The media is abuzz over recent reports of pregnancies occurring in women using Implanon, a single rod progestin-only contraceptive inserted under the skin of the upper arm and lasting for up to three years.
The headlines make it sound horrifying – “Hundreds Become Pregnant Despite Contraceptive Implanon” and “British Pregnancy Scare in UK Implicates Implanon”. I love how terminology can make something so common sound so frightening…
Actually, what happened was that 584 pregnancies occurred in Britain among about 1.3 million women using Implanon, for a failure rate of .04%. In other words, the method had an efficacy of over 99%.
That’s a pretty effective contraceptive if you ask me.
But it should have been better than that.
As good as it may seem, this failure rate is significantly higher than most of us would have expected based upon data from clinical trails of Implanon.
I recall being told at an Implanon insertion training just prior to its introduction in the US that in fact, not a single pregnancy had been reported at that point among users of the device in clinical trails. This would put the method up there with sterilization and IUD in terms of efficacy.
So what happened?
How did Implanon go from perfect efficacy to something less than perfect ?
A study of Australian Implanon failures gives us a few clues. In that country, the majority of Implanon pregnancies occurred because the Implanon never left the needle at the time of insertion. In other words, there was an unrecognized failure to insert the device correctly.
For the rest, it appears that the women were actually pregnant at the time the device was inserted, were taking another medication that interfered with Implanon’s efficacy, expelled the device or had it inserted in the wrong time of the cycle to be effective that first month of use.
Only 13 reported pregnancies were actual device failures during a period when over 200,000 devices were sold. 13/200,000, or .0065% – Now that’s more in line with what we expected of Implanon.
Did Merck Do Enough to assure Implanon’s success?
While I have no idea what happened in Britian and Australia, I have to say that Implanon’s manufacturer (Organon, now Schering-Plough, which is now Merck) made an extraordinary effort to be sure that those who inserted Implanon in the United States knew what they were doing. I was part of the first groups trained, and found the training and follow-through to be above and beyond anything I’d ever seen.
Was this because they had an inkling of the post-marketing experience in Britian and Australia?
Or because they learned from watching the Norplant debacle that bad surgical technique on the part of a few practitioners, combined with a few greedy lawyers, could take down one of the most effective contraceptivesever to hit the market?
Either way, I was impressed.
Nexplanon – The New, Improved Implanon
I’m also impressed that the manufacturer, not satisfied with the insertion failures in real-world hands, have improved upon the design of the inserter. The device is also now visible under x-ray, allowing for a reliable way to assure its presence if it cannot be palpated under the skin.
But why is all this news?
You don’t see any headlines about the millions of pregnancies conceived while using condoms or the pill, do you?
Pregnancy Horror – I was too lazy to get up and put in my diaphragm, and now I’m the mother of twins!
Or better yet –
Pregnancy Shocker! I know I missed three pills this cycle, but I figured I’d get away with it…
While it probably should be, this is not news. That’s because when we get pregnant on the pill, or while using condoms or a diaphragm, we blame ourselves.
But if it’s someone else’s fault, well, that’s something to talk (and sue) about.
What also makes Implanon pregnancies special is that when they do occur, they can go undiagnosed for such a long time due to menstrual irregularity that women are told to anticipate as an effect of the method. Inability to detect an early pregnancy, combined with failed expectation of an almost perfect efficacy based on the manufacturer’s literature, makes women feel betrayed.
And there’s nothing the media likes more than a betrayed woman.
Unintended Consequences and Unintended Pregnancies
While I don’t wish to belittle or diminish the individual impact that an unexpected pregnancy has for any individual woman, especially when she has done all she can to prevent from becoming pregnant, I do have concerns about all this media attention to Implanon failures.
That’s because, unfortunately, media attention such as this, rather than informing, tends to lead women to mistrust hormonal contraception. And when women distrust hormonal contraception, they tend to discontinue it and move towards less effective barrier methods, or worse yet, no contraception.
The end result? Unintended pregnancy.
Thus, one consequence of all this media reporting about the contraceptive failures with Implanon could actually be even more unplanned pregnancies.
Great.
Bottom Line
Implanon remains an extremely effective contraceptive, when inserted properly and at the right time in the cycle in women not taking medications that interfere with its efficacy. New generation devices will hopefully have less insertion issues among practitioners, who must be properly trained in its insertion.
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- Implanon information from Planned Parenthood
- Information on Implanon training for Practitioners
Thanks for the straight talk.
Recently saw a new ob patient who had been told by her CNM she’d gotten pregnant on Implanon. But when we wheeled out the dates, it turned out conception was about a week BEFORE the Implanon was inserted.
GREAT analysis.
