Bayer, Womens Health

Labeling Changes to Bayer’s Essure Device Include Boxed Warning

By MedTech Intelligence Staff
No Comments
Bayer, Womens Health

Approved by FDA, the changes include a warning and a patient checklist that explains the risks and benefits of the permanent birth control device.

Following a series of complaints about the safety of Bayer Healthcare’s Essure permanent birth control device, FDA has approved key changes to the product labeling, which is intended to help patients understand the risks and benefits of the device, along with what to expected during and following the Essure procedure. Included is a boxed warning and a patient decision checklist, the latter of which the FDA encourages patients to discuss with their doctor during the process of considering sterilization options.

“The Agency wants women and health care providers to be thoroughly informed about Essure in order to make educated decisions about whether or not Essure is right for them.  Patients are encouraged to discuss all available sterilization and birth control options with their health care providers before making treatment decisions.” – FDA release

FDA continues to assess safety concerns involving Essure and as part of the process will be reviewing adverse event reports, peer-reviewed scientific literature, as well as information from patients, clinicians, professional societies, and the post-market surveillance study.

Bayer also revised physician instructions for use and patient labeling for consistency with FDA’s final guidance “Labeling for Permanent Hysteroscopically-Placed Tubal Implants Intended for Sterilization”.

Related Articles

  • Unannounced Audits

    Critical subcontractors and crucial suppliers will be subject to unannounced audits by notified bodies under the revised European device regulations. Richard DeRisio of TÜV Süd provides more details in this presentation.

  • Dr. Christopher Joseph Devine, President, Devine Guidance International

    Labeling and what constitutes being a label can be confusing for device manufacturers. This week, Devine Guidance explains 21 CFR, Part 820 – Subpart – K, Labeling and Packaging Control, specifically 820.120 (Device Labeling) and 820.130 (Device Packaging). There are…

  • Top 10 Reasons for FDA Warning Letters to Medical Device Firms

    The "Warning Letter” is considered by FDA to be the first step in the enforcement process, and a firm’s response to it may be its last chance, prior to a legal or administrative action, to adequately address a situation that…

  • Supplier Responsibility in Medical Device Recalls

    What is the responsibility of the design owner? What level of accountability does the supplier have? What follow-up actions must a supplier take? A variety of best practices need to be driven forward by both suppliers and OEMs in an…

Leave a Reply

Your email address will not be published. Required fields are marked *