As of December 31, 2018, Essure is no longer sold or distributed in the United States. Bayer, the company that makes and distributes Essure, announced its decision in July 2018. The decision came after several actions by the Food and Drug Administration (FDA), including an April 2018 order that restricted the sale and distribution of Essure.
On July 20, 2018, the FDA confirmed that Bayer had notified the government that Essure sales would stop at the end of 2018. In the FDA’s press release, the agency mentions explicitly that the postmarket safety of Essure will continue to be a top priority of the FDA and that Bayer will be expected to meet its postmarket obligations with regard to Essure. FDA Commissioner, Scott Gottlieb, M.D. specifically included the following language in the press release, “I want to stress that, even when Essure is no longer sold, the FDA will remain vigilant in protecting patients who’ve already had this device implanted. We’ll continue to monitor adverse events reported to our database, as well as other data sources.”
The FDA Revises Essure Postmarket Study Requirements
On December 20, 2018, the FDA issued another press release about Essure. This time FDA Commissioner Gottlieb announced new steps to “…revise and strengthen the manufacturer’s postmarket study…” including:
- Following the women in the study for five years rather than three years.
- Requiring additional blood tests for women involved in the study to learn more about their inflammatory markers.
- Requiring Bayer to continue to enroll women in the study who decided to get Essure before it was fully discontinued in the United States.
- Requiring Bayer to submit more frequent reports to the FDA.
While the FDA is continuing to monitor adverse reports about Essure, the agency cannot provide a financial recovery for women who have been hurt.
Individual Women Hurt by Essure Can Pursue Legal Recoveries
Essure is a form of permanent birth control. The device consists of small flexible coils that were inserted into a woman’s fallopian tubes during a relatively quick and simple office procedure. About three months later, scar tissue should form around the coils and prevent sperm from reaching eggs.
Unfortunately, this form of permanent birth control came with many risks. After receiving Essure, some women experienced:
- Significant pain in the pelvis, abdomen, or back.
- Excessive bleeding.
- Unintended pregnancies.
- Migration of the Essure device into the pelvic or abdominal cavities.
- The uterus or fallopian tubes being perforated by the Essure coils.
- Allergic reactions.
- Significant and long-term mood changes or clinical conditions such as depression.
Thousands of women have pursued legal action against Bayer and against Conceptus, the pharmaceutical manufacturer that made Essure until Bayer bought the company in 2013. These women allege that the pharmaceutical companies failed to warn them about the risks of Essure and instead marketed Essure as a safe product.
Take Action Today If You’ve Had an Essure-Related Injury
If you have suffered a serious complication from Essure, then it is not too late to take action. Your legal rights have not changed just because Bayer decided to discontinue sales of Essure in the U.S.
Instead, if you have suffered a serious long-term complication from this form of birth control, then you may be able to pursue or to join a mass tort lawsuit with other women in Massachusetts, New Hampshire, and Rhode Island who have suffered similar injuries.
Essure claims, like other pharmaceutical injury claims, can be complicated. Bayer has the resources to defend itself against your claim and to make it very difficult for you to be successful unless you have an experienced lawyer on your side.
The legal team at Keefe Disability Law will protect your rights and your potential recovery if you have suffered an Essure injury. We want you to recover for the past and future medical expenses, lost income, out-of-pocket costs, pain, suffering, and other damages that you’ve suffered. Call us or reach out to us via this website today to schedule a free, no-obligation consultation to learn more about your rights and about what you can do next to protect your recovery.