Thousands of women are expressing their outrage after the FDA announced this week that it will not remove a birth control device known as Essure from the market, in spite of more than 10,000 complaints of serious injury from women, but will merely add a sterner warning to the label.

CNA/EWTN News is reporting on the announcement from the FDA saying that it intends to add the strictest possible warning to the label of Essure, a sterilization device consisting of flexible metal coils that are inserted into the fallopian tubes. The coils create an infection which causes scar tissue to form, thus closing off the tubes and rendering the woman sterile.

The problem is that the coils can dislodge and travel into the body where they have been known to lodge in, or perforate, organs. It has also been known to cause fetal disfigurement due to nickel poisoning. Chronic pain, exhaustion, bouts of depression and suicidal thoughts have also been reported by women who have used the device.

Since its introduction in 2002, the FDA has received almost 10,000 adverse event reports from women who have been injured by the device.

In spite of this evidence, the FDA decided to leave the product on the market but is recommending that a “black box” warning be placed on the packaging to call attention to “serious or life-threatening risks” associated with Essure. These include “persistent pain, perforation of the uterus or fallopian tubes from device migration, abnormal bleeding and allergy or hypersensitivity reactions.”

It will also require the manufacturer of the device, Bayer, to conduct additional studies to determine its safety.

“The actions we are taking today will encourage important conversations between women and their doctors to help patients make more informed decisions about whether or not Essure is right for them,” said William Maisel, M.D., M.P.H., deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health in a statement. “They also reflect our recognition that more rigorous research is needed to better understand if certain women are at heightened risk of complications.”

Why wasn’t this “more rigorous research” done before the product was put on the market?

This is just one of the questions being posed by the more than 27,000 women who have experienced the debilitating side effects of Essure and have banded together in a Facebook group known as Essure Problems to get the product off the market. Calling themselves the “E-sisters”, they say they provided the FDA with more than enough relevant data to prove that Essure is unsafe.

“We are outraged that it appears as if the FDA is going to leave Essure on the market while it implements a draft guidance and labeling recommendations within a black boxed warning as well as ordering new clinical studies,” the group said in a statement. “Clearly Essure’s PMA [pre-market approval] should be revoked and the device should be pulled from the market. These studies could take several years, and leaving the device on the market will only put more women’s lives at risk.”

In the wake of the disappointing decision, they are now turning their sights on Congressman Mike Fitzpatrick (R-PA) who has introduced the “E-free” act which calls for the device to be pulled from the market.

Fitzpatrick called the FDA’s latest announcement “unacceptable” to the thousands of women who have already suffered from this dangerous implant.

“It’s unbelievable that it took the FDA since September to make just two recommendations with no enforcement measures and ask the manufacturer to perform another study while leaving Essure on the market,” he said in a statement following the announcement. “It’s been done. The evidence is all there: Tens of thousands of injured women and hundreds of fetal deaths.”

The E-sisters say that they will not be stopped or silenced until Essure is off the market.

“We intend to push for Congress to force the hand of the FDA,” the group says. “While we continue to encourage women to file their adverse event reports with the FDA, our focus will be on Congress and the E-Free Act. We are disappointed but not surprised the FDA has once again chosen to side with industry rather than protect patients of a failed medical device.”

They add: “Essure is just birth control. It will not save your life, but it can certainly take your life or the life of your unborn child. The risks do NOT outweigh the benefits!”

The FDA is allowing 60 days for patients and doctors to submit their feedback on the device before the addition of the new warning labels.

Instructions on how to submit a comment can be found here.

Click here to read personal stories from women who have been harmed by Essure.

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