but when we remember that Yasmin is a combination oral contraceptive that comes a dose of ethinyl estradiol, the synthetic estrogen rife with its own side effects (blood clots and stroke), caution should have prevailed. It didn’t, and many women were injured, likely more so that we know of.

Yasmin Lawsuits

Deep vein thrombosis. As of early 2014, Bayer has settled $1.69 billion in lawsuits for deep vein thrombosis and pulmonary embolisms related to Yasmin. These included over 8000 claimants. Yet to be settled, over 4000 suits remain and likely many more as publicity and recognition of the side-effects increase. It’s important to note that, like with most drug settlements, the pharmaceutical company admits no blame, simply pays the settlements and continues with business as usual.

Gallbladder. Gallbladder disease was recently recognized as side effect, and though, Bayer initially denied a relationship, they are now settling cases there too. Only here, the amounts are paltry in comparison. Bayer has set aside $24 million for gallbladder cases; $2000 per case for disease and $3000 per case when gallbladder removal was necessitated. Currently, there are approximately 8000 of these cases pending. Whether more will emerge is unclear.

Stroke. Most recently in Zapalski vs. Aniol et al, a jury awarded Mariola Zapalski $14 million in a suit against her physician for failing to recognize and warn about the risks of Yasmin. Ms. Zapalski suffered a severe stroke two just weeks after her doctor prescribed Yasmin. She suffered permanent brain damage and now requires 24 hour per day medical care. Compared to the class settlements that range approximately $200,000 per claimant and likely include similarly disabled women, the $14 million is significantly higher. To my knowledge, this represents the first case, outside the class-action cases, against an individual physician for failing to recognize and warn of risk. This may be a new trend, but it is too early to tell.

Why is Yasmin Still on the Market?

Money, pure and simple. As I have reported previously,

The Yasmin line of birth control is one of Bayer’s most lucrative product lines with over 4 million women taking these pills monthly in the US alone. Even with the negative publicity surrounding for these products, revenue for the Yasmin line of products neared 1.1 billion for the first nine months of 2012. After 11 years on the market, total revenue for these products was likely well over $10 billion. If the company pays out $1-2 billion in claims, but makes $10-15 billion, the cost-benefit ratio is skewed in favor of maintaining their market presence. The fines become just another cost of doing business.

What about the FDA?

It goes without saying that the FDA has limited power or interest in regulating these drugs. Particularly where women’s health is concerned, the FDA has exhibited an egregious lack of regulation extending back to the DES tragedies and just about every drug or device marketed towards women since. With Yasmin specifically, attempts to include a black box warning on Yasmin were foiled by industry insiders in 2011, despite the medical experts arguing in favor of the warnings. For more details see: The High Cost of Bad Birth Control.

What Should You Do?

As with any medication, it is up to the patient to understand the risks. Do your homework, read the research, make your decision based on the data not the marketing. Drosperinone based contraceptives may not be worth the risk.

Participate in Oral Contraceptive Research – Take a Survey

If you have ever taken oral contraceptives, please take a few minutes to complete this important, anonymous, online survey about oral contraceptives. We’ve had over 800 women complete the survey so far.

You do not have to be currently using oral contraceptives to complete the survey.  Please share the link among all your female friends and family. We’re relying on the power of women and social media to help make this survey a success. The Oral Contraceptives Survey. 

What if Endometriosis Was a Men’s Health Issue?

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As a health journalist and a co-founder of Endo Warriors, a support organization for women with endometriosis, I often get asked “what is endometriosis?”

Which is funny since it is estimated that 176 million women worldwide have endometriosis and yet no one knows about this global health issue.

Sometimes I say “it’s a secondary autoimmune disease where the lining of the uterus is found outside of the uterus and throughout the abdominal cavity — to varying degrees — causing chronic pain and infertility.

And other times I say “it sucks.”

Nancy Peterson of the ERC said “If 7 million men suffered unbearable pain with sex and exercise and were offered pregnancy, castration or hormones as treatment, Endo would be a national emergency to which we would transfer the defense budget to find a cure.” And, I don’t disagree.

