Intrauterine Contraceptives: IUDs

Full update February 2017

Introduction

Intrauterine contraceptives, also referred to as intrauterine devices (IUDs) and intrauterine systems, are an effective and safe form of contraception for many women. Despite this, use in the U.S. and Canada remains low.^1-3 It is thought that this is in part due to myths and unfounded fears of potential complications that arise from the media and healthcare professionals. This document discusses the efficacy and safety of IUDs as a method of contraception.

Types of IUDs

There are two types of IUDs available in the U.S and Canada: copper- and levonorgestrel-containing. The copper IUDs include ParaGard (U.S.), and in Canada, Nova-T, Nova-T 200, Flexi-T 300, Flexi-T+300, Flexi-T +380, Liberte UT380, Liberte TT380, Mona Lisa 5, Mona Lisa 10, and Mona Lisa N. The levonorgestrel-containing IUDs include Mirena, Skyla (U.S.), Jaydess (Canada), Liletta (U.S.), and Kyleena.^1,4,5

The copper-containing IUD was developed in the 1980s. It is a T-shaped device made of polyethylene which is wrapped in copper wire. Although the exact mechanism is not known, it is thought that the copper may have an effect during prefertilization such as affecting sperm migration or altering the viability or speed of the ovum. Other theories suggest that the copper IUD affects postfertilization (but prior to implantation) such as by damaging the fertilized ovum.¹

In Canada, there are three different types of copper-releasing IUDs. The standard copper IUD was developed for use by multiparous women. It is available as Flex-T +380, Liberte TT380 (standard and short), and Mona Lisa 10. These are comparable to the ParaGard IUD in the U.S. A similar-dose version, with a different shape, is also available under the names Liberte UT 380 (standard and short) and Mona Lisa 5. A lower-dose copper IUD is available for nulliparous women (Flex T 300, Flex T +300, Mona Lisa N, Nova T 200).^4,6,7 All copper-containing IUDs in Canada are less than $100, with the exception of Nova-T, which is approximately $200. In the U.S., ParaGard costs $739 (WAC).

ParaGard copper IUD is effective for up to ten years.⁸ The Canadian copper IUDs are effective for five to ten years (depending on the type/brand used).^6,7 The table below summarizes the duration, cost, etc of the levonorgestrel-containing systems.

Levonorgestrel-Containing Intrauterine Systems

1. Wholesale acquisition cost (WAC).
   
2. Liletta will be available commercially as well as at a lower cost to public health clinics enrolled in the 340B Drug Pricing Program, so cost may be significantly lower for some patients.
   
3. Preliminary research suggests that Mirena may be effective for longer than 5 years.³⁵
   

Levonorgestrel works by causing suppression of the endometrium, increasing the amount and viscosity of cervical mucus, and reducing tubal motility. Like the copper IUD, the prefertilization and postfertilization effects occur before implantation. Of note, up to 60% of women may continue to ovulate after insertion of a levonorgestrel-containing IUD, but menstrual bleeding is usually reduced due to effects of levonorgestrel on the endometrium.^1,2

Choice of a device depends on whether a woman wants a hormonal versus nonhormonal IUD, effects on bleeding patterns, duration of contraception, and cost.¹⁶

Indications and Contraindications

IUDs (copper and levonorgestrel-containing) are an acceptable form of contraception in almost all women. The U.S. Medical Eligibility Criteria for Contraceptive Use considers IUDs acceptable in many women for whom other forms of hormonal contraception are either not ideal or are contraindicated (see https://www.cdc.gov/mmwr/ volumes/65/rr/pdfs/rr6503.pdf).^1,17 Similarly, in Canada, there are only a limited number of contraindications.⁵ Very few absolute contraindications to IUDs (copper and levonorgestrel-containing) exist and include current pregnancy, purulent cervicitis, current pelvic inflammatory disease, immediately after a postseptic abortion, current cervical cancer, untreated endometrial cancer, and a distorted uterine shape.^1,5,17 Of note, levonorgestrel-containing IUDs can be considered in most women with a history of breast cancer who are using tamoxifen.⁵ In a meta-analysis of three randomized trials, no increase in the risk of breast cancer recurrence was noted in women who were using a 52 mg levonorgestrel-containing IUD (e.g., Mirena) and who were taking tamoxifen.¹⁸ Interested women with a history of breast cancer should discuss the potential use of a levonorgestrel-containing IUD with her oncologist.⁵

