Beyond the Pill: Long Acting Reversible Contraceptives (LARC)

As we view the joyous mother holding her newborn infant, it is hard for us to believe that almost half of the births in the United States are unintended, or perhaps better described as mistimed. That is not to imply that these children are not loved, but they may have been born at a time that was not optimum for the parents or may have increased the size of the family beyond what the parents had desired. Although the percentage of unintended conceptions in the United States had remained unchanged for many decades, recent reports now reveal a decreasing rate over the last ten years. According to a paper by Finer, rates of unintended pregnancy have decreased from 51% to 45% between 2008 and 2011.¹ In addition, unplanned pregnancies have declined the most in the 15-19 year old group, which is the age group that has the highest rate of unintended pregnancy.¹ In this teenage group, the pregnancy rate has declined 25%.² This decrease is observed across the board, appearing in all subgroups, whether the population is sorted by age, race, or economic status.¹ Although the problem of unintended pregnancies is often considered a teenage issue, the second highest rate of unintended conceptions (although significantly less in absolute numbers) occurs in women over the age of 35.¹      

A number of factors may have contributed to this recent decline in unintended births, including more emphasis on sexual education in the secondary school system, new technology options which provide improved means of communicating with teenagers (such as social media), increased campaigns by medical societies to spread the word, the Affordable Care Act which has reduced the economic barrier associated with contraception, the CDC publications - the US Medical Eligibility Criteria³ and the US Selected Practice Recommendations for Contraceptive Use⁴ – which have expanded the potential patient population eligible for more reliable contraceptives, and Medicaid’s expanded coverage for postpartum LARC (intrauterine devices and implant) use.

The reason that many medical societies have devoted more effort and resources to LARC informational campaigns is that these methods are more effective, with lower real use failure rates and significantly lower complication rates.⁵ Based on many medical society guidelines (including the American Academy of Pediatrics⁶, ACOG⁷)and the CDC guidelines, all LARC devices can be placed immediately postpartum or post abortion. In fact, these devices may be placed at any time after delivery or abortion.⁴ All LARC contraceptive methods may be used whether or not the mother is breastfeeding. And all LARC methods show a rapid return to fertility when discontinued. Additionally, oral contraceptives, vaginal rings and patches have a 20-fold higher failure rate than intrauterine devices (IUDs) and implants.⁸

Currently in the US, there are six FDA approved LARC devices; five are IUDs and one is a sub dermal implant. The Skyla® IUD and Nexplanon® implant have been approved for the shortest duration of use, which is three years. The ParaGard® IUD has an approval for ten years, which is the longest approval period. Currently, ongoing studies examining the effectiveness of some of these devices beyond the length of time for which they were originally approved are underway.  At this time, despite these ongoing studies, no device is recommended for use beyond the time period that has been approved by the FDA.

Sub dermal implants

The etonogestrel contraceptive implant, Nexplanon®, is a 4cm x 2mm flexible ethylene vinyl acetate rod that contains 68 mg of etonogestrel. It is easily inserted and removed in the office under local anesthesia. Complications, such as infection, bleeding, migration of the device, and fracture of the implant are rare. As with all LARC methods, irregular uterine bleeding may occur for 1 to 6 months, but usually resolves. Only 13% of patients discontinued the implant due to bleeding issues in the US trials.⁸ The implant failure rate is .05%.⁶

Intrauterine devices

Intrauterine devices, in various forms, are reported to date back centuries. Currently, there are four progesterone secreting IUDs and one copper IUD available. The amount of progesterone in the IUD and the quantity released on a daily basis varies from a low with Skyla® to a high with Mirena®/Liletta®. Kyleena is intermediate in its released amount of progesterone. Currently, Skyla® has an approval of three years; Liletta® has a four-year approval, and Mirena® and Kyleena®, an approval of five years. ParaGard IUD, which has no hormones and is wrapped in copper, is approved for ten years of use.

Regarding nulliparous women, the CDC guidelines state that all IUDs are appropriate for nulliparous patients even though the FDA PIs have variable, vague or no recommendations.

With the exception of ParaGard® (which has FDA approval for insertion for insertion immediately after delivery)⁹, the package insert (PI) of all the hormonal IUDs states that providers must wait six weeks post delivery/abortion before inserting a device. The CDC guidelines for all IUDs, however, state that insertion anytime at the time of or after delivery/termination it is acceptable.^-In addition, the Mirena® IUD carries an indication for heavy menstrual bleeding.

