Essure Birth Control Withdrawn from Market in Canada, As Safety Concerns Mount Worldwide

Bayer has suspended sales of the Essure birth control implant in Canada, as sales have plummeted little more than a year after new label warnings were added to alert women about the risk of potentially severe complications. 

The Toronto Star reports that Bayer Healthcare gave the paper a statement, indicating that it was voluntarily withdrawing Essure from the market in Canada, citing falling sales.

In the statement, Bayer continued to deny claims that Essure complications made the birth control implant unsafe. However, the medical community appears to be moving away from the permanent sterilization procedure following thousands of reports involving problems suffered by women who had the device implanted.

Essure sterilization procedures involve the placement of coils in the fallopian tubes, which are designed to cause scar tissue to form and prevent pregnancy.

In November 2016, the FDA added a black box warning label to Essure implants, which is the strongest that the FDA can require a medical device carry. A similar warning was added to the Canadian label of the drug in May 2016.

The black box came after a large number of independent experts recommended that additional information be provided about the Essure procedure problems experienced by many women who received the coils, including perforation of the uterus and fallopian tubes, pain and allergic reactions. The new warnings also inform women that if Essure needs to be removed, it must be done through a surgical procedure.

Women who undergo the birth control procedure in the United States are now be presented with a patient checklist, which is designed ensure that they are aware of the potential side effects of Essure coils.

The warnings provide women with information about the permanent and possibly irreversible nature of the implant, the fact that there are alternative contraceptives available, the effectiveness of Essure coils and the risk of unintended and ectopic pregnancies, common adverse events, long-term risks, and what signs and symptoms they should look out for that may indicate a problem.

Bayer faces a potential Essure class action lawsuit in Canada, filed by several hundred women who say they suffered painful side effects. In the U.S., the company faces several thousand Essure lawsuits brought in courts nationwide, each raising similar allegations that Bayer knew about issues with their product for years, yet withheld information from consumers, doctors and federal regulators.

Approximately 750,000 women worldwide have been implanted with the device, and Bayer estimates that 70% of those have been implanted in women in the U.S.

As Essure injury lawyers continue to review and file claims for women nationwide, it is expected that thousands of additional cases may be filed in the coming months and years for women who still have the birth control coils in their body.