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?

Do you love your LARC?

December 12th, 2012 by Laura Wershler

Throughout the contraceptive realm, LARCs are being heralded as the best thing since Cinderella’s glass slipper with little acknowledgement that for many women LARCs are more like Snow White’s poisoned apple.

Nov. 25 to Dec. 1, 2012, was LARC Awareness Week, billed by the California Family Health Council as “a chance to increase awareness about LARCs as a safe, effective, and long-acting birth control method.” Women were invited to contribute video messages on the theme Why I Love My LARC.

This catchy acronym stands for long-acting reversible contraceptive, and the push is on for many more women to choose this form of birth control. Make no mistake, it’s all about control: What the doctor puts in, only the doctor can take out. Ergo, it’s 99% effective. You can quit taking your pills, rip off your patch, or NOT show up for your next Depo-Provera shot. But if you hate the side effects caused by your IUD or implant, you’ve gotta go see a health-care provider to have it removed.

I’ve challenged the Contraceptive Choice Project study that praised the effectiveness of LARCs over the pill, patch and ring. I took issue with the ACOG recommendation that LARCs are the best methods for teenagers. Now there’s more hype with LARC Awareness Week.

According to the awareness campaign, LARCs include the ParaGard (copper) IUD, Mirena (progestin) IUD and Implanon, a non-biodegradable flexible rod, also containing progestin, that is inserted under the skin and left for up to three years. (Here’s a story about the rods going missing in women’s bodies.) Read the patient information about Implanon. Would you agree to have it inserted into your body?

Women who hate Implanon are speaking out. So are women who don’t love their ParaGard or Mirena IUDs. On YouTube, a video by a women with Mirena issues has over 6000 views;  Why I Love My LARC, posted 8 days earlier, has about 100.

The old-school LARC – Depo-Provera – is not on the campaign’s list of LARCs, though it is heavily used in the United States. Holly Grigg-Spall recently reported that “one in five African American teens are on the Depo shot, far more than white teens.” Hmm. Will they all be switched to other LARCs when, or if, they come back for their next shot? Perhaps Depo is not on the list because women can discontinue this contraceptive without clinician intervention. But it’s probably because Depo causes bone density loss – and because this LARC is not a lark. Women are sharing their Depo stories on another re:Cycling post:  Coming off Depo-Provera can be a women’s worst nightmare. You can find more bad news about this LARC than any other.

What about getting your LARC removed if you hate it instead of love it? One re:Cycling blogger shared what happened when she wanted her ParaGard IUD removed:

I HATED the thing but the nurse who was supposed to take it out tried to talk me out of it for a good 20 minutes. Finally I was like ‘”Why do you want me to keep this item in my uterus so badly?” And she said, “I just don’t want to see you get rid of your very effective birth control.”

This is not the only reason why women who end up hating their LARCs will be discouraged from rejecting them. The Affordable Care Act requires all health plans issued on or after August 1, 2012 to provide no-charge access to FDA-approved LARCs. What’s it going to take to convince health-care providers to remove an expensive contraceptive – provided for free – that was supposed to last for three to 10 years?

Maybe a YouTube video about Why I Hate My LARC will help make it as easy to get rid of one as it now is to get one.

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.

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.