David R. Kattan, MD, MPH

CASE: Teen patient asks to switch contraceptive methods
A 17-year-old nulliparous woman comes to your clinic for an annual examination. She has no significant health problems, and her examination is normal. She notes that she was started on oral contraceptives (OCs) the year before because of heavy menstrual flow and a desire for birth control but has trouble remembering to take them—though she does usually use condoms. She asks your advice about switching to a different method but indicates that she has lost her health insurance  coverage.

What can you offer her as an effective, low-cost contraceptive?

Long-acting reversible contraception (LARC) methods are especially suited for adolescent and young adult   women, for whom daily compliance with a shorter-acting contraceptive may be problematic. Five LARC methods are available in the United States, including a new  levonorgestrel-releasing intrauterine system (LNG-IUS; Liletta), which received approval from the US Food and Drug Administration (FDA) this year. Like Mirena, Liletta contains 52 mg of levonorgestrel that is released over time. Liletta was introduced by the nonprofit organization Medicines360 and its commercial partner Actavis Pharma in response to evidence that poor women continue to lack access to LARC because of cost or problems with insurance coverage.¹

For providers who practice in settings eligible for 340B pricing, Liletta costs $50, a fraction of the cost of alternative intrauterine devices (IUDs). The cost is slightly higher for non-340B providers but is still significantly lower than the cost of other IUDs. For health care practices, the reduced price of Liletta may make it feasible for them to offer LARC to more patients. The reduced pricing also makes Liletta an attractive option for  women who choose to pay for the device directly rather than use insurance, such as the patient described above.

Patient experience with Liletta also is key. Not surprisingly, Liletta’s clinical trial found patient satisfaction to be similar to that of Mirena users.² The failure rate is less than 1%, again comparable to Mirena. The rate of pelvic infection with Liletta use was 0.5%, also comparable to previously published data.³

One difference between Liletta and Mirena is that Liletta carries FDA approval for 3 years of contraceptive efficacy, compared with 5 years for Mirena. In order to make Liletta available to US patients now, Medicines360 decided to apply for 3-year contraceptive labeling while 5- and 7-year efficacy data are being collected. Like Mirena, Liletta is expected to provide excellent contraception for at least 5 years.

Skyla is another LARC option for womenseeking an LNG-IUS for contraception. It provides highly effective contraception for at least 3 years through the release of 13.5 mg of levonorgestrel over time. Skyla’s reduced levonorgestrel content, as compared with Mirena and Liletta, means that fewer users will experience amenorrhea (13% vs 25%).

Paragard is a nonhormonal IUD that uses copper for contraceptive efficacy. The device contains a total of 380 mm of copper.  Possible mechanisms of action include interference with sperm migration in the uterus and damage to or destruction of ova. It is FDA-approved for at least 10 years of use. The lack of any hormone in Paragard IUDs may make them attractive to women who do not wish to experience amenorrhea.

Nexplanon is a subdermal implant containing 68 mg of etonogestrel; it is approved for at least 3 years of use. It is the only LARC method that does not require a pelvic examination. Providers are required to complete a training course offered by the manufacturer to ensure proper placement and removal technique.

LARC should be a first-line birth control option
The primary indication for LARC is preg-nancy prevention. Because LARC methods are the most effective reversible means to prevent pregnancy—apart from complete abstinence from sexual intercourse—they should be offered as first-line birth control options to patients who do not wish to conceive. The ability to discontinue LARC methods is an attractive option for women who may want to become pregnant in the future, such as the patient in the opening vignette.

Efficacy rates are high
Because LARC methods do not require users to take action daily or prior to intercourse, they carry a risk of pregnancy of less than 1% (TABLE 1)^4-7—equal to or better than rates seen with tubal sterilization. In comparison, the OC pill has a typical use contraceptive failure rate of about 8%.

LARC still has a low utilization rate
It is unfortunate that barriers to LARC methods remain in the United States (see, for example, “National organization identifies barriers to LARC,” above). As recently as 2011 to 2013, only 7.2% of US women aged 15 to 44 years used a LARC method.⁸ Provider inexperience and patient fears surrounding LARC use remain major barriers. In the past, nulliparity and young age were thought to be contraindications to IUD use. Research and experience have demonstrated, however, that IUDs and contraceptive implants are safe for use in young women and those who have not had children.

