90 results

• Study of Recalled Essure Implant Continues to Lose Participants, But FDA Reports Measures to Fix Data are Working

  November 1, 2023

  Irvin Jackson

  The FDA reports Bayer has made improvements to recalled Essure birth control implant studies, despite women still dropping out and having the devices removed.

• Essure Implant Lawsuit

  February 1, 2023

  Austin Kirk

  Problems with the design of the Essure birth control implant have been linked to thousands of reports involving severe complications,...

• Progress of Essure Birth Control Implant Post-Marketing Study “Inadequate,” FDA Warns Bayer

  October 11, 2022

  Irvin Jackson

  The FDA has labeled Bayer's post-marketing surveillance of its Essure birth control implants as inadequate due to a high rate of women dropping out of the study.

• 85% of Bayer Essure Adverse Event Reports Submitted Last Year Linked to Device Removal: FDA

  March 16, 2022

  Irvin Jackson

  Thousands more reports of Essure adverse events were submitted to the FDA in 2021, with most involving reports of surgical removal of the device due to problems.

• Essure Organ Perforation Experienced By One Out of Every 50 Women Receiving Sterilization Device, FDA Interim Analysis Finds

  February 17, 2022

  Irvin Jackson

  The FDA indicates nearly 2% of all women who were implanted with an Essure birth control device suffered organ perforation injuries.

• Bayer Issues Final Analysis Report on Essure Complications and Injury Reports

  October 1, 2021

  Irvin Jackson

  Bayer's final report on Essure complications indicates nearly 60,000 women reported serious injuries and at least 115 died due to Essure birth control implant complications.

• FDA Releases Plan For Better Labeling of Medical Devices

  July 9, 2021

  Irvin Jackson

  The FDA is seeking input on how it can improve medical implant labeling to warn patients of potential adverse reactions to the materials used in those devices, following problems with the Essure birth control implant and metal-on-metal hips.

• Complications With Essure Procedures Continue To Mount After Recall, Settlements

  May 26, 2021

  Irvin Jackson

  A new Essure report suggests as many as 19 women have died due to problems with the recalled birth control implant.

• Bayer Reports Nearly 12,000 Serious Injuries from Essure Birth Control Implants, Including 9 Deaths

  March 16, 2021

  Irvin Jackson

  Bayer reports it received nearly 12,000 medical reports linked to the Essure birth control implant, which is no longer sold on the market, in the second half of 2020.

• Bayer Identified Another 7,332 Reports Involving Serious Injury from Essure in June thru August 2020

  December 8, 2020

  Irvin Jackson

  A new report on Essure injuries indicates Bayer has received more than 7,000 reports of serious injuries and reports of 73 deaths associated with the birth control implant.