If 7 million American men had unbearable pain every time they ejaculated, no one would ever suggest chopping off their balls. If they went to a health clinic that also offered pregnancy prevention services, we wouldn’t shut those clinics down. If 7 million American men were in pain every time they masturbated, urinated or tried to have sex we wouldn’t tell them “it’s all in their head” or “to take the pain like a man.”  No, we would listen and try to find them a cure that didn’t include castration or drug-induced de-masculinization.

But that’s not the case.

Instead we have 7 million American women with chronic pain related to the tissue in their uterus and their menstrual cycle. 7 million American women who have pain before, during and after their menstrual cycle. 7 million American women who experience pain while exercising, having sex and going to the bathroom. So we offer them chemical-menopause and hysterectomies and when those don’t work we throw our hands up in the air and say “well, at least I tried.” Better luck in your next life, perhaps you’ll come back as a man.

The menstrual cycle is the butt of all jokes directed towards women. Bad day? Is it your period? Is Auntie Flo in town?

Seeing red? Are you on the rag?

No, actually I’m just mad that the idea of healthcare for women makes people want to cover their ears and run screaming.

Free birth control for women?

Great idea!

That is until some political pundit insinuates women should just learn to shut their legs.

Maybe instead we should learn to listen to the myriad of women on birth control for issues beyond planning pregnancies. Maybe women should just get easy access to low cost birth-control without having to recite their medical record.

October is health literacy month and when it comes to health literacy, Americans are kindergartners trying to eat the paste off their fingers.

We think Obamacare and the Affordable Care Act are two different things; getting outraged at the notion of Obamacare yet think the idea of ‘affordable’ healthcare is quite nice.

Access to low-cost health care for everyone? Let’s shutdown the government!

Rather, if we want the government out of our private healthcare, then how about they get out of our uteri as well?

The Quest for Contraception and the Plight of the Inbetweener

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When you read about what women did in ancient Greece and Rome to ward off unwanted pregnancies, you’re tempted to do a full-on spit-take! I mean, our doomed sisters had to rely on wild dances and fancy amulets to keep sperm out of the egg’s personal space.

Ever wonder how that worked out for them?

Well, we women of today also face so many nightmarish birth control options – all sorts of pills and devices that could kill us – that the ancient one of crossing your fingers as you open your legs actually sounds like a refreshing idea.

So is it really preposterous for us to want safe and affordable contraception? Is it too much to ask that a woman be able to avoid the dilemma aborting a fetus or not by safely and affordably not getting pregnant at all? Not all of us pine away to be like that ideal reality show rabbit – AHEM! I mean multi-mother – Michelle Duggar.

The struggle for reasonable contraception only gets worse for “Inbetweeners”: that growing segment of women who fall between the cracks of “too poor” and “earns too much income to qualify for…” Inbetweeners defy many stereotypes: they can be married, single, or divorced, childless or not. They can be women who’ve been thrown for a loop yet not knocked down, by huge financial setbacks like divorce, loss of home, death of a spouse, personal illness, depression and/or job loss. Inbetweeners often don’t appear “needy” in appearance or attitude though they are.

You can think of Inbetweeners as the Indiana Joneses looking for what I’ll call The Holy Grail of Contraception. Sure, their jobs might not entail surviving fire pits or jumping over piles of writhing snakes; but they toil long hours for minimum wage and have no affordable health insurance.

This propels them to the doors of Planned Parenthood, where they hope to find some contraceptive security. But Planned Parenthood has it’s own struggles. Often Planned Parenthood is at the mercy of the companies and programs that supply its contraceptives and arbitrarily change their prices. That means countless women suddenly and inexplicably get kicked off programs that have supply reduced cost birth control, leaving these Inbetweeners in the dust because they’re sorely stretched to pay the staggering full price on just a one month’s supply of birth control.  And Planned Parenthood staffers, no matter how sympathetic, can only shrug and say “I’m sorry.”

And Ms. Inbetweener can dream on about the possibility of getting a reduced-cost IUD! If she’s not destitute enough, these programs snatch that possibility from her desperate uterus, ‘cause the regular price for an IUD runs into the hundreds. In many cases, using birth control isn’t totally about avoiding unwanted pregnancy. For example, an IUD stanches periods that can be out of control and create havoc in the life of the sufferer. And many women have limited birth control options due to age or lifestyle habits.

