Following years of consumer outrage and complaint, Bayer recently announced a voluntary Essure recall in the United States.

On July 20, Bayer announced its voluntary Essure recall in the United States, citing “decline in U.S. sales of Essure in recent years and the conclusion that the Essure business is no longer sustainable.”

Declining sales are reportedly due to “declining interest” in the device. The pharmaceutical company attributes the declining interest to overall decreased use of permanent birth control methods, increased use of alternative birth control methods, and “inaccurate and misleading publicity about the device”.

The Essure birth control device is comprised of two metal coils which are inserted into the fallopian tubes in a non-surgical procedure. Over the course of six months, scar tissue forms around the coils and blocks the release of eggs into the uterus similarly to tubal ligation.

Although the device was initially praised as a non-surgical alternative to tubal ligation, thousands of reports have been filed with the U.S. Food and Drug Administration (FDA) regarding problems.

Women with the Essure device have reported the coils becoming dislodged, migrating to other parts of the body, and cause problems including pain, irregular and heavy periods, headaches, fatigue, and more. In the 15-year period from when Essure was approved to December 2017, the FDA received over 26,000 reports of problems associated with the birth control method.

In response to consumer complaints and numerous reports of side effects, the FDA launched an investigation into the safety of Essure, the results of which have not been announced. This year, the FDA announced new restrictions for the sale and distribution of Essure. These restrictions limited Bayer to sell the device to providers that had agreed to warn women fully about the device’s potential side effects. However, for some women this was not enough.

Bayer’s decision to launch their voluntary Essure recall follows years of relentless consumer advocacy and outspoken opposition to the permanent birth control device. Due to the side effects of the device, consumers argue that Essure is dangerous and numerous have filed lawsuits against Bayer for releasing the allegedly defective device.

Complaints of Essure’s alleged deficiency are widespread and over 36,000 women have formed an “Essure Problems” group on Facebook where they can discuss the birth control device and the effort to remove it from the market. Women in this group have a platform to discuss the side effects they’ve experienced while implanted with Essure, ranging from a developed nickel allergy to pregnancy.

Following the announcement of Bayer’s voluntary Essure recall, the group’s creator messaged NBC News via Facebook, saying that the years of “fighting to get Essure off the market has finally paid off.” The creator said that the announcement “has brought us all to our knees in thanks, relief and celebration. Not one more woman will be harmed by this device. We have won, we have finally won.”

Although Bayer has announced a voluntary Essure recall, the company maintains that their device is safe and effective and continues to “stand behind the product’s safety and efficacy.”