Excellent analysis. I agree that the Implanon training went above and beyond anything I had experienced previously.
hi great report by the way ! just caught myeye about the meds can effect the implanon does this include antiboitics ??
Sara –
Some medications interact with hormonal contraceptives. The word “antibiotics” is too broad for me to give you an answer. You should ask your doctor about any medications you are taking.
Take care and thanks for reading.
I recently visited my Gyne for a routine visit and asked about Implanon. I am currently using Depo and want to switch at the end of this cycle. He however admitted that he has never heard about it before, is there a way to find a Gyne who is familiar with this in NYC? thanks
Keisha – the implanon website will direct you. Providers must undergo manufacturer sponsored training, so they know who’s inserting them.
http://www.implanon-usa.com/en/consumer/get-it/find-a-clinician/index.asp
Thanks for reading!
Peggy
wow this absolutely made me feel a lot better! ive been hearing all sorts of women talking about how they became pregnant months after having implanon inserted, and not having a clue how it happened. it is clear that they were taking some sort of medication or antibiotic that made their implanon less effective, and didnt take care to make sure they were doing things correctly. i have been having fears that i am pregnant, even with the implanon, and you pretty much just blew my silly fears out of the water with this. amazing job! thank you so much! im going to post a link to this on as many “pregnant on implanon?” forums as i can!
Jenna –
Thanks for your comment, for helping to spread the word and keep the Implanon conversation based in reality.
Peggy
Hi Dr. P,I was just wondering if there have been any recalls for the implanon in the United States? I plan on getting it on 9.6.2012, but a friend of mine has mentioned a recall but cannot remember the exact birth control method that the commercial she saw was about. I have googled “implanon 2012 recall united states”, but have found nothing. Gratefully, though, your blog came up and I have read that and my husband and I are happy with this consolation about the implanon being extremely effective, and not a high chance that we’ll get pregnant while on it. But, I’m just wondering if you have come across any negative news regarding implanon being recalled this year (2012) in the United States. Thanks for any information you may be able to provide.
-AnissaP
Anissa – Haven’t heard of any recalls. You can check the FDA site anytime you have a questions about a drug http://www.fda.gov/Drugs/default.htm
Thanks for reading!
Peggy
I know this is a while after you posted this…I was just wondering when the right time in a cycle would be? I had this put in 6 weeks after my daughter was born (never had a cycle) and was told it was affective within 48 hours…I have been concerned with being pregnant as I am having some of the same symptoms and have gained 25lbs with diet and exercise and just keep gaining rather than losing 🙁 I had taken a test and the results were inconclusive so I have an appointment to have blood drawn to be sure.
This is of particular interest to me as I am currently being sued by a woman who I inserted an Implanon in, with a negative pregnancy test, was told to use condom back up for 2 weeks, and had a positive pregnancy test 22 days later. The device could not be found on ultrasound, first time our radiologists had ever looked for one. I attended the training, had previously placed several and did not deviate from the standard of care. This has caused me to question my devotion to serving uninsured, nonEnglish speakers. And of course I did have a translation nurse in the room and the patient told me she wanted more children. argh!
Hi, i ‘ve had implanon in for just over 2 years now , since my youngest daughter was 6 weeks old (whom i might add, i fell pregnant with on the pill ) only to find out i am once again pregnant! Already a mum of 3 beautiful bubbas , all unplanned , and was hoping for the chance to actually have a planned pregnancy in a few years…i guess God just had other plans!
i had implanon inserted 14/08/15 periods are usually irregular so couldnt really go off that to ensure it was inserted at the correct time of cycle, my problem is i had one inserted incorrectly causing pain and discomfort so had it removed, i tried to get another inserted but it took over a month to find someone who could actually insert not just remove implanon, i was let down by a few doctors who once at the appointment advised that they hadnt done the update course and were not allowed to insert…finally got an appointment done a pt came up negative then had it inserted, now two weeks later i went back for a check up as advised by doctor and yep a positive test result for pregnancy, now i am in absolute shock and extremely upset as i am faced with what to do next, i already have two children and am currently studying and trying to complete 3 diplomas…we cant financially afford another child and this is why we took what we thought to be the right steps to prevent this situation…i have always been against abortion and now feel so devastated 🙁
For me I am so very confused, I was deeply inserted implanon on 03/08/2015 but now I’m having symptoms of pregnancy, I’m confused and I’ve tested for pregnancy and it came out positive, I’m so confused and the implanon not palpable, I’m not yet ready to be a mom so scared. I wish someone could just brief me.confused frustrated lady Rustenburg
Actually, a failure rate of 0.04% is better than for the IUD or for male or female sterilisation, hard as that may be to believe!