Pharmaceutical Processing World

  • Home
  • Regulatory
    • Recalls
  • Pharmaceutical Processing
  • Facility
  • Supply Chain
  • Equipment and Materials
  • Contract Manufacturing
  • Resources
    • Voices
  • Advertise
  • SUBSCRIBE

The Fight Against Bayer’s Essure Continues As The FDA Orders New Safety Measures

By Fibich, Leebron, Copeland & Briggs | April 12, 2018

Even after more than 5,000 women have complained about the contraceptive device, Essure, Bayer Pharmaceuticals continues to make and sell this lucrative device. Essure is a permanent contraceptive device that creates a blockage in the fallopian tubes, thus preventing the sperm from reaching the egg.

However, several women have reported device ineffectiveness, as well as serious, life-threatening complications.

For years, the FDA has monitored Bayer, ordered medical investigations, implemented safety warnings, and enforced protection measures in an effort to safeguard potential patients. Women are still not receiving warnings about reported side effects of Essure. These measures by the FDA will hopefully help this failure to warn. 

In an effort to further restrict Bayer’s distribution of Essure, the FDA recently ordered Bayer to add a multi-page checklist of potential health risks to the Essure label. Now, however, that checklist of side effects must be distributed to potential users.

Each patient must be allowed the opportunity to read and sign this document of risks before they agree to use the Essure permanent contraceptive. All doctors and health-care facilities that provide Essure will need to give potential patients this document, and the physician who implants the device must sign the form.

The FDA has stated that Bayer will be responsible for upholding these new rules and could face serious criminal and civil penalties if they fail to comply.

To date, thousands of women have dealt with life-altering complications believed to be caused by Essure. Side effects reported by Essure users include chronic pain, heavy bleeding, debilitating fatigue, device migration, depression, headaches, unintended pregnancy, stillbirth, and autoimmune disorders.

(Source: Fibich, Leebron, Copeland & Briggs)

Related Articles Read More >

Doctor, woman patient and tablet for consulting with results, medical info and talk for healthcare with mockup space. Japanese medic, digital touchscreen or show video for surgery, wellness or advice.
Putting patients first in clinical trials
Confidently navigate the transition from bench to batch
Merck
FDA approves Merck’s Winrevair to treat pulmonary arterial hypertension
kobayashi pharmaceutical logo
Report: Japan health authorities investigate Kobayashi Pharmaceutical factory after five deaths
“ppw
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest news, technologies, and developments in Pharmaceutical Processing.

DeviceTalks Tuesdays

DeviceTalks Tuesdays

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
Pharmaceutical Processing World
  • Subscribe to our E-Newsletter
  • Contact Us
  • About Us
  • R&D World
  • Drug Delivery Business News
  • Drug Discovery & Development
  • DeviceTalks
  • MassDevice
  • Medical Design & Outsourcing
  • MEDICAL TUBING + EXTRUSION
  • Medical Design Sourcing
  • Medtech100 Index
  • R&D 100 Awards

Copyright © 2025 WTWH Media LLC. All Rights Reserved. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media
Privacy Policy | Advertising | About Us

Search Pharmaceutical Processing World

  • Home
  • Regulatory
    • Recalls
  • Pharmaceutical Processing
  • Facility
  • Supply Chain
  • Equipment and Materials
  • Contract Manufacturing
  • Resources
    • Voices
  • Advertise
  • SUBSCRIBE