New Bill Calls for FDA to Take Essure Off Market

On Wednesday, Rep. Michael Fitzpatrick (R-PA) introduced a bill that directs the U.S. Food and Drug Administration (FDA) to recall Essure, a permanent birth control device marketed by Bayer. Under the so-called “E-Free Act”, the FDA would have to withdraw approval of Essure within 60 days. Essure is comprised of two metal springs that are inserted into the fallopian tubes; the device touted as an alternative to surgery for women who no longer want to have children.

Essure has been on the market since 2002. Recently, there have been questions about whether the device is safe. Some 22,000 people have joined the Facebook group “Essure Problems”, according to Regulatory Affairs Professionals Society. To address these concerns, the FDA held an advisory panel meeting in September.

Fitzpatrick announced that Essure has been linked to thousands of complications and that the FDA has received over 5,000 formal complaints, RAPS reports. “Furthermore, the product is responsible for deaths of four women and five unborn children,” Fitzpatrick stated. “If the FDA or manufacturer aren’t willing to act in the best interest of these women, Congress must.” The FDA acknowledges that the deaths were reportedly linked to Essure. However, the agency pointed out that it is uncertain “whether a device actually caused a specific event…based solely on the information in a given report.”

Fitzpatrick’s move is considered unprecedented by some legal experts. “It would be quite unusual for Congress to legislate specific treatment of a particular type of device.” said Nate Brown, who has served in FDA’s Office of Chief Counsel, to Politico.

The FDA advisory panel recommended a label update and additional postmarket studies. The experts also wanted “ongoing trials be reviewed to determine if data could be collected to address some of the topics of concern,” Additionally, the panel sought additional data on possible allergic reactions and metal sensitivities. In response to whether Essure should be taken off the market, the panel said the device should remain available, especially for “women who are not good candidates for laparoscopic or general surgery.” The panel also advised patients to seek other options if they had “hypersensitivity to metal, autoimmune disease, history of pelvic inflammatory disease and those with a history of abnormal uterine bleeding.”

from Parker Waichman http://www.yourlawyer.com/blog/new-bill-calls-for-fda-to-take-essure-off-market/