22 July 2018

FDA Commissioner Issues Statement on Bayer Pulling Essure

fda commissioner

On July 20, the FDA released a statement from the commissioner announcing that the agency was informed by Bayer that the Essure permanent birth control device would be taken off the market in the US after Dec. 31. Commissioner Gottlieb notes that the decision to pull the controversial implant from the market follows the FDA’s patient safety action three months earlier issuing orders to restrict sales and distribution of Essure in the US.

Protecting Consumers from Essure

The commissioner stated that the move to stop Essure sales was based on the earlier actions taken by the FDA to address the serious adverse events reportedly associated with the implant. He went on to assure women who already have the implant that the Essure’s postmarked safety will continue to be a top priority for the federal agency. The FDA still expects Bayer to fulfill its postmarket requirements for the Essure implant.

According to Gottlieb, Essure has been used by over 750,000 women since being approved by global authorities. During that time, the permanent birth control implant has been linked to serious health risks, including device migration into the abdomen or pelvis, perforation of the fallopian tubes and uterus and persistent pain, among others. Gottlieb claims the FDA took action to understand the risks and benefits better in addressing patient safety concerns.

FDA Taking Action Against Essure

Actions taken by the FDA include a thorough review of their databases and other medical literature, discussing new concerns with an expert panel and ordering Bayer to run a new post-market analysis to re-evaluate its safety profile in real-world applications. Also, the FDA ordered Bayer to include a warning on the label and a patient checklist so women are more informed about the potential health risks.

When the FDA learned in April that women were not being counseled adequately, they implemented a restriction that limited the sale and distribution of Essure to health care facilities and providers who give patients information on the risks and benefits and the ability to sign a form of acknowledgment before having the device implanted. Following the boxed warning and Patient Decision Checklist requirements, Essure sales in the US declined by around 70 percent.

According to Bayer, the decision to halt the sales and distribution of Essure was made for commercial reasons. In February, Gottlieb personally met with several women who had been adversely affected by Essure or developed serious medical issues after using the device. He noted how this implant is associated with several adverse effects that require additional surgeries or removal. The FDA has been evaluating reports to better understand more about the different reasons for removing the device.

Essure’s History with the FDA

Gottlieb outlined some of the actions the FDA has taken with Essure over the years. When the agency first became aware of the increasing number of adverse events, they launched an ongoing effort to learn more about the concerns. During September 2015, the FDA convened a panel of experts to learn more about how to address complaints involving device migration, abnormal uterine bleeding, and abdominal bleeding.

In February 2016, the FDA issued an order requiring Bayer to conduct post-market analysis for Essure’s safety profile in the real world. In November 2016, the boxed warning and Patient Decision Checklist requirements were approved by the FDA. In March 2018, the FDA reported that 90 percent of the new medical device reports submitted in 2017 involved potential device removal. The move to restrict sale and distribution in April was to address concerns that patients weren’t receiving adequate risk information.

FDA on Women with Essure Implants

Even though the device is no longer being sold Gottlieb says the FDA remains diligent against those who have already had the device implanted. The agency will continue to monitor its databases and report new findings to the public. Bayer will still be required to provide the FDA with data on the postmarket analysis ordered in February. The commissioner noted that women who’ve been successful with using Essure should continue to do so.

Women who’ve had persistent pain or suspect they may have symptoms related to the device should contact a physician and a lawyer. Removing the Essure device poses its own risks as well. Patients are advised to discuss the risks and benefits of any procedure with their healthcare providers before making any final decisions. The FDA is committed to continuing to undertake initiatives to enhance their approach to medical safety and communicating publicly to help physicians and patients make informed decisions.

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