Women fall pregnant using [Implanon] contraceptive

Nevyn

http://www.rte.ie/news/2011/0105/contraception.html

Women fall pregnant using contraceptive

Updated: 17:24, Wednesday, 5 January 2011

The Irish Medicines Board has received 32 unintended pregnancy-related reports associated with use of the contraception Implanon since 1999.
1 of 1 Implanon - Tube inserted into the arm (Pic: www.implanon.co.uk)
Implanon - Tube inserted into the arm (Pic: www.implanon.co.uk)

The Irish Medicines Board says it has received 32 unintended pregnancy-related reports associated with use of the contraception Implanon since the product was authorised in Ireland in 1999.

The IMB was reacting to news that nearly 600 women in the UK became pregnant despite being fitted with the implant.

The tube is inserted in the arm and releases hormones into the bloodstream. It is designed to prevent pregnancy for three years.

In a statement, the IMB said the risks of unintended pregnancy and effects associated with Implanon are well-known.

It said the risks are detailed in the product information for healthcare professionals and patients.

The IMB is advising any woman who has concerns about their contraception method to consult their doctor.

The UK's Medicines and Healthcare products Regulatory Agency (MHRA) confirmed it had received a total of 1,607 adverse drug reaction reports linked to Implanon, relating to 2,888 incidents of suspect reactions in users.

Nine of the 584 women who reported an unwanted pregnancy used the terms 'device failure', 'device dislocation', 'device ineffective' and 'device difficult to use' to describe their experience.

Other women reported scarring and problems with removing the 40mm long implant.

In a statement, manufacturers MSD said: 'MSD is confident in the efficacy and safety of Implanon, a contraceptive medicine that has been prescribed to women since its initial approval in September 1999.

'The basis for successful use of Implanon is a correct and carefully performed subdermal insertion of the implant in accordance with the product instructions.

'If the implant is not inserted in accordance with the instructions and on the correct day, this may result in an unintended pregnancy. In addition, no contraceptive is 100% effective.'

http://www.channel4.com/news/implanon-contraception-failures-cost-nhs-200-000

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Implanon contraception failures cost NHS £200,000
Tuesday 04 January 2011
The NHS has paid out nearly £200,000 in compensation to women who have become pregnant or been injured by a contraceptive implant that is growing in popularity, Channel 4 News reveals.

More than a thousand complaints about Implanon have been received by the medicines watchdog at a time when the device is being hailed as the future of family planning.

Figures obtained by Channel 4 News reveal that 584 women who had the hormone-filled tube inserted into their arms have reported unwanted pregnancies to the Medicines and Healthcare Regulatory Agency (MHRA).

This is not what I want. I put this thing in to protect myself... I don't want kids at this time. Lara

There have been a total of 1607 complaints to the MHRA about scarring and other problems associated with the device. In the most serious cases, NHS Trusts have been forced to offer settlements to seven women totalling nearly £200,000.

Some women who took Implanon after deciding they did not want more children have had to terminated pregnancies and suffered the breakdown of their relationships.

Lara, from south London, descibed the moment four years ago she discovered she was pregnant because her implant was incorrectly fitted.
Contraceptive drugs: Implanon pregnancies trigger complaints.

She said: "I feel very very disturbed - hitting the head on the table.

"Crying, weeping again. Weeping like a young child. It really disturbed me. I wasn't happy, not feeling well. Your mind is disturbed.... my mind was so disturbed - thinking why is this happening to me?"

Lara's marriage collapsed and she suffered nightmares for months after having a termination.

"This is not what I want. I put this thing in to protect myself so I can continue with my studies. I don't want kids at this time. It really disturbed me."

Statement from Implanon manufacturer MSD:
Nexplanon will replace the currently available contraceptive implant Implanon.
The active ingredient remains the same as Implanon but the new implant is identifiable through additional localisation methods: X-ray and CT scan.
The applicator has been modified for easy insertion.
The implant is fitted by a trained healthcare professional and a training programme to re-train existing Implanon fitters or future fitters is available.