Cost barriers also have significantly limited the use of LARC methods. Over time, however, these contraceptives have become less costly to patients, and most insurance providers routinely cover LARC  devices and insertion fees. The contraceptive mandate of the Affordable Care Act ensures coverage of contraception, including LARC, for interested women. These trends suggest continued improvement in women’s access to LARC.

Noncontraceptive benefits include reduced bleeding
The 3 LNG-IUS methods and the subdermal implant offer several benefits beyond contraception. Because of their progestin content, these methods reduce or even eliminate menses. This benefit can be very helpful for women who experience heavy menstrual periods and the consequent risk of anemia. Because of reduced menstrual flow, users of hormonal LARC methods also commonly experience less cramping associated with menses.

Women with endometriosis often benefit from hormonal LARC methods, as the disease is suppressed by the progestin component. Users of IUDs also have a reduced risk of endometrial cancer.

Contraindications to LARC
There are few contraindications to LARC methods, making them an appropriate choice for most women. The US Medical  Eligibility Criteria for Contraceptive Use, 2010, published by the Centers for Disease Control and Prevention (CDC), contain guidelines that are based on the best available evidence.⁹ Contraceptive methods that are labeled as Category 1 or 2 are not contraindicated for most women. Methods that fall into Category 3 (theoretical or proven risks outweigh the advantages) or Category 4 (unacceptable health risk) are contraindicated (TABLE 2).⁹

IUDs once were thought to expose women to an increased risk of pelvic inflammatory disease, but this fear has long been disproven. Screening for chlamydia can be performed at the time of placement, as recommended annually for women younger than 25 years. Unless there is concern for active cervical or uterine infection, there is no need to delay insertion of an IUD while awaiting test results. In most cases, women found to have positive cultures after  insertion can be treated successfully without IUD removal.

Main adverse effect is altered bleeding patterns
Adverse effects vary depending on the  method being used. All LARC methods may affect menstrual patterns. For example, clinical trials involving the copper IUD indicate that abnormal heavy bleeding may lead to discontinuation in up to 10% of users.^5,10 Amenorrhea or oligomenorrhea is uncommon with this method and rarely leads to discontinuation. For example, in  one trial involving more than 900 women using a copper IUD for up to 5 years, there were no discontinuations due to amenorrhea. Dysmenorrhea may arise, but data from clinical trials indicate that its frequency decreases over time. In one trial, the frequency of any menstrual pain decreased from about 9% of users to 5% after 8 months or more of use.

The LNG-IUS also can be associated with abnormal uterine bleeding. In contrast to the copper IUD, LNG devices tend to reduce menstrual bleeding and can be unpredictable. Clinical trials involving the 5-year 52-mg LNG-IUS indicate that bleeding decreases over time, with as many as 70% of users developing amenorrhea or oligomenorrhea.^5,11 However, some women using an LNG-IUS experience heavy bleeding— although the frequency of such bleeding tends to be substantially less than that experienced by copper IUD users.⁷

A lack of comparative trials makes it unclear whether the newer 3-year LNG-IUS devices are associated with a significantly altered bleeding pattern. Noncomparative data from the package insert for Skyla suggest that women using it may have a higher frequency of heavy menstrual bleeding and less amenorrhea than users of the  5-year device.⁶

Data from a 3-year clinical trial of the newest 52-mg LNG-IUS (Liletta) indicate that bleeding and dysmenorrhea led to discontinuation 1% to 2% of the time.²

Although the concentration of progestincirculating systemically is low with the various LNG-IUS devices, some women may experience symptoms such as mood swings, headaches, acne, and breast tenderness.

Expulsions during the first year of use of the copper IUD and the 3 LNG-IUS devices range from 2% to 10%, with the higher rates associated with immediate postpartum insertion.⁵

Uterine perforation has been reported in about 1 of every 1,000 insertions. Other adverse events are uncommon.

Clinical trials indicate that about 11% of implant users will discontinue the method due to bleeding abnormalities.¹² About 25% to 30% of users will experience heavy or prolonged bleeding, while up to 33% will experience infrequent bleeding or amenorrhea. About 50% of implant users will experience improved bleeding patterns over time.

