FDA clamps down on sales of Bayer's Essure contraceptive device

Lynette PayneApr 10, 2018

"We've been closely evaluating new information on the use of Essure, and based on our review of a growing body of evidence, we believe this product requires additional, meaningful safeguards to ensure women are able to make informed decisions about risk when considering this option", FDA Commissioner Dr. Scott Gottlieb said in a written statement.

The FDA on Monday announced strict new requirements on the controversial Essure sterilization device, which already comes with a "black box warning", the strongest warning label the agency can require. The label now states that the sale and distribution of Essure is restricted to healthcare providers who counsel patients according to the approved label.

Bayer's Patient-Doctor Discussion Checklist - Acceptance of Risk and Informed Decision Acknowledgement, which is part of the patient information booklet, and has key items about the device, its use, and safety and effectiveness outcomes, which the patient should be aware of as they consider permanent birth control options.

Patients have reported cases of pain, bleeding, allergic reactions and cases where the implant punctured the uterus or shifted out of place.

The agency said Bayer, which manufactures the device, will be responsible for implementing the restrictions immediately and for ensuring that providers comply. And the agency said it will take appropriate action against Bayer, including imposing criminal and civil penalties, if the company does not follow through.

Essure, approved by US regulators in 2002, is a non-surgical and non-hormonal permanent birth control device.

The required brochure includes comparative information on various other contraception methods - IUDs; hormonal pills, patches, and implants; male condoms; female barrier devices; and the so-called rhythm method.

Since the FDA ordered Bayer to conduct a post-market study, and then to add a boxed warning and a patient decision checklist to the labeling, there has been an approximately 70 percent decline in sales of Essure in the U.S. The FDA has determined, however, that some women still are not receiving information about the known risks of Essure before implantation. Despite previous efforts to alert women to the potential complications of Essure, we know that some patients still aren't receiving this important information. Essure consists of two nickel-titanium coils inserted into the fallopian tubes, where they spur the growth of scar tissue that blocks sperm from fertilizing a woman's eggs.

Separately on Monday, Germany-based Bayer said Essure's benefit or risk profile had not changed and that the company remains positive about the product. These include perforation of the uterus and/or fallopian tubes, migration of inserts to the abdominal or pelvic cavity and persistent pain, among others.

In a financial statement on January 30, Bayer said it had been served US lawsuits from approximately 16,100 users of Essure.

For Firmalino and her fellow Facebook group members, many of whom are now suing Bayer, the FDA's move could signal an even more drastic change: the possibility that the manufacturer would pull Essure from the market.

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