On September 18, 2017, pharmaceutical giant Bayer AG announced they are terminating the sale of their permanent birth control device Essure in all markets outside of the U.S. The decision comes after years of global controversy and lawsuits directed towards the device as thousands of women and their doctors have accused the contraceptive of causing severe negative side effects, even death. Prior to Monday’s announcement, Essure was previously banned in multiple countries including Brazil last February and Canada in May due to the possibility of adverse health risks. This Summer, the E.U. also recalled the product. While Essure is still sold in the United States, some health experts believe Bayer’s recent decision foreshadows the end of the product’s usage and availability nationwide.
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.
Since Essure’s debut over a decade ago, the FDA has received more than 15,000 reports of adverse effects resulting from the use of the product. Side effects include bleeding, abdominal pain, device breakage, allergic reactions, ectopic pregnancies and organ perforation. The FDA released a “black box” warning for Essure in 2016, the highest warning level for prescription products, due to the alarming number of adverse reactions deriving from the device.
Bayer has released an official statement regarding their decision to pull the product from international markets. The company states on its website: “We would like to reassure the Essure patients and their accompanying healthcare professionals that this decision is made for commercial reasons and that it is not related to a safety or product quality issue.”
Between 2015 and 2016 alone, an alarming 11,192 incidents of adverse effects from Essure were reported to the FDA. 26 deaths are also linked to the device. Aside from mandating a “black box” warning label on all Essure packaging in 2016, the FDA stated on its website that it “has been examining the growing number of adverse event reports associated with the use of Essure.” According to a statement released to CBS News, the agency is very much aware of Bayer’s decision to pull Essure from foreign markets and is ensuring the continuous evaluation of the device’s safety and performance. This is in contradiction to Bayer’s comment that global markets, “there is not as much patient interest” in devices like Essure.
The backlash against Essure has caused its parent company a notable decrease in revenue. Around 3,700 women have filed lawsuits against Bayer due to adverse reactions and results. So far, the company has lost $413 million between legal fees and settlements to victims.
Medical experts believe that Bayer’s decision to pull out of foreign markets, coupled with the product’s banishment in other countries, indicates that the device will be removed from U.S. markets in the near future. If you think that you or a loved one have fallen victim to any of the adverse effects mentioned in this article due to the usage of Essure, you should immediately report these incidents to the FDA. Then, contact one of our attorneys at Schneider Hammers and let us take care of your defective medical product case. We are committed to representing you effectively and strategically against medical manufactures to ensure you receive the compensation you deserve.