Blog of the Society for Menstrual Cycle Research

The Truth About Skyla

June 4th, 2013 by Holly Grigg-Spall

Mirena Intra-uterine Device
Public domain image

Do women using the Mirena hormonal IUD have their period?

Does it suppress the hormone cycle for all women or just some?

How does it work to prevent pregnancy exactly?

It seems these questions can’t be answered even by the assumed experts. We are told the Mirena “partially” suppresses ovulation and that some women will bleed and some won’t bleed at all. Mostly we hear that the impact must be limited to the reproductive organs because the level of synthetic hormone used is so low.

In an article entitled ‘Mirena: The Other Side of the Story’, AAA Ewies, a consultant gynaecologist at a UK NHS hospital wrote, “The argument used that serum concentration of LNG is extremely low and that its influence on ovarian function is limited has been disputed recently by many investigators. Xiao et al. found that Mirena was associated with substantial systemic absorption of the synthetic progesterone and recorded levels equivalent to two synthetic progesterone-containing ‘minipills’ taken daily on a continuous basis. A study documented that 21% of Mirena users experienced progestogenic adverse effects. Wahab and Al-Azzawi reported that Mirena suppresses oestrogen production, inducing a clinical situation similar to a premature menopause in at least 50% of treated women”.

In an effort to cut through the confusion, Bayer Pharmaceuticals went ahead and released the Skyla hormonal IUD in February of this year. Skyla is smaller than the Mirena, lasts three instead of five years, but contains the same synthetic progesterone and is also 99% effective at preventing pregnancy.

It was interesting timing, considering the American Congress of Obstetricians and Gynecologists (ACOG) almost simultaneously released a recommendation that doctors provide the IUD (it didn’t specify if they meant the hormonal or copper device in the statement) as “first-line contraceptive options for sexually active adolescents”. Teens often struggle with heavier or painful periods and are far more likely to be offered the Skyla, which is said to lighten bleeding, than the Paragard copper IUD, which is thought to increase bleeding. Not to mention the Skyla costs significantly more, has a shorter span of use, and is backed by a Bayer’s marketing department. The Mirena has been advertised heavily since its release in 2001 and the aggressiveness of the campaign – with television commercials proclaiming Mirena would make a woman “look and feel great” – was reprimanded by the FDA.

As a consequence of this combination of the ACOG recommendation and the release of Skyla we have seen articles in recent weeks with headlines such as ‘Could New Skyla Contraception Help Women Reach For The Stars’ and yet more that worry over the lack of knowledge that is preventing doctors from providing the IUD to young women or preventing young women from asking for an IUD. There was a time when IUDs were only given to women who had already had children – in part because of concerns regarding the devices causing damage that led to infertility. The tone is always the same – why are they keeping this near-perfect sounding birth control choice from us? If it is an undercover marketing technique to get women riled up about their access to hormonal IUDs then that department of Bayer deserves a raise.

Some of the doctors may have not received the memo but others may be concerned about the mounting lawsuits regarding the serious physical side effects of the Mirena, or at least they should be. The production of Skyla appears to be a deliberate effort by Bayer to reach the teens and twenty-somethings market. Even Bitch magazine got in on the advertorial action last week linking through their website to a suspicious looking post that seemed much like a marketing placement. Most of the media coverage does not flag the difference between the hormonal IUD and the copper, blithely using the term “IUD” in the same way the phrase “birth control” is now synonymous with “hormonal birth control.”

Professor at the University of California at Riverside Chikako Takeshita outlines in her book, The Global Biopolitics of the IUD, the history of the IUD, from its coercive use in developing countries to its presentation as a convenient method for the modern woman in the US and Europe. “The ACOG recommendation and release of Skyla is clearly going to expand the market for these devices”, she states, “This normalizes the use of long-acting contraceptives. Such normalization makes the use of the devices a technological imperative. The idea is that if a solution, a technological fix, to the problem of unintended pregnancy exists then you must take it. It silences other ways to approach the problem. The IUD doesn’t fix the fundamental issue which is the lack of sex education for teenagers”.

Rather than seizing the ACOG recommendation as simply a victory in the war against the teen pregnancy “epidemic” we must look critically at the potential result. This may seem like the easy answer, but is it the right one?

“Here is the thing that is really driving me crazy about my goddamned IUD”

November 1st, 2012 by Kati Bicknell

“Population Bomb” by Jairus Khan // CC 2.0

Who among us wants to invite a T-shaped piece of plastic or metal to live in our uterus for the next 5 to 10 years, just for fun? No one! But if it’s to prevent pregnancy that’s a different story. IUDs may be uncomfortable and annoying but women still use them because they are so dang effective.

