Authors: Meghan Etsey; Rhea Manohar, MPH; Sarv Raafati; Teresa Lazar, MD, MSEd on behalf of the Gender Equity Task Force

We talk a lot about barriers in healthcare. Barriers to access. Barriers to care. Barriers that slow things down. What it rarely talks about is how often “safety” is used to justify barriers that fall almost exclusively on women. Nexplanon, the etonogestrel (progestin-only) contraceptive implant, is one of the safest and most effective forms of contraception available today, with a first-year failure rate of approximately 0.1% (Curtis & Peipert, 2017). It works consistently across body-mass indices, requires no daily action, and has some of the highest continuation rates of any contraceptive method. For these reasons and after rigorous scientific evaluation, the FDA recently approved Nexplanon for extended duration use up to 5-years. With this decision came a requirement that Nexplanon remain behind a Risk Evaluation and Mitigation Strategy (REMS) program.

The FDA-required Nexplanon REMS mandates that providers complete specific certification training before insertion or removal, that pharmacies be specially certified to dispense it, and that distributors limit access only to those certified entities (Food and Drug Administration [FDA], 2026). The justification? Improper insertion can lead to complications, including pain, paresthesia, bleeding, hematoma, scarring, infection, and migration to vasculature (including pulmonary vessels). Incorrect or deep insertions occur at a rate of approximately 12.6 per 1,000 insertions, while true vascular injury occurs in just 0.3 per 1,000 cases (FDA, 2026). Neurologic symptoms such as numbness or paresthesia occur at similarly low rates, and most insertion-site reactions are minor and self-limited.

Patient safety must always remain central. At the same time, safeguards should be proportional to risk and should not unnecessarily restrict access, particularly when the clinicians performing these procedures are already extensively trained. Physicians and advanced clinicians complete years of formal medical education, procedural training, supervised clinical practice, board certification, and ongoing continuing medical education. Manufacturer-specific training for Nexplanon insertion was already required prior to the REMS designation, directly addressing procedural competency and mitigating the very risks cited as justification for additional restrictions.

The concern, then, is not the existence of safeguards, but whether layering additional regulatory requirements meaningfully improves safety or instead introduces unintended barriers. Certification requirements, limited dispensing pathways, and restricted training availability can potentially disproportionately affect rural clinics, community health centers, and safety-net institutions, settings where access to reproductive care is already fragile. When training opportunities are limited by geography, cost, or scheduling, patients are the ones who bear the consequences through delayed care, reduced availability, or complete loss of access to a highly effective contraceptive option.

Safety and access are not opposing goals; they must be pursued together. Protocols such as REMS warrant ongoing evaluation to ensure they are evidence-based, equitable, and responsive to real-world clinical practice. To ensure that safety measures like REMS do not become additional barriers to women’s health, particularly in rural and underserved settings, several principles must guide their design and ongoing evaluation.

  1. Access to required training must be universal, flexible, and free. If certification is mandated, then training must be available on demand, without geographic, financial, or scheduling barriers. Asynchronous online modules, integration into residency and continuing medical education, and elimination of travel-based requirements are essential to avoid excluding clinicians who already practice in high-need areas.
  2. Existing clinical training and competency must be recognized. REMS programs should acknowledge the extensive education, procedural training, and ongoing certification already required of clinicians. Board certification, institutional privilege, or demonstrated procedural competency should allow for streamlined or automatic certification, rather than duplicative requirements that imply a lack of trust in clinicians’ expertise.
  3. Safeguards must not restrict care to narrow providers or geographic pools. Certification pathways should explicitly include advanced practice clinicians and align with established scope-of-practice laws. Distributors and pharmacies should be required to ensure equitable access across rural and underserved regions, with monitoring and accountability for geographic gaps in availability.
  4. Equity impact must be assessed alongside safety outcomes. REMS programs should undergo routine review not only for complication rates, but also for their effects on access, wait times, and disparities in care. If a safety program does not demonstrate meaningful improvement in outcomes, its restrictions should be scaled back or sunsetted rather than perpetuated by default.
  5. Timely access itself must be recognized as a patient safety issue. Delays in contraceptive access increase the risk of unintended pregnancy and associated morbidity. Safety frameworks must balance rare procedural risks against the very real harms of restricted or delayed reproductive care, treating access as a core component of patient-centered safety.

Protecting patients means more than preventing rare complications. It means ensuring timely, equitable access to evidence-based care. When safeguards begin to obstruct that access, it is no longer safety that is being served.

