U.S. Medical Eligibility Criteria for Contraceptive Use, 2024.

The 2024 U.S. Medical Eligibility Criteria for Contraceptive Use (U.S. MEC) comprises recommendations for the use of specific contraceptive methods by persons who have certain characteristics or medical conditions. These recommendations for health care providers were updated by CDC after review of the scientific evidence and a meeting with national experts in Atlanta, Georgia, during January 25-27, 2023. The information in this report replaces the 2016 U.S. MEC (CDC. U.S. Medical Eligibility Criteria for Contraceptive Use, 2016. MMWR 2016:65[No. RR-3]:1-103). Notable updates include 1) the addition of recommendations for persons with chronic kidney disease; 2) revisions to the recommendations for persons with certain characteristics or medical conditions (i.e., breastfeeding, postpartum, postabortion, obesity, surgery, deep venous thrombosis or pulmonary embolism with or without anticoagulant therapy, thrombophilia, superficial venous thrombosis, valvular heart disease, peripartum cardiomyopathy, systemic lupus erythematosus, high risk for HIV infection, cirrhosis, liver tumor, sickle cell disease, solid organ transplantation, and drug interactions with antiretrovirals used for prevention or treatment of HIV infection); and 3) inclusion of new contraceptive methods, including new doses or formulations of combined oral contraceptives, contraceptive patches, vaginal rings, progestin-only pills, levonorgestrel intrauterine devices, and vaginal pH modulator. The recommendations in this report are intended to serve as a source of evidence-based clinical practice guidance for health care providers. The goals of these recommendations are to remove unnecessary medical barriers to accessing and using contraception and to support the provision of person-centered contraceptive counseling and services in a noncoercive manner. Health care providers should always consider the individual clinical circumstances of each person seeking contraceptive services. This report is not intended to be a substitute for professional medical advice for individual patients; when needed, patients should seek advice from their health care providers about contraceptive use.

Case Series of Thrombosis With Thrombocytopenia Syndrome After COVID-19 Vaccination-United States, December 2020 to August 2021.

BACKGROUND: Thrombosis with thrombocytopenia syndrome (TTS) is a potentially life-threatening condition associated with adenoviral-vectored COVID-19 vaccination. It presents similarly to spontaneous heparin-induced thrombocytopenia. Twelve cases of cerebral venous sinus thrombosis after vaccination with the Ad26.COV2.S COVID-19 vaccine (Janssen/Johnson & Johnson) have previously been described. OBJECTIVE: To describe surveillance data and reporting rates of all reported TTS cases after COVID-19 vaccination in the United States. DESIGN: Case series. SETTING: United States. PATIENTS: Case patients receiving a COVID-19 vaccine from 14 December 2020 through 31 August 2021 with thrombocytopenia and thrombosis (excluding isolated ischemic stroke or myocardial infarction) reported to the Vaccine Adverse Event Reporting System. If thrombosis was only in an extremity vein or pulmonary embolism, a positive enzyme-linked immunosorbent assay for antiplatelet factor 4 antibodies or functional heparin-induced thrombocytopenia platelet test result was required. MEASUREMENTS: Reporting rates (cases per million vaccine doses) and descriptive epidemiology. RESULTS: A total of 57 TTS cases were confirmed after vaccination with Ad26.COV2.S (n = 54) or a messenger RNA (mRNA)-based COVID-19 vaccine (n = 3). Reporting rates for TTS were 3.83 per million vaccine doses (Ad26.COV2.S) and 0.00855 per million vaccine doses (mRNA-based COVID-19 vaccines). The median age of patients with TTS after Ad26.COV2.S vaccination was 44.5 years (range, 18 to 70 years), and 69% of patients were women. Of the TTS cases after mRNA-based COVID-19 vaccination, 2 occurred in men older than 50 years and 1 in a woman aged 50 to 59 years. All cases after Ad26.COV2.S vaccination involved hospitalization, including 36 (67%) with intensive care unit admission. Outcomes of hospitalizations after Ad26.COV2.S vaccination included death (15%), discharge to postacute care (17%), and discharge home (68%). LIMITATIONS: Underreporting and incomplete case follow-up. CONCLUSION: Thrombosis with thrombocytopenia syndrome is a rare but serious adverse event associated with Ad26.COV2.S vaccination. The different demographic characteristics of the 3 cases reported after mRNA-based COVID-19 vaccines and the much lower reporting rate suggest that these cases represent a background rate. PRIMARY FUNDING SOURCE: Centers for Disease Control and Prevention.