There are many ways to prevent pregnancy. Abstinence, Condoms, the Fertility Awareness Method, Birth Control Pills…and more. One form of contraception that has grown in popularity in recent years is the Intra-Uterine Device (IUD). One study found that teenagers who use long-acting reversible contraception (LARC) had fewer unplanned pregnancies. IUDs and sub-dermal implants are two LARCs. In light of this study, doctors have been recommending IUDs to teenagers as the most effective form of contraception. In the past, it was commonly held that only women who had already had children would be good candidates for IUDs, but today they are recommended for women regardless of whether or not they’ve had children. These devices are very effective at preventing pregnancy, and some even work without hormones. For many women, the IUD is a great option, effective contraception that they rarely have to think about.

But IUDs are not all butterflies and rainbows. I had one briefly, even after knowing my mom’s horror story with the Dalkon Shield in the late 60s. At the age of 27, I was done with the pill and all hormonal contraception, and as I didn’t have a history of heavy periods, my doctor said that the Paragard would be a good choice for me. So I got one. And…I freaking hated it! For the first three weeks after it was inserted, I had cramps so severe that even with intense pain killers, I found it hard to go about my life without thinking I was dying and/or wishing I was dead. My light 3-day periods turned into heavy 10-day affairs with crippling cramps the entire time. An additional unexpected and unpleasant side effect was a sudden inability to reach orgasm during sex. (Anyone else ever have this side effect?)

The one good thing about having the IUD was that one time when I sneezed while on my new heavier period and blood exploded out of my vagina like a gunshot wound, which I found HILARIOUS! But I digress…

A friend of mine says this about her Paragard:

“Here is the thing that is really driving me crazy about my goddamned IUD — my crotch has no idea what it’s doing anymore, and hence neither do I.”

Her cervical fluid is all out of whack, there is no longer any discernable pattern, so she doesn’t know where she is in her cycle. So, while she is using the IUD for contraception, and doesn’t need to chart her fertility for contraceptive purposes, the monthly cues her cervical fluid usually gives her about where she is in her cycle are no longer there.

She also brought up a study that found elevated levels of Mast Cells in the endometrium of women with IUDs. Mast Cells are what your body produces when it’s having an allergic reaction, like if you get hives after eating shellfish. So, are IUDs actually producing allergic reactions in women’s uteruses? That would probably help prevent pregnancy, but what about the woman who has to live with this every day?

Ultimately, I had my IUD removed after four months because I couldn’t stand it any more. All that blood and pain, and lack of orgasms, in a word, sucked! I really feel for women who have periods like this normally, it’s the worst! I was not going to subject myself to this if I didn’t have to.

Thinking I had fully exhausted all medical contraceptive options, I was resigned to using condoms or other barrier methods for the rest of my life. Luckily I didn’t have to do that! I soon found out about the Fertility Awareness Method and started charting my fertility. I can now have unprotected sex with my husband when I’m not fertile, and use barrier methods only when I am fertile.  It’s the best possible solution for us.

IUDs are very effective, but as my story shows, having one in your uterus can be pretty gnarly. In general, I am very glad that IUDs exist. The side effects of today’s IUDs are minimal when compared to the ones in the 60s and 70s, but that doesn’t mean that they are the magic bullet of contraception (see a recent post by Laura Wershler expressing some overlapping views). For me and many other women, the Fertility Awareness Method is a wonderful contraceptive. I want more women to hear about it so it can be brought to light as a serious contender for mainstream contraceptive use.

Teens and the IUD

July 8th, 2010 by Elizabeth Kissling

Art by Flickr user Buhny | CC 2.0

Art by Flickr user Buhny | CC 2.0

A new study published in the Journal of Obstetrics and Gynecology has found that adolescents are usually able to tolerate the Mirena® IUD rather well. The mean age of girls in this British study was 15.3 years, and they were prescribed the Mirena® for painful and/or heavy periods that did not respond to oral medications. 93.4% of girls in the study (45 young women) reported “significant improvement” within four months. The researchers conclude “that Mirena is a well tolerated and effective alternative for heavy periods±dysmenorrhoea in adolescents who do not respond to oral therapy.”

So will this finding make it easier for young women to obtain an IUD if they’d like it for birth control, now that there is evidence that it is well tolerated?

Does your birth control method stop your cycle?

April 20th, 2010 by Chris Hitchcock

It’s starting. With the approaching 50th anniversary of the birth control pill, there will be a flood of anniversary celebrations and reviews of birth control methods. Which is good. We should have those discussions more often. Just say “no” (on the part of parents who don’t want to hear about it) is a big contributor to unwanted teen pregnancy.