Noncontraceptive benefits of levonorgestrel-containing IUDs, such as a reduction in menstrual blood flow and effects on the endometrium, make it an ideal method of contraception for certain populations. These include women with menorrhagia without structural abnormalities, anemia due to menstruation, endometriosis-induced pelvic pain, and for endometrial protection against hyperplasia in women at risk.^1,5

Insertion

All IUDs can be placed through the cervix into the uterus as an outpatient. In certain circumstances, such as women with mental impairment or in younger adolescents, it can be performed with sedation. Although a variety of pharmacologic agents have been tried to lessen the discomfort of insertion, no method has conclusively been shown to eliminate the pain.¹⁹ Insertion is often performed during menses, but it can be performed at other times during the menstrual cycle, as long as pregnancy is excluded. Two to four weeks after insertion, placement should be confirmed by a speculum exam or ultrasound.

Back-up contraception is needed for seven days after insertion of levonorgestrel-containing IUDs.^2,5 Per ACOG, if the IUD was placed within five days after the start of menses, back-up contraception is not needed.² (Note that product labeling for the various levonorgestrel-containing IUDs may differ concerning the need for back-up contraception.)^9-15 Back-up contraception is also not needed if the IUD is placed immediately after childbirth or an abortion, or after switching from another form of contraception.^1,10,12,14 No back-up contraception is necessary after the insertion of a copper-containing IUD.¹

Efficacy

The efficacy of IUDs has been well studied and has been shown to be one of the most effective forms of contraception, comparable to laparoscopic permanent contraception.⁵ In a large, prospective cohort study of 7,486 women, IUDs and implants were found to be more effective than contraceptive pills, patches, and rings.²⁰ At one year, the copper-containing IUD has a failure rate, with typical use, of 0.8% (versus 9% with combined pills or progestin-only pills).¹ In a meta-analysis of 21 trials evaluating the efficacy of the levonorgestrel IUD, Mirena, the efficacy was noted to be similar to the copper IUD.²¹ In a prospective, non-interventional cohort study of 61,448 women with a newly inserted IUD, overall failure rates were 0.06% and 0.52% for Mirena and copper IUDs, respectively.²² Trials of another levonorgestrel-containing IUD, Skyla, also show similar efficacy with copper-containing IUDs, with a pregnancy rate of 0.9% over three years.²³ Efficacy among the various levonorgestrel IUDs is expected to be similar, but comparative studies are not available.

Following placement of an IUD, some women may experience mild to moderate cramps. OTC non-steroidal anti-inflammatory agents should be recommended for this pain. However, if the pain is severe, or if the patient develops a fever, she should be instructed to call her healthcare provider.²

Efficacy is not affected by the patient’s age (e.g., adolescent) or whether she has had children (e.g., nulliparous). Evidence suggests that IUDs are effective and safe in both populations.^2,3,5,20,24 Based on this information, the U.S. Medical Eligibility Criteria for Contraceptive Use rates the use of IUDs in nulliparous women and adolescents as Category 1, meaning that there is no restriction to the use of an IUD in these populations.¹⁷ Recent Canadian guidelines state that nulliparous women and adolescents who desire a highly effective method of contraception should be offered an IUD.⁵