Use of COVID-19 Vaccines After Reports of Adverse Events Among Adult Recipients of Janssen (Johnson & Johnson) and mRNA COVID-19 Vaccines (Pfizer-BioNTech and Moderna): Update from the Advisory Committee on Immunization Practices - United States, July 2021.

In December 2020, the Food and Drug Administration (FDA) issued Emergency Use Authorizations (EUAs) for Pfizer-BioNTech and Moderna COVID-19 vaccines, and in February 2021, FDA issued an EUA for the Janssen (Johnson & Johnson) COVID-19 vaccine. After each EUA, the Advisory Committee on Immunization Practices (ACIP) issued interim recommendations for vaccine use; currently Pfizer-BioNTech is authorized and recommended for persons aged ≥12 years and Moderna and Janssen for persons aged ≥18 years (1-3). Both Pfizer-BioNTech and Moderna vaccines, administered as 2-dose series, are mRNA-based COVID-19 vaccines, whereas the Janssen COVID-19 vaccine, administered as a single dose, is a recombinant replication-incompetent adenovirus-vector vaccine. As of July 22, 2021, 187 million persons in the United States had received at least 1 dose of COVID-19 vaccine (4); close monitoring of safety surveillance has demonstrated that serious adverse events after COVID-19 vaccination are rare (5,6). Three medical conditions have been reported in temporal association with receipt of COVID-19 vaccines. Two of these (thrombosis with thrombocytopenia syndrome [TTS], a rare syndrome characterized by venous or arterial thrombosis and thrombocytopenia, and Guillain-Barré syndrome [GBS], a rare autoimmune neurologic disorder characterized by ascending weakness and paralysis) have been reported after Janssen COVID-19 vaccination. One (myocarditis, cardiac inflammation) has been reported after Pfizer-BioNTech COVID-19 vaccination or Moderna COVID-19 vaccination, particularly after the second dose; these were reviewed together and will hereafter be referred to as mRNA COVID-19 vaccination. ACIP has met three times to review the data associated with these reports of serious adverse events and has comprehensively assessed the benefits and risks associated with receipt of these vaccines. During the most recent meeting in July 2021, ACIP determined that, overall, the benefits of COVID-19 vaccination in preventing COVID-19 morbidity and mortality outweigh the risks for these rare serious adverse events in adults aged ≥18 years; this balance of benefits and risks varied by age and sex. ACIP continues to recommend COVID-19 vaccination in all persons aged ≥12 years. CDC and FDA continue to closely monitor reports of serious adverse events and will present any additional data to ACIP for consideration. Information regarding risks and how they vary by age and sex and type of vaccine should be disseminated to providers, vaccine recipients, and the public.

Required examinations and tests before initiating contraception: Provider practices from a national cross-sectional survey.

OBJECTIVE(S): We estimated the prevalence of requiring specific examinations or tests before providing contraception in a nationwide survey of family planning providers. STUDY DESIGN: We conducted a cross-sectional survey of public-sector health centers and office-based physicians providing family planning services across the United States in 2019 (n = 1395). We estimated the weighted proportion of providers (or their health center or practice) who required blood pressure measurement, pelvic examination (bimanual examination and cervical inspection), Papanicolaou (Pap) smear, clinical breast examination (CBE), and chlamydia and gonorrhea (CT/GC) screening before initiating hormonal or intrauterine contraception (IUC) for healthy women. We performed multivariable regression to identify factors associated with pelvic examination practices aligned with clinical recommendations; these recommendations classify examinations and tests as recommended or unnecessary before initiation of specific contraceptive methods. RESULTS: The overall response rate was 51%. Most providers required blood pressure measurement before initiating each method. Unnecessary CBE, Pap smears, and CT/GC screening were required by 14% to 33% of providers across methods. Fifty-two to 62% of providers required recommended pelvic examination before IUC placement; however, 16% to 23% of providers required unnecessary pelvic examinations before non-intrauterine hormonal method initiation. Factors associated with recommendation-aligned pelvic examination practices included having a higher proportion of patients using public funding (Medicaid or other assistance) and more recently completing formal clinical training. CONCLUSIONS: Almost half (47%) of providers did not require necessary pelvic examination before placing IUC. Conversely, many providers required unnecessary examinations and tests before contraception initiation for patients. IMPLICATIONS: Most providers required the few recommended examinations and tests for safe contraceptive provision. Reduction of unnecessary examinations and tests may reduce barriers to contraceptive access. There are also opportunities to increase use of recommended examinations, as up to 48% of providers did not require recommended pelvic examination before IUC.

Hormonal Contraceptive Use Among Women of Older Reproductive Age: Considering Risks and Benefits.

