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Commentary| Volume 106, P1-2, February 2022

Society of Family Planning Committee statement on IUD nomenclature

  • Mitchell Creinin
    Correspondence
    Corresponding author. M.D. Creinin.
    Affiliations
    Department of Obstetrics and Gynecology, University of California, Davis, Sacramento, CA, United States
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  • Julia E. Kohn
    Affiliations
    Planned Parenthood of Northern, Central and Southern New Jersey, Morristown, NJ, United States
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  • Jennifer H. Tang
    Affiliations
    Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States
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  • Tania Basu Serna
    Affiliations
    Department of Obstetrics, Gynecology and Reproductive Sciences, University of California, San Francisco, San Francisco, CA, United States
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  • on behalf of theSociety of Family Planning Clinical Affairs Committee
    Author Footnotes
    † This commentary was authored by Mitchell D. Creinin, MD on behalf of the Society of Family Planning Clinical Affairs Committee in collaboration with Julia E. Kohn, PhD, MPA, Jennifer H. Tang, MD, MSCR, and Tania Basu Serna, MD, MPH. The Board of the Society of Family Planning reviewed and approved the document. The findings and conclusions in this article are those of the authors and do not necessarily represent the views of Planned Parenthood Federation of America, Inc.
  • Author Footnotes
    † This commentary was authored by Mitchell D. Creinin, MD on behalf of the Society of Family Planning Clinical Affairs Committee in collaboration with Julia E. Kohn, PhD, MPA, Jennifer H. Tang, MD, MSCR, and Tania Basu Serna, MD, MPH. The Board of the Society of Family Planning reviewed and approved the document. The findings and conclusions in this article are those of the authors and do not necessarily represent the views of Planned Parenthood Federation of America, Inc.

      Keywords

      1. Introduction

      Recently, the World Health Organization (WHO) released a statement regarding intrauterine device (IUD) nomenclature to clarify various terms used for intrauterine contraception [

      World Health Organization. WHO statement on levonorgestrel-releasing intrauterine device nomenclature, 2021. Available at: https://www.who.int/publications/i/item/9789240021730. Accessed July 25, 2021.

      ]. This clarification was prompted, according to the statement, because “(t)he use of many different acronyms to describe a method category can lead to confusion among governments, procurers, distributors, academics, providers and users.” The WHO added that “(i)t is important to select and align a single term.”
      The Society of Family Planning fully agrees with this reasoning to move forward with clarifying terminology related to intrauterine contraceptives. While, historically, these contraceptives had always been referred to as IUDs, the pharmaceutical industry introduced the term “intrauterine system” and the abbreviation “IUS” as a means of differentiating levonorgestrel from copper devices in marketing and promotional materials.
      As we have learned from misunderstandings related to combined oral contraceptive “generations,” attempts by pharmaceutical companies to create new product types for market differentiation simply leads to confusion [
      • Creinin MD
      • Jensen JT.
      Oral contraceptive generations - Time to stop using a marketing myth to define nomenclature.
      ], as the WHO appropriately summarizes.
      The WHO statement dictates that IUDs be categorized as nonhormonal IUDs and hormonal IUDs. The WHO further defines terminology within these categories, stating that nonhormonal IUDs should be called copper-bearing IUDs and hormonal IUDs should be called “hormone”-releasing IUDs, identified by the type of hormone (e.g., levonorgestrel-releasing IUD). The WHO stresses the importance of naming the hormone to ensure that patients and providers are aware that the IUD releases a hormone, and that the product does not contain estrogen.
      The Society of Family Planning applauds the WHO for its efforts and agrees with the conclusion that any intrauterine contraceptive should be referred to as an intrauterine device (IUD), and that IUDs should be categorized as nonhormonal IUDs and hormonal IUDs. The WHO issued this statement to name categories in line with their common approach to nomenclature for a broad global audience. The Society feels the nomenclature needs additional detail to be appropriate for more potential audiences like researchers, authors, and pharmaceutical companies, and makes the following recommendations.

