Karen Fratti
February 14, 2018 12:18 pm
Katherine Frey/The Washington Post via Getty Images

When something sounds too good to be true, it sometimes is. That’s what a group of women are saying about Essure, a “permanent contraceptive” made by Bayer, that can reportedly do more harm than good. Essure is a non-surgical alternative to tubal ligation, the procedure commonly known as “getting your tubes tied.” It’s a pair of metal and polyester coils that a doctor puts into your fallopian tubes, creating scar tissue which blocks your eggs from being fertilized. Many women choose to get one when they know they’re done with having children, largely because it’s less invasive than surgery. It’s like a permanent IUD.

But for some women, Essure has caused more trouble than solace. In some women, it’s provoked allergic reactions (possibly due to the material of the devices), as reported in the Washington Post. Women have reported dental problems, cramping, and clumps of hair falling out. There have been thousands of women who have had to get the device surgically removed. Other complications, according to the FDA, include, “persistent pain, perforation of the uterus or fallopian tubes from device migration, abnormal bleeding, and allergy or hypersensitivity reactions.”

But the most shocking thing about the research on Essure is that it isn’t even all that effective, according to some patients who say they got pregnant with the device inserted.

In the Essure Problems Facebook group, there’s even a place for women to post pictures about their “E-babies,” or babies conceived despite the fact that that women assumed they had eliminated the chance of getting pregnant. However, Bayer assures HelloGiggles that the product underwent the FDA’s rigorous Class III safety and efficacy reviews and since approval, continues to find that the benefits outweigh the risks of the device, although that’s a personal decision every woman should make with her doctor.

Katherine Frey/The Washington Post via Getty Images

The Essure Probems Facebook group, with some 36,000 members, has been the catalyst behind asking the FDA to continue to look in to the product. In 2016, members pressured the Food and Drug Administration to give Essure their most severe “black box warning,” along with a checklist for doctors to go over with with their patients. But those same women don’t think that the warning is doing enough and want the FDA to ban the device outright. Last week, they met with FDA Director Scott Gottlieb to that effect, but the agency says it is waiting for a safety report from Bayer to be completed, which is expected to happen sometime in 2023, according to BuzzFeed News.

That’s a really long time, especially since the device has received around 26,000 complaints since it was approved in 2002.

The worry is that more and more women will get the device and be stuck with managing the possibly dangerous side effects, not to mention an unplanned and presumably unwanted pregnancy. But the FDA and Bayer maintain that the device is safe and that they are looking into how to best inform women of their choices when they want to be sterilized.

A spokesperson for the FDA told HelloGiggles in a statement:

They added that they are conducting more research into the device and its safety. “Women considering permanent birth control should make fully informed decisions by getting information from their health care provider about the risks and benefits of each option,” they added.

Currently, the device is not on the market anywhere else in the world. A spokesperson from Bayer tells HelloGiggles that the decision to not make the device available in other countries was a “commercial” one and not tied to the coincidental health warnings in each country about the safety of the product. It maintains that women in the U.S. are just more interested in permanent birth control than women elsewhere in the world. Bayer adds that:

The company added that the “FDA states on its website that it ‘continues to believe that the benefits of the device outweigh its risks, and that Essure’s updated labelling helps to assure that women are appropriately informed of the risks.’ Recent medical literature is in accord. For example, a Journal of the American Medical Association study concluded that there is no increased risk of medical outcomes related to hysteroscopic sterilization.” The company has previously dismissed the Essure Problems group as activists waging a “meritless” campaign.

Despite that, another study found that women who get the device inserted are ten times more likely to need follow-up surgeries than women who get their tubes surgically tied, which is a major issue if you’re a woman on Medicaid or don’t have health insurance at all to cover these complications later on. By choosing a non-surgical procedure, some women claim to have had multiple replacement procedures and other surgical complications. Bayer maintains that this study is “limited” since the follow-up surgeries may not have any thing to do with the efficacy of the original Essure insertion procedure. But fact that any women at all might be opting for a surgical procedure to tie their tubes after using the device, or that there are side effects that you might have to seek more medial attention for (and pay for) is something to consider when weighing the actual cost benefits of this or any birth control.

Although Bayer maintains that it’s not offering the device elsewhere because of their market research, other countries do have bans on the device. Both things can be true. If anything, Essure highlights a major issue with our health care system: As long as you’re able to list the possible side effects on a “Patient Decision Checklist” before having a patient sign off on a procedure, it’s perfectly acceptable to offer potentially dangerous health care options to people. Our system, in which regulatory agencies and pharmaceutical companies work so closely together, can be detrimental to women and lower-income people, who end being data for procedures and devices pushed onto doctors, and then later left to figure out how to pay for more procedures, treatments, and maybe even a pregnancy. Again, the FDA hasn’t banned the product because they feel the rewards outweigh the risks, but that doesn’t mean the device shouldn’t be considered very, very carefully, given that there are birth control methods that don’t pose all of those risks and are more effective. Every birth control has its risks, but this one seems to have a lot more than others given its FDA black box warning.

It’s very worth mentioning that the reimbursement rates for doctors are a lot higher if they offer Essure as opposed to surgical sterilization. The Washington Post reports that 2011 Conceptus reports show that a doctor is reimbursed about a $1,000 for inserting the device as opposed to $500 for the more expensive, time-consuming surgical procedure, which, one could assume, is why the device quickly caught on with the medical community.

A study based on health care data from France found that within three years of getting the device, there were fewer medical complications (like the pain and other reactions), but there was a “higher risk of sterilization failure and repeat procedures.” BuzzFeed News reported that both the FDA and Bayer point to the study as a sign that the device is safe, but that totally ignores the fact that some women are getting pregnant with the device or have to have it replaced.

So if you’re considering Essure, make sure you talk to your doctor and really get a full understanding of the research before making a decision about the device, because this sterilization method, as is, might be too good to be true.

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