Other reasons for discontinuation of implant use in a very small percentage of users include emotional lability, weight gain, acne, and headaches.⁴ Complications due to insertion and removal are rare and include pain, bleeding, and hematoma formation.

Public health impact of LARC methods
An important question in regard to LARC use is: How do we best provide safe and effective contraception for teens and young adult women? There is increasing evidence that, with appropriate counseling and the removal of cost barriers, LARC methods can have a significant public health impact in this population.

The Contraceptive CHOICE Project, a cohort study in a teenage population of women in the St. Louis, Missouri, area, achieved increased utilization of LARC methods and significantly lower rates of pregnancy, birth, and abortion.¹³ Investigators proactively counseled young women about the advantages of LARC methods and offered them free of charge. As a result, 72% of women in the study chose an IUD or implant as their method of contraception. Pregnancy, birth, and abortion rates among participants were 34.0, 19.4, and 9.7 per 1,000 teens, respectively. By comparison, national statistics during the same time frame for pregnancy, birth, and abortion were 158.5, 94.0, and 41.5 per 1,000 US teens, respectively.¹³

A similar project in Colorado received $23.6 million in 2009 from an outside donor to make LARC methods more affordable to patients in family planning clinics in the state.¹⁴ Between 2009 and 2014, 30,000 contraceptive implants or IUDs were made available at low or no cost to low-income women attending 68 family planning clinics statewide. The use of these methods at participating clinics quadrupled. Further, the teen birth rate declined by 40% between 2009 and 2013—from 37 to 22 births per 1,000 teens.¹⁴ Seventy-five percent of this decline was attributable to increased use of these methods. The teen abortion rate declined by 35% in the same time frame.

In 2014, the Colorado governor’s office indicated that the state had saved $42.5 million in health care expenditures associated with teen births. It was estimated that, for every dollar spent on contraceptives, the state saved $5.68 in Medicaid costs. However, a bipartisan bill to continue funding the project has failed so far in 2015 due to concerns among some legislators that these methods—particularly the IUDs—are abortifacients. The reduced cost of the 3-year LNG-IUS (Liletta) and recent guidance from the US Department of Health and Human Services mandating that at least 1 form of contraception in each of the FDA-approved categories must be covered by insurers may help to overcome this barrier.

CASE: Resolved
You counsel the patient about the value of each LARC method, letting her know that they are all highly effective in the prevention of pregnancy. You also let her know how each method would affect her menstrual cycle and acknowledge that she may have a preference for whether the contraceptive is placed in her uterus or under the skin of her arm. She chooses the contraceptive implant, which you insert during the same visit. At a follow-up visit 6 weeks later, she reports satisfaction with the method.

Share your thoughts on this article! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

CASE: Teen patient asks to switch contraceptive methods
A 17-year-old nulliparous woman comes to your clinic for an annual examination. She has no significant health problems, and her examination is normal. She notes that she was started on oral contraceptives (OCs) the year before because of heavy menstrual flow and a desire for birth control but has trouble remembering to take them—though she does usually use condoms. She asks your advice about switching to a different method but indicates that she has lost her health insurance  coverage.

What can you offer her as an effective, low-cost contraceptive?

Long-acting reversible contraception (LARC) methods are especially suited for adolescent and young adult   women, for whom daily compliance with a shorter-acting contraceptive may be problematic. Five LARC methods are available in the United States, including a new  levonorgestrel-releasing intrauterine system (LNG-IUS; Liletta), which received approval from the US Food and Drug Administration (FDA) this year. Like Mirena, Liletta contains 52 mg of levonorgestrel that is released over time. Liletta was introduced by the nonprofit organization Medicines360 and its commercial partner Actavis Pharma in response to evidence that poor women continue to lack access to LARC because of cost or problems with insurance coverage.¹

For providers who practice in settings eligible for 340B pricing, Liletta costs $50, a fraction of the cost of alternative intrauterine devices (IUDs). The cost is slightly higher for non-340B providers but is still significantly lower than the cost of other IUDs. For health care practices, the reduced price of Liletta may make it feasible for them to offer LARC to more patients. The reduced pricing also makes Liletta an attractive option for  women who choose to pay for the device directly rather than use insurance, such as the patient described above.

