FDA’s ENG Label Change: What To Know

Summary

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Podcast Summary: FDA’s ENG Label Change – What To Know

Podcast: Dr. Chapa’s OBGYN Clinical Pearls
Host: Dr. Chapa
Date: January 23, 2026

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Episode Overview

This episode is a rapid, evidence-based rundown aimed at OBGYN providers about the FDA’s label update for the etonogestrel implant (Nexplanon) from three to five years of approved use. Dr. Chapa highlights the clinical data driving this change, addresses skeptics of off-label recommendations, and provides guidance about updated practice logistics, including a new REMS (Risk Evaluation and Mitigation Strategy) requirement. The episode is informative, engaging, and packed with clinical pearls for current and future contraceptive care.

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Key Discussion Points and Insights

1. Background on Etonogestrel (Nexplanon) Implant

• Dr. Chapa's longstanding support:
  “I am a little bit of a fan of the EternalGestrel implant for contraception, for menstrual suppression, for chronic pelvic pain. It just works really well.” [01:08]
• History:
  Recaps the progression from Norplant (multiple capsules, challenging removal), to Implanon (single rod, 2006), to radiopaque Nexplanon (2010).
• Original label:
  Approved for 3 years, despite mounting real-world and clinical trial evidence suggesting 5-year efficacy.
• Off-label frustrations:
  “Every time I’ve said that, somebody sends me a message... ‘What if a pregnancy happens after five years—are you going to go and defend them?’ Yes, I’ve received those messages.” [01:48]

2. Clinical Data Driving the Label Change

• Evidence preceded approval:
  “It's interesting because sometimes the FDA releases something or approves something, then the clinical data builds on that. In this case, it was the reverse.” [02:27]

• Peer-reviewed studies:

  • Prospective study: 390 women past 3 years up to 5 years.

    “Overall 5-year, the Kaplan-Meier cumulative pregnancy rate was 0.6 per 100 woman-years...There was no additional pregnancies recorded [in the additional two years]. It was phenomenal.” [07:18]

  • Contraceptive CHOICE Project: Nearly 300 users beyond 3 years, 0 pregnancies per 100 woman-years in years four and five.

• Pharmacokinetic support:

  • Suppressive hormone levels well above threshold at years 4 and 5:

    “You need around 90 picograms per milliliter...in year four and five, there were well over 150.” [08:55]

• Key FDA trial:

  • Registration number: NCT 0462-6596.
  • Design: Multicenter, single-arm, open-label.
  • 399 women enrolled, allowed to continue implant past original 36 months.
  • Results: No pregnancies in years 4 or 5.
  • Inclusion of women with BMI >30 (38%) and >40 (10%): No loss of efficacy.

    “No pregnancies were recorded in years four and five. None.” [10:32]

  • Reported Pearl Index:

    “This is the official Pearl index of 0.0 pregnancies per 100 woman years. What?! I mean, it’s insane.” [11:04]

3. FDA Approval and Clinical Practice Updates

• Label extension:
  As of January 2026, legal duration officially increased to 5 years.
• REMS program:
  • New requirement: All prescribers need to re-register with the manufacturer under the FDA’s Risk Evaluation and Mitigation Strategy (REMS) by February 23, 2026.

    “You may have to re-register with them, because they are launching a new REMS database for this...just one more thing we have to do. You gotta register by the end of February.” [06:52]

• Providers’ practical response:

  “If a patient asks you, ‘Is it safe? Can I go to five years?’ You go, ‘Yep. If you choose to, you can.’” [05:13]

• Similarities with IUD label evolutions:

  “This is very similar to the Mirena story. Remember, Mirena was like five years and then miraculously went to seven years—nothing changed except the label.” [12:31]

4. Dr. Chapa’s Tone and Key Message

• Playful vindication:
  Jokes throughout about prior criticisms and being “right all the time” (recurring soundbites).

