No, Essure is no longer on the market. Bayer stopped selling the device in the United States at the end of 2018, and the FDA required that all unused units be returned to Bayer by December 31, 2019. No Essure devices are available for implantation anywhere in the U.S., and the product was also pulled from international markets around the same time.
What Essure Was and Why It Was Removed
Essure was a permanent birth control device made of small, flexible metal coils that a doctor inserted into the fallopian tubes through the vagina, without surgery. Once placed, scar tissue formed around the coils over about three months, blocking the tubes and preventing pregnancy. The FDA approved it in 2002, and for years it was marketed as a convenient, non-surgical alternative to tubal ligation.
Problems emerged as more women received the device. Thousands of reports poured into the FDA describing serious complications: chronic pain, heavy or irregular bleeding, device migration (where the coils moved out of position), perforation of the uterus or fallopian tubes, and allergic reactions. The coils contain a nickel-titanium alloy, and some women developed hypersensitivity reactions to the nickel, though the reported rate was low (around 0.01% of recipients). Of patients who underwent skin patch testing for nickel allergy, about 65% tested positive.
The FDA responded with increasingly strict measures. In 2016, it added a boxed warning to the device’s label. In 2018, it took the unusual step of restricting sales so that only doctors who reviewed specific safety information with patients could perform the procedure. Bayer announced it would discontinue U.S. sales effective December 31, 2018, citing commercial reasons rather than safety concerns. By the end of 2019, all remaining devices had been returned.
The FDA Is Still Tracking Outcomes
Even though Essure is off the market, the FDA continues to monitor women who still have the device implanted. A large post-market surveillance study, mandated by the FDA, is still ongoing. As of late 2023, interim results were released from a third planned analysis after all patients in the study completed three years of follow-up. The full study requires five years of follow-up for every participant before final conclusions can be drawn.
The FDA has noted challenges keeping participants enrolled in the study over time. In 2022, the agency asked Bayer to develop additional strategies to reduce the number of patients lost to follow-up. The study’s status remains “ongoing” and consistent with its original plan. The FDA has committed to sharing final results publicly once the data is complete.
Bayer Faced Thousands of Lawsuits
The removal from market did not end the legal fallout. Tens of thousands of women filed lawsuits against Bayer, alleging the company knew about or should have known about the risks of the device and failed to adequately warn patients. Bayer agreed to a major settlement in 2020 to resolve the bulk of U.S. claims. The company consistently denied wrongdoing throughout the litigation but chose to settle to avoid prolonged court battles.
If You Still Have Essure Implants
Hundreds of thousands of women had Essure placed before it was discontinued, and many still have the coils in their bodies. If you’re one of them and you’re not experiencing symptoms, medical guidance is straightforward: removal is not automatically recommended. Removing the device requires surgery, typically involving removal of the fallopian tubes (salpingectomy) or, in some cases, a hysterectomy. These procedures carry their own risks, including the potential for injury during extraction, so the decision involves weighing real surgical risks against the absence of current symptoms.
If you are experiencing problems you think may be related to Essure, such as persistent pelvic pain, unusual bleeding, or allergic-type symptoms, a pelvic exam and conversation with a gynecologist can help determine whether removal makes sense in your case. Surgeons with specific experience removing Essure devices may offer better outcomes, since the coils can be embedded in scar tissue and require careful extraction.
Permanent Birth Control Options Now
With Essure gone, tubal ligation is the only permanent sterilization option currently available for women in the U.S. This is a surgical procedure, typically done laparoscopically, where the fallopian tubes are cut, tied, clipped, or removed entirely. It’s a well-established procedure with a long safety record, though it does require anesthesia and a short recovery period, usually a few days. Vasectomy remains the permanent option for male partners and is less invasive, performed under local anesthesia in an office setting.
For women who want highly effective but reversible contraception, long-acting options like hormonal IUDs and implants offer pregnancy prevention rates comparable to sterilization, with the advantage of being removable if plans change.