Classifications for Intrauterine Devices

Classifications for intrauterine devices (IUDs) are for the copper-containing IUD and levonorgestrel-releasing IUD (containing a total of either 13.5 mg or 52 mg levonorgestrel) (Box B1) (Table B1). IUDs do not protect against sexually transmitted diseases (STDs), including human immunodeficiency virus (HIV), and women using these methods should be counseled that consistent and correct use of the male latex condom reduces the risk for transmission of HIV and other STDs. Use of female condoms can provide protection from transmission of STDs, although data are limited.

BOX B1. Categories for Classifying Intrauterine Devices

1 = A condition for which there is no restriction for the use of the contraceptive method.2 = A condition for which the advantages of using the method generally outweigh the theoretical or proven risks.

3 = A condition for which the theoretical or proven risks usually outweigh the advantages of using the method.

4 = A condition that represents an unacceptable health risk if the contraceptive method is used.

TABLE B1. Classifications for intrauterine devices, including the copper-containing intrauterine device and levonorgestrel-releasing intrauterine device
Condition Category Clarifications/Evidence/Comments
Cu-IUD LNG-IUD
Personal Characteristics and Reproductive History
Pregnancy 4 4 Clarification: The IUD is not indicated during pregnancy and should not be used because of the risk for serious pelvic infection and septic spontaneous abortion.
Age
a. Menarche to <20 years 2 2 Comment: Concern exists both about the risk for expulsion from nulliparity and for STDs from sexual behavior in younger age groups.
b. ≥20 years 1 1
Parity
a. Nulliparous 2 2 Evidence: Data conflict about whether IUD use is associated with infertility among nulliparous women, although well-conducted studies suggest no increased risk (19).
b. Parous 1 1
Postpartum (including cesarean delivery)
a. <10 minutes after delivery of the placenta Clarification: Insertion of IUDs among postpartum women is safe and does not appear to increase health risks associated with IUD use such as infection. Higher rates of expulsion during the postpartum period should be considered as they relate to effectiveness, along with patient access to interval placement (i.e., not related to pregnancy) when expulsion rates are lower.Clarification (breastfeeding): Breastfeeding provides important health benefits for mother and infant. The U.S. Department of Health and Human Services recommends increasing the proportion of infants initially breastfed, exclusively breastfed through 6 months of life, and continuing breastfeeding through at least 1 year of life as key public health goals (10).

Evidence: Studies suggest that immediate postplacental (<10 minutes) and early postpartum (10 minutes up until 72 hours) placement of Cu-IUDs and LNG-IUDs is associated with increased risk for expulsion compared with interval placement (i.e., not related to pregnancy). Early postpartum placement has similar or increased risk for expulsion compared with immediate postplacental placement. Although immediate postplacental placement at the time of cesarean delivery might have increased risk for expulsion compared with interval placement, risk appears lower than that for placement at the time of vaginal delivery. Evidence for infection, perforation, and removals for pain or bleeding are limited; however, these events are rare (1162).

Evidence (breastfeeding): Two randomized controlled trials found conflicting results on breastfeeding outcomes when LNG-IUDs were initiated immediately postpartum compared with 6–8 weeks postpartum. Initiation of LNG-IUDs immediately postpartum had no other harmful effect on infant health, growth, or development (63,64). Breastfeeding women using IUDs do not have an increased risk for certain IUD-related adverse events including expulsion, infection, pain, or bleeding compared with nonbreastfeeding women. The risk for perforation is increased independently among breastfeeding women and among women ≤36 weeks postpartum, compared with non-postpartum women; however, the absolute risk for perforation remains low (1162,65).

Comment (breastfeeding): Certain women might be at risk for breastfeeding difficulties, such as women with previous breastfeeding difficulties, certain medical conditions, or certain perinatal complications and those who deliver preterm. For these women, as for all women, discussions about contraception for breastfeeding women should include information about risks, benefits, and alternatives.

