Announced today, July 20, 2018, Bayer will phase out the Essure birth control device in the United States by the year’s end. The Essure device had already been taken off the shelves worldwide after Bayer’s announcement in September 2017. Doctors, however, will be able to use the devices during 2019. They will be asked to return the unused devices by the end of 2019.
In the fall of 2017, the FDA released a report that showed a 70% decline in sales and required Essure devices to add a warning label. Earlier this year, the U.S. FDA issued an order to restrict the sale and distribution of the contraceptive due to women not being sufficiently informed of the risks of Essure before undergoing the implantation procedure.
Essure was first introduced in 2002 by Conceptus Inc., a branch of Bayer AG. The contraceptive device is a coil consisting of stainless a steel inner layer and a nickel titanium alloy outer layer. The coiled insert contains polyethylene terephthalate to induce the growth of scar tissue in the fallopian tubes. Essure is a non-hormonal form of contraception.
Bayer continued their narrative and said the decision to pull the device was unrelated to safety concerns but rather due to a major decline in Essure sales. “The benefit-risk profile of Essure has not changed, and we continue to stand behind the product’s safety and efficacy, which are demonstrated by an extensive body of research,” Bayer’s statement said.
Bayer is facing over 16,000 lawsuits in regard to Essure’s health risks and terrible consequences. Claimants say the device has pierced fallopian tubes, migrated into other body parts, caused severe pain and bleeding, induced nickel allergies, caused depression, and led to unwanted pregnancies. These women allege Bayer was aware of these dangers and failed to educate doctors, sellers, and patients on those risks. The number of lawsuits continues to grow.
If you were one of the two million women implanted with one of these dangerous Essure devices and you are experiencing any of the symptoms listed above, please see your healthcare provider immediately. Then, reach out to our defective device team at Hammers Law Firm. We are here to hold Bayer accountable and get you the compensation you deserve.