As women approach menopause, fertility declines but pregnancy can still occur. Maternal and infant risks are increased among women of older reproductive age compared with younger women. A high proportion of pregnancies among women of older reproductive age are unintended and these pregnancies can also be associated with negative maternal and infant consequences. However, women and their healthcare providers may have concerns about risks associated with contraceptive use, particularly combined hormonal contraceptives, among women of older reproductive age who already may be at increased risk for conditions such as cardiovascular disease and breast cancer. Nonetheless, available evidence does not suggest that hormonal contraceptive use among women of older reproductive age substantially increases age-related risks of cardiovascular events or breast cancer. CDC recommends that contraception is still needed for women older than 44 years who have not reached menopause and wish to avoid pregnancy, and that based on age alone, all contraceptive methods are considered safe or generally safe for use by women of older reproductive age.

Nonoral combined hormonal contraceptives and thromboembolism: a systematic review.

BACKGROUND: Combined hormonal contraceptives (CHCs), containing estrogen and progestin, are associated with an increased risk of venous thromboembolism (VTE) and arterial thromboembolism (ATE) compared with nonuse. Few studies have examined whether nonoral formulations (including the combined hormonal patch, combined vaginal ring and combined injectable contraceptives) increase the risk of thrombosis compared with combined oral contraceptives (COCs). OBJECTIVES: The objectives were to examine the risk of VTE and ATE among women using nonoral CHCs compared to women using COCs. METHODS: We searched the PubMed database for all English language articles published from database inception through May 2016. We included primary research studies that examined women using the patch, ring or combined injectables compared with women using levonorgestrel-containing or norgestimate-containing COCs. Outcomes of interest included VTE (deep venous thrombosis or pulmonary embolism) or ATE (acute myocardial infarction or ischemic stroke). We assessed the quality of each individual piece of evidence using the system developed by the United States Preventive Services Task Force. RESULTS: Eight studies were identified that met inclusion criteria. Of seven analyses from six studies examining VTE among patch users compared with levonorgestrel- or norgestimate-containing COC users, two found a statistically significantly elevated risk among patch users (risk estimates 2.2-2.3), one found an elevated risk that did not meet statistical significance (risk estimate 2.0), and four found no increased risk. Of three studies examining VTE among ring users compared with levonorgestrel COC users, one found a statistically significantly elevated risk among patch users (risk estimate 1.9) and two did not. Two studies did not find an increased risk for ATE among women using the patch compared with norgestimate COCs. We did not identify any studies examining combined injectable contraceptives. CONCLUSION: Limited Level II-2 good to fair evidence demonstrated conflicting results on whether women using the patch or the ring have a higher risk of VTE than women using COCs. Evidence did not demonstrate an increased risk of ATE among women using the patch. Overall, any potential elevated risk likely represents a small number of events on a population level. Additional studies with standard methodology are needed to further clarify any associations and better understand mechanisms of hormone-induced thrombosis among users of nonoral combined hormonal contraception.

U.S. Medical Eligibility Criteria for Contraceptive Use, 2016.

The 2016 U.S. Medical Eligibility Criteria for Contraceptive Use (U.S. MEC) comprises recommendations for the use of specific contraceptive methods by women and men who have certain characteristics or medical conditions. These recommendations for health care providers were updated by CDC after review of the scientific evidence and consultation with national experts who met in Atlanta, Georgia, during August 26-28, 2015. The information in this report updates the 2010 U.S. MEC (CDC. U.S. medical eligibility criteria for contraceptive use, 2010. MMWR 2010:59 [No. RR-4]). Notable updates include the addition of recommendations for women with cystic fibrosis, women with multiple sclerosis, and women receiving certain psychotropic drugs or St. John's wort; revisions to the recommendations for emergency contraception, including the addition of ulipristal acetate; and revisions to the recommendations for postpartum women; women who are breastfeeding; women with known dyslipidemias, migraine headaches, superficial venous disease, gestational trophoblastic disease, sexually transmitted diseases, and human immunodeficiency virus; and women who are receiving antiretroviral therapy. The recommendations in this report are intended to assist health care providers when they counsel women, men, and couples about contraceptive method choice. Although these recommendations are meant to serve as a source of clinical guidance, health care providers should always consider the individual clinical circumstances of each person seeking family planning services. This report is not intended to be a substitute for professional medical advice for individual patients. Persons should seek advice from their health care providers when considering family planning options.

Developing Federal Clinical Care Recommendations for Women.