Patient experience with Liletta also is key. Not surprisingly, Liletta’s clinical trial found patient satisfaction to be similar to that of Mirena users.² The failure rate is less than 1%, again comparable to Mirena. The rate of pelvic infection with Liletta use was 0.5%, also comparable to previously published data.³

One difference between Liletta and Mirena is that Liletta carries FDA approval for 3 years of contraceptive efficacy, compared with 5 years for Mirena. In order to make Liletta available to US patients now, Medicines360 decided to apply for 3-year contraceptive labeling while 5- and 7-year efficacy data are being collected. Like Mirena, Liletta is expected to provide excellent contraception for at least 5 years.

Skyla is another LARC option for womenseeking an LNG-IUS for contraception. It provides highly effective contraception for at least 3 years through the release of 13.5 mg of levonorgestrel over time. Skyla’s reduced levonorgestrel content, as compared with Mirena and Liletta, means that fewer users will experience amenorrhea (13% vs 25%).

Paragard is a nonhormonal IUD that uses copper for contraceptive efficacy. The device contains a total of 380 mm of copper.  Possible mechanisms of action include interference with sperm migration in the uterus and damage to or destruction of ova. It is FDA-approved for at least 10 years of use. The lack of any hormone in Paragard IUDs may make them attractive to women who do not wish to experience amenorrhea.

Nexplanon is a subdermal implant containing 68 mg of etonogestrel; it is approved for at least 3 years of use. It is the only LARC method that does not require a pelvic examination. Providers are required to complete a training course offered by the manufacturer to ensure proper placement and removal technique.

LARC should be a first-line birth control option
The primary indication for LARC is preg-nancy prevention. Because LARC methods are the most effective reversible means to prevent pregnancy—apart from complete abstinence from sexual intercourse—they should be offered as first-line birth control options to patients who do not wish to conceive. The ability to discontinue LARC methods is an attractive option for women who may want to become pregnant in the future, such as the patient in the opening vignette.

Efficacy rates are high
Because LARC methods do not require users to take action daily or prior to intercourse, they carry a risk of pregnancy of less than 1% (TABLE 1)^4-7—equal to or better than rates seen with tubal sterilization. In comparison, the OC pill has a typical use contraceptive failure rate of about 8%.

LARC still has a low utilization rate
It is unfortunate that barriers to LARC methods remain in the United States (see, for example, “National organization identifies barriers to LARC,” above). As recently as 2011 to 2013, only 7.2% of US women aged 15 to 44 years used a LARC method.⁸ Provider inexperience and patient fears surrounding LARC use remain major barriers. In the past, nulliparity and young age were thought to be contraindications to IUD use. Research and experience have demonstrated, however, that IUDs and contraceptive implants are safe for use in young women and those who have not had children.

Cost barriers also have significantly limited the use of LARC methods. Over time, however, these contraceptives have become less costly to patients, and most insurance providers routinely cover LARC  devices and insertion fees. The contraceptive mandate of the Affordable Care Act ensures coverage of contraception, including LARC, for interested women. These trends suggest continued improvement in women’s access to LARC.

Noncontraceptive benefits include reduced bleeding
The 3 LNG-IUS methods and the subdermal implant offer several benefits beyond contraception. Because of their progestin content, these methods reduce or even eliminate menses. This benefit can be very helpful for women who experience heavy menstrual periods and the consequent risk of anemia. Because of reduced menstrual flow, users of hormonal LARC methods also commonly experience less cramping associated with menses.

Women with endometriosis often benefit from hormonal LARC methods, as the disease is suppressed by the progestin component. Users of IUDs also have a reduced risk of endometrial cancer.

