FDA’s ENG Label Change: What To Know

Implanon (etonogestrel implant) first received FDA approval in 2006, followed by the improved, radiopaque version, Nexplanon, approved by the FDA in 2010, which is now the only contraceptive implant available in the U.S. It was originally FDA approved for a 3-year use duration, although peer reviewed clinical data had demonstrated efficacy through year 5. Now, as of January 2026, the FDA has formally agreed to extend the label for 5-year use. In this episode, we will review the clinical data that prompted the FDA’s decision, based on a multicenter, single-arm, open-label study evaluating contraceptive efficacy and safety during years 4 and 5 of implant use.1. https://www.contemporaryobgyn.net/view/fda-approves-5-year-use-for-etonogestrel-implant-68-mg-contraceptive2. Organon announces US Food and Drug Administration approval of supplemental new drug application extending duration of use of NEXPLANON (etonogestrel implant) 68 mg Radiopaque. Organon. Press release. January 16, 2026. Accessed January 19, 2026. https://www.organon.com/news/organon-announces-us-food-and-drug-administration-approval-of-supplemental-new-drug-application-extending-duration-of-use-of-nexplanon-etonogestrel-implant-68-mg-radiopaque/3. Ali M, Akin A, Bahamondes L, et al. Extended Use Up to 5 Years of the Etonogestrel-Releasing Subdermal Contraceptive Implant: Comparison to Levonorgestrel-Releasing Subdermal Implant. Human Reproduction. 2016. 4. McNicholas C, Swor E, Wan L, Peipert JF. Prolonged Use of the Etonogestrel Implant and Levonorgestrel Intrauterine Device: 2 Years Beyond Food and Drug Administration-Approved Duration. American Journal of Obstetrics and Gynecology. 2017. 5. McNicholas C, Maddipati R, Zhao Q, Swor E, Peipert JF. Use of the Etonogestrel Implant and Levonorgestrel Intrauterine Device Beyond the U.S. Food and Drug Administration-Approved Duration. Obstetrics and Gynecology. 2015.

Ursodiol (ursodeoxycholic acid) is a prescription bile acid medication used to dissolve cholesterol gallstones, prevent gallstones during rapid weight loss, and treat liver diseases like primary biliary cholangitis (PBC) by reducing toxic bile acids and cholesterol production. It works by changing bile composition, making it less saturated with cholesterol, and is available as oral medication. Of course, it is also the foundational medication for treatment of diagnosed Intrahepatic Cholestasis of Pregnancy (ICP). Does this medication reduce adverse perinatal outcomes? In this episode, we will review a new study from the Green Journal, which will be out in February 2026, examining the recurrence risk for ICP using data from NY. In a patient with prior history of ICP, is there any guidance on monitoring of serum bile acids in the subsequent pregnancy before symptoms develop? We will explain. PLUS we will review the data on whether Ursodiol may hold promise in recurrence prevention or in reduction of adverse outcomes once the condition is diagnosed. Listen in for details. 1. 2019: Chappell LC, Bell JL, Smith A, Linsell L, Juszczak E, Dixon PH, Chambers J, Hunter R, Dorling J, Williamson C, Thornton JG; PITCHES study group. Ursodeoxycholic acid versus placebo in women with intrahepatic cholestasis of pregnancy (PITCHES): a randomised controlled trial. Lancet. 2019 Sep 7;394(10201):849-860. doi: 10.1016/S0140-6736(19)31270-X. Epub 2019 Aug 1. PMID: 31378395; PMCID: PMC6739598. https://pubmed.ncbi.nlm.nih.gov/31378395/2. February 08, 2025: Rahim, Mussarat N et al. Pregnancy and the liver. The Lancet. 2021; Volume 405, Issue 10477, 498 – 513 https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(24)02351-1/fulltext3. SMFM CS 53; 20214. Rosenberg, Henri M. MD; Sarker, Minhazur R. MD; Ramos, Gladys A. MD; Bianco, Angela MD; Ferrara, Lauren MD; DeBolt, Chelsea A. MD. Intrahepatic Cholestasis of Pregnancy Recurrence in a Subsequent Pregnancy. Obstetrics & Gynecology 147(2):p 239-241, February 2026. | DOI: 10.1097/AOG.0000000000006033 https://journals.lww.com/greenjournal/fulltext/2026/02000/intrahepatic_cholestasis_of_pregnancy_recurrence.13.aspx5. Ovadia C, Sajous J, Seed PT et al. Ursodeoxycholic acid in intrahepatic cholestasis of pregnancy: a systematic review and individual participant data meta-analysis. Lancet Gastroenterol Hepatol. 2021 Jul;6(7):547-558. doi: 10.1016/S2468-1253(21)00074-1. Epub 2021 Apr 27. PMID: 33915090; PMCID: PMC8192305.6. EASL Clinical Practice Guidelines on the management of liver diseases in pregnancy. European Association for the Study of the Liver; 2023

