Kyleena is a new intra-uterine system (IUS) very similar to the Mirena.  It is a device that is inserted into the uterus to serve as a so-called Long-Acting Reversable Contraceptive (LARC) and it’s a great option for every woman from as early as the teenage years (yes, you can use the Kyleena even if you have never had children!).

I recently attended training on the Kyleena and thought our readers may be interested in a bit more in-depth knowledge:

*Please Note: I have not been paid, asked or contracted by Bayer to write this article – I do it purely to inform our readers on the latest contraception options available.

 

How does the Kyleena work?

It secretes a very small amount of Levonorgestrel into your uterus daily, for a period of at least five years.  Levonorgestrel is a progestogen – a chemical produced by scientists to work similarly to your own progesterone.  It prevents pregnancy by changing the mucus in the mouth of your womb (your cervix) to make it impossible for sperm to swim through it.

How is it different from the pill?

  • It does not contain any estrogen.
  • It contains about a tenth of the amount of Levonorgestrel used in the pill and only 1% of the amount used in the morning after pill (i.e. much less hormones and much more natural to your body).
  • It does not suppress ovulation the way the pill does – your body continues to ovulate naturally.
  • It is much safer! In one study it was shown that you are up to 20 times more likely to fall pregnant on the pill than you are on Kyleena or the Mirena, over a three-year period.  If used correctly and with perfect consistency, the pill should be very safe, but the reality is that most women do not use it correctly. In fact, it is estimated that up to one in ten women fall pregnant on the pill within the first year!
  • On the pill, if you have diarrhoea or take anti-biotics, you risk falling pregnant. Kyleena remains effective regardless of what you do, what you take or what illness you might have!

How is it different form the Mirena?

  • The Kyleena contains less hormone (Levonorgestrel) in total than the Mirena and releases a smaller amount of it per day.
  • It is significantly smaller than the Mirena and therefore easier and less painful to insert.
  • Fewer women on the Kyleena will stop bleeding completely than on the Mirena (25% vs 60%).
  • Kyleena is not registered for menopausal women to use as endometrial protection in conjunction for estradiol hormonal treatment, like the Mirena is.
  • Kyleena is not registered for the treatment of heavy menstrual bleeding like the Mirena is.

What are my chances of falling pregnant on the Kyleena?

According to the research done by Bayer during the testing of the product, less than 1% risk over three years (for the pill, that figure is about 10%) and 1.4% over five years.

What are the advantages of the Kyleena?

  • Fit and forget – nothing that you can do (apart from removing it!) can influence its efficacy. Once it is in, you can forget about birth control – it’s taken care of!
  • No change in body weight was observed during the studies – it does not make you gain weight!
  • Among the studies, 99% of patients were satisfied with the Kyleena after using it for five years. That is much higher than the satisfaction rate on the pill for instance. Four out of five patients taking part in the studies chose to have the Kyleena inserted again after five years – a very good indication that they were happy with it!
  • It has no effect on bone mineral density like other progestogen-only contraceptives (because it just works inside the uterus).
  • You will have lighter, shorter and less painful periods compared to not taking a contraceptive.
  • You will have instant return to fertility if you have it removed – you can even fall pregnant the same day!
  • Like all other intra-uterine devices or systems, it reduces the risk of cancer in the cervix.
  • It does not increase or reduce the risk for breast or ovarian cancer.
  • It can be even used by women who have not had children and we frequently insert IUSs for virgins at MSH!
  • If you use it for longer than 18 months, it is more cost-effective than being on the pill.

What are the potential complications of having the Kyleena fitted?

  • The most dangerous complication is that the doctor might push the device right through your uterus (womb).  That is called a uterine perforation.  It could result in the Kyleena ending up in your abdomen and that you will need to have it surgically removed.  This happens in about once in 1000 cases and is slightly more likely to happen if you have recently had a baby.
  • It could move or fall out.  During the studies, this happened in 3.7% of cases.  If you have significant bleeding or pain after having it fitted, you should have an ultra-sound done to ensure that it is in the correct place.People have historically believed that intra-uterine devices or systems could cause infections like Pelvic Inflammatory Disease.  This was proven to be untrue in the case of Kyleena and Mirena.
  • Although it is very rare, you may get a vaso-vagal attack, which is similar to fainting when you have your blood drawn, and your blood pressure and pulse rate could fall very low, causing you to feel sick.  Your doctor should have emergency treatment available to treat you if this happens.
  • You are slightly more at risk of getting so-called “functional cysts” on your ovaries.  Up to one in five women on Kyleena/Mirena will sometimes show a cyst on their ovaries when doing an ultrasound, but it will not cause pain or any other problems and it should disappear within two to three months. It does not result in more surgeries for cysts than in the general population.
  • Although not really a complication, in about 4% of the study cases, the doctors were not able to get it fitted the first time.  In such a case you may be referred to have it inserted in theatre.
  • Ectopic (tube) pregnancies:  Kyleena does not cause ectopic pregnancies, but if you do fall pregnant on the Kyleena, please see a gynaecologist immediately and make sure it is an intra-uterine pregnancy and not an ectopic.  Up to half of pregnancies on the Kyleena or Mirena are ectopic pregnancies.  Tube pregnancies can be very dangerous, even life-threatening.  Remember: pregnancies on the Kyleena are extremely rare, but please see your doctor immediately if it does happen.

Will it be painful to have the Kyleena inserted?

  • 8% of women in the studies rated the pain from insertion as severe.
  • 20% said that the insertion was “not even uncomfortable”.

If you are worried about pain, we prefer to insert it during your menstruation and we also offer conscious sedation to patients who prefer to be sedated.

IN SHORT:  If falling pregnant is not on the radar of your immediate future and if you prefer to use birth control that does not influence your hormones or menstrual cycle, Kyleena is most likely the best contraceptive choice for you.

I hope this information has answered most of your questions.  Again, please note that Bayer did not pay or ask me to write this article and the information provided are from my notes taken during the training session.

Please do not hesitate to contact any of the MSH doctors if you have any questions. Our doctors have inserted hundreds of IUSs over the years and will be very happy to answer your questions and fit your device if you select the Kyleena as contraceptive.

Dr Elna Rudolph
Written by Dr Elna Rudolph – Clinical Head of My Sexual Health
011 568 4800
www.DrElnaRudolph.co.za
www.mysexualhealth.co.za