But of course sorry is what an Inbetweener will be if she gets knocked up and can’t provide for the needy little cherub that’s been conceived. Her choices boil down to: Cough up big bucks to stay baby-free, leave the whole responsibility for “protection” with her partner (fuggeddabboudditt!), or have one baby after another, get even poorer and more dependent on public assistance, and find herself accused of  “living off the system.”

Inbetweeners aren’t financially irresponsible; it’s just that once the bills are paid, they don’t have much left for food, never mind paying for reproductive freedom. Yet they wish to make mature choices about reproducing – and shouldn’t that be respected???

Any which way an Inbetweener tries to seek help, she is discriminated. There’s just no way to win at being a grown, responsible and sexual woman in America.

Still, we women have always been more resilient than we’ve ever let on. The ladies of ancient Greece and Rome knew it in their bones as they whirled feverishly to stave off undesirable futures. Their light fingers rubbed the milky amulets while prayers dripped from their quivering lips. Though their choice always teetered between  peril and bliss, they still fiercely claimed it.

Let’s not be lesser sisters than our ancient ones – let’s keep up the good fight for safe and affordable contraception they started as best they could, long ago!

Birth Control vs Hysterectomy in Catholic Hospitals

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I was raised Catholic but did not agree with some of Church doctrine and left the Church as a young adult. In my wildest dreams, I never imagined that I would have a hysterectomy and be castrated in a Catholic hospital (or any hospital for that matter) for a benign ovarian cyst. You can read about my Unnecessary Hysterectomy here. I suspect many other women have had healthy organs removed at this greater metropolitan Catholic hospital or some other Catholic hospital. With hysterectomy the second most common surgical procedure and the prevalence of Catholic hospitals growing, millions of women likely have had unnecessary hysterectomies at Catholic hospitals. This made me wonder, why would the Catholic Church condone (and profit from) unnecessary hysterectomies but prohibit contraception. It seems a bit hypocritical at least, unethical at worst.

A Spider Web of Contradictions in Catholic Hospitals

Catholic doctrine prohibits contraceptives. Yet, Catholic hospitals perform hysterectomies and ovary removals (castrations) for benign conditions that can typically be treated with less drastic measures such as contraceptives. Hysterectomy is permanent birth control. So is removal of ovaries. How is hysterectomy justified but not contraceptives?

In an article entitled Do Religious Restrictions Force Doctors to Commit Malpractice, the hazards of treatment at religious hospitals are discussed. In the case of a potentially fatal ectopic pregnancy, removal of the fallopian tube which negatively affects fertility complies with Catholic doctrine while an injection of methotrexate that preserves the tube and fertility does not.

According to Catholic moralists, an injection that destroys an ectopic embryo is a direct abortion, while removing the part of a woman’s reproductive system containing the embryo is not.

But the end result is the same – a pregnancy is terminated. So why not at least preserve the woman’s fertility and health-promoting hormone production by administering the drug versus removing her fallopian tube?!

Another story in the cited article involved a woman with Lupus who was pregnant with a nonviable anencephalic fetus. Although continuing the pregnancy risked the woman’s health and her very life, pregnancy termination was denied.

The above situations would be considered medical malpractice since they caused harm to the patients. And what makes even less sense is that neither of these were viable pregnancies. Catholic Church dogma caused (intentional) harm to these women.

Another treatment done in Catholic hospitals that has me scratching my head is endometrial ablation. Although it reduces fertility, pregnancy can still occur but can be dangerous to mother and unborn child. So some form of birth control is recommended after ablation if tubal ligation was not also performed. Yet according to Is the Novasure System Ethical?, Novasure ablation has been given a passing grade by the Catholic Church. With the Church’s mandate against contraceptives, I wonder how many women are prescribed contraceptives to treat their heavy bleeding BEFORE this procedure is offered. However, in defense of the article, it does state that drug therapy is typically the first-line treatment after doing a full work-up to determine the cause of the bleeding. And if that fails then D&C should be the next step which should include polyp removal if polyps are found. However, it does not mention removal of fibroids despite being a common cause of abnormal bleeding. Although the article recommends starting with conservative treatments, the high rate of unwarranted hysterectomies and ablations indicate poor compliance with these standards.

