(Published February 2001)

• Pregnancy Prevention and the Levonorgestrel Intrauterine System
• Mechanism of Action
• Altered Menstrual Bleeding Pattern
• Patient Selection/Contraindications
• Side Effects
• Possible Complications
• Methods for Removing a Displaced IUS
• Patient Counseling on LNG IUS
• Non-Contraceptive Benefits and Therapeutic Uses of LNG IUS
• Insertion Instructions
• Publication Information

Pregnancy Prevention and the Levonorgestrel Intrauterine System

Each year, nearly 50 percent of pregnancies in the United States are unintended. ¹ Although a variety of reversible contraceptive methods are available, standard choices have not proven to be a solution for many women. For some, induced abortion is the response to unintended pregnancy. Others elect sterilization, even women age 30 and younger-about 20% of whom later express regret over their decision. ² In fact, sterilization is the most widely used form of birth control in the U.S. ³

However, the family planning landscape is rapidly changing in the U.S., offering the potential to reduce these concerns. Many new contraceptive methods are now or soon to become available, and information resources that make patients aware of them (e.g., the Internet and direct-to-patient advertising) also are continuing to expand. In addition, a recent study shows that a majority of women in the U.S. and around the world are open to considering new types of birth control. ⁴

In December 2000, the Food and Drug Administration (FDA) approved the levonorgestrel intrauterine system (LNG IUS) for use in the U.S. Over two million women in Europe have used this system for the past decade. The purpose of this brochure is to provide information about the LNG IUS, including efficacy, mechanism of action, contraindications, side effects, patient counseling, and insertion.

The LNG IUS consists of a small T-shaped frame with steroid reservoir that contains LNG. This hormone is a potent progestin found in many combination oral contraceptives, progestin-only pills and implants. The steroid reservoir releases a low daily dose of LNG into the uterine cavity for at least five years. The LNG IUS has success rates nearly equal to those of sterilization, based on seven years of study and over 12,000 women-years of usage. The five-year cumulative failure rate is 0.71 per 100 women. Return to fertility is rapid, and conception rates following removal are similar to those of non-users.

Mechanism of Action

The mechanism of action of the LNG intrauterine system is similar to that of LNG implants or LNG containing mini-pills. As with these methods, thickening the cervical mucous and inhibiting sperm motility and function are considered to be the primary means of preventing pregnancy. A weak foreign-body effect is also noted. Although endometrial concentrations of LNG are initially high, systemic concentrations are uniformly low. Ovulation is rarely suppressed after the first year, and even women who experience absence or bleeding using the LNG IUS have the same incidence of ovulation as those who continue menstruating. ⁵

Altered Menstrual Bleeding Pattern

The LNG IUS causes an initial increase in spotting or bleeding during the first few months of use. After about three to six months, however, a significant reduction in both the amount and length of menstrual bleeding occurs, as well as a reduction in dysmenorrhea. Fourteen to twenty percent of women stop having their periods, which women often welcome once counseled that it is safe and not a sign of pregnancy.

Patient Selection/Contraindications

The ideal candidate for the LNG IUS use is a woman who has had at least one child, has no history of pelvic inflammatory disease (PID), and is in a stable, mutually monogamous relationship.

Side Effects

No serious side effects have occurred with the LNG IUS. Benign follicular cysts may be more common in women using the LNG IUS, but usually resolve spontaneously and ultrasound monitoring is not necessary. A small number of women have hormonal side effects, similar to those of oral contraceptives.

Possible Complications

Potential complications with the LNG IUS include perforations, inappropriate IUS location, expulsions, and pelvic inflammatory disease.

Perforations
Perforation is a rare complication of LNG IUS use (1/1000), and it occurs only at the time of insertion. Insertion techniques illustrated in this program's videotape can help physicians avoid perforations.

Inappropriate IUS Location
If a patient is unable to locate the IUS string, the following may have occurred: 1) the IUS may have been expelled; 2) the IUS may be embedded in the myometrium; 3) the IUS may be perforating the myometrium; or 4) the IUS may be in the abdominal cavity. To locate the IUS, begin by using transvaginal ultrasound. If you cannot locate it: 1) look outside the uterus using trans-abdominal ultrasound, and, if necessary 2) radiographs [at least two views].

Methods for Removing a Displaced IUS

Location Method
Uterine cavity or imbedded in the myometrium Grasping forceps with transabdominal ultrasound guidance Perforating myometrium or in abdominal cavity Laparoscopy

Expulsions
Rates of expulsion from 2% to 12% have been reported with the LNG IUS. Most expulsions occur in the first months following insertion, with decreasing frequency thereafter.

Pelvic Inflammatory Disease (PID)
Some evidence suggests that the LNG IUS itself offers protection from PID, perhaps due to the thickening of cervical mucus (which may prevent infection from ascending), endometrial suppression, or reduced bleeding. There is no evidence suggesting an increase in PID incidence.

Patient Counseling on LNG IUS

The following are key points to discuss when counseling patients about the LNG IUS.

During the Decision Process

Discuss:
Efficacy, highly effective, failure rate of less than 1%, comparable to female and male sterilization; continuous protection for up to five years.

Side effects, other than irregular uterine bleeding are uncommon and usually occur in the initial months of use. Possible hormonal side effects include:

• Mood changes
• Acne
• Headache
• Breast tenderness
• Nausea
• Hirsutism
• No reported weight gain

Bleeding patterns

• 1-3 months: frequent spotting
• 1-6 months: reduced duration and amount of bleeding
• Overall 90% reduction in menstrual bleeding
• After 12 months, about 20% of women have no bleeding, which is considered a benefit by many

Explaining the absence of bleeding

• Local effect, no proliferation of endometrium
• Not a sign of pregnancy, ovarian or pituitary dysfunction, or menopause
• Menstruation will return rapidly after the LNG IUS removal

Health benefits

• Reduction in bleeding (and related anemia)
• Reduction in menstrual pain
• Reduction in ectopic pregnancies

Safety

• No serious side effects in over ten years of European use, 2 million users worldwide; does not prevent sexually transmitted disease (STDs), condom use advised for women at risk for STDs.