UNLABELLED: The provision of family planning services has important health benefits for the U.S. POPULATION: Approximately 25 million women in the U.S. receive contraceptive services annually and 44 million make at least one family planning-related clinical visit each year. These services are provided by private clinicians, as well as publicly funded clinics, including specialty family planning clinics, health departments, Planned Parenthoods, community health centers, and primary care clinics. Recommendations for providing quality family planning services have been published by CDC and the Office of Population Affairs of the DHHS. This paper describes the process used to develop the women's clinical services portion of the new recommendations and the rationale underpinning them. The recommendations define family planning services as contraceptive care, pregnancy testing and counseling, achieving pregnancy, basic infertility care, sexually transmitted disease services, and preconception health. Because many women who seek family planning services have no other source of care, the recommendations also include additional screening services related to women's health, such as cervical cancer screening. These clinical guidelines are aimed at providing the highest-quality care and are designed to establish a national standard for family planning in the U.S.

Physical examination prior to initiating hormonal contraception: a systematic review.

BACKGROUND: Provision of contraception is often linked with physical examination, including clinical breast examination (CBE) and pelvic examination. This review was conducted to evaluate the evidence regarding outcomes among women with and without physical examination prior to initiating hormonal contraceptives. STUDY DESIGN: The PubMed database was searched from database inception through March 2012 for all peer-reviewed articles in any language concerning CBE and pelvic examination prior to initiating hormonal contraceptives. The quality of each study was assessed using the United States Preventive Services Task Force grading system. RESULTS: The search did not identify any evidence regarding outcomes among women screened versus not screened with CBE prior to initiation of hormonal contraceptives. The search identified two case-control studies of fair quality which compared women who did or did not undergo pelvic examination prior to initiating oral contraceptives (OCs) or depot medroxyprogesterone acetate (DMPA). No differences in risk factors for cervical neoplasia, incidence of sexually transmitted infections, incidence of abnormal Pap smears or incidence of abnormal wet mount findings were observed. CONCLUSIONS: Although women with breast cancer should not use hormonal contraceptives, there is little utility in screening prior to initiation, due to the low incidence of breast cancer and uncertain value of CBE among women of reproductive age. Two fair quality studies demonstrated no differences between women who did or did not undergo pelvic examination prior to initiating OCs or DMPA with respect to risk factors or clinical outcomes. In addition, pelvic examination is not likely to detect any conditions for which hormonal contraceptives would be unsafe.

Pregnancies after hysteroscopic sterilization: a systematic review.

BACKGROUND: Female sterilization is the second most commonly used form of contraception in the United States. Newer approaches to female sterilization, including hysteroscopic methods, have been approved for use in the United States since 2002. Little is known about the occurrence and timing of pregnancies after these procedures. STUDY DESIGN: The objective of this systematic review was to identify evidence that assesses when and how often pregnancies occur following hysteroscopic sterilization. The PubMed database was searched for all studies published from database inception through March 2012 that reported whether or not pregnancies occurred following hysteroscopic sterilization. RESULTS: Twenty-four original research articles of fair quality met the inclusion criteria: 22 studies of women who underwent Essure® placement and 2 studies of women who underwent Adiana® placement. Eleven articles that documented bilateral tubal occlusion with hysterosalpingogram (HSG) or placement with X-ray or ultrasound following Essure® placement did not report any pregnancies with follow-up ranging from 7 months to 7 years. The remaining 11 articles identified 102 reported pregnancies. Eighteen of these pregnancies occurred prior to the 3-month period required before imaging for contraceptive reliability. Two articles did not report what follow-up imaging was performed among women after Essure® placement; one of these articles reported three pregnancies. Two reports from the same study of women who underwent Adiana® placement reported six pregnancies during the first year of follow-up, three pregnancies during the second year of follow-up and no pregnancies during the third year of follow-up. CONCLUSIONS: Fair-quality evidence suggests that among women who were followed beyond 3 months after hysteroscopic sterilization, pregnancies were rare and generally occurred among women who had no imaging follow-up or had inadequate confirmation of placement or occlusion. Few pregnancies occurred in women with documented bilateral tubal occlusion by HSG or correct placement at 3 months by ultrasound or X-ray. Only one study reported follow-up past 5 years. Further studies are needed to address the long-term effectiveness of hysteroscopic sterilization.

Laboratory screening prior to initiating contraception: a systematic review.