Implanon should prevent women becoming pregnant for up to three years after the £90 device is fitted into the arm by slowly releasing similar chemicals to those in the pill.

Family planning clinics in England report contraceptive implants are soaring in popularity from 16,000 women in 2005 to nearly 82,000 in 2010.

It is particularly popular amongst teenagers with 10 per cent of 16-19-year-olds saying they prefer an implant largely because they do not have to remember to take a pill. But the majority of complaints about Inplanon have been made by doctors and nurses who claim it's difficult to insert properly and cannot be checked afterwards.

Under pressure from the MHRA, its manufacturer, MSD, has launched an upgrade called Nexplanon but the original implant will remain on the market until stocks run out.

A spokesman for MHRA said: "The reports we received from healthcare professionals and consumers played a strong role in the update of the device."

Just a heads up ladies, if you have one and are worried get your dr to check it.

banshee_bones

From The journal

http://www.thejournal.ie/women-report-falling-pregnant-while-using-implanon-contraceptive-2011-01/

The British Pregnancy Advisory Service says that if women using Implanon can feel the device under their skin and are within the three-year timeframe of its use, they have no reason to get the device checked, but says “if you cannot feel it, or if you are having any problems with it, do get it seen. An ultrasound or x-ray will quickly establish whether the device is there.”

NoDice

I read this yesterday and it was good too as I was thinking of switching to it. I can never remember the pill on time and always feck it up, which in turn fecks up my body. It's unfortunate and a dose (for want of a better word) for those who fell pregnant or those who are now devastated from having had an abortion. It's said they have a new one on the way.

valerie

Actually this is a bit sensationalist and scaremongering.
584 reported pregnancy with Implanon in the last 11 years in the UK. There have been over 1 million users of the Implanon in the UK in that timeframe. This equates to a failure rate of 0.06%. This is within the expected failure rate of the product and medical literature.
Every form on contraception has a risk of failure. Implanon and Mirena are some of the most effective, much more so than the pill.

cmaclo

NoDice wrote: »

I read this yesterday and it was good too as I was thinking of switching to it. I can never remember the pill on time and always feck it up, which in turn fecks up my body. It's unfortunate and a dose (for want of a better word) for those who fell pregnant or those who are now devastated from having had an abortion. It's said they have a new one on the way.

Just a word of advice before you get this.... it's a bit of a commitment compared to other contraceptives being that its inserted in to your arm. I gave it 6 months of an almost constant period (awful awful) before i eventually gave in and decided to get it removed.

...and like the thought that goes through every girls mind when getting it inserted "would'nt it be funny if this got lost?! " ....well mine did!!! The doctor poked around for ages (with a blade) and could not reach the implanon becasue it had moved further in to the muscle. 2 months, $500 and one ultrasound later they detected and removed it. What a nightmare.


But i do have a suggestion! Try Nuvaring.. you only need to remember to take it out after 21 days... its sooo hassle free, now lots of my mates are on it and no-one has had any complaints. Good luck

spinandscribble

Personally I had a lot of pain with the nuvaring and switched back to the implant, I'm on my second one right now. I'm a little nervous as this time round my periods seem so light its unnerving for me. I guess I'll never know why.

Lcronin2011

this really scares me i say just stick to the pill girls... keep it in ur bag and just turn on a recurrent alarm on your phone. thats the only way i remember it. then again nothing is ever 100% is it?:(

spinandscribble

I don't think ther'es any reason to switch back to the pill. Its not like its safer than the implant even after this scaremongering announcement. Its still good to question it though and push the company to improve.

miaowmiaow

Hey, I definitely wouldn't believe the hype! A good few of the mistakes made with implanon are due to the contraceptive not being inserted properly, or in some cases, not being inserted at all!
Also, the side effects are totally different for everyone, but personally mine has left me convinced it's the best thing since sliced pan! I didn't want to go on the pill, as I didn't want oestrogen messing with my hormones, and Implanon suits me. Plus the failure rate speaks for itself, and when condoms are also used the risk is itsy-bitsy-teeny-tiny.

