With reports of high success rates, ease of use, low risks and positive side effects; it’s no wonder doctors regularly recommend them and women sing their praises.
But one IUD, the relatively new Mirena, while greeted with enthusiasm by doctors and many patients, has also been the subject of controversy among some women who have taken to social media to vent concerns about possible side effects of the implant.
In the US and in Australia, Facebook support groups, petitions and websites have been launched to detail experiences by women who say they have been badly affected by the Mirena.
American consumer advocate Erin Brokovich has created a website Mirena Side Effects to educate women about possible Mirena side effects and to collect the stories of women who have used it. A class action lawsuit is also in the works.
It’s not the first time Brokovich has taken aim at Bayer – the drug company that makes the Mirena. She also attacked the company for its birth control method Essure (similarly an insert) which she claimed had injured thousands of women.
Now Brokovich has joined a growing chorus of women questioning the Mirena.
“I have been amazed at the number of women who have written to me with their stories and the serious medical issues they are having due to these implants,” she writes on her website. .
Yet despite Brokovich’s campaigning and the personal stories of women – some detailing what they claim are serious side effects- doctors maintain the device is safe and ill effects rare.
So we asked the experts again. What’s the deal with the Mirena?
Let’s start with the basics. The Mirena is a small, T-shaped plastic device that is inserted into the uterus by a gynaecologist or GP.
It was approved by the Therapeutic Goods Administration in 2000 as a contraceptive device and then again later for assisting women with endometriosis or heavy periods.
It releases the hormone levonorgesterel which thickens the mucus lining of the womb and prevents sperm from entering or surviving in the uterus, therefore becoming effective at preventing pregnancy – more than 99 per cent effective in fact (although manufacturer Bayer says it’s not entirely sure how it works).
It lasts up to five years, is relatively inexpensive, can be taken out at any time. It is a ‘fit and forget’ contraceptive (unlike the pill which requires a daily action), with the added bonus of reduced or no periods for most users.
The list of possible side effects of the Mirena is long, although for some of the most serious effects the risk is less than one per cent, according to the most current reports available.
Listed possible side effects include: Pelvic Inflammatory Disease (PID – which can cause infertility, ectopic pregnancy and ongoing pelvic pain), sepsis (a life-threatening infection), perforation (the IUD can become embedded or go through the uterus wall leading to ineffectiveness against pregnancy or worse still it migrating throughout the body causing damage and requiring surgery removal), ovary cysts, depression, weight gain, pain during intercourse, heavy bleeding, anemia and hair loss; plus miscarriage, infection or even death in the rare event of pregnancy (if no abortion is carried out).
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Some women have claimed additional complications and adverse reactions (although there is no proven link at this stage), such as: seizures, blackouts, memory loss, neurological problems, infertility, muscle and joint pain, heart problems, hysterectomies resulting from perforation.
Some women report having no symptoms with their first Mirena over five years, and then severe reactions with a second insertion.
So are these risks real?
Dr Alex Polyakov, a consultant Obstetrician, Gynaecologist and Fertility Specialist (and clinical lecturer at the University of Melbourne), believes the threats are uncommon and the risks associated with an unwanted pregnancy are higher than those associated with Mirena.
“I recommend it almost daily for a number of indications including contraception, excessive bleeding and pelvic pain. It is usually very well tolerated, doesn’t have a lot of severe side effects and provides non-user dependant contraception for up to five years,” Polyakov says.
In his 16 year career in obstetrics and gynaecology he has had to perform surgery twice to locate Mirenas that were embedded in the uterus wall. In both instances he claims they were inserted by a less experienced clinician and no long-term damage was sustained.
He says his overall experience with the Mirena is positive, with rare side effects, however he does stress that no contraceptive option is 100 per cent effective or 100 per cent safe.
“The main problem with Mirena is irregular bleeding and spotting. There are other side effects usually outlined with patient information handouts,” he says.
“Most gynaecologists would use Mirena almost exclusively. In terms of contraceptive efficacy it is as good as it gets.”
On the flip side, some women speaking out about their bad experiences with the IUD believe the risks might be higher than doctors and reports indicate. And they are determined to get their message out on social media.
Gold Coast mother Jodie Rowsell is one of the women who says she has experienced serious negative side effects from her Mirena.
“I feel totally let down… had I been aware of the risk there is no way in hell I would have put this toxic thing in my body,” Roswell says.
She says she feels she was she was pushed into getting the Mirena by her doctor after the birth of her third child, and was told she would have no side effects.
But after experiencing myriad complications over the 4½ years after insertion (such as uterus infections, seizures and panic attacks), she conducted her own research and deduced the cause was most likely her IUD (despite being told otherwise by doctors).