i. Breastfeeding 1 2
ii. Nonbreastfeeding 1 1
b. 10 minutes after delivery of the placenta to <4 weeks (breastfeeding or nonbreastfeeding) 2 2 Clarification: Insertion of IUDs among postpartum women is safe and does not appear to increase health risks associated with IUD use such as infection. Higher rates of expulsion during the postpartum period should be considered as they relate to effectiveness, along with patient access to interval placement (i.e., not related to pregnancy) when expulsion rates are lower.
Clarification (breastfeeding): Breastfeeding provides important health benefits for mother and infant. The U.S. Department of Health and Human Services recommends increasing the proportion of infants initially breastfed, exclusively breastfed through 6 months of life, and continuing breastfeeding through at least 1 year of life as key public health goals (10).
Evidence: Studies suggest that immediate postplacental (<10 minutes) and early postpartum (10 minutes up until 72 hours) placement of Cu-IUDs and LNG-IUDs is associated with increased risk for expulsion compared with interval placement (i.e., not related to pregnancy). Early postpartum placement has similar or increased risk for expulsion compared with immediate postplacental placement. Although immediate postplacental placement at the time of cesarean delivery might have increased risk for expulsion compared with interval placement, risk appears lower than that for placement at the time of vaginal delivery. Evidence for infection, perforation, and removals for pain or bleeding are limited; however, these events are rare (1162).
Evidence (breastfeeding): Two randomized controlled trials found conflicting results on breastfeeding outcomes when LNG-IUDs were initiated immediately postpartum compared with 6–8 weeks postpartum. Initiation of LNG-IUDs immediately postpartum had no other harmful effect on infant health, growth, or development (63,64). Breastfeeding women using IUDs do not have an increased risk for certain IUD-related adverse events including expulsion, infection, pain, or bleeding compared with nonbreastfeeding women. The risk for perforation is increased independently among breastfeeding women and among women ≤36 weeks postpartum, compared with non-postpartum women; however, the absolute risk for perforation remains low (1162,65).
Comment (breastfeeding): Certain women might be at risk for breastfeeding difficulties, such as women with previous breastfeeding difficulties, certain medical conditions, or certain perinatal complications and those who deliver preterm. For these women, as for all women, discussions about contraception for breastfeeding women should include information about risks, benefits, and alternatives.
c. ≥4 weeks (breastfeeding or nonbreastfeeding) 1 1 Clarification: Insertion of IUDs among postpartum women is safe and does not appear to increase health risks associated with IUD use such as infection. Higher rates of expulsion during the postpartum period should be considered as they relate to effectiveness, along with patient access to interval placement (i.e., not related to pregnancy) when expulsion rates are lower.
Clarification (breastfeeding): Breastfeeding provides important health benefits for mother and infant. The U.S. Department of Health and Human Services recommends increasing the proportion of infants initially breastfed, exclusively breastfed through 6 months of life, and continuing breastfeeding through at least 1 year of life as key public health goals (10).
Evidence (breastfeeding): Initiation of LNG-IUDs at 4 weeks postpartum or later demonstrated no detrimental effect on breastfeeding outcomes and no harmful effect on infant health, growth, or development (63,64). Breastfeeding women using IUDs do not have an increased risk for certain IUD-related adverse events including expulsion, infection, pain, or bleeding compared with nonbreastfeeding women. The risk for perforation is increased independently among breastfeeding women and among women ≤36 weeks postpartum, compared with non-postpartum women; however, the absolute risk for perforation remains low (1162,65).
Comment (breastfeeding): Certain women might be at risk for breastfeeding difficulties, such as women with previous breastfeeding difficulties, certain medical conditions, or certain perinatal complications and those who deliver preterm. For these women, as for all women, discussions about contraception for breastfeeding women should include information about risks, benefits, and alternatives.
d. Postpartum sepsis 4 4 Comment: Theoretical concern exists that postpartum insertion of an IUD in a women with recent chorioamnionitis or current endometritis might be associated with increased complications.
Postabortion
a. First trimester 1 1 Clarification: IUDs can be inserted immediately after spontaneous or induced abortion.
Evidence: Risk for complications from immediate versus delayed insertion of an IUD after abortion did not differ. Expulsion was greater when an IUD was inserted after a second trimester abortion than when inserted after a first trimester abortion. Safety or expulsion for postabortion insertion of an LNG-IUD did not differ from that of a Cu-IUD (66).
b. Second trimester 2 2
c. Immediate postseptic abortion 4 4 Comment: Insertion of an IUD might substantially worsen the condition.
Past ectopic pregnancy 1 1 Comment: The absolute risk for ectopic pregnancy is extremely low because of the high effectiveness of IUDs. However, when a woman becomes pregnant during IUD use, the relative likelihood of ectopic pregnancy increases substantially.
History of pelvic surgery
(see Postpartum [Including Cesarean Delivery] section)
1 1
Smoking
a. Age <35 years 1 1
b. Age ≥35 years
i. <15 cigarettes per day 1 1
ii. ≥15 cigarettes per day 1 1
Obesity
a. BMI ≥30 kg/m2 1 1
b. Menarche to <18 years and BMI ≥30 kg/m2 1 1
History of bariatric surgery
This condition is associated with increased risk for adverse health events as a result of pregnancy (Box 2).
a. Restrictive procedures: decrease storage capacity of the stomach (vertical banded gastroplasty, laparoscopic adjustable gastric band, or laparoscopic sleeve gastrectomy) 1 1
b. Malabsorptive procedures: decrease absorption of nutrients and calories by shortening the functional length of the small intestine (Roux-en-Y gastric bypass or biliopancreatic diversion) 1 1
Cardiovascular Disease
Multiple risk factors for atherosclerotic cardiovascular disease (e.g., older age, smoking, diabetes, hypertension, low HDL, high LDL, or high triglyceride levels) 1 2
Hypertension
Systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥100 mm Hg are associated with increased risk for adverse health events as a result of pregnancy (Box 2).
a. Adequately controlled hypertension 1 1 Clarification: For all categories of hypertension, classifications are based on the assumption that no other risk factors for cardiovascular disease exist. When multiple risk factors do exist, risk for cardiovascular disease might increase substantially. A single reading of blood pressure level is not sufficient to classify a woman as hypertensive.
b. Elevated blood pressure levels
(properly taken measurements)
Clarification: For all categories of hypertension, classifications are based on the assumption that no other risk factors for cardiovascular disease exist. When multiple risk factors do exist, risk for cardiovascular disease might increase substantially. A single reading of blood pressure level is not sufficient to classify a woman as hypertensive.Comment: Theoretical concern exists about the effect of LNG on lipids. Use of Cu-IUDs has no restrictions.
i. Systolic 140–159 mm Hg or diastolic 90–99 mm Hg 1 1
ii. Systolic ≥160 mm Hg or diastolic ≥100 mm Hg 1 2
c. Vascular disease 1 2 Clarification: For all categories of hypertension, classifications are based on the assumption that no other risk factors for cardiovascular disease exist. When multiple risk factors do exist, risk for cardiovascular disease might increase substantially. A single reading of blood pressure level is not sufficient to classify a woman as hypertensive.
Comment: Theoretical concern exists about the effect of LNG on lipids. Use of Cu-IUDs has no restrictions.
History of high blood pressure during pregnancy (when current blood pressure is measurable and normal) 1 1
Deep venous thrombosis/
Pulmonary embolism
a. History of DVT/PE, not receiving anticoagulant therapy
i. Higher risk for recurrent DVT/PE (one or more risk factors)