According to a study published in 2008, the long-term problems caused by ablation too often lead to hysterectomy, the rate being highest (40%) for women having the procedure before age 41. This is further discussed in Endometrial Ablation – Hysterectomy Alternative or Trap?. However, again, in defense of the above cited Novasure article, it was published in 2005, three years prior to this study on the long-term effects of ablation. And, in addition to surgical risks, the article does mention the long-term risks of accumulation of blood in the uterus and the risk of impeding diagnosis of endometrial hyperplasia or cancer. Despite this 2008 study showing the long-term harm of ablation, the use of this procedure does not appear to be declining.

According to Catholic Doors,

To obtain a hysterectomy is a mortal sin.

The ruling by the Congregation for the Doctrine of the Faith stipulates that the only time a woman is morally permitted to have a hysterectomy is when the uterus is so damaged it presents an immediate threat to her health or life. [National Catholic Reported; August 12, 1994]

In general, an hysterectomy is morally justified if the removal of the uterus is necessary for grave medical reasons. It is not justified when the purpose is direct sterilization.

Therapeutic means which induce infertility are allowed (e.g., hysterectomy), if they are not specifically intended to cause infertility (e.g., the uterus is cancerous, so the preservation of life is intended). [Humanae Vitae]

Unnecessary Hysterectomy, Ethical Principles and the Hippocratic Oath

Birth control issues aside, how do all these overused gynecological procedures comply with the three ethical principles of the Catholic Church – respect for persons, beneficence, and nonmaleficence? For that matter, how do they comply with the Hippocratic Oath to “first, do no harm?” Since they cause harm, they violate the three ethical principles of the Catholic Church as well as the Hippocratic Oath. One must question if women are getting INFORMED CONSENT in any facility, religious or secular, but that is a topic for another day.

Ascension Health defines beneficence as follows:

As a middle principle, the principle of beneficence (and nonmaleficence) is the basis for certain specific moral norms (which vary depending on how one defines “goodness”). Some of the specific norms that arise from the principle of beneficence in the Catholic tradition are: 1) never deliberately kill innocent human life (which, in the medical context, must be distinguished from foregoing disproportionate means); 2) never deliberately (directly intend) harm; 3) seek the patient’s good; 4) act out of charity and justice; 5) respect the patient’s religious beliefs and value system in accord with the principle of religious freedom; 6) always seek the higher good; that is, never neglect one good except to pursue a proportionately greater or more important good; 7) never knowingly commit or approve an objectively evil action; 8) do not treat others paternalistically but help them to pursue their goals; 9) use wisdom and prudence in all things; that is, appreciate the complexity of life and make sound judgments for the good of oneself, others, and the common good.

Why is Hysterectomy So Pervasive at Catholic Hospitals?

For Catholic hospitals with accredited Graduate Medical Education (GME) programs, resident minimum surgical requirements may very well increase the rate of unwarranted hysterectomies. But that is certainly a poor excuse for removing an organ. Even so, if they can get around the GME abortion requirements for religious reasons (Catholic hospitals will not perform abortions) they should be able to do the same for hysterectomies, 98% of which do not meet the “grave medical reasons” test.

Hysterectomies and ablations (that too often lead to hysterectomy) are big business. Hysterectomies are estimated at generating $5-16 billion annually, and so revenues may be another reason Catholic hospitals prefer gynecological procedures over medical (pharmaceutical) intervention (birth control or other). Refusing to prescribe contraceptives may increase their ablation and hysterectomy business and therefore their bottom line. So the 76% of hysterectomies that don’t meet ACOG criteria may be even higher in Catholic hospitals. And the ongoing negative health effects of these procedures further contribute to the bottom line of these “health care” conglomerates.

Could profits trump Catholic doctrine on contraceptives and Catholic ethical principles when it comes to performing destructive gynecological procedures in Catholic hospitals?   

My experience certainly proves this as all my sex organs were removed for a benign ovarian cyst, certainly not a “grave medical reason.” I can say the same for many other women with whom I’ve connected since my unwarranted hysterectomy and castration. And the overuse of ablation appears to be just as rampant. This procedure is being done on women in their 20’s and 30’s, many of whom are now considering hysterectomy or have had one to get relief from the post-ablation pelvic pain.

Just as a man’s sex organs have lifelong (non-reproductive) functions, so do a woman’s. Any procedure that disrupts their normal functioning can cause permanent adverse effects. At least medications can be stopped if the side effects outweigh the benefits.

For more information on the necessity of the uterus beyond the childbearing years, watch this video.

 

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