Six months ago after attempting to have it taken out, the Mirena was discovered to be embedded in her uterus wall and Roswell was told to prepare for the possibility of a hysterectomy (in the event they could not remove it).
Associate Professor Kirsten Black, Joint Head of Obstetrics, Gynaecology and Neonatology at the University of Sydney, says all procedures carry a level of risk.
“Nothing in life is without risks. But those risks are very clearly identified and it seems to be right for many more women than not,” she says.
“Mirena has high satisfaction rates and high continuation rates. It’s reversible and there is no known association with fertility problems.”
Prof. Black says all the evidence points to Mirena being a safe and effective method of contraception. And the high continuation rates (people persisting with a particular treatment or medication) show that for many women, there are no problems.
But of course, some women will experience the side effects that Mirena lists.
After her own health issues, Roswell started a Facebook page called Mirena Contraceptive Problems Australia and an online petition. The Facebook page has more than 100 members, and the petition has been signed by 190 people.
“It pushed me to get the word out there because for so long I was sick and doctors made me feel like I was crazy… I thought there must be so many other women who are feeling like I was,” says Roswell.
“I couldn’t stop what was happening to me but I could stop other women from having to go through what I was, and still am going through.”
Roswell says she is still waiting to find out how doctors will remove her Mirena.
“I strongly feel there needs to be more research into long-term effects of Mirena. Thousands of women reporting the same symptoms with only one thing in common – this cannot be coincidental,” she says.
“And what I find most scary is this product doesn’t just hit you with all the ill effects at once, it’s a gradual thing so a lot of women wouldn’t link Mirena to their issues.”
Her story is similar to that of a 22-year-old mother in the US whose Facebook post about her experience in July last year was shared over a million times in a matter of days.
American woman Sarah Bergman is another who after a bad experience started her Facebook group BAN Mirena IUD in 2009. It now has over 2,700 members from all over the world.
“For a while I believe the negative cases were under reported because we didn’t know where to go with this information. Given the recent surge in social media and the weight it carries, I believe we have finally found our voices,” Bergman says.
“While it is true that a large number of women who have used the Mirena have been quite happy with it, the more the product is used, over time the number of us who have had these horrible side effects has become greater, and the louder we have spoken.”
In the US there have been more than 100,000 complaints against Mirena with the FDA (American Food and Drug Administration). But, in a country with more than 60 million women using contraceptives, and more than 3.8 million of them using IUDs, that may be a small percentage of Mirena users lodging a complaint.
Still, campaigners against Mirena think more needs to be done to ensure the device is safe.
“I think that a device such as this should be given the full weight of the thought-provoking conversation given by a physician when one is about to undergo surgery,” Burgman says.
“They are usually very clear before you go into surgery what the possible side effects are, especially mentioning the most frightening of possibilities, however unlikely, including death.”
Roswell wants a review of the device.
“I think it’s so important to get the information out there and for a medical review to be done – Australia is letting their women down by allowing this product to continue without a lot more independent research done,” Roswell says.
Bayer told Mamamia they take questions about the safety of their medical products very seriously, but that the evidence supporting Mirena remains strong.
“Bayer takes the safety of its medicines seriously and always closely collaborates with health and regulatory authorities and medical professionals to exchange all relevant information concerning the use and the benefit-risk profile of its products,” a spokeswoman said.
“Based on the total data available to Bayer since the global launch of Mirena in 2001, a positive benefit-risk profile continues to be observed and is fully aligned with what was seen during the clinical development program that formed the basis for the product’s approval worldwide.
“Bayer continuously reviews the safety profiles of its products worldwide.
“We investigate reports on side-effects thoroughly and collaborate closely with the Therapeutic Goods Administration (TGA) concerning the use, benefits and risks of all products.
“Bayer strongly encourages all patients and healthcare professionals to report adverse events to the company directly or to the TGA.”
Doctors are so confident in the device that some proposed making them mandatory for young female doctors while they complete their training.
Prof. Black says the side effects of Mirena are well-publicised, and that the most common side effects might be a problem for around 10 per cent of women who use the device.
“Ninety per cent of women who use Mirena are happy and for some, the side effects will disappear over time,” she said.
What’s even more important to Black is making sure that women understand that just because some women have had bad experiences with Mirena, doesn’t mean it is the norm.
“A few years ago there were reports that the pill caused blood clots and it led to a lot of women dropping off. But that is a really rare side effect and it’s really important not to over inflate the risks,” she says.
Right now, the research shows the Mirena is the most effective contraceptive available, short of not having sex. And the vast majority of women who use it don’t suffer side effects.
As with all health decisions, the bottom line would be to see your doctor, do your research, weigh up the risks, decide whether it’s the right contraception for you, and be sure to speak to your doctor immediately if you experience any side effects.
Would you consider getting a Mirena?
Feature Image via http://www.mirena-us.com/