• History of estrogen-associated DVT/PE

• Pregnancy-associated DVT/PE

• Idiopathic DVT/PE

• Known thrombophilia, including antiphospholipid syndrome

• Active cancer (metastatic, receiving therapy, or within 6 months after clinical remission), excluding nonmelanoma skin cancer

• History of recurrent DVT/PE

1 2
ii. Lower risk for recurrent DVT/PE (no risk factors) 1 2
b. Acute DVT/PE 2 2 Evidence: No direct evidence exists on the use of POCs among women with acute DVT/PE. Although findings on the risk for venous thrombosis with the use of POCs in otherwise healthy women are inconsistent, any small increased risk is substantially less than that with COCs (6769).
c. DVT/PE and established anticoagulant therapy for at least 3 months Evidence: No direct evidence exists on the use of POCs among women with acute DVT/PE. Although findings on the risk for venous thrombosis with the use of POCs in otherwise healthy women are inconsistent, any small increased risk is substantially less than that with COCs (6769).Evidence: Limited evidence indicates that insertion of the LNG-IUD does not pose major bleeding risks in women receiving chronic anticoagulant therapy (7073).

Comment: The LNG-IUD might be a useful treatment for menorrhagia in women receiving long-term anticoagulation therapy.

i. Higher risk for recurrent DVT/PE (one or more risk factors)

• Known thrombophilia, including antiphospholipid syndrome

• Active cancer (metastatic, receiving therapy, or within 6 months after clinical remission), excluding nonmelanoma skin cancer