HCG is a heterodimeric glycoprotein typically produced by trophoblastic tissue. However, there are occasions where a serum HCG is obtained that remains low level POSITIVE, yet the patient is not pregnant, nor does she have a gynecologic malignancy. Why dose this happen. Not all these instances can be explained by the “PHANTOM” HCG. In this episode, we will review a new Clinical Consensus guideline from the ACOG officially being released in Feb 2026. Like the finding of an aberrant aneuploidy on cell-free DNA testing in pregnancy (NIPT) where the child is found to NOT be affected, where that abnormal result may signal a hidden malignancy, a persistent low level positive HCG that cannot be explained by pregnancy or a gyn cancer may signal a hidden malignancy elsewhere. Listen in for details. 1. ACOG CC #11, February 2026

The ENG implant has data placing it as the most reversible, hormonal contraceptive agent available with a typical use failure rate of 0.05%. Unfavorable bleeding patterns, such as frequent or prolonged bleeding, affect approximately 40% of ENG implant users within the first 3 months but typically improve over time. Nonetheless, it is the main reason for patient discontinuation. In the past, various medications have shown to have at least some short-term reduction in bothersome breakthrough bleeding (BTB). These include doxycycline, ethinyl estradiol (EE), mefenamic acid, combined oral contraceptives (COCs), short term tamoxifen, norethindrone, and ulipristal acetate. In this episode, we will summarize a new RCT (AJOG, released as epub on Jan 7, 2026) which describes the use of TXA for ENG related BTB. Did it work? Listen in for details.1. Andrade, Maíra Cristina Ribeiro et al. Norethisterone for prolonged uterine bleeding associated with etonogestrel implant (IMPLANET): a randomized controlled trialAmerican Journal of Obstetrics & Gynecology, Volume 234, Issue 1, 101 - 1152. Edelman, Alison et al. Treatment of unfavorable bleeding patterns in contraceptive implant users with tranexamic acid: randomized clinical trial. American Journal of Obstetrics & Gynecology, Volume 0, Issue (Articles in Press January 07, 2026)

It’s a controversial topic: the impact of uterine incision (hysterectomy) on the neonate delivery interval (also called the U-D interval). Does it matter? Just to be clear, we’re talking about time from uterine entry to fetal extraction, not skin incision to fetal extraction. Past publications have produced conflicting results, often limited by small sample sizes, heterogeneous indications for delivery, and reliance on surrogate markers (like apgar scores) rather than clinical morbidity. But a new study published in the Gray journal at the end of 2025 (December 30, 2025) gives some new insights. In this episode, we will review this retrospective study and play the “Devil’s advocate” as we summarize the rebuttal data. As the reports are conflicting, we will end the podcast with a real-world interpretation and application of this data. Listen in for details. 1. Bart, Yossi et al. Uterine Incision-to-Delivery Interval and Neonatal Outcomes among Non-urgent, Term, Cesarean Deliveries. American Journal of Obstetrics & Gynecology, Volume 0, Issue 0. https://www.ajog.org/article/S0002-9378(25)00980-9/fulltext?rss=yes2. Maayan-Metzger A, Schushan-Eisen I, Todris L, Etchin A, Kuint J. The effect of time intervals on neonatal outcome in elective cesarean delivery at term under regional anesthesia. Int J Gynaecol Obstet. 2010 Dec;111(3):224-8. doi: 10.1016/j.ijgo.2010.07.022. Epub 2010 Sep 19. PMID: 20855070. https://pubmed.ncbi.nlm.nih.gov/20855070/3. Spain JE, Tuuli M, Stout MJ, Roehl KA, Odibo AO, Macones GA, Cahill AG. Time from uterine incision to delivery and hypoxic neonatal outcomes. Am J Perinatol. 2015 Apr;32(5):497-502. doi: 10.1055/s-0034-1396696. Epub 2014 Dec 24. PMID: 25539409.4. Bader AM, Datta S, Arthur GR, Benvenuti E, Courtney M, Hauch M. Maternal and fetal catecholamines and uterine incision-to-delivery interval during elective cesarean. Obstet Gynecol. 1990 Apr;75(4):600-3. PMID: 2107478.5. Tekin, E., Inal, H.A. & Isenlik, B.S. A Comparison of the Effect of Time from Uterine Incision to Delivery on Neonatal Outcomes in Women with One Previous and Repeat (Two or More) Cesarean Sections. SN Compr. Clin. Med. 5, 80 (2023). https://doi.org/10.1007/s42399-023-01427-x

