Mirena side effects reviews

IUD and hysterectomy best options for heavy bleeding

Hormone IUD provides relief for heavy menstrual bleeding 5 February 2018 | Contraception and abortion | Gynaecology | Research and clinical trials

Hormone releasing IUDs are more effective than the contraceptive pill and other medication for treating heavy or abnormal menstrual bleeding a review by Royal Women’s Hospital researchers has found.

Published in the Medical Journal of Australia, the research review found that the use of IUDs as a treatment for uterine bleeding had almost doubled in the past five years.

One in 20 women will experience abnormal uterine bleeding such as heavy or long periods or bleeding in between periods.

Lead researcher Dr Annabelle Brennan said while a hysterectomy provided the most effective treatment for women who have completed their family, the review has shed light on the most effective treatments for women who are wanting to maintain their fertility.

“This study shows that hormone releasing IUDs, such as the Mirena, is the most effective form of non-surgical treatment for abnormal menstrual bleeding,” Dr Brennan said.

Research shows more than 97 per cent of women experienced a reduction in blood loss and around half of patients stopped having their menstrual cycle altogether which is what an IUD – a form of contraceptive – is supposed to achieve.

Satisfaction rates amongst patients appeared to be high with 80 per cent of women continuing to use the IUD 12 months later as treatment for heavy menstrual bleeding, while 96 per cent of women who experienced fibroid problems were using the device a year later. However, more research is needed into patient satisfaction.

“Heavy menstrual bleeding has a significant impact on a woman’s quality of life,” Dr Brennan said. “We know women miss work, face bleeding through clothing, often take a change of clothes with them and miss out on activities with friends and family as a result of their heavy bleeding. It is important they are advised of effective treatments.”

Surgery is also used to remove fibroids that may cause heavy bleeding, however problems can return in about a third of cases. Researchers found a hysterectomy including the removal of the uterus was the most effective form of treatment and had very high levels of satisfaction amongst patients.

“The removal of the uterus is the most effective treatment as it removes the source of the bleeding,” Dr Brennan said. ”Current guidelines recommend hysterectomy as a first-line therapy for patients who have finished childbearing and are seeking a definitive treatment of fibroids or for patients with symptoms uncontrolled by minimally invasive management.”

Dr Brennan said the research should provide clear guidance for clinicians in advising patients on the best treatment options for this condition.

Study Says Mirena is Best Treatment for Heavy Periods; Risks Exist

A clinical trial conducted by researchers from the Universities of Birmingham and Nottingham revealed that the Mirena intrauterine device (IUD) treated heavy menstrual cycles better than other conventional medical options. The study, called the ECLIPSE study, was published in the December 2012 issue of the New England Journal of Medicine.

The trial involved 571 women who consulted general practitioners about heavy periods, a condition known as menorrhagia. Large numbers of women suffer from menorrhagia, and it accounted for 20 percent of all gynecological referrals in the United Kingdom. In the United States, 10 million women are affected by menorrhagia. Although Mirena was shown to be effective at treating heavy periods, it still has a risk of side effects.

More Women Preferred Mirena

The study participants agreed to be randomly assigned various treatments for heavy periods, including Mirena or mefenamic acid and tranexamic acid combined with varying combinations of estrogen and progestin. Scientists measured factors such as individual patient experience, practical difficulties with work, social and family life, and overall physical and mental health over a period of two years.

After two years, women using Mirena were roughly twice as likely to still be using it than those taking other medications, and 49 percent of the women in the trial who were not initially assigned to the IUD switched to it. According to the participants, the other treatments were not effective.

One of the study authors, Janesh Gupta, professor of Obstetrics and Gynecology at the University of Birmingham, said: “This trial should encourage the use of IUDs in primary care. This trial shows that LNG-IUS (Mirena) is the more effective first choice, as assessed by the impact of bleeding on women’s quality of life.”

The doctors in the study also pointed out that many women who have heavy menstrual bleeding do not seek help, and one goal is to educate women about the options for treatment.

In the United States, Mirena is an attractive birth control option for women who have at least one child and are looking for convenient, long-term birth control. Under the Affordable Care Act, most insurance plans offer Mirena and other contraceptive options with no cost to the patient.