• History of recurrent DVT/PE

2 2
ii. Lower risk for recurrent DVT/PE (no risk factors) 2 2
d. Family history (first-degree relatives) 1 1
e. Major surgery
i. With prolonged immobilization 1 2
ii. Without prolonged immobilization 1 1
f. Minor surgery without immobilization 1 1
Known thrombogenic mutations (e.g., factor V Leiden; prothrombin mutation; and protein S, protein C, and antithrombin deficiencies)
This condition is associated with increased risk for adverse health events as a result of pregnancy (Box 2).
1 2 Clarification: Routine screening is not appropriate because of the rarity of the conditions and the high cost of screening.
Superficial venous disorders
a. Varicose veins 1 1
b. Superficial venous thrombosis (acute or history) 1 1
Current and history of ischemic heart disease
This condition is associated with increased risk for adverse health events as a result of pregnancy (Box 2).
1 Initiation Continuation Comment: Theoretical concern exists about the effect of LNG on lipids. Use of Cu-IUDs has no restrictions.
2 3
Stroke (history of cerebrovascular accident)
This condition is associated with increased risk for adverse health events as a result of pregnancy (Box 2).
1 2 Comment: Theoretical concern exists about the effect of LNG on lipids. Use of Cu-IUDs has no restrictions.
Valvular heart disease
Complicated valvular heart disease is a condition associated with increased risk for adverse health events as a result of pregnancy (Box 2).
Comment: According to the American Heart Association, administration of prophylactic antibiotics solely to prevent endocarditis is not recommended for patients who undergo genitourinary tract procedures, including insertion or removal of IUDs (74).
a. Uncomplicated 1 1
b. Complicated (pulmonary hypertension, risk for atrial fibrillation, or history of subacute bacterial endocarditis) 1 1
Peripartum cardiomyopathy
This condition is associated with increased risk for adverse health events as a result of pregnancy (Box 2).
Evidence: No direct evidence exists on the safety of IUDs among women with peripartum cardiomyopathy. Limited indirect evidence from noncomparative studies did not demonstrate any cases of arrhythmia or infective endocarditis in women with cardiac disease who used IUDs (75).Comment: IUD insertion might induce cardiac arrhythmias in healthy women; women with peripartum cardiomyopathy have a high incidence of cardiac arrhythmias.
a. Normal or mildly impaired cardiac function (New York Heart Association Functional Class I or II: patients with no limitation of activities or patients with slight, mild limitation of activity) (76)
i. <6 months 2 2
ii. ≥6 months 2 2
b. Moderately or severely impaired cardiac function (New York Heart Association Functional Class III or IV: patients with marked limitation of activity or patients who should be at complete rest) (76) 2 2
Rheumatic Diseases
Systemic lupus erythematosus
This condition is associated with increased risk for adverse health events as a result of pregnancy (Box 2).
Initiation Continuation
a. Positive (or unknown) antiphospholipid antibodies 1 1 3 Clarification: Persons with SLE are at increased risk for ischemic heart disease, stroke, and VTE. Categories assigned to such conditions in U.S. MEC should be the same for women with SLE who have these conditions. For all subconditions of SLE, classifications are based on the assumption that no other risk factors for cardiovascular disease are present; these classifications must be modified in the presence of such risk factors. Many women with SLE can be considered good candidates for most contraceptive methods, including hormonal contraceptives (73,7794).
Evidence: Antiphospholipid antibodies are associated with a higher risk for both arterial and venous thrombosis (95,96).
b. Severe thrombocytopenia 3 2 2 Clarification: Persons with SLE are at increased risk for ischemic heart disease, stroke, and VTE. Categories assigned to such conditions in U.S. MEC should be the same for women with SLE who have these conditions. For all subconditions of SLE, classifications are based on the assumption that no other risk factors for cardiovascular disease are present; these classifications must be modified in the presence of such risk factors. Many women with SLE can be considered good candidates for most contraceptive methods, including hormonal contraceptives (73,7794).
Clarification: Severe thrombocytopenia increases the risk for bleeding. The category should be assessed according to the severity of thrombocytopenia and its clinical manifestations. In women with very severe thrombocytopenia who are at risk for spontaneous bleeding, consultation with a specialist and certain pretreatments might be warranted.