Das Kitty

I read this article by Ben Goldacre yesterday. It sums it up really.

http://www.badscience.net/2011/01/putting-a-number-in-its-context/

Putting a number in its context

January 8th, 2011 by Ben Goldacre in bad science |

Ben Goldacre, The Guardian, Saturday 8th January 2011

---

“600 pregnancies despite contraceptive implant” said the BBC. *“500 fall pregnant after having contraceptive implant” said the Express. “Contraceptive implant alert” said the Daily Mail: “Hundreds of women fall pregnant after birth control fails”.

The story first broke on Channel 4, and it’s still not entirely clear why it’s the biggest medical story so far this year. Some women have had some compensation: but a lot of people get a lot of payouts. There’s a law firm touting for more business, but that’s hardly news either, and the news story was: this contraceptive device has failed.

But is the failure rate exceptional? A figure means nothing if it has no context: 600 pregnancies sounds like a big number, but there is no way to know what it means unless we know how many women had Implanon, and for how long. The device was first launched in 1999, so that makes 60 pregnancies a year, which feels like a smaller number, but that’s still not enough information. The figure that epidemiologists use for context is “person-years-at-risk”.

I contacted the MHRA. They estimate that 1.355 million Implanon implants have been sold.* If we assume that each implant lasted 3 years, which they do, this gives a total exposure time of 4.06 million women-years at risk. 584 unplanned pregnancies in this exposed population means there were 1.4 unwanted pregnancies reported for every 10,000 women with Implanon implants per year. If you prefer, you can say that the failure rate is 0.014% per year. This is rather good: in fact, implants are still the most reliable form of contraception.

Back with our 584 unwanted pregnancies, meanwhile, we see the difference between individuals and statistics. For some of the people who got pregnant, from their end of the telescope, this is a disaster. Some cases may well have been avoidable. Some will want financial compensation, and you’ll have your own views on the state’s role in this more broadly. But for you as a potential user of the implant, or a news editor, looking at the whole population, even though this particular variety of implant had a problem with insertion – which has already been improved on – at its worst, it still seems to be one of the most effective forms of contraception available.

Meanwhile there were 1,669 reports of suspected adverse events associated with the device, including arm scarring and other injuries. This is a rate of 4 adverse events for every 10,000 women per year, or if we assume that the implant lasts for 3 years, around 1 in every 1,000 insertions results in a suspected adverse event report.

Every medical intervention can have unintended side effects. It’s worth noting that for the past 5 years, patients have been able to report adverse events for any drug directly to the MHRA online, just like doctors have always done, and I encourage you to do so, as it provides an important resource for the fascinating problem of catching adverse reactions before they affect too many people.

Spotting a true signal of a problem in this database, incidentally, presents an awesome methodological challenge, because any one of thousands of drugs could cause any one of thousands of types of adverse reactions or symptoms. What you get, as a result, is a giant spreadsheet with a number in each cell, and inevitably, with such a vast number of cells, by the simple play of chance, there will also be a vast number of cells with an unusually high number of event reports in them, simply through random variation. Geniuses who worship the Reverend Bayes, with his statistical methods that exploit prior probability, have enjoyed scratching their heads over this resource for many decades.

And lastly, just like a number deserves its context, so too does a scare. In the 1990s, a temporary concern about a modestly increased risk of blood clot, particularly in one type of oral contraceptive pill, resulted in a mass abandonment of oral contraceptives generally, around the world, including among low risk women, and the following years saw an increase in both pregnancies and abortions, with all that this entails. Words can do harm, just as surely as hormones can.

tatabubbly

I use implanon and when getting it was told by the doctor that the only problems which occur are when the implant is inserted. Surely these women would have been told the same?? Also, in the packaging, it states this on the warnings..

I trust it, i'm happy with it as i never have to worry about contraception..

Ben Goldacre via Das Kitty

Ben Goldacre via Das Kitty wrote: »

If we assume that each implant lasted 3 years, which they do

Implanon doesn't necessarily last 3 years. If your overweight, the recommendation is you replace it after 2.