Although IUDs are approved for a certain duration of use (usually five to ten years), they may be effective for a longer period of time than the manufacturer’s recommendations.⁵ For example, because of the decreasing likelihood of pregnancy in women over the age of 50 years, women who have the 52 mg levonorgestrel IUD (e.g., Mirena) inserted at age 45 years or older can use the device for seven years, or if they are amenorrheic until menopause is diagnosed, although this is an off-label indication.⁵

Safety

Concerns about safety with IUDs arise from complications associated with the Dalkon Shield IUD (marketed in the 1970s) which was associated with a variety of adverse effects including pelvic inflammatory disease (PID) and fertility issues. However, these concerns are unfounded with the present day IUDs.^1,5

The risk of PID is similar in IUD users compared with non-IUD users. While there is an increased risk in the first 20 days after insertion, it is thought that this is due to bacterial contamination from the procedure rather than due to the IUD itself.^1,2,5 Antibiotic prophylaxis before IUD insertion has not been shown to reduce this early risk of PID.^3,25

Another unfounded concern with IUD use regards impairment of future fertility. Fertility returns to normal after IUD removal, and it can be removed at any time if the woman wants to get pregnant.^5,26 In a large case-control study of 1,895 nulliparous women, there was no association between infertility and prior IUD use.²⁷ In addition, pregnancy rates in women younger than 30 years at one year following removal of the IUD were similar to that seen in women who did not use any form of birth control.²⁸

An increased risk of ectopic pregnancy due to IUD use is another myth. The absolute risk of ectopic pregnancy is low at 0 to 0.5 per 1000 women-years in those who have an IUD compared with 3.25 to 5.25 per 1000 women-years in those who do not use contraception.² But if pregnancy occurs with an IUD in place, it will be an ectopic pregnancy in 15% to 50% of cases.⁵ The U.S. Medical Eligibility Criteria for Contraceptive Use rates the use of IUDs in women who have a history of ectopic pregnancy as Category 1, meaning that there is no restriction to the use of an IUD in this population.¹⁷

Uterine perforation is a rare adverse effect that occurs with IUD insertion. It is estimated to occur in 0 to 1.4 per 1000 insertions. The risk of uterine perforation decreases with inserter experience. However, the risk of perforation is higher in women who are postpartum and in those who are breastfeeding.⁵ Adherence to the IUD insertion guidelines provided by the manufacturer may help avoid this complication. If this occurs, the IUD should be removed, but this is not an emergency procedure and future use of an IUD remains an option.²

Lastly, expulsion of the IUD can occur, but this is not common.⁵ Expulsion occurs in approximately 5% of patients. Expulsion is most common within the initial three months, especially after heavy menses.^5,16 This rate can be reduced with proper insertion technique.^5,29 The risk of expulsion does not appear to be related to nulliparity or the use of tampons.⁵ If the IUD is expelled, future insertion of an IUD remains a viable option for birth control.²

Effects on the Menstrual Cycle

Patients should be counseled on the potential effects of the IUD on their menstrual cycle prior to insertion of the device. Women who chose the copper IUD may experience heavy menstrual bleeding, cramping, and intermenstrual spotting after insertion. Patients should be told that heavy bleeding and dysmenorrhea decrease over time, but most women continue to have regular periods.^2,5,29

In women who receive a levonorgestrel-containing IUD, ovulation typically continues after insertion of the IUD. It is normal to have unpredictable bleeding for the initial three months after placement. However, the amount of menstrual bleeding and duration of bleeding is usually reduced, and some women may experience no bleeding (amenorrhea).^2,5,30

All patients should understand that an IUD does not protect against sexually transmitted infections.²

IUD in the Immediate Postpartum Period

Because unintended pregnancy continues to be a public health problem, there has been a renewed interest in increasing access to IUDs and other contraceptive implants. ACOG suggests that all appropriate candidates, including nulliparous women and adolescents, should be encouraged to consider the use of a long-acting reversible form of contraception, including an IUD.³¹ Another group of women who can be considered as candidates for IUDs are women in the immediate postpartum period. Women should be counseled prenatally about the option of an IUD inserted in the delivery room or at any time during the woman’s stay in the postpartum unit after childbirth. There are only a limited number of contraindications to IUD insertion at this time including intrauterine infection, postpartum hemorrhage, and postpartum sepsis.³²