Evidence: The LNG-IUD might be a useful treatment for menorrhagia in women with severe thrombocytopenia (73).
c. Immunosuppressive therapy 2 1 2 Clarification: Persons with SLE are at increased risk for ischemic heart disease, stroke, and VTE. Categories assigned to such conditions in U.S. MEC should be the same for women with SLE who have these conditions. For all subconditions of SLE, classifications are based on the assumption that no other risk factors for cardiovascular disease are present; these classifications must be modified in the presence of such risk factors. Many women with SLE can be considered good candidates for most contraceptive methods, including hormonal contraceptives (73,7794).
d. None of the above 1 1 2 Clarification: Persons with SLE are at increased risk for ischemic heart disease, stroke, and VTE. Categories assigned to such conditions in U.S. MEC should be the same for women with SLE who have these conditions. For all subconditions of SLE, classifications are based on the assumption that no other risk factors for cardiovascular disease are present; these classifications must be modified in the presence of such risk factors. Many women with SLE can be considered good candidates for most contraceptive methods, including hormonal contraceptives (73,7794).
Rheumatoid arthritis Initiation Continuation Initiation Continuation
a. Receiving immunosuppressive therapy 2 1 2 1
b. Not receiving immunosuppressive therapy 1 1
Neurologic Conditions
Headaches
a. Nonmigraine (mild or severe) 1 1
b. Migraine
i. Without aura (This category of migraine includes menstrual migraine.) 1 1 Evidence: No studies directly examined the risk for stroke among women with migraine using LNG-IUDs (97). Limited evidence demonstrated that women using LNG-IUDs do not have an increased risk for ischemic stroke compared with women not using hormonal contraceptives (98).Comment: Menstrual migraine is a subtype of migraine without aura. For more information see The International Headache Society Classification, 3rd edition (http://www.ihs-classification.org/_downloads/mixed/International-Headache-Classification-III-ICHD-III-2013-Beta.pdfpdf iconexternal icon).
ii. With aura 1 1
Epilepsy
This condition is associated with increased risk for adverse health events as a result of pregnancy (Box 2).
1 1
Multiple sclerosis
a. With prolonged immobility 1 1
b. Without prolonged immobility 1 1
Depressive Disorders
Depressive disorders 1 1 Clarification: If a woman is receiving psychotropic medications or St. John’s wort, see Drug Interactions section.
Evidence: The frequency of psychiatric hospitalizations for women with bipolar disorder or depression did not significantly differ among women using DMPA, LNG-IUD, Cu-IUD, or sterilization (99).
Reproductive Tract Infections and Disorders
Vaginal bleeding patterns Initiation Continuation
a. Irregular pattern without heavy bleeding 1 1 1
b. Heavy or prolonged bleeding (includes regular and irregular patterns) 2 1 2 Clarification: Unusually heavy bleeding should raise suspicion of a serious underlying condition.
Evidence: Evidence from studies examining the treatment effects of the LNG-IUD among women with heavy or prolonged bleeding reported no increase in adverse effects and found the LNG-IUD to be beneficial in treating menorrhagia (100107).
Unexplained vaginal bleeding
(suspicious for serious condition) before evaluation
Initiation
4
Continuation
2
Initiation
4
Continuation
2
Clarification: If pregnancy or an underlying pathological condition (e.g., pelvic malignancy) is suspected, it must be evaluated and the category adjusted after evaluation. The IUD does not need to be removed before evaluation.
Endometriosis 2 1 Evidence: LNG-IUD use among women with endometriosis decreased dysmenorrhea, pelvic pain, and dyspareunia (108112).
Benign ovarian tumors (including cysts) 1 1
Severe dysmenorrhea 2 1 Comment: Dysmenorrhea might intensify with Cu-IUD use. LNG-IUD use has been associated with reduction of dysmenorrhea.
Gestational trophoblastic disease
This condition is associated with increased risk for adverse health events as a result of pregnancy (Box 2).
a. Suspected gestational trophoblastic disease (immediate postevacuation) Clarification: For all subconditions of gestational trophoblastic disease, classifications are based on the assumption that women are under close medical supervision because of the need for monitoring of β-hCG levels for appropriate disease surveillance.Evidence: Limited evidence suggests that women using an IUD after uterine evacuation for a molar pregnancy are not at greater risk for postmolar trophoblastic disease than are women using other methods of contraception (113).