Also it's efficacy can be reduced if you take certain medications or herbal supplements. Just like the pill.

Karen23

I'm currently on my second Implanon and due to have it removed next month and I intend to get another straight in because I've had no concerns about it over the last six years.

Azureus

So I know they last three years, mines up at the end of the summer, could I get it replaced now ? The articles at the start of the year made me slightly worried, but I do love implanon so keeping it, just might consider bumping up my replacement date for effectiveness if it works this way!

Also, out of curiousity, do most women use condoms aswell?? I dont (longterm bf) but I dont wanna be takin chances!!

Karen23

You could have it replaced early but I dont think it will a make it any more effective. My last one was removed and a new one put in on the day before it was due out

Azureus wrote: »

Also, out of curiousity, do most women use condoms aswell?? I dont (longterm bf) but I dont wanna be takin chances!!

The only time we used extra precautions was for a couple of weeks after the implant was first put in.

psycho-hope

Lcronin2011 wrote: »

this really scares me i say just stick to the pill girls... keep it in ur bag and just turn on a recurrent alarm on your phone. thats the only way i remember it. then again nothing is ever 100% is it?:(

I have the implant and had a chat with my gp about it, the reason it failed for most of those women in the uk and here is because a) it wasnt inserted full stop or b) it was inserted wrong and the womens body healed over it so it couldnt realise the hormone.

I cant take the combined pill because of a family history of breast cancer and the mini pill turned me into a hormonal, crying, psycho, so I think ill take my chances with my implant, rather than relying on condoms alone.

as usual its the tabloid newspapers scaremongering, no contraceptive is 100% effective.

RonFan

Why not just use condoms??

Seriously, I would appreciate an answer.

Adelie

RonFan wrote: »

Why not just use condoms??

Seriously, I would appreciate an answer.

One big reason, check out the Wikipedia comparison of birth control methods. Implanon has a typical use failure rate of 0.05%, and a perfect use failure rate of 0.05%. Condoms have a typical use failure rate of 15% and a perfect use failure rate of 2%. That means if you use condoms correctly you have a 2% chance to get pregnant in a year, with Implanon it's 0.05%.

Another major reason is that a lot of couples much prefer the feeling without a condom as well as the lack of interruption.

the_syco

RonFan wrote: »

Why not just use condoms??

Seriously, I would appreciate an answer.

For many women, it's a case of extra security. If the condom breaks, or tares, you could be in trouble.

RonFan

Adelie wrote: »

One big reason, check out the Wikipedia comparison of birth control methods. Implanon has a typical use failure rate of 0.05%, and a perfect use failure rate of 0.05%. Condoms have a typical use failure rate of 15% and a perfect use failure rate of 2%. That means if you use condoms correctly you have a 2% chance to get pregnant in a year, with Implanon it's 0.05%.

I would find those statistics questionable at best. The chances of a condom breaking and leaking out enough gunk to reach the ovary seems a lot less likely than 2%. And that's before taking into consideration that a man ejaculating inside a woman's vagina does not always equal pregnancy.

Surely the trouble of getting this procedure done isn't that much less time and hassle than getting an abortion anyway??

Adelie

RonFan wrote: »

I would find those statistics questionable at best. The chances of a condom breaking and leaking out enough gunk to reach the ovary seems a lot less likely than 2%. And that's before taking into consideration that a man ejaculating inside a woman's vagina does not always equal pregnancy.

That's 2% over the course of a year, it does not seem unreasonable to me.

It's very likely that a couple would have at least one broken condom in a year, and if that happens at the wrong time of the month and they aren't using a back-up method then the chances of pregnancy are actually quite high.

Azureus

RonFan wrote: »

I would find those statistics questionable at best. The chances of a condom breaking and leaking out enough gunk to reach the ovary seems a lot less likely than 2%. And that's before taking into consideration that a man ejaculating inside a woman's vagina does not always equal pregnancy.