Before Insertion

• paracervical anesthesia).
• Allow her to have someone with her during the insertion.

Follow-Up

• Schedule follow-up visit at one to three months to check placement.
• Address her questions or concerns; reassure her regarding side effects.

Non-Contraceptive Benefits and Therapeutic Uses of LNG IUS

The LNG IUS is also associated with several non-contraceptive benefits that may enable therapeutic applications of this product. These benefits are a function of LNG's endometrial suppression and decreased menstrual flow. Suggested therapeutic uses include:

• Providing an alternative to hysterectomy in women with heavy uterine bleeding.
• Effectively treating heavy idiopathic and adenomyosis related bleeding and offering an alternative to endometrial resection for dysfunctional bleeding.
• Delivery of progestin component in hormone replacement therapy (HRT) to protect the endometrium, with the advantage of not causing monthly bleeding-the principal reason women currently discontinue HRT.

Insertion Instructions

Clinicians are urged to become thoroughly familiar with the complete instructions before any insertions. The LNG IUS should be inserted within seven days of the onset of menstruation or immediately after early pregnancy loss. The IUS can be replaced with a new system at any time during the menstrual cycle.

Preparation for insertion

• Examine the patient to establish the size and position of the uterus to detect acute cervicitis or other genital contraindi- cations and to exclude pregnancy.
• Visualize the cervix by using a speculum. Thoroughly cleanse the cervix and vagina with a suitable antiseptic solution.
• Use an assistant when necessary.
• Grasp the upper lip of the cervix with a tenaculum. Gentle traction on the tenaculum has been shown to align the cervical canal with the uterine cavity. The tenaculum should remain in position throughout the insertion proce- dure to maintain gentle traction on the cervix against the pushing force of the insertion.
• Gently move a uterine sound across the uterine cavity to the fundus to determine the direction of the cervical canal and the depth of the uterine cavity (sound measure) and to exclude a uterine septum, synechiae, and submucus fibroids. Should the cervical canal be too narrow, dilation is recom- mended and consider the use of analgesics and/or para- cervical block.

Insertion

IMPORTANT! Should you suspect that the system is not in the correct position, check with ultrasound and if necessary remove the system and insert a new, sterile system. A removed system must not be reinserted.

Summary

Less than one woman in 100 will become pregnant while using the LNG IUS, and the five-year cumulative failure rate is 0.71 per 100 women. This system also offers the advantage of reduced menstrual bleeding and discomfort after an initial period of irregular bleeding. In addition, LNG IUS lowers a womanís risk of anemia, ectopic pregnancy, and PID. No serious side effects have been reported.

References

1. Henshaw, SK. Abortion incidence and services in the United States, 1995-1996. Fam Plann Perspect. 1998 Nov-Dec;30(6):263-70, 287.
   2. Hillis SD, Marchbanks PA, Tylor LR, Peterson HB. Poststerilization regret: findings from the United States Collaborative Review of Sterilization. Obstet Gynecol. 1999 Jun; 93(6):889-95.
2. Spinelli A, Talamanca IF, Lauria L. Patterns of contraceptive use in 5 European countries. European Study Group on Infertility and Subfecundity. Am J Public Health. 2000 Sep; 90(9):1403-8.
3. Roper Starch Worldwide, 1999
4. Nilsson CG, Lahteenmaki PL, Luukkainen T. Ovarian function in amenorrheic and menstruating users of a levonorgestrel-releasing intrauterine device. Fertil Steril. 1984 Jan;41(1):52-5.

Publication Information

This publication is a component of New Developments in Contraception: Counseling and Insertion Training Featuring the Levonorgestrel Intrauterine System. This program has been sponsored by the Association of Reproductive Health Professionals and the Ithaca Center for Poastgraduate Medical Education and has been made possible by an unrestricted educational grant from Berlex Laboratories, Inc.

The Association of Reproductive Health Professionals (ARHP) is an interdisciplinary association composed of professionals who provide reproductive health services or education, conduct reproductive health research, or influence reproductive health policy. ARHP, founded in 1963, has a mission to educate health care professionals, public policy makers, and the public. The organization fosters research and advocacy to promote reproductive health. For more information please call 202-466-3825 or visit our website at www.arhp.org

The Ithaca Center for Postgraduate Medical Education is an independent medical education company accredited by the Accreditation Council for Continuing Medical Education (ACCME). The purpose of the Ithaca Center is to provide independent, quality continuing education for physicians and other health care professionals on a national level. The Ithaca Center offers products and services which include: audio and video lectures; print, audio, and video self-study courses; Internet-based CME; journal-based CME; and meeting management expertise in local, regional, national, and international conferences. For more information please call 607-257-5860 or visit our website at www.ithacacenter.com.

Clinical Advisory Committee

David A. Grimes, MD (co-chair)
Research Triangle Park, NC

Kirtly Parker Jones, MD (co-chair)
Salt Lake City, UT

Andrew M. Kaunitz, MD
Jacksonville, FL

Tapani Luukkainen, MD, PhD
Helsinki, Finland

Daniel R. Mishell Jr., MD
Los Angeles, CA

Anita L. Nelson, MD
Torrance, CA

Felicia H. Stewart, MD
San Francisco, CA

David Turok, MD, MPH
Salt Lake City, UT

Susan Wysocki, RNC, NP
Washington, DC

This program is made possible by an unrestricted educational grant from Berlex Laboratories, Inc.