Comment: The risk for expulsion immediately postevacuation for gestational trophoblastic disease is unknown. Expulsion is greater after IUD insertion immediately postevacuation for a spontaneous or induced abortion in the second trimester compared with IUD insertion after a first trimester abortion.

i. Uterine size first trimester 1 1
ii. Uterine size second trimester 2 2
b. Confirmed gestational trophoblastic disease (after initial evacuation and during monitoring) Initiation Continuation Initiation Continuation
i. Undetectable/nonpregnant β-hCG levels 1 1 1 1 Clarification: For all subconditions of gestational trophoblastic disease, classifications are based on the assumption that women are under close medical supervision because of the need for monitoring of β-hCG levels for appropriate disease surveillance.
Evidence: Limited evidence suggests that women using an IUD after uterine evacuation for a molar pregnancy are not at greater risk for postmolar trophoblastic disease than are women using other methods of contraception (113).
Comment: Once β-hCG levels have decreased to nonpregnant levels, the risk for disease progression is likely to be very low.
ii. Decreasing β-hCG levels 2 1 2 1 Clarification: For all subconditions of gestational trophoblastic disease, classifications are based on the assumption that women are under close medical supervision because of the need for monitoring of β-hCG levels for appropriate disease surveillance.
Clarification: For women at higher risk for disease progression, the benefits of effective contraception must be weighed against the potential need for early IUD removal.
Evidence: Limited evidence suggests that women using an IUD after uterine evacuation for a molar pregnancy are not at greater risk for postmolar trophoblastic disease than are women using other methods of contraception (113).
iii. Persistently elevated β-hCG levels or malignant disease, with no evidence or suspicion of intrauterine disease 2 1 2 1 Clarification: For all subconditions of gestational trophoblastic disease, classifications are based on the assumption that women are under close medical supervision because of the need for monitoring of β-hCG levels for appropriate disease surveillance.
Evidence: Limited evidence suggests that women using an IUD after uterine evacuation for a molar pregnancy are not at greater risk for postmolar trophoblastic disease than are women using other methods of contraception (113).
iv. Persistently elevated β-hCG levels or malignant disease, with evidence or suspicion of intrauterine disease 4 2 4 2 Clarification: For all subconditions of gestational trophoblastic disease, classifications are based on the assumption that women are under close medical supervision because of the need for monitoring of β-hCG levels for appropriate disease surveillance.
Evidence: Limited evidence suggests that women using an IUD after uterine evacuation for a molar pregnancy are not at greater risk for postmolar trophoblastic disease than are women using other methods of contraception (113).
Comment: For women with suspected or confirmed intrauterine disease, an IUD should not be inserted because of theoretical risk for perforation, infection, and hemorrhage. For women who already have an IUD in place, individual circumstance along with the benefits of effective contraception must be weighed against theoretical risks of either removal or continuation of the IUD.
Cervical ectropion 1 1
Cervical intraepithelial neoplasia 1 2 Comment: Theoretical concern exists that LNG-IUDs might enhance progression of cervical intraepithelial neoplasia.
Cervical cancer (awaiting treatment) Initiation Continuation Initiation Continuation Comment: Concern exists about the increased risk for infection and bleeding at insertion. The IUD most likely will need to be removed at the time of treatment but until then, the woman is at risk for pregnancy.
4 2 4 2
Breast disease
Breast cancer is associated with increased risk for adverse health events as a result of pregnancy (Box 2).
a. Undiagnosed mass 1 2
b. Benign breast disease 1 1
c. Family history of cancer 1 1
d. Breast cancer Comment: Breast cancer is a hormonally sensitive tumor. Concerns about progression of the disease might be less with LNG-IUDs than with COCs or higher-dose POCs.
i. Current 1 4
ii. Past and no evidence of current disease for 5 years 1 3
Endometrial hyperplasia 1 1 Evidence: Among women with endometrial hyperplasia, no adverse health events occurred with LNG-IUD use; most women experienced disease regression (114).
Endometrial cancer
This condition is associated with increased risk for adverse health events as a result of pregnancy (Box 2).
Initiation Continuation Initiation Continuation Comment: Concern exists about the increased risk for infection, perforation, and bleeding at insertion. The IUD most likely will need to be removed at the time of treatment, but until then, the woman is at risk for pregnancy.
4 2 4 2
Ovarian cancer
This condition is associated with increased risk for adverse health events as a result of pregnancy (Box 2).
1 1 Comment: Women with ovarian cancer who undergo fertility-sparing treatment and need contraception may use an IUD.
Uterine fibroids 2 2 Evidence: Among women with uterine fibroids using an LNG-IUD, most experienced improvements in serum levels of hemoglobin, hematocrit, and ferritin and in menstrual blood loss (115). Rates of LNG-IUD expulsion were higher in women with uterine fibroids (11%) than in women without fibroids (0%–3%); these findings were either not statistically significant or significance testing was not conducted (115). Rates of expulsion found in noncomparative studies ranged from 0%–20% (115).
Comment: Women with heavy or prolonged bleeding should be assigned the category for that condition.