IUD for Emergency Contraception

According to the ACOG and SOGC, insertion of a copper-containing IUD is the most effective method of emergency contraception, when inserted within five days (ACOG) or seven days (SOGC) of unprotected intercourse.^2,5,33 Levonorgestrel-containing IUDs have not been studied for use as an emergency contraceptive.^2,5 In one study of 1,963 women who used a copper-IUD for emergency contraception, the rate of pregnancy was 0.23%.³⁴ Following insertion for emergency contraception, the IUD can be used for long-term contraception.

Conclusion

IUDs are an effective and safe method of long-term contraception in most women.^2,5 Due to myths and unfounded fears, the rate of use of this type of contraception is low. Patients should be counseled on the benefits and risks of IUDs so they can make an informed decision when choosing a contraceptive method.

Project Leader in preparation of this clinical resource (330336): Neeta Bahal O’Mara, Pharm.D., BCPS, Drug Information Consultant

References

1. Yoost J. Understanding the benefits and addressing misperceptions and barriers to intrauterine device access among populations in the United States. Patient Prefer Adherence 2014;8:947-57.
2. American College of Obstetricians and Gynecologists. ACOG practice bulletin no. 121: long acting reversible contraception: implants and intrauterine devices. Obstet Gynecol 2011;118:184-96.
3. Caddy S, Yudin MH, Hakim J, et al. Best practices to minimize the risk of infection with intrauterine device insertion. J Obstet Gynaecol Can 2014;36:266-76.
4. Pymar H. Intrauterine contraception and the Caya diaphragm in Canada – What’s new and how should your practice change to reflect this! http://mcfp.mb.ca/wp-content/uploads/2014/07/Contraception-Update.pdf. (Accessed February 13, 2017).
5. Black A, Guilbert E, Costescu D, et al. Canadian contraception consensus (part 3 of 4): chapter 7—Intrauterine contraception. J Obstet Gynaecol Can 2016;38:182-222.
6. Mona Lisa website. Products. 2014. http://www.monalisa.eu/en/products. (Accessed February 13, 2017).
7. Medisafe Medical. Liberte IUDs. 2015. http://medisafecanada.com/products/liberte-iuds/. (Accessed February 13, 2017).
8. Product information for ParaGard. Teva Women’s Health. North Wales, PA 19454. September 2014.
9. Product information for Liletta. Actavis Pharma, Inc. Parsippany, NJ. 07054. May 2016.
10. Product monograph for Jaydess. Bayer Inc. Toronto, ON M9W 1G6. November 2014.
11. Product information for Kyleena. Bayer Healthcare Pharmaceuticals. Whippany, NJ 07981. September 2016.
12. Product monograph for Kyleena. Bayer, Inc. Mississauga, ON L4W 5R6. December 2016.
13. Product information for Mirena. Bayer Healthcare Pharmaceuticals. Whippany, NJ 07981. December 2016.
14. Product monograph for Mirena. Bayer, Inc. Mississauga, ON L4W 5R6. October 2014.
15. Product information for Skyla. Bayer Healthcare Pharmaceuticals. Whippany, NJ 07981. December 2016.
16. Stephen Searle E. The intrauterine device and the intrauterine system. Best Pract Res Clin Obstet Gynaecol 2014;28:807-24.
17. Curtis KM, Tepper NK, Jatlaoui TC, et al. U.S. medical eligibility criteria for contraceptive use, 2016. MMWR Recomm Rep 2016;65:1-103.
18. Fu Y, Zhuang Z. Long-term effects of levonorgestrel-releasing intrauterine system on tamoxifen-treated breast cancer patients: a meta-analysis. Int J Clin Exp Pathol 2014;7:6419-29.