Mirena’s manufacturer, Bayer, recently released a new hormonal IUD called Skyla. Unlike Mirena, the new IUD is intended for use by women who have not yet had children and is effective for 3 years, two years less than Mirena.

The FDA first approved Mirena in 2000 and then in 2009 to treat heavy periods in women who already use IUD birth control. Though, in an editorial that accompanies the ECLIPSE study, Dr. Eve Espey of the University of New Mexico says: “The data from the support broadening its approval to include menorrhagia generally, whether or not contraception is needed.”

Mirena Side Effects Lead to Lawsuits

These studies and others conducted on Mirena have shown the IUD to be convenient and effective in preventing pregnancy and treating heavy periods. Unfortunately, Mirena has also been shown to have a number of side effects, some serious.

The Food and Drug Administration (FDA) has received more than 45,000 reports of adverse events related to Mirena. One of the most dangerous side effects is the potential for the IUD to migrate out of the uterus. Device dislocation occurred in more than 5,000 cases, and the device migrated out of the uterus in nearly 1,500 cases, leading to hospitalization and surgery in some cases.

Perforation of the uterus occurred in a number of Mirena users, and these women are now filing lawsuits claiming Bayer failed to warn them of the side effects and that the product is defective. Legal experts estimate that hundreds more cases may follow.

Bayer petitioned for consolidation of the cases in New Jersey Supreme Court, but the request was denied in January.

Abnormal bleeding in your female patient? Consider a progestin IUD


› Recommend the 52 mg levonorgestrel-releasing intrauterine device (LNG-IUD) as a first-line treatment for heavy menstrual bleeding. A
› Advise patients with dysmenorrhea that the 52 mg LNG-IUD is an effective nonsurgical treatment. A

Strength of recommendation (SOR)

A Good-quality patient-oriented evidence
B Inconsistent or limited-quality patient-oriented evidence
C Consensus, usual practice, opinion, disease-oriented evidence, case series

CASE Jane K, a 40-year-old multiparous woman, is seeking treatment for heavy menstrual bleeding and cramping, both of which have troubled her for 4 years. Another physician had given her oral contraceptive pills (OCPs) to decrease the pain and bleeding, she reports, but she has difficulty remembering to take a pill every day.

On physical exam, you note an enlarged uterus (approximately 16-week size). A pregnancy test is negative, her thyroidstimulating hormone level is normal, and her hemoglobin is 9 g/dL. Transvaginal ultrasound reveals multiple fibroids.

What can you offer her?

At some point in their reproductive years, 10% to 15% of women experience heavy menstrual bleeding (HMB), or menorrhagia.1,2 In fact, HMB and dysmenorrhea are among the most common reasons for office visits and missed work among women in this age group.3,4 In addition to having a negative impact on quality of life, HMB can cause severe anemia.5

All too often, the suggested solution is a hysterectomy. In fact, 90% of the more than 600,000 hysterectomies performed annually in the United States are for benign disease.6,7 Yet many women with HMB want nonsurgical treatments, and some seek to preserve their fertility. A progestin IUD can often fulfill both of these desires.

An IUD containing 52 mg levonorgestrel (Mirena) has US Food and Drug Administration (FDA) approval both for use as a contraceptive and for the treatment of HMB in women who want intrauterine contraception.8 Recent studies have confirmed its efficacy in treating a wide variety of conditions associated with menorrhagia and dysmenorrhea. In 2013, a smaller, lower dose (13.5 mg) levonorgestrel-releasing IUD (Skyla) received FDA approval as a contraceptive.9 But because this device has been neither tested nor approved for other applications, the following review applies only to Mirena—referred to throughout this article as the LNG-IUD.

A proven (and often superior) treatment for menorrhagia

Leiomyomas, or fibroids—the most common benign tumor of the female genital tract—are a frequent cause of menorrhagia.10 OCPs are often used for the treatment of symptomatic fibroids for women who wish to avoid surgery. When compared with low-dose OCPs for the treatment of menorrhagia secondary to fibroids, however, the LNG-IUD resulted in a significantly greater reduction in blood loss.11

While fibroid size does not appear to decrease significantly after insertion of the device, a systematic review found that menstrual bleeding lessens and hemoglobin levels improve in women with symptomatic fibroids.12,13 The LNG-IUD has also been shown to improve symptoms in women with dysmenorrhea secondary to fibroids.14

Hemostatic disorders. Anticoagulants are vital for women with hemostatic disorders such as Von Willebrand disease, immune thrombocytopenia, or a clotting factor deficiency (See “Is a novel anticoagulant right for your patient?”), but their use may cause or worsen menorrhagia. In such cases, the LNG-IUD appears to be an effective treatment.