  “Boy, do I hate being right all the time” [Multiple, 02:11, 04:15, 04:30, 05:13, 06:33]

• Reassuring attitude:
  Encourages providers not to worry about the REMS change and underscores that updated guidance is entirely data-driven.
• Bottom line:
  The Nexplanon implant is now FDA-approved for 5 years of use, and the data is “astonishingly strong.”

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Notable Quotes & Memorable Moments

• [01:08] Dr. Chapa:
  “I am a little bit of a fan of the EternalGestrel implant for contraception, for menstrual suppression, for chronic pelvic pain. It just works really well.”
• [02:27] Dr. Chapa:
  “It's interesting because sometimes the FDA releases something or approves something, then the clinical data builds on that. In this case, it was the reverse.”
• [04:18] Dr. Chapa:
  “The data was there and I said on various podcast episodes in the past, the label will change. We just gotta wait for it.”
• [08:55] Dr. Chapa:
  “In general, you need around 90 picograms per milliliter of this hormone for suppression. And in year four and five, there were well over 150.”
• [11:04] Dr. Chapa:
  “This is the official Pearl index of 0.0 pregnancies per 100 woman years. What? I mean, it’s insane.”
• [12:31] Dr. Chapa:
  “This is very similar to the Mirena story. Remember, Mirena was like five years and then miraculously went to seven years and then a competitor came about and miraculously went to eight years. Nothing changed—just the label.”

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Important Timestamps

| Timestamp | Segment/Topic |
|-----------|----------------|
| 01:08 | Dr. Chapa introduces episode, personal connection to ENG implant |
| 02:27 | Explanation of evidence preceding FDA action |
| 04:18 | Comments on previous predictions about label changing |
| 06:52 | Announcement and details of upcoming REMS re-registration requirement |
| 07:18 | Key findings from 5-year efficacy studies |
| 08:55 | Discussion of hormone levels and pharmacokinetic data |
| 10:32 | Official FDA trial findings: no pregnancies in years 4 and 5 |
| 11:04 | Pearl Index “0.0” per 100 woman-years emphasized |
| 12:31 | Comparison of ENG extension to Mirena history |

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Clinical Pearls & Takeaways

• Nexplanon (etonogestrel) is now FDA-approved for 5 years of use.
• Clinical and pharmacological data robustly support efficacy through year 5—including in women with higher BMIs.
• Pearl Index of 0.0 in years 4 and 5: “astonishing” protection.
• Providers must re-register for a REMS program by Feb 23, 2026, to maintain access to the device.
• Advise patients they may confidently use the device for 5 years, not just 3.

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Conclusion

Dr. Chapa delivers clear, practical, and empirically grounded guidance on the FDA’s new duration for the etonogestrel implant, interwoven with humor and candor. This episode empowers providers to confidently advise and manage patients using Nexplanon for up to five years, backed by both official FDA approval and “rockstar” supporting data.

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Transcript

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[Dr. Chapa]

Podcast Family as you all know, if you've listened to the show, I am a little bit of a fan of the EternalGestrel implant for contraception, for menstrual suppression, for chronic pelvic pain. It just works really well. It eternorgestrel implant. Not a sponsor, but we've covered that in a variety of ways and shapes and flavors in the past. And on some episodes I've said, hey, even though the itranorgestrel implant, otherwise known as Nexplanon, is approved for three years, very well established in the clinical data that it is okay to use off label until five years. Okay? Now every time I've said that, somebody sends me a message going, I can't believe. I can't believe you're promoting something off label. What if a pregnancy happens after five years? Are you going to go and defend them? Yes, I've received those messages. Well, in the middle of January 2026. Yeah, vindicated.

[Commercial Narrator]

Boy, I hate being right all the time.

[Dr. Chapa]

Well, it is true. I can do hate being right all the time. It's a joke guys. Just a joke.

[Commercial Narrator]

Boy, do I hate being right all the time.