19. Bahamondes L, Mansour D, Fiala C, et al. Practical advice for avoidance of pain associated with insertion of intrauterine contraceptives. J Fam Plann Reprod Health Care 2014;40:54-60.
20. Winner B, Peipert JF, Zhao Q, et al. Effectiveness of long-acting reversible contraception. N Engl J Med 2012;366:1998-2007.
21. French R, Van Vliet H, Cowan F, et al. Hormonally impregnated intrauterine systems (IUSs) versus other forms of reversible contraceptives as effective methods of preventing pregnancy. Cochrane Database Syst Rev 2004;(3):CD001776.
22. Heinemann K, Reed S, Moehner S, Minh TD. Comparative contraceptive effectiveness of levonorgestrel-releasing and copper intrauterine devices: the European Active Surveillance Study for Intrauterine Devices. Contraception 2015;91: 280-3.
23. Nelson A, Apter D, Hauck B, et al. Two low-dose levonorgestrel intrauterine contraceptive systems: a randomized controlled trial. Obstet Gynecol 2013;122:1205-13.
24. American College of Obstetricians and Gynecologists. Committee opinion no. 539: adolescents and long-acting reversible contraception: implants and intrauterine devices. Obstet Gynecol 2012;120:983-88.
25. Grimes DA, Schulz KF. Antibiotic prophylaxis for intrauterine contraceptive device insertion. Cochrane Database Syst Rev 2001;(1):CD001327.
26. Belhadj H, Sivin I, Diaz S, et al. Recovery of fertility after use of the levonorgestrel 20 mcg/d or Copper T 380 Ag intrauterine device. Contraception 1986;34:261-7.
27. Hubacher D, Lara-Ricalde R, Taylor DJ, et al. Use of copper intrauterine devices and the risk of tubal infertility among nulligravid women. N Engl J Med 2001;345:561-7.
28. Andersson K, Batar I, Rybo G. Return to fertility after removal of a levonorgestrel-releasing intrauterine device and Nova-T. Contraception 1992;46:575-84.
29. Peterson HB, Curtis KM. Long-acting methods of contraception. N Engl J Med 2005;353:2169-75.
30. Gemzell-Danielsson K, Inki P, Boubli L, et al. Bleeding pattern and safety of consecutive use of the levonorgestrel-releasing intrauterine system (LNG-IUS) - a multicentre prospective study. Hum Reprod 2010;25:354-9.
31. Committee on Gynecologic Practice Long-Acting Reversible Contraception Working Group. Committee opinion no. 642: Increasing access to contraceptive implants and intrauterine devices to reduce unintended pregnancy. Obstet Gynecol 2015;126:e44-8.
32. American College of Obstetricians and Gynecologists’ Committee on Obstetric Practice. Committee opinion no. 670: Immediate postpartum long-acting reversible contraception. Obstet Gynecol 2016;128:e32-7.
33. Dunn S, Guilbert E; Society of Obstetricians and Gynaecologists of Canada. Emergency contraception. J Obstet Gynaecol Can 2012;34:870–8.
34. Wu S, Godfrey EM, Wojdyla D, et al. Copper T380A intrauterine device for emergency contraception: a prospective, multicentre, cohort clinical trial. BJOG 2010;117:1205-10.
35. McNicholas C, Swor E, Wan L, Peipert JF. Prolonged use of the etonogestrel implant and levonorgestrel intrauterine device—two years beyond FDA-approved duration. Am J Obstet Gynecol 2017. Published on-line ahead of print, January 29, 2017. doi.org/10.1016/j.ajog.2017.01.036.

Cite this document as follows: Clinical Resource, Intrauterine Contraceptives: IUDs. Pharmacist’s Letter/Prescriber’s Letter. March 2017.

Related Articles

• Women Will Have More Hormonal Contraceptive Options
• Dispel Myths About Intrauterine Contraceptives.
• Help Put IUD Myths to Rest