In a retrospective case review of 28 women with menorrhagia secondary to various hemostatic disorders, 68% experienced improvement after insertion of the IUD.15 Another study compared women on anticoagulant therapy for cardiac valve disease (N=40) with and without the LNG-IUD. Compared with the control group, those with the IUD were found to have significant increases in hemoglobin levels 3 months after insertion.16

Obesity-related uterine bleeding. Obese women are at higher risk for excessive uterine bleeding, the result of increased conversion of plasma androstenedione to estrogen in adipose tissue. In one study evaluating the use of the LNG-IUD in this patient population, 75% of participants experienced a reduction in bleeding.17

Idiopathic HMB. The IUD is as good as, or better than, other treatments for idiopathic menorrhagia. It results in a significantly higher reduction in both blood loss and days out of work than OCPs.1 The device also reduces blood loss more effectively than oral medroxyprogesterone,18 another common approach to idiopathic HMB; and, compared with hysterectomy, it results in similar patient satisfaction—but lower costs and complication rates.19

In a randomized controlled trial that compared the LNG-IUD with tranexamic acid, mefenamic acid, combined estrogenprogesterone, or progesterone alone over a 2-year period, scores on a menorrhagia symptom scale were significantly higher (indicating greater improvement) in the LNG-IUD group.20

What is the link between breast cancer and Mirena IUD?

Share on PinterestResearch has not concluded whether using a Mirena IUD could increase the risk of breast cancer.

The most recent label information from the U.S. Food and Drug Administration (FDA) acknowledges a potential breast cancer risk for women who use the Mirena IUD, stating:

“Women who currently have or have had breast cancer, or suspect breast cancer, should not use hormonal contraception because some breast cancers are hormone-sensitive.”

However, the label goes on to note that research studies on the increased risk are not definite, advising the following:

“Observational studies of the risk of breast cancer with use of a LNG-releasing IUS do not provide conclusive evidence of increased risk.”

Research that found no link

Mirena has been available for more than 15 years. Research has not yet provided a conclusive answer about its possible link to breast cancer.

One of the earliest studies about a link between Mirena and breast cancer appeared in the journal Obstetrics & Gynecology in 2005. The results of that study concluded that there was not an association between the use of Mirena and increased breast cancer risk.

Another study from 2011 in the journal Contraception also did not find an increased risk of breast cancer in people using Mirena.

Research suggesting a link

A 2014 observational study in Obstetrics & Gynecology looked at women aged 30–49 years from Finland who used the Mirena IUD to control heavy menstrual bleeding.

The findings showed that Mirena decreased the risk of endometrial, ovarian, pancreatic, and lung cancers. However, the study reported a higher incidence of breast cancer than the researchers expected.

The journal Acta Oncologica published a large study in 2015 that also found a connection between the increased risk of breast cancer and Mirena use.

A 2016 systematic review in Breast Cancer Research and Treatment did not associate progestin-only birth control with a higher incidence of breast cancer. However, the researchers noted that small sample size limited most of the studies, and there was a need for scientists to do further research.

More studies are necessary to help medical professionals better understand the effects of synthetic progesterone on women when they are prescribing a Mirena IUD.

Post Reproductive Health published a more recent review in 2017. It stated that the risk of breast cancer that hormonal contraception induced is relatively low and that the benefits of contraceptives may outweigh the risks. However, again, the review said the limited evidence should not imply safety.

When I first started considering the IUD in my early 20s, I went really deep into the online forums. Reddit, Livejournal (!), Tumblr, all of them. There, I found so many wildly different experiences of IUDs, from “totally uneventful” to “worse than childbirth.” The most horrific and scary ones tend to float to the top, which is an unfortunate aspect of the internet.

But after considering all the potential benefits, when I was 26 and in a long-term relationship, I finally decided to go ahead with it. I decided to get the Kyleena, which is available in the US and lasts five years. It has a slightly lower hormone dose than the more-common Mirena hormonal IUD, and is smaller in size. I was lucky enough to have health insurance through my workplace at the time, and living in New York City with relatively-easy access to good healthcare.

