The Essure birth control system will no longer be sold in Canada, in the midst of serious injury reports submitted by patients. According to the Star, Bayer Inc. announced that declining sales had led the company to voluntarily discontinue the Essure birth control system.

“In light of the change in patient demand, Bayer has decided to voluntarily discontinue the sale and distribution of Essure in Canada over the next few months. This decision was taken for commercial reasons, and the favorable benefit-risk profile of Essure remains unchanged. This is not a recall of the product from the market,” Bayer said in a written statement provided to the Star.

Bayer Inc. had heavily marketed the Essure birth control system towards women who wanted a permanent but convenient method of permanent sterilization. After its release in 2002, the Essure birth control system became the first and only alternative female sterilization method to tubal ligation.

The device consists of two metal coils that are directly inserted into the fallopian tubes. The tissue will eventually grow around the coils, which ultimately prevents sperm to egg fertilization.

The device’s convenience and quick recovery time have made the Essure birth control system a popular choice. However, the numerous injury reports from women who used the Essure birth control system have caused Bayer Inc. to face major criticism.

Overview of Essure Birth Control System Problems

The Essure birth control system injury reports indicate side effects ranging from mild pain to ectopic pregnancies, which have been submitted since the product was released in Canada since 2001. Thousands of injury reports in conjunction with the Essure birth control system, throughout North America for years.

The complications associated with the Essure birth control system included: bleeding, unintended pregnancy, chronic pain, tissue perforation, device migration, and allergic symptoms. An advisory from Health Canada concluded that patients had not been properly informed of these risks associated with the Essure birth control system.

Canadian health officials had previously conducted a safety review of Essure and advised doctors in May 2016 that Bayer Inc. would be required to add a black box warning label to the Essure birth control system. Bayer Inc. will also be required to provide a patient information checklist to provide to patients, so women properly understood the device’s potential side effects.

In 2016, approximately 8,000 Canadian women had opted for the Essure birth control system to be implanted. Bayer Inc. has stated that a total of 750,000 women, mostly in the United States, had the Essure birth control system implanted. However, Essure complications had eventually led to the device becoming banned in Brazil, Finland, and United Kingdom.

The numerous injury reports eventually led to a potential Essure class action lawsuit launched in Canada, involving 297 women who had used the Essure birth control system. Some of these women alleged they had to undergo hysterectomies due to the Essure complications. Many similar claims have been filed by women in the United States.

Even though these side effects can be potentially devastating to patients, Bayer Inc. allegedly failed to warn patients against potential complications. Patients who may have experienced Essure complications, may be able to file legal action.