Jen Juneau
March 02, 2016 10:09 am
Twitter / Bayer

If you are considering an Essure birth-control implant, or are one of the 750,000 women who have gotten the implant since 2002, we have some news for you. This past Monday, the U.S. Food and Drug Administration issued a press release outlining measures they were taking to further ensure the safety of women who use Essure.

For those who aren’t familiar with Essure, it’s a pair of tiny, flexible coils made of nickel and titanium. These are placed inside a woman’s Fallopian tubes, where they prevent sperm from fertilizing a woman’s eggs and generate the growth of scar tissue. According to TODAY, Essure “is frequently pitched to women as the only non-surgical option for permanent birth control.”

And though the implant obviously has its pros, there have been many reports from women who have suffered side effects like abnormal bleeding, chronic pelvic pain, problems with their mood, hair loss, allergic reactions, and more. In their press release, the FDA even stated the possibility of damage to both the Fallopian tubes and the uterus if the coiled devices shift unfavorably. Many people vehemently oppose the existence of the device, period.

And although the FDA hasn’t banned Essure altogether, they did state that they would be requiring its manufacturer, Bayer, to conduct “a new, mandatory clinical study for Essure to determine heightened risks for particular women.” These studies will analyze reported complications related to the implant such as pain, surgery to remove or replace the implant, and even unplanned pregnancy, then compare their results to those of the more traditional incision-based “getting your tubes tied” surgical procedure.

While such studies can take years to complete, the FDA also announced they would be requiring “changes to product labeling, including a boxed warning and a Patient Decision Checklist to help to ensure women receive and understand information regarding the benefits and risks of this type of device.” The proposed black-box warning will either join or replace the previous one, which warns of potential allergic reactions to nickel (e.g., hives and itching).

“The actions we are taking today will encourage important conversations between women and their doctors to help patients make more informed decisions about whether or not Essure is right for them,” stated Deputy Director for Science and Chief Scientist at the FDA’s Center for Devices and Radiological Health William Maisel, M.D., M.P.H., in the press release. “They also reflect our recognition that more rigorous research is needed to better understand if certain women are at heightened risk of complications.”

We hope this new set of requirements from the FDA reduces the number of complications women have from using Essure, and are grateful more women will know the risks involved before making the decision to get the implant. Kudos to the FDA for requiring Bayer to conduct more thorough studies on Essure, and making sure we are all more educated in the meantime.

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