When the ParaGard IUD was first marketed in the US in 1988, the product label contained a section indicating that this IUD was recommended for women who have had at least one child. Unfortunately, this product label restricted IUD use in nulliparous women (women who have never had children).
In 2005, the FDA approved a new product label for ParaGard to prevent further deterrence of IUD use by women who had never given birth. This new label removed any information suggesting that IUD candidates be limited to those having one or more children.
Currently, the label for the Mirena IUD still states that it is intended for women who have had a least one child, yet the manufacturer also states that this is because most of the research on Mirena for FDA approval was conducted on women who had at least one child.
What Does ACOG Say?
The latest Practice Bulletin released by the American College of Obstetricians and Gynecologists (ACOG) suggests that both adult women and adolescents who have not given birth could benefit from IUD use. In fact, many doctors and teaching hospitals have been inserting IUDs in these populations for years, so the new ACOG recommendations are actually a reflection of what has already been happening in the real world.
The U.S. Medical Eligibility Criteria for Contraceptive Use classifies IUD use in nulliparous women and teenagers for both ParaGard and Mirena under a Category 2. This means that the advantages to using the contraceptive generally outweigh the risks.
What Does the Research Say?
Recent literature proposes that IUDs are more effective and have higher rates of satisfaction in women who haven't had a child as compared to the birth control pill. In a 1-year study (of 200 nulliparous women aged 18–25 years seeking contraception), approximately half of the women chose to use Mirena and the other half chose the pill. Whereas 27% of the women in the birth control pill group stopped use during the year, only 20% of the Mirena users discontinued. In this study, more of the women in the Mirena group (vs. those who were in the birth control pill group) reported that the their contraceptive method was moderately good to very good. Pain was the most commonly cited reason for Mirena IUD removal and discontinuation, while hormonal side effects were the main reason why the pill users chose to stop. This study concluded that the safety and acceptability of Mirena in women who have never given birth was observed to be as good as the pill, with a high rate of continued use.
Research from another study examined available data about nulliparous women’s concerns about IUD use (such as effectiveness, safety, PID risk, side effects, etc.). After evaluating existing research, this study found that IUDs have a similarly low failure rate in nulliparous and parous women (so they are equally effective in both populations) and do not cause PID or infertility. Also, nulliparous women continue their IUD use at comparable or higher rates of use as compared to women who use other contraception methods. The authors suggest that the Mirena IUD may be better tolerated in nulliparous women than the ParaGard based on lower expulsion rates (when the IUD partially or completely slips out of the uterus) and less bleeding (as a side effect). They also caution that IUD insertion may be more difficult in nulliparous women. But, overall, this study advised that nulliparous women who desire effective contraception should be considered as candidates for either Mirena or ParaGard and that because of the benefits of IUD use, doctors should not be discouraged from offering IUDs as a first-line contraceptive choice for this population.
A review of the literature on copper IUD use among nulliparous women was done to analyze information on expulsion rates and removal due to bleeding and pain. Results suggest that expulsion rates for both Mirena and ParaGard are fairly similar in nulliparous women and parous ones. That being said, it seems that the rate of expulsion may be slightly higher for nulliparous users who use ParaGard as compared to parous users who use this same IUD.
The most common side effects reported for ParaGard use in nulliparous women were pain and increased menstrual bleeding. Nulliparous women who used Mirena generally reported no periods or lighter menstrual bleeding, but unpredicatable spotting between periods. Research indicates that nulliparous women may have higher rates of ParaGard removal due to bleeding and pain as compared to women who have given birth. These rates ranged from 9.1% to 24% in most studies. However, nulliparous women typically report high overall satisfaction levels with IUD use.
The general research consensus is that IUD continuation rates for women who haven't had a child are high. Additionally, ParaGard appears to be a good first-line contraceptive option for women who can’t or don’t want to use hormonal contraception.
ACOG practice guidelines agree that even if a woman hasn't yet given birth, she can and should be offered long-acting reversible contraceptive methods like IUDS. The benefits and advantages of ParaGard and/or Mirena IUD use in these women generally outweigh the theoretical or proven risks, so these are good, effective birth control options that should be recommended to women whether or not they have had a child.
American College of Obstetricians and Gynecologists. "Practice Bulletin #121 - Long-Acting Reversible Contraception: Implants and Intrauterine Devices." Obstetrics & Gynecology. July 2011. 118(1):184-196. Accessed via private subscription.
Hubacher, D. “Copper intrauterine device use by nulliparous women: Review of side effects.” Contraception. 2007. 75(6 suppl):S8–11. Accessed via private subscription.
Society of Family Planning Guideline 20092. "Use of the Mirena LNG-IUS and Paragard CuT380A intrauterine devices in nulliparous women." Contraception. 2010. 81(5):367-371. Accessed via private subscription.
Suhonen S, Haukkamaa M, Jakobsson T, Rauramo I. “Clinical performance of a levonorgestrel-releasing intrauterine system and oral contraceptives in young nulliparous women: A comparative study.” Contraception. 2004. 69(5):407-412. Accessed via private subscription.
World Health Organization. “Medical eligibility criteria for contraceptive use.” 4th ed. Geneva: WHO; 2009. Accessed July 12, 2011.