I wanted to share my experience because birth control and especially IUDs are not one-size-fits-all. Even among the team at Clue, we’ve had a wide range of experiences with birth control methods. The more stories that we can share—even the uneventful ones—the better informed we can be about our options.

We’ve also collected a bunch of stories and experiences from others who have tried hormonal IUDS. Share your IUD story with us on Instagram and Twitter.

Birth control trial and error, and then BV

For years, I used condoms (with new partners) and then the “pull-out” method (with long-term partners). I knew the risks. But about twice a year, I experienced a flush of stress and anxiety about possibly being pregnant, though usually my periods were delayed due to stress.

I’d asked two gynecologists about getting the IUD. The first said that I should try the pill first. I never filled the prescription. I was worried about the way the pill might affect my mood and mental health, as I take antidepressant medication.

The second gynecologist told me that if it were her, she wouldn’t get an IUD in before having children. She scared me about the possibility of perforation. I’ve since learned that this is not standard advice, and that most gynecologists do recommend IUDs as long-acting reversible contraception.

The third time’s the charm! Goldilocks, etc. When I told the next gynecologist that I was interested in getting an IUD, she trusted I had done my research. She said that she had to make sure I had no infections with a pelvic exam and Pap test, and would then refer me to another doctor to do the insertion.

During my pelvic exam, she told me that I had “a little BV.” “What’s BV?” I had no idea.

She let me know that bacterial vaginosis is really common and easy to treat. She prescribed an antibiotic vaginal gel like Metrogel, which I used over the next five days.

Then, preparation for the insertion

On the morning of the insertion, I followed all the doctor’s instructions. I ate a good meal, took ibuprofen one hour ahead of my appointment time, and then took a previously-prescribed anxiety medication 30 minutes ahead, to ease my nerves.

At the clinic, a very knowledgeable and warm nurse practitioner asked me some questions. Though I had used Clue to schedule the appointment on my expected first day of my period—they recommended this, so that my cervix was more open—I hadn’t gotten my period yet.

About two weeks prior, I had taken Plan B (emergency contraception), which tends to alter my cycles. I had no idea where I was in my cycle, and was slightly relieved when they gave me a pregnancy test and confirmed it was negative. But they told me to take another test in two weeks, just to make sure that there wasn’t any pregnancy developing.

They offered a local anesthetic for my cervix and I enthusiastically said yes.

The procedure

During the procedure, the nurse practitioner did most of the work under the supervision of a doctor. The whole thing took 10 minutes, tops. She walked me through everything that was happening. At the end, I think the doctor stepped in to do the actual insertion, and the ultrasound to confirm its proper placement. There was a bit of discomfort during the procedure, but I’d compare it to the discomfort of a Pap test, with a bit of pinching. I did some deep breathing throughout the entire time I was in stirrups. I hate stirrups.

After the insertion

My partner at the time had accompanied me to the clinic. Afterward we ate fried chicken sandwiches, and then I went home to lie down.

I didn’t have any cramping at first, but I had a bit of mild cramping later in the day. About 36 hours after the procedure, I had pretty bad cramps, comparable to my heaviest period days. I think having a heavy period with pretty bad cramps for most of my life prepped me well—if I wasn’t used to bad cramps, I would have been shocked by their intensity.

Nearly two years after the insertion

I am coming up on my second anniversary of the insertion. Overall, I’m really glad I have it.

My periods have lightened significantly, and are these days mostly brown blood that I don’t even need to wear a tampon for. I don’t have debilitating cramps anymore, which has vastly improved my quality of life.

I like that I’m still ovulating and still have a real period on the IUD—unlike with the pill, which causes withdrawal bleeding and stops monthly cycles. It is nice to have a monthly confirmation that I’m not pregnant.

After six months, I noticed that I had more coarse facial hairs on my chin and that my premenstrual acne was a bit worse. Nothing else has really changed in my life, so my new gynecologist in Germany speculated it could have been due to the IUD. But she couldn’t confirm it. She also spotted a cyst on my ovary, which I learned is very common—it went away after a few months.

I decided that these potential side effects are not outweighed by the peace of mind and the lighter periods that I experience now. Thumbs up for the IUD (so far!).

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