Regulatory Focus™ > News Articles > New Bill Directs FDA to Pull Bayer Birth Control Device

New Bill Directs FDA to Pull Bayer Birth Control Device

Posted 04 November 2015 | By Zachary Brennan 

New Bill Directs FDA to Pull Bayer Birth Control Device

In an unprecedented move, Rep. Michael Fitzpatrick (R-PA) on Wednesday unveiled a new bill that directs the US Food and Drug Administration (FDA) to withdraw from the market Bayer’s birth control implant Essure.

The safety of the implantable device, which is used for permanent birth control, has been called into question recently, with FDA holding an advisory panel meeting on the device's safety in September. Rep. Rosa DeLauro (D-CT) also requested FDA pull the product from the market last month because its “benefits do not outweigh its risks.”

New Legislation

The short bill, known as the “E-Free Act,” would force FDA, no later than 60 days after the bill’s enactment, to withdraw its approval of Essure.

Fitzpatrick said in an announcement that since the device first appeared on the market in 2002, thousands of complications have occurred and FDA has received over 5,000 formal complaints.

“Furthermore, the product is responsible for deaths of four women and five unborn children,” Fitzpatrick said in a statement. “If the FDA or manufacturer aren’t willing to act in the best interest of these women, Congress must.”

Since FDA is still reviewing the device, some legal experts believe the idea of legislating how FDA deals with a particular device is an unprecedented move. Nate Brown, who previously served in FDA’s Office of Chief Counsel, told Politico, “It would be quite unusual for Congress to legislate specific treatment of a particular type of device.”

And DeLauro may see issues with the legislation, too, as she apparently backed out of co-signing the bill, according to the Facebook group “Essure Problems,” which has about 22,000 members and raised concerns about the side effects of the device.

Safety Questions

Back in 2013, FDA reviewed Essure's safety based on the available literature and adverse event reports. At the time, the agency concluded that Essure was an effective alternative to surgical sterilization options and that the risks posed by the device were rare and made known in the device's labeling.

And although FDA acknowledges the deaths reportedly linked to Essure, the agency cautions that it is difficult to confirm "whether a device actually caused a specific event … based solely on the information in a given report."

In addition, the FDA panel from September called on the agency to update Essure's label and require additional postmarket studies on the device. The panel also sought "ongoing trials be reviewed to determine if data could be collected to address some of the topics of concern," and more data on potential allergic reactions or sensitivities to the metals used in the device.

As far as whether to pull the device from the market, FDA's panel suggested that the device should remain an option, especially for "women who are not good candidates for laparoscopic or general surgery." Additionally, the panel recommended patients with "hypersensitivity to metal, autoimmune disease, history of pelvic inflammatory disease, and those with a history of abnormal uterine bleeding" look to other options for permanent sterilization.

Video of the Announcement of E-Free Act


Categories: Regulatory News

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