Anatomical abnormalities
a. Distorted uterine cavity (any congenital or acquired uterine abnormality distorting the uterine cavity in a manner that is incompatible with IUD insertion) 4 4 Comment: An anatomical abnormality that distorts the uterine cavity might preclude proper IUD placement.
b. Other abnormalities (including cervical stenosis or cervical lacerations) not distorting the uterine cavity or interfering with IUD insertion 2 2
Pelvic inflammatory disease Initiation Continuation Initiation Continuation
a. Past PID Comment: IUDs do not protect against STDs, including HIV, or PID. In women at low risk for STDs, IUD insertion poses little risk for PID.
i. With subsequent pregnancy 1 1 1 1
ii. Without subsequent pregnancy 2 2 2 2
b. Current PID 4 2 4 2 Clarification (continuation): Treat the PID using appropriate antibiotics. The IUD usually does not need to be removed if the woman wants to continue using it. Continued use of an IUD depends on the woman’s informed choice and her current risk factors for STDs and PID.
Evidence: Among IUD users treated for PID, clinical course did not differ regardless of whether the IUD was removed or left in place (116).
Sexually transmitted diseases Initiation Continuation Initiation Continuation
a. Current purulent cervicitis or chlamydial infection or gonococcal infection 4 2 4 2 Clarification (continuation): Treat the STD using appropriate antibiotics. The IUD usually does not need to be removed if the woman wants to continue using it. Continued use of an IUD depends on the woman’s informed choice and her current risk factors for STDs and PID.
Evidence: Among women who had an IUD inserted, the absolute risk for subsequent PID was low among women with STD at the time of insertion but greater than among women with no STD at the time of IUD insertion (117123).
b. Vaginitis (including Trichomonas vaginalis and bacterial vaginosis) 2 2 2 2
c. Other factors related to STDs 2 2 2 2 Clarification (initiation): Most women do not require additional STD screening at the time of IUD insertion. If a woman with risk factors for STDs has not been screened for gonorrhea and chlamydia according to CDC STD treatment guidelines (124), screening may be performed at the time of IUD insertion and insertion should not be delayed.
Evidence: Women who undergo same-day STD screening and IUD insertion have low incidence rates of PID. Algorithms for predicting PID among women with risk factors for STDs have poor predictive value. Risk for PID among women with risk factors for STDs is low (125).
HIV
High risk for HIV Initiation Continuation Initiation Continuation Evidence: Among women at risk for HIV, Cu-IUD use did not increase risk for HIV acquisition (126136).
2 2 2 2
HIV infection
For women with HIV infection who are not clinically well or not receiving ARV therapy, this condition is associated with increased risk for adverse health events as a result of pregnancy (Box 2).
Evidence: Among IUD users, limited evidence shows a low risk for PID among HIV-infected women using IUDs and no higher risk for pelvic infectious complications in HIV-infected than in HIV-noninfected women or among women with varying degrees of HIV severity. IUD use did not adversely affect progression of HIV during 6–45 months of follow-up or when compared with hormonal contraceptive use among HIV-infected women. Furthermore, IUD use among HIV-infected women was not associated with increased risk for transmission to sex partners or with increased genital viral shedding (137).
a. Clinically well receiving ARV therapy 1 1 1 1
b. Not clinically well or not receiving ARV therapy 2 1 2 1
Other Infections
Schistosomiasis
Schistosomiasis with fibrosis of the liver is associated with increased risk for adverse health events as a result of pregnancy (Box 2).
a. Uncomplicated 1 1
b. Fibrosis of the liver (if severe, see Cirrhosis section) 1 1
Tuberculosis
This condition is associated with increased risk for adverse health events as a result of pregnancy (Box 2).
Initiation Continuation Initiation Continuation
a. Nonpelvic 1 1 1 1
b. Pelvic 4 3 4 3 Comment: Insertion of an IUD might substantially worsen the condition.
Malaria 1 1
Endocrine Conditions
Diabetes
Insulin-dependent diabetes; diabetes with nephropathy, retinopathy, or neuropathy; diabetes with other vascular disease; or diabetes of >20 years’ duration are associated with increased risk for adverse health events as a result of pregnancy (Box 2).
a. History of gestational disease 1 1
b. Nonvascular disease Evidence: Limited evidence on the use of the LNG-IUD among women with insulin-dependent or non–insulin-dependent diabetes suggests that these methods have little effect on short-term or long-term diabetes control (e.g., glycosylated hemoglobin levels), hemostatic markers, or lipid profile (138,139).
i. Non-insulin dependent 1 2
ii. Insulin dependent 1 2
c. Nephropathy, retinopathy, or neuropathy 1 2
d. Other vascular disease or diabetes of >20 years’ duration 1 2
Thyroid disorders
a. Simple goiter 1 1
b. Hyperthyroid 1 1
c. Hypothyroid 1 1
Gastrointestinal Conditions
Inflammatory bowel disease (ulcerative colitis or Crohn’s disease) 1 1 Evidence: Although two case reports described three women with IBD who experienced exacerbation of disease 5 days–25 months after LNG-IUD insertion, no comparative studies have examined the safety of IUD use among women with IBD (140).
Gallbladder disease
a. Symptomatic
i. Treated by cholecystectomy 1 2
ii. Medically treated 1 2
iii. Current 1 2
b. Asymptomatic 1 2
History of cholestasis
a. Pregnancy related 1 1
b. Past COC related 1 2 Comment: Concern exists that history of COC related cholestasis might predict subsequent cholestasis with LNG use. Whether risk exists with use of LNG-IUD is unclear.
Viral hepatitis
a. Acute or flare 1 1
