FDA Approves New Labeling for Essure, Closes Trade Complaint Against Bayer

Regulatory News

The US Food and Drug Administration (FDA) on Tuesday said it has approved new labeling for Bayer's permanent birth control device Essure, in line with the agency's recently finalized labeling guidance.

With the approval of the new labeling, FDA said it has also closed its investigation of a trade complaint, initially filed as a citizen petition, against Bayer concerning the device.

FDA spokesperson Angela Stark told Focus the investigation included a review of Essure's labeling, as well as "inspections of Bayer, including surveillance of ongoing clinical investigations related to the Essure device, to ensure that the manufacturer was complying with FDA's laws and regulations."

Labeling Changes

According to Stark, the language of the box warning in the new label is the same as the wording used in the agency's final guidance:

Stark also told Focus that the patient decision checklist included in the newly approved labeling is not identical to the example in the final guidance, but that it was consistent with the agency's aims for the checklist.

"The Essure Patient Decision Checklist was evaluated by the FDA and was determined to adequately convey safety and effectiveness information about the device … FDA worked with Bayer to incorporate the appropriate risk information in the labeling information for both physicians and patients. The agency wanted to ensure the boxed warning and Patient Decision Checklist [were] consistent with the final guidance," she said.

While the newly approved labeling has not been released by Bayer, Stark said that "Bayer has committed to posting their updated labeling as quickly as possible, and the FDA will provide links to the labeling on its website … as soon as the labeling is made public." Currently, FDA's webpage for Essure labeling information points to the company's 2015 labeling, as well as the product's original labeling from 2002.

According to Stark, FDA also approved a number of other changes included in Bayer's updated labeling for both physicians and patients:

"Physician instructions for use:

• More specific information about Essure's material properties
• Updated warning information
• New contraindications related to hysteroscopy procedures
• Added additional observed and potential adverse events
• More detailed information about patient counseling and the inclusion of the Patient Decision Checklist
• More instructions on placement procedure
• More detailed information on device removal

Patient labeling:

• Included boxed warning and Patient (and Physician) Decision (Discussion) Checklist
• Removed references to non-surgical (now minimally invasive)
• Revised long-term risks (pain and potential for surgery to relieve pain, hypersensitivity reactions, pregnancy risk information, more information about confirmation test)"
• Lastly, Stark told Focus that FDA "will ensure that Bayer's revisions to their marketing and promotional materials are consistent with the new, approved labeling."