In January 2026, the ACOG released its Practice Advisory on Screening for fetal Chromosomal Abnormalities. This comes after its Nov 2025 endorsement of the SMFM’s Consult Series #74, “Cell-free DNA screening for aneuploidies: Updated guidance”. In this episode we will review the key parts of this PA. Is screening for microdeletions recommended? PLUS, we will focus on cfDNA for sex chromosomal abnormalities. Should screening for sex chromosomal abnormalities (SCAs) be an “opt in” or “opt out” process for patients? What are nest steps after an abnormal SCA screening result? Are commercial tests available for fetal gender recommended? Listen in for details. 1. ACOG PA Jan 2026: https://www.acog.org/clinical/clinical-guidance/practice-advisory/articles/2026/01/screening-for-fetal-chromosomal-abnormalities?utm_source=higher-logic&utm_medium=email&utm_content=Jan-07&utm_campaign=acog2026-digest2. Society for Maternal-Fetal Medicine Consult Series #74: Cell-free DNA screening for aneuploidies: Updated guidance1 in November 2025.

Uterine rupture or dehiscence associated with TOLAC results in the most significant increase in the likelihood of additional maternal and neonatal morbidity. It should be noted that the terms “uterine rupture” and “uterine dehiscence” are not consistently distinguished from each other in the literature and often are used interchangeably. Furthermore, the reported incidence of uterine rupture varies in part because some studies have grouped true, catastrophic uterine rupture together with asymptomatic scar dehiscence. In January 2026, a new meta-analysis examines the relationship between oxytocin use with TOLAC and uterine rupture. In this episode, we will summarize the key findings in that study and review the data on the use of internal monitors during TOLAC. Do internal monitors (FSE, IUPC) offer a safer TOLAC compared with external monitors? Listen in for details.1. Nicolì, Pierpaolo et al.Oxytocin dosing during trial of labor after cesarean to minimize the risk of uterine rupture: a systematic review and meta-analysisAmerican Journal of Obstetrics & Gynecology MFM, Volume 8, Issue 1, 1018462. Practice Bulletin No. 184: Vaginal Birth After Cesarean Delivery. Obstetrics & Gynecology 130(5):p e217-e233, November 2017. | DOI: 10.1097/AOG.00000000000023983. ACOG Clinical Practice Guideline No. 10:Intrapartum Fetal Heart Rate Monitoring: Interpretation and Management. Obstetrics & Gynecology 146(4):p 583-599, October 2025. | DOI: 10.1097/AOG.00000000000060494. Bruno AM, Allshouse AA, Metz TD. Maximum Oxytocin Dose and Uterine Rupture During Trial of Labor After Cesarean. Obstet Gynecol. 2025 Dec 1;146(6):843-850. doi: 10.1097/AOG.0000000000006106. Epub 2025 Oct 30. PMID: 41325062.

Currently, as of today’s date, neither the ACOG nor SMFM currently support routine early induction of labor for suspected fetal macrosomia, instead recommending individualized counseling and reserving elective cesarean for extreme estimated fetal weights. However, a 2025 multicenter, open-label, randomized controlled trial was published in the Lancet comparing induction of labor versus standard care in pregnant women with fetuses suspected to be large for gestational age. The study used a parallel-group design with 1:1 randomization, enrolling women from 106 NHS hospitals across England, Scotland, and Wales. The per-protocol analysis demonstrated a significant reduction (40%) in shoulder dystocia with induction of labor at 38- 38 weeks and 4 days. Is this in conflict with the ACOG current guidance? In this episode, we will review the “Big Baby study” from the Lancet and provide 3 main limitations of this very large study, review the importance of PP vs ITT results, and explain why more data is still needed. Listen in for details. 1. ACOG PB 178; 2017 (reaffirmed 2024)2. Gardosi J, Ewington LJ, Booth K, Bick D, Bouliotis G, Butler E, Deshpande S, Ellson H, Fisher J, Gornall A, Lall R, Mistry H, Naghdi S, Petrou S, Slowther AM, Wood S, Underwood M, Quenby S. Induction of labour versus standard care to prevent shoulder dystocia in fetuses suspected to be large for gestational age in the UK (the Big Baby trial): a multicentre, open-label, randomised controlled trial. Lancet. 2025 May 17;405(10491):1743-1756. doi: 10.1016/S0140-6736(25)00162-X. Epub 2025 May 1. PMID: 40319899.3. Blaauwgeers, Anne N et al. Rethinking induction of labour for LGA fetuses: the Big Baby trial. The Lancet, Volume 406, Issue 10512, 1562