[Dr. Chapa]

But there is data for Nexplanon eternorgestrel for five years. So even though I've told my patients many, many times since before the middle of January 2026, having to place this little device, you can actually use it for five years with zero problems all. Although I have to tell you, the manufacturer wants it out at three years just because that data is still evolving. Now it's interesting because sometimes the FDA releases something or approves something, then the clinical data builds on that. In this case, it was the reverse. All right, so there was a lot of peer reviewed community data saying, hey, this thing seems to work for those patients who went over the three year mark, no pregnancies, it seems to have the same efficacy. Even though the pharmacokinetics was still known to work by the manufacturer, they did not have the original approval. So even though the body of evidence first existed saying pretty near zero pregnancies up to five years, that then prompted the FDA to launch its own investigation, which it has to do to get label change for the 68 milligram radiopaque implant called Nexplanon. And now that data, of course, has been done. This was a multicenter single arm, open label study looking at the efficacy of this between year four and five. And that clinical trial is now done. It enrolled 399 women, so just call it close to 400 who use this past the original 36 month indication. And the results were astounding. We're going to cover this because the FDA did approve this now officially for five years. So 20 to all those very kind individuals who sent me the message that I can't believe you're promoting something off label. Just a very quick message for you.

[Commercial Narrator]

Boy, do I hate being right all the time.

[Dr. Chapa]

Well, I mean that in all humility. No, but it's true. The data was there and I said on various podcast episodes in the past, the label will change. We just gotta wait for it.

[Commercial Narrator]

Boy, do I hate being right all the time.

[Dr. Chapa]

And now it has happened. So in this episode, very quickly, we're gonna show you the pre existing D data from the peer reviewed clinical communities that showed maybe this thing should be five years. Then we're gonna discuss the official FDA extender trial that looked at this. So we'll give you that clinical trial information. It was clinical trial registration number NCT 0462-6596. Very impressive. Including in patients who had BMIs greater than 30, no drop in efficacy. So again, just having fun with this. Nobody be upset. Just being a little sarcastic.

[Commercial Narrator]

Boy, I hate being right all the time.

[Dr. Chapa]

Oh boy, I hate being right all the time. So in this episode, we're gonna cover this data, take a look at the FDA approval, that quick assessment. So if a patient asks you, is it safe? Can I go to five years? You go, yep. If you choose to, you can. I think I've set it up enough and now we will be right back.

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Boy, do I hate being right all the time.

[Dr. Chapa]