b. Carrier 1 1
c. Chronic 1 1
Cirrhosis
Severe cirrhosis is associated with increased risk for adverse health events as a result of pregnancy (Box 2).
a. Mild (compensated) 1 1
b. Severe (decompensated) 1 3
Liver tumors
Hepatocellular adenoma and malignant liver tumors are associated with increased risk for adverse health events as a result of pregnancy (Box 2).
a. Benign
i. Focal nodular hyperplasia 1 2
ii. Hepatocellular adenoma 1 3 Comment: No evidence is available about hormonal contraceptive use in women with hepatocellular adenoma. COC use in healthy women is associated with development and growth of hepatocellular adenoma; whether other hormonal contraceptives have similar effects is not known.
b. Malignant (hepatoma) 1 3
Respiratory Conditions
Cystic fibrosis
This condition is associated with increased risk for adverse health events as a result of pregnancy (Box 2).
1 1 Clarification: Persons with cystic fibrosis are at increased risk for diabetes, liver disease, gallbladder disease, and VTE (particularly related to use of central venous catheters) and are frequently prescribed antibiotics. Categories assigned to such conditions in U.S. MEC should be the same for women with cystic fibrosis who have these conditions. For cystic fibrosis, classifications are based on the assumption that no other conditions are present; these classifications must be modified in the presence of such conditions.
Anemias
Thalassemia 2 1 Comment: Concern exists about an increased risk for blood loss with Cu-IUDs.
Sickle cell disease
This condition is associated with increased risk for adverse health events as a result of pregnancy (Box 2).
2 1 Comment: Concern exists about an increased risk for blood loss with Cu-IUDs.
Iron deficiency anemia 2 1 Comment: Concern exists about an increased risk for blood loss with Cu-IUDs.
Solid Organ Transplantation
Solid organ transplantation
This condition is associated with increased risk for adverse health events as a result of pregnancy (Box 2).
Initiation Continuation Initiation Continuation Evidence: No comparative studies have examined IUD use among transplant patients. Four case reports of transplant patients using IUDs provided inconsistent results, including beneficial effects and contraceptive failures (141).
a. Complicated: graft failure (acute or chronic), rejection, or cardiac allograft vasculopathy 3 2 3 2
b. Uncomplicated 2 2 2 2
Drug Interactions
Antiretroviral therapy Initiation Continuation Initiation Continuation Clarification: No known interaction exists between ARV therapy and IUD use. However, IUD insertion is classified as category 2 if the woman is not clinically well or not receiving ARV therapy. Otherwise, both insertion and continuation are classified as category 1 (see HIV Infection section).
a. Nucleoside reverse transcriptase inhibitors (NRTIs)
i. Abacavir (ABC) 1/2 1 1/2 1
ii. Tenofovir (TDF) 1/2 1 1/2 1
iii. Zidovudine (AZT) 1/2 1 1/2 1
iv. Lamivudine (3TC) 1/2 1 1/2 1
v. Didanosine (DDI) 1/2 1 1/2 1
vi. Emtricitabine (FTC) 1/2 1 1/2 1
vii. Stavudine (D4T) 1/2 1 1/2 1
b. Nonnucleoside reverse transcriptase inhibitors (NNRTIs)
i. Efavirenz (EFV) 1/2 1 1/2 1
ii. Etravirine (ETR) 1/2 1 1/2 1
iii. Nevirapine (NVP) 1/2 1 1/2 1
iv. Rilpivirine (RPV) 1/2 1 1/2 1
c. Ritonavir-boosted protease inhibitors
i. Ritonavir-boosted atazanavir (ATV/r) 1/2 1 1/2 1
ii. Ritonavir-boosted darunavir (DRV/r) 1/2 1 1/2 1
iii. Ritonavir-boosted fosamprenavir (FPV/r) 1/2 1 1/2 1
iv. Ritonavir-boosted lopinavir (LPV/r) 1/2 1 1/2 1
v. Ritonavir-boosted saquinavir (SQV/r) 1/2 1 1/2 1
vi. Ritonavir-boosted tipranavir (TPV/r) 1/2 1 1/2 1
d. Protease inhibitors without ritonavir
i. Atazanavir (ATV) 1/2 1 1/2 1
ii. Fosamprenavir (FPV) 1/2 1 1/2 1
iii. Indinavir (IDV) 1/2 1 1/2 1
iv. Nelfinavir (NFV) 1/2 1 1/2 1
e. CCR5 co-receptor antagonists
i. Maraviroc (MVC) 1/2 1 1/2 1
f. HIV integrase strand transfer inhibitors
i. Raltegravir (RAL) 1/2 1 1/2 1
ii. Dolutegravir (DTG) 1/2 1 1/2 1
iii. Elvitegravir (EVG) 1/2 1 1/2 1
g. Fusion inhibitors
i. Enfuvirtide 1/2 1 1/2 1
Anticonvulsant therapy
a. Certain anticonvulsants (phenytoin, carbamazepine, barbiturates, primidone, topiramate, and oxcarbazepine) 1 1 Evidence: Limited evidence suggests use of certain anticonvulsants does not interfere with the contraceptive effectiveness of the LNG-IUD (142).
b. Lamotrigine 1 1 Evidence: No drug interactions have been reported among women with epilepsy who are receiving lamotrigine and using the LNG-IUD (143).
Antimicrobial therapy
a. Broad-spectrum antibiotics 1 1
b. Antifungals 1 1
c. Antiparasitics 1 1
d. Rifampin or rifabutin therapy 1 1 Evidence: One cross-sectional survey found that rifabutin had no impact on the effectiveness of the LNG-IUD (142).
Psychotropic medications Comment: For many common psychotropic agents, limited or no theoretical concern exists for clinically significant drug interactions when co-administered with hormonal contraceptives. However, either no or very limited data exist examining potential interactions for these classes of medications.
a. SSRIs 1 1
St. John’s wort 1 1

Abbreviations: ARV = antiretroviral; BMI = body mass index; COC = combined oral contraceptive; Cu-IUD = copper-containing IUD; DVT = deep venous thrombosis; hCG = human chorionic gonadotropin; HDL = high-density lipoprotein; HIV = human immunodeficiency virus; IBD = inflammatory bowel disease; IUD = intrauterine device; LDL = low-density lipoprotein; LNG = levonorgestrel; LNG-IUD = levonorgestrel-releasing IUD; PE = pulmonary embolism; PID = pelvic inflammatory disease; POC = progestin-only contraceptive; SLE = systemic lupus erythematosus; SSRI = selective serotonin reuptake inhibitor; STD = sexually transmitted disease; VTE = venous thromboembolism.

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