Essure is a device used for permanent sterilization. It is a nickel-titanium alloy coil placed through the uterus into the Fallopian tube and causes scaring that the blocks the tubes. The upside is that it is a relatively short office procedure when performed by a skilled practitioner that does not require surgery to enter the belly like a tubal ligation, but the major downside is that it takes three months for this scaring to happen and special x-rays are required at the three-month mark to make sure the tubes are indeed blocked.
Some women claim that they have been harmed by Essure and the growing number of reports has led the FDA to re-evaluate the device. Are they right or is this reminiscent of silicone breast implants when everyone thought they were causing autoimmune conditions when they were not. Getting the answer with Essure may actually be very challenging.
Essure was woefully untested. This doesn’t necessarily mean it’s bad, but it does mean that there is no large data set to look back at to offer explanations or reassurance. For example, when girls and women claim injury from the HPV vaccine we can look at clinical trials of over 23,000 and extensive post-marketing surveillance and say the conditions experienced by the girls are unrelated to the vaccine. We have literally hundreds of thousands documented doses with follow-up.
But Essure is a device that is implanted, how can it be less tested than a vaccine you say? Many medical devices require less testing than a new drug. One-year safety data on Essure for less than 700 patients (based on two studies) was sufficient to get premarket approval so Bayer could roll out the device. If you want to read more about the studies and was required of Bayer and what was actually done I suggest you read this editorial in the New England Journal of Medicine.
So here’s the problem, some people get devices and some people develop problems. We already know some women blame irregular bleeding on their tubal ligation (done the traditional way via laparoscopy or post delivery with a small incision), but studies tell us there is no change in hormone levels after a tubal and there is no change in bleeding pattern related to the tubal. Yes women have symptoms, but no they are not related to the tubal ligation. Why does this happen? Likely it is the fact that many women stop birth control pills or depo provera after their tubal and all of a sudden their periods return and they now have symptoms that were otherwise well-treated. Since the symptoms start with the tubal (because that’s when the hormonal contraception was also stopped) they blame the surgery. What this should tell any manufacturer with a device for permanent sterilization is that your studies need to address this confounder. The Essure studies were not.
As a pelvic pain expert I have seen women who feel their symptoms were caused by Essure and I also see very many patients with identical symptoms who never had the device placed. To sort out the role of Essure in symptoms there are three possibilities to consider:
- Essure is not causing any harm, this is a form of tubal ligation syndrome or another unrelated phenomenon.
- Women are having bad effects from Essure related to the nickel
- Women are having bad effects unrelated to the nickel
I was trained to put Essure in when it came out and I will admit my bias, I think it’s a device looking for an indication. It’s not that much cheaper than a tubal ligation and it far more expensive than an IUD. Basically, two copper IUDs will give you 24 years of contraception (12 years back to back) and are cheaper than an Essure. In addition, a traditional tubal and an copper IUD work immediately, none of this three month follow up stuff.
And then there is the nickel. I am highly nickel allergic. The thought of nickel in my Fallopian tubes conjured up images of rotting from the inside out. Could many women who claim injury from Essure really be having an allergic reaction to the nickel and not a true device complication? As far as nickel is concerned the manufacturer states that an “allergic reaction is possible and if you have a nickel allergy you should “speak with your doctor.” But here’s the thing, I didn’t know I was nickel allergic until I was in medical school and heard a lecture on allergies. Only then did the years of not being able to wear most jewelry because of severe itching and rashes made sense. Not everyone will know they have a nickel allergy, maybe like me they just thought they had infected ears for five years after they had them pierced so just gave up on earrings. About 8% of the population has a nickel allergy.
Nickel in implants is interesting. Studies evaluating nickel in heart stents, some of which contain up to 35% nickel, suggest that stent failure may be more common in those who are nickel allergic, but these are small studies. Currently the FDA warns against nickel containing stents for patients who are nickel allergic. Studies evaluating the association between nickel and orthopedic implant failure have been inconclusive. I know so much about nickel in devices as my son has an Amplatzer device that was placed when he was two years old to close a hole in his heart and these devices are 50% nickel. Given my history I read up a lot on the subject.
What it really boils down to is the lack of good data. If we had decent studies we wouldn’t be wondering if we had another silicone breast implant fiasco (i.e. the device is safe, but people think it isn’t) or a Dalkon shield (the device is really unsafe). I doubt most women who received Essure were aware the device was so inadequately tested. The correct study would have been Essure vs. tubal ligation or Essure vs. copper IUD, but those would have been expensive and time consuming (which delays getting to market). Now Bayer has to play catch up and of course only after prodding by the FDA.
In my opinion the next steps should include the following:
- Making sure everyone who is offered an Essure is adequately informed about the relative lack of long-term data and the lower quality of the data versus traditional tubal ligation and IUDs.
- Bayer funding a study that patch tests women with and without device complaints for nickel allergy with tubal ligation as controls. This obviously won’t account for damage done by perforation, but if everyone who has an issue is nickel allergic then patch testing should be recommended before implantation.
- Bayer doing the right studies comparing Essure with tubal and/or the copper IUD.
- The American College of OB/GYN issue a policy statement on Essure and the lack of good data on true risks with the device insertion (procedure-related risks) and the fact that the failure rate (i.e. pregnancy rate) is likely 5-6%, so much higher than a copper or a Mirena IUD,
This is what happens when a device is inadequately tested, women suffer whether the device is at fault or not. If the device is causing direct harm then the affected women are obviously suffering from a direct complication and if the device is not at fault (meaning these reported complaints are no greater with Essure than a control population) women have suffered because no one was able to adequately reassure them their Essure wasn’t the cause.
Even if I didn’t have a severe nickel allergy I would never get an Essure myself. It’s fiddly (too much room for operator error), you have to wait three months to see if it worked and even then the failure rate may be higher than an IUD, and it hasn’t been studied to my satisfaction.