Bayer Announces Essure Settlement Agreement for $1.6 Billion

The makers of Essure announced this week that they will pay $1.6 billion to settle a large percentage of the claims pending against the company over allegations that the controversial Essure birth control device causes painful and debilitating complications in users. The Essure settlement agreement was disclosed in a press release issued on August 20, in which Bayer stated that the $1.6 billion settlement will resolve 90% of the nearly 39,000 total filed and unfiled Essure claims over device-related injuries, including an allowance for outstanding claims. Bayer also noted that it is in resolution discussions with attorneys for the remaining plaintiffs involved in the Essure litigation. If you or someone you love has suffered serious side effects or complications allegedly caused by Essure birth control, contact us today to find out if you are eligible for compensation through the Essure settlement.

What is Essure?

Prior to its removal from the market, Essure was sold by Bayer as an implantable birth control device featuring a metal coil design. The device was meant to be placed in the fallopian tubes of women who wanted to become permanently sterile and the nickel and titanium coil was designed to encourage the formation of scar tissue, thus preventing sperm from reaching eggs and fertilizing them. However, Essure was eventually removed from the market amid thousands of reports of complications such as chronic pain, bleeding and cramping occurring during or after implantation of the device. Some more serious complications, like organ perforation and device migration, required surgery to correct.

Approved by the FDA in 2002, Essure has been implanted in an estimated 750,000 people worldwide, with approximately 70% of those procedures taking place in the United States. Unfortunately, while Bayer made the decision to remove Essure from the market in most other countries in 2017, the company continued selling the birth control device in the United States until the end of 2018, thereby exposing more women to an unnecessary risk of potential side effects.

Black Box Warning Added to Essure Label

When Bayer discontinued the sale and distribution of Essure in the United States at the end of 2018, the company cited declining sales due to women favoring permanent contraception, as well as “inaccurate and misleading publicity” surrounding the birth control device. “Our decision to discontinue sales is for business reasons, and not for any safety or efficacy concerns about Essure,” the company said in a statement. The decision to recall Essure came roughly two years after the FDA required a boxed warning to be added to the Essure label highlighting the potential risk of side effects associated with the device. This so-called “black box warning” is among the most serious warnings the FDA can put on a product label and is “designed to call attention to serious or life-threatening risks,” the FDA says on its website. The new Essure warnings were proposed by the FDA after more than 5,000 women reported experiencing painful and debilitating side effects following Essure implantation between November 2002 and May 2015, including severe pain and bleeding, unintended pregnancies, miscarriages and stillbirths.

Lawsuits Filed Over Essure Complications

Nearly 39,000 product liability lawsuits have been brought against Bayer by women who claim that Essure’s defective design exposed them to serious device-related side effects, ranging from severe pain and allergic reactions to the nickel used in the device, to perforation of the fallopian tubes, migration of the implant to other parts of the body, and the need for a hysterectomy, among other major complications. As a condition of the recently announced settlement agreement, plaintiffs in the Essure litigation who accept the settlement will be required to dismiss their cases or not file.

In agreeing to the Essure settlement, Bayer admits no liability or wrongdoing in connection with Essure complications. “With the settlements, Bayer resolves virtually all of the U.S. Essure litigation so that the company can focus on its commitment to women’s health, where it has long been a leader, without the distractions and uncertainties associated with this litigation,” the press release states. “Bayer sympathizes with all women who have experienced adverse health conditions, regardless of the cause, but the company continues to stand by the science supporting the safety and efficacy of Essure.”