Craig D. Rosenbaum | August 28, 2018 | Defective Drugs, Defective Medical Devices, Products Liability
Following the continuous efforts by health advocates and thousands of women, Bayer announced that it will no longer sell its Essure birth control implant by the end of the year. The permanent birth control method resembles the spring of a ballpoint pen and does not require an incision or invasive surgery.
The company says the decision to discontinue the device was because of declining sales. The several lawsuits against Bayer and a Netflix documentary may also have been factors. A sisterhood of women came together to share their experiences of the side effects of Essure. The Facebook group, “Essure Problems” has grown to 38,000 members since 2011. The creator of the group suffers from an autoimmune disorder because of her Essure implant.
Women demand FDA ban the device
After hearing the women’s stories, the FDA required Bayer to limit sales to doctor’s offices and medical practices that agreed to fully warn patients about the risks of Essure, and also issued a “black box warning.”
Bayer halted all international sales of Essure in 2017, but the medical device will remain available in the United States until the end of 2018. The company said it would continue to enroll patients in a postmarket surveillance study and will work with the FDA to ensure appropriate follow up. “We believe we have meritorious defenses and intend to continue to vigorously defend Essure,” says a Bayer spokesman. As the debate continues, women can rest easy knowing that Essure will be off the market by the new year.
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