Surely the trouble of getting this procedure done isn't that much less time and hassle than getting an abortion anyway??

:eek: Are you talking about the procedure of getting Implanon inserted?
Abortion=massive costs (procedure plus travel fares for Irish women), aswell as traumatic and a (hopefully) once in a lifetime negative experience.
Implanon= 20minute process with a local doctor, at much less cost and no heartache. Incomparable!!

As for the condom argument, I hate the bloody things with a passion as does my boyfriend. Any excuse not to use them is a plus for me and thats before the whole splitting/effectiveness issues.

Ickle Magoo

RonFan wrote: »

Surely the trouble of getting this procedure done isn't that much less time and hassle than getting an abortion anyway??

FonFan infracted for trolling.

Please read the forum charter here before posting in this forum again.

bella_14

well it DOES happen...I have just found out I am pregnant on it and it was removed and confirmed that it was successfully inserted and was due to be replaced in 2 months, which is well under the 3 year period and I´m not overweight or have been using any medications throughout (not that this makes a difference btw) But nothing is 100% certain so while the chances are slim someone has to fall into that 0.04%

saa

Azureus wrote: »

So I know they last three years, mines up at the end of the summer, could I get it replaced now ? The articles at the start of the year made me slightly worried, but I do love implanon so keeping it, just might consider bumping up my replacement date for effectiveness if it works this way!

Also, out of curiousity, do most women use condoms aswell?? I dont (longterm bf) but I dont wanna be takin chances!!

You can get it replaced now I got it replaced a few months earlier before my medical card went out of date. Definitely condoms for the first week after getting it inserted, you hear a few weeks but doctors always say 7 days besides you won't be feeling too up for it during the first week with the discomfort.

Salty

I was thinking of getting Implanon inserted over the summer. I'm torn between that and the depo injection, though leaning towards Implanon.

Is Nexplanon available yet or is that just something in the pipeline?

OkayWhatever

I've been on Implanon for 2 and a half years and I swear by it. I would highly recommend it, as soon as I get this one out i'm gonna get another one. Sure, there's risks and side effects but that's the same with everything.

pampootie

_meehan_ wrote: »

Is Nexplanon available yet or is that just something in the pipeline?

AFAIK nexplanon is just the UK name for Implanon NXT which is whats available here now, "old" implanon is gone. It's essentially the same thing, exact same strength of the same drug but a slightly modified insertion method and its radioopaque. can double check at work for you thurs

lilsis

I was thinking of switching to the implant, currently on the pill but it's such hassle and I'm very bad at taking it on time and that. I was wondering if anyone can give me a price range though? As funds are currently low and I'm not entirely sure if I'll be able to afford it right now. Also is there any problem with the implant and PCOS. It runs in my family and while I haven't been diagnosed, if there was a problem with PCOS and the implant then I would obviously want to get that checked out first.

_meehan_

_meehan_ wrote: »

I was thinking of getting Implanon inserted over the summer. I'm torn between that and the depo injection, though leaning towards Implanon.

Is Nexplanon available yet or is that just something in the pipeline?

I think the advantage over the injection would be that the injection can take up to 6 months to leave your system? So if you do experience any side effects, I can only imagine you have to put up and wait, whereas presumably if you have any problems with the implant you can get it removed again.

lilsis wrote: »

I was thinking of switching to the implant, currently on the pill but it's such hassle and I'm very bad at taking it on time and that. I was wondering if anyone can give me a price range though? As funds are currently low and I'm not entirely sure if I'll be able to afford it right now. Also is there any problem with the implant and PCOS. It runs in my family and while I haven't been diagnosed, if there was a problem with PCOS and the implant then I would obviously want to get that checked out first.

from WWC:

Implanon**

Initial Consultation €55.00
Implanon (fitting only) €125.00
Removal €150.00
Removal and Re-fit (same day) €175.00

squeakyduck

One of my best friends who is from Glasgow has gotten pregnant. She had the implanon in. She is delighted though.

If that was me my world would end.

