Essure: Be careful what you wish for

“If you’re sure you’re done having children, and want a permanent form of birth control, talk to your doctor about Essure,” purred the smooth female voice at the end of the radio commercial. I had heard this ad a couple of times and thought, ‘Essure? What’s that?’ Because I worked in women’s health care for about a decade, it’s rare that I haven’t heard anything about something as basic as a birth control method.

A quick glance at the Essure website gave me the snapshot. A doctor places a very small coil in each of a woman’s two fallopian tubes. The coils cause mild irritation inside the tubes, which prompts the body to produce scar tissue. Over a period of three months, enough scar tissue builds up to block the tubes so that sperm can’t pass through to fertilize the eggs.

In the interim, a woman must use another form of birth control. At the end of three months, the woman needs to have an imaging test (specifically a hystereosalpingogram, or HSG) of her uterus performed to determine whether her tubes are fully blocked. On the surface, the procedure makes sense, and even sounds appealing.

A dream come true?

The site’s Benefits and Risks page features a long list of positives, with several items seemingly taken directly from the “birth control wish-list” of many women I know. For instance, Essure is a non-surgical sterilization procedure that can be performed in a doctor’s office with no cutting whatsoever. It doesn’t use any hormones or silicone, both of which have received negative press recently and are causing women to think carefully about what goes into their bodies. The fact that the procedure is often covered by insurance makes it seem like a dream come true. But as with anything, it’s important to look past the hyped-up language and directly into the facts.

Essure makes the following claims on its website:
“Quick recovery - … most women return to their normal activities within one day.”
Some women return to their normal activities that quickly, but many need three to five days, and some women claim that it took up to two weeks. Remember, each of us is different.

“No general anesthesia required - … Although some physicians may offer general anesthesia, this is not a requirement of the procedure …”
It’s true that the procedure doesn’t require general anesthesia. However, many doctors require it for the placement of the coils.

“No hormones or silicone - … Essure micro-inserts do not contain silicone or release hormones…”
The inserts are hormone and silicone free, but they contain nickel, which many people are allergic to. If you’ve ever had a reaction to jewelry or the snap on your jeans, you are at risk to have a reaction to the inserts, as well.

“The Essure procedure is covered by most health insurance plans …”
The procedure is usually covered, however, the follow-up HSG rarely is. The cost on that was reported to be $900 to $2,000.

Turn the coin over

If you’ve been reading my columns for very long, you know that I’m typically skeptical of any medical procedure that is hard-sold to the public. So, despite the fact that the risks were buried in a PDF several clicks down from the Essure home page (and invisible to search engines), I dug them up and looked them over carefully.

There were just two clinical trials for the Essure Permanent Birth Control Procedure, testing its effectiveness on a total of 745 women. This seems like an awfully small sample size, especially since the trial period was only five years old at the time the results were published. Essure does disclose that “(v)ery little is known about how well the Essure micro-inserts work beyond the first 5 years. What is currently known about the Essure micro-inserts may change as new information becomes available.”

But “what is currently known” is still plenty. Of the 745 women in the trials, 104 were unable to have both coils placed during the procedure. Sixteen had one or both of the tubes come out of their bodies. Thirteen had either their fallopian tube(s) or uterus perforated by one or both coils. When a perforation occurs, the coil is then floating in the abdominal cavity or the uterus. Not only will Essure not be able to provide any birth control in that case, it will probably need to be surgically removed.

Because it takes approximately three months for Essure to be fully effective, the trials tracked the women for 15 months after the placement procedure, so that the first year of infertility could be studied. The problems reported from this period of time included steady or recurrent back pain for 67 women, abdominal pain for 28 and painful sexual intercourse for 27 women.

But wait, there’s more

The Summary of Risks paperwork dutifully reported these statistics, but couldn’t possibly reveal how the women who had undergone the placement procedure felt about the Essure method. I was able to find a few online bulletin boards where women were sharing their own experiences and this told me more about Essure than any of my other reading.

To be clear, more than 90% of the women posting on the largest bulletin board were positive about the procedure and their resulting sterility (though several posters sold a little too far past the close to be trusted as innocent participants). However, I did read about some very negative experiences, both in having the coils placed and in their effectiveness.

Women are reporting ongoing, persistent pain in their backs, sides and/or abdomens. Many women say their periods have changed since the procedure. For some, it got shorter and easier. For others, it was much longer and much more painful. I read several reports of one or both coils perforating the fallopian tubes and requiring major surgery to remove them. For other women, one or both coils just went missing. They weren’t in the fallopian tubes, nor could they be located in the uterus or in the abdominal cavity. This was the case in one woman who had been told that her tubes were completely blocked at three months post-procedure, but then conceived twins.

In total, I read about four pregnancies after women had been told that they were sterile. In one very sad case, the woman’s back-up birth control method failed in the first three months after coil placement. Her husband’s sperm was able to travel to the egg, but the fertilized egg was not able to return to the uterus via the mostly blocked fallopian tube. She had an ectopic pregnancy (in the fallopian tube instead of the uterus) and her tube ruptured one night, waking her with terrible pain and requiring immediate surgery to remove the tube and ovary.

Essure is brought to us by the same medical industry that has given women Thalidomide, the Dalcon Shield, Norplant and Premarin. For better or worse, the world we live in is driven by profit, even in what should be an inviolable realm – our basic physical well-being. As always, it’s important to be a knowledgeable consumer, especially of medical care. VS