Contraindications to LARC
There are few contraindications to LARC methods, making them an appropriate choice for most women. The US Medical  Eligibility Criteria for Contraceptive Use, 2010, published by the Centers for Disease Control and Prevention (CDC), contain guidelines that are based on the best available evidence.⁹ Contraceptive methods that are labeled as Category 1 or 2 are not contraindicated for most women. Methods that fall into Category 3 (theoretical or proven risks outweigh the advantages) or Category 4 (unacceptable health risk) are contraindicated (TABLE 2).⁹

IUDs once were thought to expose women to an increased risk of pelvic inflammatory disease, but this fear has long been disproven. Screening for chlamydia can be performed at the time of placement, as recommended annually for women younger than 25 years. Unless there is concern for active cervical or uterine infection, there is no need to delay insertion of an IUD while awaiting test results. In most cases, women found to have positive cultures after  insertion can be treated successfully without IUD removal.

Main adverse effect is altered bleeding patterns
Adverse effects vary depending on the  method being used. All LARC methods may affect menstrual patterns. For example, clinical trials involving the copper IUD indicate that abnormal heavy bleeding may lead to discontinuation in up to 10% of users.^5,10 Amenorrhea or oligomenorrhea is uncommon with this method and rarely leads to discontinuation. For example, in  one trial involving more than 900 women using a copper IUD for up to 5 years, there were no discontinuations due to amenorrhea. Dysmenorrhea may arise, but data from clinical trials indicate that its frequency decreases over time. In one trial, the frequency of any menstrual pain decreased from about 9% of users to 5% after 8 months or more of use.

The LNG-IUS also can be associated with abnormal uterine bleeding. In contrast to the copper IUD, LNG devices tend to reduce menstrual bleeding and can be unpredictable. Clinical trials involving the 5-year 52-mg LNG-IUS indicate that bleeding decreases over time, with as many as 70% of users developing amenorrhea or oligomenorrhea.^5,11 However, some women using an LNG-IUS experience heavy bleeding— although the frequency of such bleeding tends to be substantially less than that experienced by copper IUD users.⁷

A lack of comparative trials makes it unclear whether the newer 3-year LNG-IUS devices are associated with a significantly altered bleeding pattern. Noncomparative data from the package insert for Skyla suggest that women using it may have a higher frequency of heavy menstrual bleeding and less amenorrhea than users of the  5-year device.⁶

Data from a 3-year clinical trial of the newest 52-mg LNG-IUS (Liletta) indicate that bleeding and dysmenorrhea led to discontinuation 1% to 2% of the time.²

Although the concentration of progestincirculating systemically is low with the various LNG-IUS devices, some women may experience symptoms such as mood swings, headaches, acne, and breast tenderness.

Expulsions during the first year of use of the copper IUD and the 3 LNG-IUS devices range from 2% to 10%, with the higher rates associated with immediate postpartum insertion.⁵

Uterine perforation has been reported in about 1 of every 1,000 insertions. Other adverse events are uncommon.

Clinical trials indicate that about 11% of implant users will discontinue the method due to bleeding abnormalities.¹² About 25% to 30% of users will experience heavy or prolonged bleeding, while up to 33% will experience infrequent bleeding or amenorrhea. About 50% of implant users will experience improved bleeding patterns over time.

Other reasons for discontinuation of implant use in a very small percentage of users include emotional lability, weight gain, acne, and headaches.⁴ Complications due to insertion and removal are rare and include pain, bleeding, and hematoma formation.

Public health impact of LARC methods
An important question in regard to LARC use is: How do we best provide safe and effective contraception for teens and young adult women? There is increasing evidence that, with appropriate counseling and the removal of cost barriers, LARC methods can have a significant public health impact in this population.

The Contraceptive CHOICE Project, a cohort study in a teenage population of women in the St. Louis, Missouri, area, achieved increased utilization of LARC methods and significantly lower rates of pregnancy, birth, and abortion.¹³ Investigators proactively counseled young women about the advantages of LARC methods and offered them free of charge. As a result, 72% of women in the study chose an IUD or implant as their method of contraception. Pregnancy, birth, and abortion rates among participants were 34.0, 19.4, and 9.7 per 1,000 teens, respectively. By comparison, national statistics during the same time frame for pregnancy, birth, and abortion were 158.5, 94.0, and 41.5 per 1,000 US teens, respectively.¹³

A similar project in Colorado received $23.6 million in 2009 from an outside donor to make LARC methods more affordable to patients in family planning clinics in the state.¹⁴ Between 2009 and 2014, 30,000 contraceptive implants or IUDs were made available at low or no cost to low-income women attending 68 family planning clinics statewide. The use of these methods at participating clinics quadrupled. Further, the teen birth rate declined by 40% between 2009 and 2013—from 37 to 22 births per 1,000 teens.¹⁴ Seventy-five percent of this decline was attributable to increased use of these methods. The teen abortion rate declined by 35% in the same time frame.