Today’s Wall Street Journal is running an article called The Birth-Control Riddle. The riddle is apparently the high rate of unwanted pregnancy, despite the availability of a range of effective birth control methods. And, as befits the Wall Street Journal, each birth control method is accompanied by a price tag, so you can make an informed consumer decision.

But what I noticed was that there is no real awareness of what we at SMCR feel is an important consideration: Does your birth control method stop your cycle?

Some methods do – they deliver progestins and/or estradiol in high enough doses to act on the parts of the brain that normally make the hormones that talk to the ovaries that stimulate growth of a follicle, then trigger its release. This is a complex, whole body system, that normally we only notice because of uterine effects (that would be menstrual bleeding or pregnancy). And as a culture we have fairly casually accepted the idea that it is optional, and perhaps even optimally replaced by a pill made by a drug company.

When addressing the (no longer so) new extended use cycle-stopping contraceptive options, the WSJ glibly explains that “Experts say there is no health reason that women need to have a period if they are not ovulating or building up uterine lining each month.” In other words, so long as your uterus is not endangered (by pregnancy or endometrial cancer), there is no worry. Never mind that both estrogen and progesterone act on receptors throughout the body (bone, skin, blood vessels, brain, gut, breast), or that the synthetic estrogens and progestins don’t quite act in the same way, and we don’t quite completely understand how yet. And it’s just a change of schedule, so what difference can it make that your tissues are stimulated for 12 (or 52) weeks at a time instead of 3 before they get a break?

The problem is, with changes in the schedule of delivery and the reduction in hormone-free time, we really won’t know whether there are any consequences for a while. Oral contraceptives are taken by healthy young women, so the base rate of problems is low, and you need large numbers to measure the rates of serious side effects. I haven’t heard any further about the post-marketing surveillance studies for blood clots (venous thromboembolism) that the FDA asked Lybrel to conduct following its 2007 approval. But those 5-year followup data should be out around 2013. It will be interesting to see whether they are published, or just submitted as a report to the FDA. I’m guessing that will depend on whether the company likes the story they tell.

In addition, there’s increasing evidence that the effects of the pill vary with your age and the maturity of your hormonal system. So, for young women, it is looking more and more as though the pill is bad for bones, slowing or stopping the accumulation of bone mineral during teens and twenties. And maybe you can make that up after you come off. But many women never come off, replace their hormonal cycle with a pharmaceutical cycle for literally decades. And shouldn’t we be a bit concerned about that? At the other end of the reproductive life cycle, it’s important to know that the large safety trials exclude older women. Regulators want contraceptives tested on fertile women (which makes sense), but that means that safety trials usually cut off at 35 or 40. And as you get older, your chances of blood clots and strokes goes up anyway, so even if the relative risk were the same, the absolute risk (the number of new events) is going to go up with age. We do know that smokers who are over 35 are at very high risk.

Not only that, but the non-hormonal options are getting harder. To use a diaphragm, you need to also use a spermicidal jelly. Here in Canada, the company that has the rights has decided to stop distributing it, because the market is too small. I’ve just learned that there is a local clinic in my hometown (Willow Women’s Clinic in Vancouver) who are importing it. And those who want to use natural family planning methods (fertility awareness) need to look for educators to support them; most GP’s don’t have the knowledge or the time to support this choice.

The WSJ also incorrectly says that the Mirena IUD affects ovulation. Turns out that the dose of levonorgestrel (a progestin) is local enough that many women maintain a hormonal cycle, even as the progestin reduces menstrual flow and prevents pregnancy through local action. Which, to this consumer, is looking pretty good these days.

When Mirena Meets Mommybloggers

February 9th, 2010 by Elizabeth Kissling

Guest Post from Evil Slutopia

There are Tupperware parties, Passion Parties, Pampered Chef parties, and…Mirena IUD parties? Yes, apparently these events popped up early last year and were a joint effort from Bayer Pharmaceuticals and the mom marketing site Mom Central.

Here’s one mom blogger’s description of the Mirena party that she hosted:

Then tonight I hosted a party at my house with Mom Central. Mom Central had found me through this blog and asked me if I would be interested in hosting an event sponsored by Mirena. As I welcome any opportunity to sit down with some girlfriends with some free food and drink, I was happy to accept. Before the party started, I walked around nervously, terrified that only a couple of people would show up. We’re all so busy, and I worried that people would end up skipping a strange commercial-sounding event. But one by one, they rolled in and I began to relax.

We had an amazing evening, talking about sex, fashion, and living a simpler life. I realized that we don’t actually spend a lot of time talking about sex and relationships. We laughed a lot but also went home with some great tips.