In mid-December 2025, the FDA approved an at home devicethat aims to treat depression by sending electric current into a part of the brain (the prefrontal cortex) known to regulate mood. This has been available in the UK since 2019 but it is new to the US. The manufacturer has stated that over 55,000 patients have used the device across Europe, the UK, Switzerland, and Hong Kong. How does this work? Is there data to support this new therapy? In this episode, we will summarize three consecutive years of data (2023, 2024,2025) to answer that question. Listen in for details. 1.     Sci Amer: https://www.scientificamerican.com/article/u-s-approves-first-device-to-treat-depression-with-brain-stimulation-at-home/2.     August 12, 2023: Burkhardt, Gerrit et al.Transcranial direct current stimulation as an additional treatment to selectiveserotonin reuptake inhibitors in adults with major depressive disorder inGermany (DepressionDC): a triple-blind, randomised, sham-controlled,multicentre trial The Lancet, Volume 402, Issue 10401, 545 – 5543.     October 21, 2024: Woodham, R.D., Selvaraj, S.,Lajmi, N. et al. Home-based transcranial direct current stimulation treatmentfor major depressive disorder: a fully remote phase 2 randomizedsham-controlled trial. Nat Med 31, 87–95 (2025). https://doi.org/10.1038/s41591-024-4.     December 15, 2025: Moshfeghinia R, Bordbar S,Roointanpour Y, Arab Bafrani M, Shalbafan M. Efficacy and safety of home-basedtranscranial direct current stimulation (tDCS) on patients with depressivedisorders: a systematic review and meta-analysis of randomized clinical trials.Sci Rep. 2025 Dec 15;15(1):43850. doi: 10.1038/s41598-025-28648-5. PMID:41398008; PMCID: PMC12705823.

While endometriosis is highly associated with Chronic Pelvic Pian (CPP), some women may suffer from a different primary or coexistent secondary etiology: pelvic vascular congestion, called vascular origin (VO)- CPP. Although controversial as an entity, there have been diagnostic algorithms published (via pelvic ultrasound. MRI, or venography) for this condition. Approximately 10-40% of chronic pelvic pain cases may be attributed to pelvic vascular congestion (now termed pelvic venous disorder), though estimates vary considerably depending on the population studied and diagnostic criteria used. In premenopausal women specifically, the prevalence appears higher. One study found that 8% of all premenopausal women had documented chronic pelvic pain of unclear etiology along with dilated ovarian and pelvic veins on cross-sectional imaging. Therapies for this have been limited. Flavonoids are abundant in a colorful diet of fruits, vegetables, tea, and wine, with common sources including citrus fruits (flavanones), berries, apples, grapes (flavan-3-ols/anthocyanins), onions, kale, broccoli (flavonols), and tea, cocoa, red wine (flavan-3-ols), plus soybeans (isoflavones), all providing antioxidants and potential health benefits like better heart and brain health. On Dec. 23, 2025, in the journal Phlebology, researchers published a systematic review on the potential benefits of specific flavonoid mixtures which may provide relief to VO-CPP. Listen in for insights and details.1. Gloviczki ML, Demetres MR, Salazar G, Khilnani NM. Venoactive drugs for venous origin chronic pelvic pain in women: A systematic review. Phlebology. 2025 Dec 23:2683555251411027. doi: 10.1177/02683555251411027. Epub ahead of print. PMID: 41432346.2. Knuttinen MG, Machan L, Khilnani NM, Louie M, Caridi TM, Gupta R, Winokur RS. Diagnosis and Management of Pelvic Venous Disorders: AJR Expert Panel Narrative Review. AJR Am J Roentgenol. 2023 Nov;221(5):565-574. doi: 10.2214/AJR.22.28796. Epub 2023 Apr 5. PMID: 37095667.