A group of women have banded together in an effort to get Essure birth control off the market.

The women say they developed damaging and sometimes permanent Essure problems after being implanted with the devices, which were designed to be used as an alternative to permanent surgical sterilization.

What is Essure Birth Control?

The Essure birth control implant is a small metal coil that a physician implants in the fallopian tubes using a quick outpatient procedure. No surgical incision is necessary.

About three months later, if all goes as planned, the body surrounds the implants with scar tissue, blocking the fallopian tubes and preventing conception.

But thousands of women have reported considerable complications related to these implants. Since Essure was made available in 2002, the FDA has received over 5,000 reports of adverse events related to Essure.

Women have reported symptoms like pelvic pain, fatigue and weight fluctuations. Some implants have fractured or migrated out of place, and the nickel in the metal coils has allegedly caused allergic responses in some women.

The implants have even been reported to fail to prevent pregnancy. Essure removal has in some cases required women to undergo a hysterectomy.

Over 30,000 women with stories like these have signed on to a Facebook support page called Essure Problems. Angela L., one of the administrators of that page, says she suffered from migraines and extreme fatigue after receiving Essure birth control. She reported needing to go right back to bed after sleeping for 14 hours.

Another woman, April H., says she suffered from chronic back pain for five years. She also reported extreme fatigue. At some point her hair started falling out in clumps. Her doctors couldn’t figure out what was wrong, but she says she eventually figured out her symptoms were related to her Essure birth control.

Limited Response From The FDA

As a group, these women take issue with the fact that Essure birth control is still on the market.

In February 2016, the FDA issued new requirements of a boxed warning and a patient checklist. It also ordered manufacturer Bayer to conduct new studies, but the agency stopped short of taking the device off the market.

Elizabeth C. feels that in leaving Essure on the market, the FDA failed to do its job. She became pregnant despite using Essure, and problems she attributes to the implants required her to get a hysterectomy. She believes it’s self-evident that Essure is neither safe nor effective.

In explaining its decision, the FDA acknowledged that some women have suffered severe Essure problems, but that for many other women the product is safe and effective. The agency said that taking Essure off the market would limit physicians’ and patients’ options.

Other women have taken matters into their own hands via litigation. These women have brought Essure lawsuits alleging, among other things, that Bayer failed to warn physicians and patients about the risks of Essure problems.

Some claim that Bayer willfully concealed the dangers associated with Essure birth control and the possibility that Essure removal via hysterectomy might be necessary.