Essure (contraceptive implants)

The Essure device consists of two metal spirals implanted in fallopian pipes. Bayer AG positions this product as an alternative to tubal dressing surgery, which requires surgery using general anesthesia.

Essure Implant Insertion Process

Among the complications that the device can cause are bleeding, unwanted pregnancy, chronic pain, uterine perforation, the possibility of implant displacement and allergic reactions in the form of itching and urticaria. However, the manufacturer states that the Essure installation is a minimally invasive procedure that provides permanent contraception.

2020

Bayer paid $1.6 billion for defective contraceptive implants

At the end of August 2020, Bayer announced that it had settled approximately 90% of claims in the United States filed by women affected by Essure defective contraceptive implants. According to the press release, Bayer negotiated with the law firms that represent the plaintiffs and closed most of the 39,000 lawsuits filed. As part of the settlement of claims, the company will pay about $1.6 billion.

The agreements cover all jurisdictions within the United States where affected women have applied and where Essure cases are pending, including the Joint State Council Agreed Litigation California (JCCP) and the Federal District Court for the Eastern District of Pennsylvania (EDPA). According to the company, all victims will have to withdraw claims already sent to the court or agree not to file claims in the future. The agreements do not recognize Bayer's wrongdoing or liability. The remaining terms are considered confidential. Agreements concluded in the United States do not affect litigation in other countries.

Bayer paid $1.6 billion for defective contraceptive implants

Bayer said that almost all Essure litigation in the United States has been settled, adding that the company "sympathizes with all women who experienced adverse effects after surgery, regardless of their cause." However, the company continues to insist that the safety and effectiveness of Essure have been proven in clinical research, and therefore Bayer allegedly bears no responsibility for side effects. The company said women using the implant can "continue to rely on Essure, which ensures reproductive health is maintained." In case of any questions or problems, the company recommends that women with an Essure implant installed should contact doctors.^[1]

Bayer allocated $1.4 billion for payments to victims of defective contraceptive implants

In early August 2020, Bayer allocated $1.4 billion for payments to victims of rejected Essure contraceptive implants. Some of these funds were also related to the cost of judicial protection and other pharmaceutical matters.

According to the company, as of July 24, 2020, approximately 32,000 people who used Essure implants submitted lawsuits against Bayer. All claimed adverse events and injuries associated with the device, including hysterectomy, uterine perforation, severe pain syndrome, bleeding, weight gain, nickel sensitivity, depression and unwanted pregnancy. In the United States, the Essure contraceptive device for permanent use is forbidden to be implanted from December 2019, and sales of this device in the United States were discontinued in December 2018.

Bayer to pay $1.4 billion to victims of defective contraceptive implants

Discussions about the possible settlement of many claims related to Essure contraceptive implants have recently intensified and have made significant progress, officials said. - Therefore, Bayer has created appropriate reserves for legal costs and compensation payments. The pharmaceutical division provided 1.245 billion euros for special expenses related to litigation, primarily with Essure.

The published results of the interim analysis conducted in the Essure post-marketing study showed that the implantation of this device is accompanied by a higher incidence of chronic pain in the lower abdomen and/or pelvis and more frequent abnormal uterine bleeding than laparoscopic tubal dressing used as an irreversible contraceptive operation.^[2]

Bayer kept silent about thousands of complaints about defective contraceptive implants

In mid-July 2020, it became known that Bayer kept silent about thousands of complaints received about Essure defective contraceptive implants. The content of the relevant court documents was disclosed by Bloomberg.

According to these materials, Bayer acquired the manufacturer Essure Conceptus for $1.1 billion in 2013 and since then has steadily underestimated the indicators of injuries associated with implants.

It was Bayer's failure to comply with its reporting obligations that caused regulators to update warnings regarding Essure implants too late, said lawyer Fidelma Fitzpatrick.

Bayer kept silent about thousands of complaints about defective contraceptive implants

However, in 2018, US regulators banned the sale of Bayer contraceptive implants due to frequent complaints, and Essure has not been available for implantation in the United States since December 2019.

Bloomberg submitted its documents on July 10, 2020, immediately after the regulators published the interim results of the Essure post-marketing study. According to these data, women with the Essure implant installed were more likely to experience cases of chronic pain in the lower abdomen and/or pelvic region and cases of abnormal bleeding than with laparoscopic tubal dressing. Bayer kept quiet about these results when it prepared reports for regulators.

According to the publication, reports of undesirable phenomena related to the Essure implant continue to be regularly received. However, in response to the publication, Bayer reported that it "insists on the safety and effectiveness of Essure, as evidenced by the vast array of research conducted by Bayer and independent medical researchers and covering more than 270,000 women over the past two decades."^[3]

2018: Implant problems

At the end of November 2018, the International Consortium of Investigative Journalists (ICIJ) released the results of an investigation called Implant Files on implant problems. The report reports that Essure, a metal contraceptive in the form of a spiral, was placed in the fallopian pipes of more than a million women. Thousands later reported serious injuries, including uterine perforation. More details here.

2017: Stop sales in Europe, Canada and Australia

In August 2017, it became known about the suspension in Europe of sales of Essure contraceptive implants, around the safety of the use of which controversy erupts.

The Irish National Standards Authority of Ireland; NSAI) did not renew the Essure license, stating the need for more complete information regarding the contraceptive device manufactured by the German company Bayer AG. As a result, the implementation of Essure was discontinued in France other countries European Union for three months, until November 2017, a representative of the French National Agency for the Safety of Medical Products (ANSM) told Agence France-Presse (AFP).^[4]

Essure Contraceptive Implant

We would like to assure women using Essure and the medical community of the safety and effectiveness of the device, which are proven by many years of scientific research and clinical experience, the company said in a statement.

However, the French health regulator recommended that women not use Essure as a precaution.

Earlier, in February 2017, Brazilian health authorities announced the suspension of sales of Bayer contraceptive implants, however, in July the ban was lifted, AFP notes.

In turn, The Star reports that since June 2017, Essure has been discontinued in Canada. Bayer says that this step is not a recall of products, but a voluntary decision of the manufacturer associated with a drop in demand for products.^[5]

However, in recent years, contraceptive implants have caused numerous complaints from patients in North America. For example, in Canada, about 300 women say that their health was harmed by the use of Essure, and many of the victims ended in removal of the uterus.

The BBC publication on this topic gives the story of one of the patients who underwent a hysterectomy due to Essure. According to the woman, after installing the implant in 2013, she experienced such unbearable pain that she even thought about suicide.

The BBC notes that in the United States, the Food and Drug Administration (FDA) has received more than 15,000 complaints from women about complications due to Essure. Despite massive demands to ban Bayer contraceptive implants, they are still in use in the United States.^[6]

Later on August 30, 2017, news appeared about the termination of Essure sales in Australia. According to the Daily Hornet, the manufacturer said the decision was made for business reasons.^[7]

At the same time, the Australian Therapeutic Goods Administration (TGA) issued a warning noting that patients who agreed to the Essure installation may not have been fully informed of the associated risks. The regulator recommended returning unused implants to the manufacturer and announced the termination of the Essure installation in the country.^[8]

Notes