If you’re thinking that “strange commercial-sounding event” sounds like an accurate description for a party like this, you won’t be surprised by what comes next. What this mom didn’t mention, possibly because she wasn’t aware, was the fact that the script used at these parties didn’t comply with FDA implementing regulations or the Federal Food, Drug, and Cosmetic Act, prompting the FDA to send a warning letter to Bayer at the end of last year. (Bayer is no stranger to FDA warnings – they recently had to “correct” ads for their Yaz/Yasmin birth control pills, which are also the subject of several lawsuits, after the FDA said they were unclear and misleading.)

Before I get into the specifics of the FDA violations in this case, let’s take a look at some more details about these events. First, let’s look at Mom Central. The main Mom Central site has forums, blogs, parenting tips, a product testing panel, giveaways, and so on, but it’s the Mom Central Consulting site that we’re really interested in. Here are some quotes from the site about what they do:

  • Companies eager to tap the powerful, abundant, dominant women’s market are often challenged to target and reach Moms simply through their own internal “experts.” We at Mom Central Consulting are Mom Experts currently engaged in crafting messaging, marketing to mothers and reaching millions of Moms nationwide every month.
  • TODAY’S MOMS REQUIRE TARGETED, HOLISTIC MARKETING APPROACHES that reach them where they are in their lives today. At Mom Central Consulting we create customer loyalty and word of mouth programs that: foster credibility, drive evangelism and engage Moms in irresistible brand experiences that drive sales and fuel profits.

    Our two-pronged targeted approach connects clients with our vast proprietary network of leading Mom Experts and Opinion Leaders and then activates Moms to become trusting, loyal advocates and consumers of your brand, product or service, making us experts at marketing to women.

  • CORPORATE SPOKESPERSON BUREAU: We can draw from our pool of hundreds of talented media savvy spokespeople to create a customized corporate press campaign featuring credible experts within your product category.

So maybe the goal of the hosts and attendees at these parties was to have a fun night eating free food and talking about sex and relationships, but it’s important to keep in mind that that’s not the main goal of Mom Central or the product that they’ve been hired to represent. What they want to do is “activate” some Mirena evangelists.

In the case of these Mirena parties, the expert spokesperson that Mom Central used was Barb Dehn, Nurse Practitioner and member of the Mom Central Advisory Board. Barb is the author of a series of Blue Orchid Guides on women’s health topics like breastfeeding and menopause. In addition to those guides, Blue Orchid Press also has a Partner Program:

Blue Orchid Press provides partners with a non-biased, highly credible communication tool that physicians perceive as a true value-add to their practice and that patients actually use, enabling partners to deliver their messages directly to patients via the most trusted channel there is: the doctor. Physicians who see the value of the Blue Orchid Guides give them to all their patients, thus potentially expanding the target audience for partner products and services, and patients who receive the Guides from their physicians actually use them on a regular basis.

Benefits of an accessible reference
Unlike a typical sales brochure, the Guides serve as a constant, easily accessible reference; with increased usage comes increased exposure to the partner’s service/product without a “hard sell” – the products and services gain credibility from both the sponsorship of the Guides and from association with the perceived value of the content. Blue Orchid Guides are all fully endorsed and approved by leaders in their field.

So it’s sort of a targeted, holistic marketing approach that fosters credibility and activates women to become trusting, loyal advocates and consumers of your brand, product or service? That sounds familiar.

The Blue Orchid Press site has a list of Barb’s speaking engagements, including this one:

February & March, 2009: 3 City tour speaking with Moms about intimacy concerns

New Data on Toxic Shock Syndrome

December 17th, 2009 by Elizabeth Kissling

The first known case of fatal TSS related to an IUD was recently reported recently. Here’s the abstract from the November 2009 Annals of Emergency Medicine (the full article is behind a subscription firewall):

Toxic shock syndrome is a rare toxin-mediated condition that can rapidly produce multiorgan failure and severe shock. Toxic shock syndrome has been previously recognized in various clinical situations relating to surgery, nasal packing, abscesses, burns, and most notably menstrual-related cases. This case report describes a previously healthy 33-year-old woman presenting to the emergency department with complaints of nausea, vomiting, and diarrhea; vital signs at triage were normal. Within hours, she developed shock and cardiopulmonary arrest. The patient met all 6 of the Centers for Disease Control and Prevention diagnostic criteria for toxic shock syndrome, and her intrauterine device grew out Staphylococcus aureus. To our knowledge, this is the first reported case in the medical literature of fatal toxic shock syndrome related to an intrauterine device.

Readers should note that statements published in re: Cycling are those of individual authors and do not necessarily reflect the positions of the Society as a whole.