Bayer's Quarterly Analysis Reports Problems With Essure

Bayer's Quarterly Analysis Reports Problems With Essure

Introduction

On Monday, Bayer, the manufacturer of the controversial birth control device, Essure, issued the first quarterly analysis report required by the U. S. Food and Drug Administration (FDA) to track the adverse event information associated with the implant.

The analysis is based on the summarized data of the reports identified between June 2020 and August 2020 by the manufacturer. The report covered 7,509 reportable events, which included 7,332 cases involving serious injury, 104 cases of malfunctions, and 73 death reports.

Additionally, the FDA also included two reports about adverse events that noted there were 4,855 cases in September and 3,386 cases in October involving Essure. The common problems mentioned in the reports were pain, perforation, fragmentation, pregnancy, and heavier periods.

The company had released the first batch of adverse event reports based on social media posts in August, which contained 1,453 reportable events, including 53 deaths and 24 malfunction cases.

In August, Bayer officials also disclosed that the company had reached an agreement with plaintiff law firms to pay approximately $1.6 billion to settle nearly 90% of all the lawsuits, including the cases filed in the state of California Joint Council Coordinated Proceedings (JCCP) and the cases pending in the Federal District Court for the Eastern District of Pennsylvania (EDPA).

Conceptus Inc., a subsidiary of Bayer AG, developed Essure which is a Class III device for permanent surgical sterilization in women. Essure was approved by the Food and Drug Administration (FDA) on November 4, 2002. The device has two metal coils made from polyester fibers, nickel-titanium, stainless steel, and solder which are placed in fallopian tubes to induce fibrosis and block the fallopian tubes to prevent fertilization. Since 2002, it is estimated by Bayer that 750,000 women have received the Essure IUD.

Essure was suspended from the market in most countries since 2017, but Bayer continued to sell the device in the U.S. until the end of 2018. In July 2018, Bayer announced to remove all the Essure devices from the U.S. market by December 31, 2018. Following the removal, the FDA required Bayer to extend the postmarket surveillance study and report problems associated with the device.