BACKGROUND: Certain contraceptive methods may increase the risk of adverse events for women with certain medical conditions, including some women with diabetes, hyperlipidemia, liver disease, cervical cancer, sexually transmitted infections (STIs) or human immunodeficiency virus (HIV). This review was conducted to evaluate the evidence regarding health outcomes among women with and without laboratory testing to identify certain medical conditions prior to initiating contraceptives. STUDY DESIGN: The PubMed database was searched from database inception through April 2012 for all peer-reviewed articles in any language evaluating health outcomes among women who initiated certain contraceptive methods and who had or had not received glucose, lipid, liver enzyme, cervical cytology, STI or HIV screening. RESULTS: The systematic review did not identify any relevant direct evidence. CONCLUSIONS: While certain methods of hormonal contraception may not be safe for use by some women with diabetes, hyperlipidemia or liver disease, there is little value in screening for these conditions in asymptomatic women prior to initiation of contraceptive methods due to the low prevalence of these conditions among women of reproductive age. Although intrauterine devices (IUDs) and cervical caps should not be initiated in women with cervical cancer, the high rates of cervical screening and low incidence of cervical cancer in the United States make this scenario unlikely. Although some women at risk for, or infected with, STIs or HIV should not undergo IUD insertion, if women have been screened for STIs or HIV according to guidelines, additional screening at the time of IUD insertion is not warranted. Requiring unnecessary laboratory screening prior to initiation of contraceptive methods may impose barriers to contraceptive access, and efforts to remove such barriers are critical in reducing unintended pregnancy.

Intrauterine device use among women with uterine fibroids: a systematic review.

BACKGROUND: There are concerns that intrauterine device (IUD) use by women with uterine fibroids might increase their uterine bleeding or risk for device expulsion. The objective of this systematic review was to evaluate evidence concerning the safety and effectiveness of IUD use among women with uterine fibroids. Key questions included whether IUD use is associated with increased risk for uterine bleeding among women with uterine fibroids and whether the presence of uterine fibroids is associated with an increased risk for device expulsion among IUD users. STUDY DESIGN: We searched the PubMed database for peer-reviewed articles relevant to IUD (copper or levonorgestrel-releasing) use and uterine fibroids published in any language from database inception through June 2009. We used standard abstract forms and a grading system to summarize and assess the quality of the evidence. RESULTS: From 202 articles found in the database search, we identified 11 studies that met our inclusion criteria, all of which examined outcomes among users of the levonorgestrel-releasing IUD (LNG-IUD). Evidence from 10 of 11 noncomparative studies (Level II-3, fair) suggests that LNG-IUD use among women with fibroids does not increase menstrual bleeding, and results from all 11 showed that menstrual blood loss decreased among women who continued to use the LNG-IUD through the end of the study period. Overall, serum levels of hemoglobin, hematocrit and ferritin increased among LNG-IUD users in studies that assessed these outcomes. Several studies reported some occurrences of irregular bleeding. Findings from two cohort studies (Level II-2, fair to poor) showed rates of LNG-IUD expulsion to be higher among women with uterine fibroids (11% in each) than among women without uterine fibroids (0% and 3%); however, in one study the difference was not statistically significant, and in the other significance testing was not conducted. Six prospective noncomparative studies reported expulsion rates of 0-20% among women with uterine fibroids. CONCLUSIONS: Most women with uterine fibroids are likely to have less menstrual blood loss and higher serum levels of hemoglobin, hematocrit and ferritin after insertion of an LNG-IUD, despite some occurrences of irregular bleeding. LNG-IUD users with uterine fibroids may have higher rates of expulsion than those without fibroids.

Use of contraceptive methods among women with endometrial hyperplasia: a systematic review.

BACKGROUND: The objective of this systematic review is to evaluate the evidence for the safety of contraceptive use among women with endometrial hyperplasia. STUDY DESIGN: We searched the PubMed database for peer-reviewed articles published in any language from database inception through February 2009 concerning the safety of using any contraceptive method among women diagnosed with endometrial hyperplasia. We excluded case reports but included all other study designs. The quality of each individual piece of evidence was assessed using the United States Preventive Services Task Force grading system. RESULTS: We identified nine articles that met the criteria for review. Each study examined levonorgestrel intrauterine devices (LNG-IUDs); no studies were identified that examined other contraceptive methods. Overall, these studies suggest that LNG-IUD use is not associated with adverse health events among women diagnosed with endometrial hyperplasia. Disease regression with LNG-IUD use was observed in all women in seven studies, in 90% of women in one study, and in 67% of women in one study. Limitations of the studies include small sample sizes and lack of a comparison group or nonrandomized assignment to LNG-IUD. CONCLUSIONS: There is fair quality evidence indicating that use of the LNG-IUD is safe for women with endometrial hyperplasia and may have therapeutic benefits.