Ksusha26

Lcronin2011 wrote: »

this really scares me i say just stick to the pill girls... keep it in ur bag and just turn on a recurrent alarm on your phone. thats the only way i remember it. then again nothing is ever 100% is it?:(

+1

It has only been in the last couple of months that I have been taking the pill. It's better and more reliable and myself and my fiance are both comfortable with it. No more interrupting foreplay for my fiance to reach for the condoms. We have been discussing having children so it will be just a matter of stop taking the pill and letting nature take its course....when i'm ready of course

OkayWhatever

lilsis wrote: »

I was wondering if anyone can give me a price range though? As funds are currently low and I'm not entirely sure if I'll be able to afford it right now.

Mine, i think, was 120 to put in. Give or take a few, but that was 2 years ago. And I had to pay the GP fee aswell.. But removal is free with my GP, not sure if it's the same for every GP.

Karen23

The implant and insertion comes to total of €120 under the drugs payment scheme http://www.hse.ie/eng/services/Find_a_Service/entitlements/Drugs_Payment_Scheme/

I'm currently on my third implant

Karen23

bluewolf wrote: »

from WWC:

Implanon**

Initial Consultation €55.00
Implanon (fitting only) €125.00
Removal €150.00
Removal and Re-fit (same day) €175.00

Nobody needs to pay more than €120 . I'v posted the link to the DPS above

Morgase

Are you sure, Karen23? I understand that the DPS covers only the drugs and devices. Then fitting would cost extra at the GP / Well Woman.

When I got the Mirena, the device and associated drugs were covered by the DPS so I paid €120 for that but then had to pay for the fitting at the clinic aswell.

mcmoustache

Alarm bells were ringing in my head when I couldn't find out any percentages from the article. 600 failures out of how many implants? Thanks Das Kitty for providing Ben Goldacre's synopsis. This is common in the reporting of medical "news". Numbers without context just to sex up a non-story.

Karen23

Morgase wrote: »

Are you sure, Karen23? I understand that the DPS covers only the drugs and devices. Then fitting would cost extra at the GP / Well Woman.

When I got the Mirena, the device and associated drugs were covered by the DPS so I paid €120 for that but then had to pay for the fitting at the clinic aswell.

You could be right , I have GP Visit card so maybe the fitting was covered with that card , I was told the total cost would be €120 due to the DPS and that was all I paid , apologies.

saa

Wow how can people freak out about this, the numbers are so low and is usually the practitioners fault

Women fall pregnant on the pill however all the time because every day there's a chance it might not work, you may forget.. you have to abstain from sex for 1/4 of the year... whilst on the implanon you'll probably get a few periods a year


No contraceptive works 100% of the time but atleast the risk is so much lower with the implant as long as it is inserted correctly, I'm on my second and have done my research I obviously recommend it.

I will not be getting a third implanon most likely for financial reasons and then I will have the thoughts of accidentally falling pregnant on my mind

Karen23

I got pregnant twice on the pill , I've had Implanon for 7 years and it hasnt let me down yet so yes I would recommend it too

saa

saa wrote: »

I will not be getting a third implanon most likely for financial reasons and then I will have the thoughts of accidentally falling pregnant on my mind

I hate to be trite but a baby will cost more
I was a bit taken aback at the implanon cost too, but over 3 years, I reckon it works out a good bit cheaper than the costs of GP visits & pill every 6 months...

nikkibikki

OkayWhatever wrote: »

Mine, i think, was 120 to put in. Give or take a few, but that was 2 years ago. And I had to pay the GP fee aswell.. But removal is free with my GP, not sure if it's the same for every GP.

I paid €120 for the implant, €100 to get it fitted and €60 to get it removed, and have a lovely little scar on my arm because of it now! It did wear off early though, but I am overweight. I knew coz I hadn't had a period on it at all but 2.5years into it I got spotting and major cramps, so bad I actually thought I'd gotten pregnant and was miscarrying. My advice to anyone getting it is to think of it as lasting 2.5 years and not 3 years, just to be on the safe side......