      2. Recommendations

      • 1.
        The IUD should be referred to as the hormone (e.g., levonorgestrel) or copper with the dose included to help patients and providers differentiate the products.
      The Society recommends matching terminology for IUDs like other hormonal contraceptive drugs or devices by not including the terms “releasing” or “bearing.” For example, implants are not labeled as hormone-releasing implants, but simply etonogestrel or levonorgestrel implants. Of note, copper is released from the IUD as it elutes in the intrauterine environment. The WHO proposed terminology of copper-bearing IUD implies that the copper is stagnant on the IUD and is not released.
      • 2.
        The nomenclature should account for doses in both hormonal and nonhormonal IUDs.
      Currently available levonorgestrel IUDs come in different doses with different release rates. Importantly, the same issue exists for copper IUDs, with ranges from 200 to 380 mm2 doses, based on surface area. Note that a new copper IUD, currently in phase 3 studies, has only 175 mm2 of exposed copper [
      • Turok DK
      • Nelson AL
      • Dart C
      • Schreiber CA
      • Peters K
      • Schreifels MJ
      • et al.
      Efficacy, safety, and tolerability of a new low-dose copper and nitinol intrauterine device: Phase 2 data to 36 months.
      ], so differentiating dose is important.
      • 3.
        IUD types and doses in publications and communications should be written according to standard medical practice.
      Many providers are not used to writing prescriptions because medications and devices are commonly ordered through electronic medical record systems. How we talk about a drug or device is not how we write the same information. Clinicians correctly write medications as NAME DOSE followed by instructions for use, including ROUTE [
      ]. Nothing about the dose relates to a release rate but, rather, the amount and units present in or on the product.
      Based on these recommendations, currently available products in the United States would include (Fig. 1):
      • Copper 380 mm2 IUD
      • Levonorgestrel 13.5 mg IUD
      • Levonorgestrel 19.5 mg IUD
      • Levonorgestrel 52 mg IUD
      Fig. 1
      Fig. 1Society of family planning intrauterine device nomenclature for currently available products. IUD = Intrauterine Device.
      The Society of Family Planning recognizes that names alone are sometimes not enough to explain the product in totality; other features, including the type of frame, may also be necessary to fully differentiate products. Accordingly, the Society endorses that clinicians remain well educated about the different options so as to provide the best counseling for patients.
      This Committee Statement will be used as guidance for IUD terminology in all Society of Family Planning publications. The Society cannot control others’ text but can only create guidance. Accordingly, the Society hopes this recommended IUD nomenclature will be referenced as a standard by clinicians, researchers, pharmaceutical companies, other national and international organizations, and agencies such as the U.S. Food and Drug Administration.

      3. Future considerations

      Reference to IUD frame shape or form are not part of the WHO or Society of Family Planning recommendations. Currently available IUDs in most of the world are “T-shaped,” although some rings and omega-shaped IUDs exist in China. Importantly, not all T-shaped IUDs are the same T. The Copper T380A, for example, is a “Tatum-T” which is a true T-shape. Hormonal IUDs and some copper IUDs are actually a Nova-T, in which there is no perpendicular meeting of the arm and stem. Rather, the stem diverges at the top to curve into each of the arms, forming a small “V” which allows the arms to easily fold upward. The new lower dose copper IUD uses a T-shaped nickel titanium frame [
      • Turok DK
      • Nelson AL
      • Dart C
      • Schreiber CA
      • Peters K
      • Schreifels MJ
      • et al.
      Efficacy, safety, and tolerability of a new low-dose copper and nitinol intrauterine device: Phase 2 data to 36 months.
      ]. Lastly, a multiload frame is a “shaped” frame with 2 arms that bend downward from the stem, like wings, with small outward facing spikes, which is different from a “T” shape. The Society of Family Planning notes that, as shape and form continue to evolve, future nomenclature will need to include these differentiators as well.

      Declaration of Competing Interest

      Mitchell D. Creinin has received speaking honorarium from Gedeon Richter, serves on an Advisory Board for Evofem and Merck, and is a consultant for Danco, Estetra, Mayne, Medicines360, and Merck. The Department of Obstetrics and Gynecology, University of California, Davis, receives contraceptive research funding for Dr. Creinin from Chemo Research SL, Evofem, HRA Pharma, Medicines360, Merck, and Sebela. All other authors report no conflicts of interest.

      References

      1. World Health Organization. WHO statement on levonorgestrel-releasing intrauterine device nomenclature, 2021. Available at: https://www.who.int/publications/i/item/9789240021730. Accessed July 25, 2021.

        • Creinin MD
        • Jensen JT.
        Oral contraceptive generations - Time to stop using a marketing myth to define nomenclature.
        Contraception. 2020; 102: 143-144
        • Turok DK
        • Nelson AL
        • Dart C
        • Schreiber CA
        • Peters K
        • Schreifels MJ
        • et al.
        Efficacy, safety, and tolerability of a new low-dose copper and nitinol intrauterine device: Phase 2 data to 36 months.
        Obstet Gynecol. 2020; 135: 840-847
      2. Hilal-Dandan R Brunton LL Goodman and Gilman's manual of pharmacology and therapeutics. 2nd edition. McGraw Hill, New York2014: 1169