References

  1. American College of Obstetricians and Gynecologists. (2017). Practice Bulletin No. 186: Long-acting reversible contraception: Implants and intrauterine devices. Obstetrics & Gynecology, 130(5), e251–e269. 
  2. Curtis, K. M., & Peipert, J. F. (2017). Long-acting reversible contraception. New England Journal of Medicine, 376(5), 461–468. https://doi.org/10.1056/NEJMcp1608736
  3. Fassett, M. J., Reed, S. D., Rothman, K. J., et al. (2023). Risks of uterine perforation and expulsion associated with intrauterine devices. Obstetrics & Gynecology, 141(2), 276–286. https://doi.org/10.1097/AOG.0000000000005211 
  4. Food and Drug Administration. (2026). Nexplanon (etonogestrel implant) prescribing information. U.S. Department of Health and Human Services.
  5. Gatz, J. L., Armstrong, M. A., Postlethwaite, D., et al. (2022). Association between intrauterine device type and risk of perforation and device expulsion. American Journal of Obstetrics and Gynecology, 227(2), 270.e1–270.e11. https://doi.org/10.1016/j.ajog.2022.03.030 
  6. Reed, S. D., Zhou, X., Ichikawa, L., et al. (2022). Intrauterine device–related uterine perforation incidence and risk (APEX-IUD): A large multisite cohort study. The Lancet, 399(10336), 2103–2112. https://doi.org/10.1016/S0140-6736(22)00410-0 

About the Authors

Meghan Etsey, MS4

Meghan Etsey is a fourth year medical student from St. George’s University. She has a Bachelors of Arts in Biology and a Bachelors of Arts in Nutrition and Dietetics from Bluffton University in Bluffton, Ohio. She served as the President of the St. George’s University’s Women in Medicine chapter in St. George, Grenada where she expanded relationships with the community and worked towards educating women and helping the youth. She is also a member of the Gender Equity Task Force and Sex and Gender Health Collaborative Committees within the American Medical Women’s Association. When she is not pursuing medicine, you can find her with her friends and family on different road trips and adventures exploring the world. 

Rhea Manohar, MPH, MS3

Rhea Manohar is a third year medical student from St. George’s University. She has a Masters in Public Health with a concentration in Maternal and Child Health from George Washington University Milken Institute of Public Health and a Bachelors of Science in Microbiology & Immunology, and Public Health from the University of Miami. She served as Co-VP of OB/GYN Education for St. George’s University’s Women in Medicine chapter in St. George, Grenada where she developed hands-on workshops to further reproductive health issues and navigating challenging physician-patient communication scenarios. Prior to medical school, she was a Research Associate for Fors Marsh Group, where she led qualitative and quantitative public health research and campaign development for federal agencies (e.g., CDC, NIH, DHHS, CPSC). She is also a member of the Gender Equity Task Force of the American Medical Women’s Association. When she is not pursuing medicine, you can find her reading, exploring artistic passions, and spending time connecting with friends and family.

Sarv Raafati MS3

Sarv Raafati is a third year medical student at St. George’s University. She completed her undergraduate at the University of Utah with a Bachelor of Science in Biomedical Engineering and a minor in Middle East Studies. She also holds a ​Bachelor of Medical Science from Northumbria University in England. During her time at SGU she was the lesson coordinator in STEMM, an organization committed to providing lessons to local classrooms in Science, Technology, Engineering, Math, and Medicine. When not focusing on medicine she can be found at your local rock climbing gym, reading, skiing, or just randomly exploring to find the best coffee shop to study. 

Teresa Lazar, MD, MSEd

Teresa Lazar, MD MSEd is the clerkship director of the Advanced Clinical Experience in Obstetrics and Gynecology and Assistant Professor at the Donald and Barbara Zucker School of Medicine at Hofstra Northwell (ZSOM). She obtained her medical degree and completed her residency in obstetrics and gynecology from the State University of New York Health Science Center in Brooklyn and graduated with a Master of Science in Education degree in health professions from Hofstra University. Dr. Lazar was recognized with the APGO Excellence in Teaching Award and is a member of the Academy of Medical Educators and Alpha Omega Alpha Honor Medical Society at the ZSOM. Currently, a member of the American Medical Women’s Association Gender Equity Task Force and the Education Committee. Dr. Lazar is board certified by the American Board of Obstetrics and Gynecology, areas of clinical interest include general obstetrical care, gynecologic care and pelvic ultrasounds. Additionally, she is passionate about medical education, faculty development, communication, and leadership. She is fluent in both English and Spanish.

Formatting, publication management, and editorial support for the AMWA GETF Blog by Vaishnavi J. Patel, DO