When It Comes to Birth Control Devices and Drugs, Women Deserve to Know the Risks

A controversial female sterilization device called Essure is making the news after the FDA issued a restriction last month that limits where this device can be sold. Specifically, the restriction limits sales of Essure to medical practices that agree to mandate informing women about the dangerous side-effects they might experience by using it. This new restriction comes two years after the FDA issued a black-box warning to be placed on the device, also detailing these side-effects. In 2017 alone, the FDA received nearly 12,000 reports about the device’s adverse side effects, ranging from long-term chronic pain to ectopic pregnancies.

Issuing a black-box warning is serious enough but following that up with restricting sales amplifies the FDA’s signal that this product is unsafe for some women. So how is this type of birth control different from other options on the market?

For starters, unlike the Pill or other popular methods, Essure is a “permanent form of birth control” that is hormone free but works by essentially creating scar tissue in a woman’s fallopian tubes. Essure consists of tiny coils made of nickel and other synthetic fibers (akin to polyester) that are placed into a woman’s fallopian tubes. The way these coils work is by evoking the body’s immune system to respond—kind of like an intruder alert.

When Essure’s metal devices are inserted into a woman’s fallopian tubes, her body recognizes them as invaders. The immune system gets revved up and starts attacking. This creates a hostile environment because the immune system is sending cells to try and protect her body from what it sees as a threat to her health. And her fallopian tubes face off with her fighter cells, and in the meantime, her fallopian tubes become the war zone that gets scarred over from the battle.

The scar tissue that builds up seals off an Essure-user’s fallopian tubes so that her eggs can’t get through to the uterus, and sperm can’t get up to the eggs, which prevents pregnancy and causes permanent sterilization. All of this is supposed to happen without the Essure-user ever feeling the war going on, because the battle is only supposed to be happening around the sites where the Essure coils are placed in the fallopian tubes.

Sounds like a pretty sure-fire way to prevent pregnancy, right?

But it turns out that a lot of the women who used Essure experienced things like headaches and back or pelvic pain, or allergic reactions to the metal coils. Some women had scary effects like the coils perforating through the fallopian tubes, or the fallopian tubes not getting fully sealed off by the scar tissue, resulting in unintended pregnancies and ectopic pregnancies for some women. And tragically, at least one woman died due to complications from this device.

Most likely, many of these side effects occurred because the battle being waged wasn’t properly contained in the fallopian tubes, as expected with this kind of device. Whereas the idea of inserting the tiny coils and allowing the body to scar the tubes shut seems pretty straightforward, the actual immune system response is more complicated.

There is emerging evidence of similar conundrums with respect to other insertable birth control devices as well. Take for instance copper intrauterine devices (IUDs), which we can think of along the same lines using our immune system battle analogy. The copper IUD was designed to work at the level of the uterus, thinning the lining of the uterus to make it inhospitable to pregnancy, and revving up an immune response that is toxic to sperm and eggs, which is used to prevent fertilization.

A large, multicenter research study is currently being conducted as part of the Evidence for Contraceptive Options and HIV Outcomes (ECHO) Trial, which is looking to assess and compare the effects of copper IUDs and two other long-acting reversible contraceptive methods (LARCs) on rates of depression and sexual dysfunction. And a recent study of 14 million women in Denmark found a statistically significant increase in rates of depression among women, especially adolescents, using any type of hormonal birth control.

These studies are important, as they are shedding new light on the unintended effects of various birth control options, which women should be made aware of when they are making their family planning choices.

In a more general sense, as we continue to search for the best family planning options for women, the Essure developments are further confirmation of what we already know: that one size never fits all. Women are on the move, working and caring for their families, and they want and deserve reliable methods of family planning that are affordable, low maintenance, and safe.

It’s important to remember that with every new type of birth control—whether it’s a medical pill, patch, ring or rod—anything we’re putting into our bodies that contains either hormones or devices comes with some risks.

We have a responsibility to women to inform them about all of the risks associated with various methods of family planning. Women also deserve to know that there are hormone and device-free methods (called Fertility Awareness-Based Methods, or FABMs) available for those who want to space their pregnancies by monitoring their natural biomarkers of fertility.

The bottom line is that we need to challenge the medical community to not only alert women about the risks of various contraceptive devices and drugs but also to fully inform them about the natural alternatives that exist. As Helen Alvare has written on this blog, “Information empowers women to decide if the advantages of hormonal contraception outweigh the risks.”

Women deserve the truth because it’s our health and long-term fertility on the line.

Ana Maria Dumitru is an MD/PhD candidate at the Geisel School of Medicine at Dartmouth College. She is a member of Women Speak for Themselves. Kat Talalas is communications director for Women Speak for Themselves.

Editor’s Note: The views and opinions expressed in this article are those of the authors and do not necessarily reflect the official policy or views of the Institute for Family Studies.