In 2014, the Colorado governor’s office indicated that the state had saved $42.5 million in health care expenditures associated with teen births. It was estimated that, for every dollar spent on contraceptives, the state saved $5.68 in Medicaid costs. However, a bipartisan bill to continue funding the project has failed so far in 2015 due to concerns among some legislators that these methods—particularly the IUDs—are abortifacients. The reduced cost of the 3-year LNG-IUS (Liletta) and recent guidance from the US Department of Health and Human Services mandating that at least 1 form of contraception in each of the FDA-approved categories must be covered by insurers may help to overcome this barrier.

CASE: Resolved
You counsel the patient about the value of each LARC method, letting her know that they are all highly effective in the prevention of pregnancy. You also let her know how each method would affect her menstrual cycle and acknowledge that she may have a preference for whether the contraceptive is placed in her uterus or under the skin of her arm. She chooses the contraceptive implant, which you insert during the same visit. At a follow-up visit 6 weeks later, she reports satisfaction with the method.

Share your thoughts on this article! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

CASE: Teen patient asks to switch contraceptive methods
A 17-year-old nulliparous woman comes to your clinic for an annual examination. She has no significant health problems, and her examination is normal. She notes that she was started on oral contraceptives (OCs) the year before because of heavy menstrual flow and a desire for birth control but has trouble remembering to take them—though she does usually use condoms. She asks your advice about switching to a different method but indicates that she has lost her health insurance  coverage.

What can you offer her as an effective, low-cost contraceptive?

Long-acting reversible contraception (LARC) methods are especially suited for adolescent and young adult   women, for whom daily compliance with a shorter-acting contraceptive may be problematic. Five LARC methods are available in the United States, including a new  levonorgestrel-releasing intrauterine system (LNG-IUS; Liletta), which received approval from the US Food and Drug Administration (FDA) this year. Like Mirena, Liletta contains 52 mg of levonorgestrel that is released over time. Liletta was introduced by the nonprofit organization Medicines360 and its commercial partner Actavis Pharma in response to evidence that poor women continue to lack access to LARC because of cost or problems with insurance coverage.¹

For providers who practice in settings eligible for 340B pricing, Liletta costs $50, a fraction of the cost of alternative intrauterine devices (IUDs). The cost is slightly higher for non-340B providers but is still significantly lower than the cost of other IUDs. For health care practices, the reduced price of Liletta may make it feasible for them to offer LARC to more patients. The reduced pricing also makes Liletta an attractive option for  women who choose to pay for the device directly rather than use insurance, such as the patient described above.

Patient experience with Liletta also is key. Not surprisingly, Liletta’s clinical trial found patient satisfaction to be similar to that of Mirena users.² The failure rate is less than 1%, again comparable to Mirena. The rate of pelvic infection with Liletta use was 0.5%, also comparable to previously published data.³

One difference between Liletta and Mirena is that Liletta carries FDA approval for 3 years of contraceptive efficacy, compared with 5 years for Mirena. In order to make Liletta available to US patients now, Medicines360 decided to apply for 3-year contraceptive labeling while 5- and 7-year efficacy data are being collected. Like Mirena, Liletta is expected to provide excellent contraception for at least 5 years.

Skyla is another LARC option for womenseeking an LNG-IUS for contraception. It provides highly effective contraception for at least 3 years through the release of 13.5 mg of levonorgestrel over time. Skyla’s reduced levonorgestrel content, as compared with Mirena and Liletta, means that fewer users will experience amenorrhea (13% vs 25%).

Paragard is a nonhormonal IUD that uses copper for contraceptive efficacy. The device contains a total of 380 mm of copper.  Possible mechanisms of action include interference with sperm migration in the uterus and damage to or destruction of ova. It is FDA-approved for at least 10 years of use. The lack of any hormone in Paragard IUDs may make them attractive to women who do not wish to experience amenorrhea.

