What is Essure?
Essure is a method of permanent birth control that involves placing a two metal coils into the female reproductive anatomy to block eggs from travelling from the ovaries to the uterus. It was developed as a non-invasive alternative to tubal ligation. Since Essure first gained regulatory approval, an estimated 750,000+ patients worldwide have used the device.
What are adverse events related to Essure?
Numerous adverse events have been reported to the FDA in relation to Essure use. Patients have reported unfortunate experiences ranging from chronic pain, changes in menstrual bleeding and allergic reactions to unintended pregnancies, perforation of the uterus, and even migration of the device into other areas of the abdomen.
From 2017 alone, more than 90% of adverse event reports to the FDA mentioned the potential need for surgical intervention to remove the device. Additionally, a total of more than 16,000 lawsuits have been filed against Bayer for problems related to Essure
Why is Essure being pulled now?
Bayer’s decision to pull Essure rides on the heels of an FDA mandate in April of this year restricting its sales and distribution. Due to an increase in reports of adverse events in 2017, the FDA performed an investigation that revealed that many patients weren’t being adequately informed of the potential risks of Essure. So now, Essure is only available from healthcare providers who follow specific guidelines ensuring that patients fully understand its risks before getting the device implanted.
But even prior to this restriction, Bayer was already having trouble with Essure sales. In 2016, the FDA ordered Bayer to include a “black box” warning (the toughest warning label available for drugs) and a Patient Decision Checklist in Essure’s packaging. After that, US sales declined by about 70%. In 2017, Bayer pulled Essure from international markets due to concerns over safety, thus leaving the US as the only remaining country in the world to sell the device.
When will Essure no longer be available?
Bayer announced that Essure will no longer be sold or distributed after December 31, 2018. Until then, the FDA’s restriction on sales and distribution will remain in effect, and Bayer will continue to enroll patients in their post-market study to monitor any complications that patients might experience.
What should you do if you already use Essure?
FDA Commissioner Scott Gottlieb, MD states that patients who already use Essure successfully should continue to do so. If you think you might be experiencing symptoms related to using the device, contact your doctor about appropriate next steps. One option might be to have the device removed—but this presents its own risks. So, be sure to discuss risks and benefits of all possible options with your healthcare provider.
In addition to consulting your doctor, you might want to consider documenting the problem in Bayer’s post-market safety survey or reporting it to the FDA’s MedWatch Reporting Program here.
What are other options for long-term birth control?
Birth control consists of two categories: reversible and permanent. For women, surgical tubal ligation and non-surgical Essure are really the only two options for truly permanent birth control.
Tubal ligation is where a surgeon uses one of several methods to effectively create a blockage in the fallopian tubes so that an egg cannot pass from the ovaries to the uterus where it would normally be fertilized. This procedure works immediately and is reportedly more than 99% effective. That’s in contrast to Essure which takes about three to six months after insertion to become effective, and failure rates may be as high as 9.6% within 10 years of use.
Essure and tube tying aren’t your only options for long-term contraception though. IUDs (intrauterine devices), for example, are long-acting reversible birth control options that can last three to 12 years depending on the device. They can be medicated (like Skyla) or non-medicated (like ParaGard). Another advantage? IUD failure rates can be as low as 0.2%.
As always, consult your doctor if you are considering starting or changing birth control methods. Choosing a method of contraception is a very personal decision that will depend on your individual health profile and preferences.
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