The LARC failure rates are extremely low, varying from 0.05% (Nexplanon®) to 0.6 % (ParaGard®). Contraindications are few. Nexplanon® implants are contraindicated in breast cancer patients. All IUDs are contraindicated in patients with distorted endometrial cavities for any reason, intrauterine infections, and undiagnosed abnormal uterine bleeding. ParaGard® is contraindicated in patients with Wilson’s disease; progesterone IUDs are contraindicated in patients with breast cancer.

Many providers labor under the misconception (no pun intended) that teenagers and younger adults wouldn’t be accepting of LARC methods and would prefer pills, rings or patches. More often the case is that teens are unfamiliar with other methods of birth control beyond oral hormonal contraceptives. The CHOICE study published in 2014, debunked this myth. In this study, when teens were counseled by trained providers regarding the benefits and risks of LARC and in addition when all methods of contraception were provided free of charge, 72% of the participants chose LARC as their preferred method.¹¹By comparison, less than 5% of contracepting teens in the general population use IUDs or implants.¹² Most importantly, the failure rate of oral contraceptives, rings and patches in teenagers ranges from 5.2% to 6.1%; the failure rate of IUDs/implants are approximately 0-0.5% - a tenfold difference.¹²

After years of stagnation with no lowering of the unintended pregnancy rate, we are finally seeing some change in a positive direction. The cost factor has been eliminated for a large percentage of women due the Affordable Care Act, which at the present time remains mostly unchanged. It has been demonstrated that given the appropriate counseling, the majority of young women would choose LARC as their method of contraception.

What can we do as providers to make sure that this decline in unintended pregnancies (which is likely related to patients selecting a more reliable contraceptive method) continues? How do we make sure that the information we provide to young women is appropriate and addresses their specific concerns?

These are a few tips that should help when providers begin the contraceptive conversation with young women.¹³

1. “I want to go on the pill”: means I want contraception. Don’t take the request at face value; change the conversation to “let’s talk about birth control choices”.

2. Most young women believe all methods of birth control are effective; although relative effectiveness can be discussed, it is not the point of emphasis to be made with young women; from their perspective, overall effectiveness is not an important issue.

3. “Long acting” is not important to young women; as a method, it would have been more effective if this group of contraceptives had been called “LOMREC” – Low Maintenance  Reversible Contraception. Let them know that once it is a LARC device is placed, they can forget about it for the next 3 - 10 years. Nothing to remember, no prescriptions to pick up, and hidden from view!

4. Young women are very concerned about side effects – will I gain weight? will my hair fall out? will I get acne? will my partner or I feel it? will it affect me if I want to have kids later?, etc. Listen to her concerns and answer her questions.

Significant progress in reducing the unintended pregnancy rate has been made in the United States during this last decade. New methods of contraception, updated knowledge regarding a woman’s contraceptive desires, improved methods of communicating and delivering contraceptive information, and the establishment of modern guidelines that have redefined the appropriateness of these new methods for an expanded population of users have all contributed to lowering the unintended pregnancy rate and aiding couple’s in having the number of children that they desire.

References

1. Finer LB, et al. N Engl J Med. 2016; 374(9):843-52.
2. Kavanaugh ML, et al ObstetGynecol.2015;126(5):917-27.         
3. US Medical Eligibility Criteria for Contraceptive Use, MMWR, Vol 65, No.3, July 29, 2016.
4. CDC, US Selected Practice Recommendations for Contraceptive Use, 2013.
5. Trussell J, et al. Contraceptive Technology, 20th edition.  New York, NY. Ardent Media. 2011:50.
6. Committee on Adolescents. Pediatrics. 2014;134(4):1244-56.
7.  ACOG Committee Opinion. Obstet Gynecol. 2009;114(6):1434-8.
8.  Winner, et al. NEJM 2012.
9. Whiteman MK, et al. Contraception. 2013;87(5):666-73.
10.  Masour D, et al. Eur J Contracept Reprod Health Care. 2008;(1):13-28.
11. Secura GM, et al. N Engl J Med. 2014;371(14):1316-23.
12. Finer LB, et al. Fertil Steril. 2012;98(4):89-7.
13. http://thenationalcampaign.org/sites/default/files/resource-primary-download/whoops_proof_insights.pdf