Nexplanon is a subdermal implant containing 68 mg of etonogestrel; it is approved for at least 3 years of use. It is the only LARC method that does not require a pelvic examination. Providers are required to complete a training course offered by the manufacturer to ensure proper placement and removal technique.

LARC should be a first-line birth control option
The primary indication for LARC is preg-nancy prevention. Because LARC methods are the most effective reversible means to prevent pregnancy—apart from complete abstinence from sexual intercourse—they should be offered as first-line birth control options to patients who do not wish to conceive. The ability to discontinue LARC methods is an attractive option for women who may want to become pregnant in the future, such as the patient in the opening vignette.

Efficacy rates are high
Because LARC methods do not require users to take action daily or prior to intercourse, they carry a risk of pregnancy of less than 1% (TABLE 1)^4-7—equal to or better than rates seen with tubal sterilization. In comparison, the OC pill has a typical use contraceptive failure rate of about 8%.

LARC still has a low utilization rate
It is unfortunate that barriers to LARC methods remain in the United States (see, for example, “National organization identifies barriers to LARC,” above). As recently as 2011 to 2013, only 7.2% of US women aged 15 to 44 years used a LARC method.⁸ Provider inexperience and patient fears surrounding LARC use remain major barriers. In the past, nulliparity and young age were thought to be contraindications to IUD use. Research and experience have demonstrated, however, that IUDs and contraceptive implants are safe for use in young women and those who have not had children.

Cost barriers also have significantly limited the use of LARC methods. Over time, however, these contraceptives have become less costly to patients, and most insurance providers routinely cover LARC  devices and insertion fees. The contraceptive mandate of the Affordable Care Act ensures coverage of contraception, including LARC, for interested women. These trends suggest continued improvement in women’s access to LARC.

Noncontraceptive benefits include reduced bleeding
The 3 LNG-IUS methods and the subdermal implant offer several benefits beyond contraception. Because of their progestin content, these methods reduce or even eliminate menses. This benefit can be very helpful for women who experience heavy menstrual periods and the consequent risk of anemia. Because of reduced menstrual flow, users of hormonal LARC methods also commonly experience less cramping associated with menses.

Women with endometriosis often benefit from hormonal LARC methods, as the disease is suppressed by the progestin component. Users of IUDs also have a reduced risk of endometrial cancer.

Contraindications to LARC
There are few contraindications to LARC methods, making them an appropriate choice for most women. The US Medical  Eligibility Criteria for Contraceptive Use, 2010, published by the Centers for Disease Control and Prevention (CDC), contain guidelines that are based on the best available evidence.⁹ Contraceptive methods that are labeled as Category 1 or 2 are not contraindicated for most women. Methods that fall into Category 3 (theoretical or proven risks outweigh the advantages) or Category 4 (unacceptable health risk) are contraindicated (TABLE 2).⁹

IUDs once were thought to expose women to an increased risk of pelvic inflammatory disease, but this fear has long been disproven. Screening for chlamydia can be performed at the time of placement, as recommended annually for women younger than 25 years. Unless there is concern for active cervical or uterine infection, there is no need to delay insertion of an IUD while awaiting test results. In most cases, women found to have positive cultures after  insertion can be treated successfully without IUD removal.

Main adverse effect is altered bleeding patterns
Adverse effects vary depending on the  method being used. All LARC methods may affect menstrual patterns. For example, clinical trials involving the copper IUD indicate that abnormal heavy bleeding may lead to discontinuation in up to 10% of users.^5,10 Amenorrhea or oligomenorrhea is uncommon with this method and rarely leads to discontinuation. For example, in  one trial involving more than 900 women using a copper IUD for up to 5 years, there were no discontinuations due to amenorrhea. Dysmenorrhea may arise, but data from clinical trials indicate that its frequency decreases over time. In one trial, the frequency of any menstrual pain decreased from about 9% of users to 5% after 8 months or more of use.

