Bayer Blues: A History of the Essure Device

Bayer is a German corporation that owns companies in the healthcare, agriculture, cleaning product, and over-the-counter medication fields, and its subsidiaries are involved in many more markets. Its name may be best known for the label on aspirin, but Bayer has diversified its portfolio to reach a wide variety of customers and industries worldwide.
 
In July 2018, Bayer announced it would be pulling its permanent contraceptive device Essure from the United States market by 2019. This decision was not surprising to many people living outside of the United States, as sales of Essure had been halted due to painful and dangerous complications two years prior. Bayer cited a decline in sales for its reasoning, but it became abundantly clear the device was becoming a financial pain for its manufacturer and a physical and emotional pain for many of its users.
 
Conceptus, the original manufacturer, first brought Essure to the market in 2002 after it was approved by the FDA. It was marketed as a safe, easy alternative to surgical sterilization; and consisted of a pair of metal coils. A user would have the device implanted in each of her fallopian tubes by an OB/GYN, and could walk out of the provider’s office immediately afterwards. The sterilization device was designed for an easy recovery with less pain than a surgical procedure, while providing the same permanent contraception users desire.
 
The coils worked effectively by causing irritation and a buildup of scar tissue in each fallopian tube, blocking any sperm from reaching a woman’s eggs. Many users, however, began to experience adverse effects from the coils. One commonly reported issue with Essure was its potential to expel. Device expulsion happens when one or both coils are rejected by the body, which could lead to unintended pregnancy, scar tissue formation outside the fallopian tubes, and even potentially deadly ectopic pregnancies. Another unwanted complication that arose was coil migration, which could leave a trail of scar tissue throughout patients’ fallopian tubes, uteruses, and even abdominal cavities. A class-action lawsuit was even filed by Essure users who got nickel poisoning from the metal coils.
 
Despite thousands of reports of these negative side effects, Bayer bought the rights to Essure from Conceptus in 2013 and continued sales of the device under the same name. The device was still being sold globally until 2017 when it was banned in the United Kingdom and Australia. Instances of pain and scar tissue complications were so severe that some women needed complete surgical hysterectomies to fully remove their Essure devices, while others could not have their coils removed because doctors did not want to cause further fallopian tube damage.
 
Negative press surrounding Essure came to a head in 2018, when Netflix announced it would release a documentary about medical devices that harmed consumers, including Essure. Before this movie’s streaming release date, Bayer officially announced that U.S. sales would be discontinued, but its reputation had already been tarnished due to Essure complications.
 
Nearly 20,000 women have pursued litigation against Bayer for failure to disclose all potential side effects and complications that can result from Essure. In 2016 alone, the device allegedly cost Bayer more than $400 million USD, stemming from a decline in global sales, lawsuit settlements and legal fees, and “impairment losses.” This came after the United States and Canada issued black box warnings for the device, which indicated use of the device could pose serious or potentially life-threatening risks. Bayer, in turn, hiked up the price of the device, which further decreased its sales.
 
Recent quarterly reports for the company state that it is involved in more than 45,000 lawsuits regarding safety and risk disclosure for its products, medical devices, and prescription drugs. Despite this, there have been discussions of reintroducing the device to the market in the future. Advocates of the device argue that it is the female equivalent to a vasectomy, and that it is the only available method of female sterilization besides a complete hysterectomy. Because Bayer voluntarily halted the sale of Essure and it was not banned in the United States by the FDA, there is a possibility that a change in market demand could lead to a revival of this medical device.