Foreign. This is Dr. Chapa's obgyn no spin podcast. Yeah, Implanons had kind of a long history. It's had a long pedigree. I mean, I actually trained with Norplant that was kind of kind of a bear. That was multiple capsules put into the arm. Putting them in was one thing. Taking them out was a beast. Then came Implanon, which was in 2006. Then it got revamped as Implanon 2.0, which was this radiopaque version. Had a nice little applicator that was Nexplanon in 2010 again, originally approved for three years duration. But a lot of data was circulating in print that this thing actually works for five, and some sites were actually advertising it for five years, though it was clearly at that time off label. But yeah, I did receive multiple messages every time I mentioned that, you know, you can use this for five. Some were like, I can't believe I'm saying I'm promoting something off label. Honey, we do things off label all the time. It's all right. Especially when there's data behind it. So very quickly, let me just show you some of the data we'll get into the, the, the clinical trial that the FDA used and what you need to know about this. Because in February 2026, if you are currently a nexplanon registered user, meaning you have an account with the manufacturer to get the device and use it, you may have to re register with them because they are launching a new REMS database for this. All right, so that's why you gotta know about this. Cause these tests can go, oh great. Things are gonna continue as is. Well, yes and no. Because you've gotta be re registered through the and mitigation strategy. That's rams anytime that there's an extension unlabel. This is not unique. This is not anything to be concerned about. This is what the FDA does because they have to make sure that no one's going to be harmed by this. So it's not a worrisome thing. It's just one more thing we have to do. And you got to register by the end of February, actually February 23, 2026, according to the manufacturer, so you don't lose the account. All right, so it is a part of the FDA label change is that this will now have a REMS program, a risk evaluation and mitigation strateg. That's all right. It's not nothing to worry about. That's what Oregon is required to do as part of the label agreement. All right. It's all right. This is nothing concerning that's expected. But we've had this data for a while now, even before this label change. All right, so there was a prospective study that looked at 390 women who used the implant beyond three years and those who went all the way up to five years. And the overall five year, the Kaplan Meier cumulative pregnancy rate was 0.6 per 100 woman years. In other words, that was statistically a blip when there was no pregnancies which occurred in the additional two years of follow up beyond the FDA approved duration. So in those patients who actually completed follow up, which was 200 women actually completing the five year Spanish, there was no additional pregnancies recorded. It was phenomenal. There's also data from the Contraceptive Choice Project. We've covered this. This was in close to 300 implant users who again use this beyond the original FDA label of three years. And it was 0 per 100 woman years in both years four and five, meaning no additional pregnancies. Now there's two things to look at here, whenever something is looked at for duration of use, you want to look at clinical pregnancy, which we've just discussed. And if that is supported by the pharmacological data, in other words, was it because they didn't have sex, Was it because something else happened, or was it in fact attributed to the agent? Well, we do have the pharmacological support for this because each andorgestrel levels do remain well above ovulation suppressive zone at years four and five. All right, so they didn't really differ much after the three year span. Yes, it kind of dropped a little bit, but clinically they're still above the ovulation suppression threshold. In general, you need around 90 picograms per milliliter of this hormone for suppression. And in year four and five, there were well over 150. Okay. So short of it is we have clinical data that says no pregnancy in year four and five. And that is also supported by the pharmacological data both in bench and in patients. This led to a multicenter single arm, open label study involving patients who already were wearing the implant and said, do you want to continue this joker for four or five years? We know it should work, but do you want to be officially part of this NCT registered trial? And they said, yes. Fine. Let me give you the key data here, and then we're going to wrap this up. This is just a quick awareness of what's out now and so you can be aware as of the end of February, before you get to the end of February 2026, contact your. And if you do this displacement, you got to re register with their REMS protocol. And again, or I just want to be clear, not a direct sponsor. I'm doing this on my own initiative. And so anyway, I just thought I'd throw that out there. So this key study finding had several remarkable things. Number one, no pregnancies were recorded in years four and five. None. No pregnancies recorded in years four or five. Not one, not two. No pregnancies. Amazing. That's a pearl index, y'. All. Listen to this. This is the official Pearl index of 0.0 pregnancies per 100 woman years. What? I mean, it's insane. So, yes, it's still one of the best methods of contraception out there, even in patients with a BMI over 30. Because there was about 38% who had a BMI over 30 in this study and about 10% who had a BMI over 40. It is pretty darn phenomenal. Okay, so the new label change is up to five years. You do have to register with the REMS protocol and this data is now accepted by the FDA as proof of efficacy. Now we don't have to do it off label. You will have protection if the patient wants to use it for five years to go, no problem, y'. All. This is very similar to the Mirena story. Remember, Mirena was like five years and then miraculously went to seven years and then a competitor came about and miraculously went to eight years. Nothing changed that that information was there, guys. They just didn't seek label change. So these are all good things. The patient does win with this because if she wants to extend its use, she should not fear pregnancy with this device because the Pearl index was 0.0 per 100 woman years in the official FDA trial. Phenomenal. Anyway, this is very quick. Just want to let you know what is up and out with the eternorgestrel implant 68 milligram contraceptive device. Now FDA approves for five years duration. Podcast family, as always, we're thankful for you. We're glad you're part of our podcast community. This was a short one. Now that we've done all that, let's take it home.