The LNG-IUS also can be associated with abnormal uterine bleeding. In contrast to the copper IUD, LNG devices tend to reduce menstrual bleeding and can be unpredictable. Clinical trials involving the 5-year 52-mg LNG-IUS indicate that bleeding decreases over time, with as many as 70% of users developing amenorrhea or oligomenorrhea.^5,11 However, some women using an LNG-IUS experience heavy bleeding— although the frequency of such bleeding tends to be substantially less than that experienced by copper IUD users.⁷

A lack of comparative trials makes it unclear whether the newer 3-year LNG-IUS devices are associated with a significantly altered bleeding pattern. Noncomparative data from the package insert for Skyla suggest that women using it may have a higher frequency of heavy menstrual bleeding and less amenorrhea than users of the  5-year device.⁶

Data from a 3-year clinical trial of the newest 52-mg LNG-IUS (Liletta) indicate that bleeding and dysmenorrhea led to discontinuation 1% to 2% of the time.²

Although the concentration of progestincirculating systemically is low with the various LNG-IUS devices, some women may experience symptoms such as mood swings, headaches, acne, and breast tenderness.

Expulsions during the first year of use of the copper IUD and the 3 LNG-IUS devices range from 2% to 10%, with the higher rates associated with immediate postpartum insertion.⁵

Uterine perforation has been reported in about 1 of every 1,000 insertions. Other adverse events are uncommon.

Clinical trials indicate that about 11% of implant users will discontinue the method due to bleeding abnormalities.¹² About 25% to 30% of users will experience heavy or prolonged bleeding, while up to 33% will experience infrequent bleeding or amenorrhea. About 50% of implant users will experience improved bleeding patterns over time.

Other reasons for discontinuation of implant use in a very small percentage of users include emotional lability, weight gain, acne, and headaches.⁴ Complications due to insertion and removal are rare and include pain, bleeding, and hematoma formation.

Public health impact of LARC methods
An important question in regard to LARC use is: How do we best provide safe and effective contraception for teens and young adult women? There is increasing evidence that, with appropriate counseling and the removal of cost barriers, LARC methods can have a significant public health impact in this population.

The Contraceptive CHOICE Project, a cohort study in a teenage population of women in the St. Louis, Missouri, area, achieved increased utilization of LARC methods and significantly lower rates of pregnancy, birth, and abortion.¹³ Investigators proactively counseled young women about the advantages of LARC methods and offered them free of charge. As a result, 72% of women in the study chose an IUD or implant as their method of contraception. Pregnancy, birth, and abortion rates among participants were 34.0, 19.4, and 9.7 per 1,000 teens, respectively. By comparison, national statistics during the same time frame for pregnancy, birth, and abortion were 158.5, 94.0, and 41.5 per 1,000 US teens, respectively.¹³

A similar project in Colorado received $23.6 million in 2009 from an outside donor to make LARC methods more affordable to patients in family planning clinics in the state.¹⁴ Between 2009 and 2014, 30,000 contraceptive implants or IUDs were made available at low or no cost to low-income women attending 68 family planning clinics statewide. The use of these methods at participating clinics quadrupled. Further, the teen birth rate declined by 40% between 2009 and 2013—from 37 to 22 births per 1,000 teens.¹⁴ Seventy-five percent of this decline was attributable to increased use of these methods. The teen abortion rate declined by 35% in the same time frame.

In 2014, the Colorado governor’s office indicated that the state had saved $42.5 million in health care expenditures associated with teen births. It was estimated that, for every dollar spent on contraceptives, the state saved $5.68 in Medicaid costs. However, a bipartisan bill to continue funding the project has failed so far in 2015 due to concerns among some legislators that these methods—particularly the IUDs—are abortifacients. The reduced cost of the 3-year LNG-IUS (Liletta) and recent guidance from the US Department of Health and Human Services mandating that at least 1 form of contraception in each of the FDA-approved categories must be covered by insurers may help to overcome this barrier.

CASE: Resolved
You counsel the patient about the value of each LARC method, letting her know that they are all highly effective in the prevention of pregnancy. You also let her know how each method would affect her menstrual cycle and acknowledge that she may have a preference for whether the contraceptive is placed in her uterus or under the skin of her arm. She chooses the contraceptive implant, which you insert during the same visit. At a follow-up visit 6 weeks later, she reports satisfaction with the method.

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