FDA Decision on Essure Expected in February

By February 2016, the U.S. Food and Drug Administration (FDA) will have come to a decision on what action to take over Essure, Bayer’s permanent birth control device. Essure is meant to permanently prevent pregnancy through two coils, which are inserted into each fallopian tube. As scar tissue grows around the coils, it blocks sperm and egg from meeting. There are more than 5,000 adverse event reports linked to the use of Essure. In light of this, the FDA held a Obstetrics and Gynecology Devices panel in September. The agency’s decision will be based on a review of evidence from this meeting, along with Essure studies and other data.

“We wish to acknowledge the numerous stakeholders who testified at the September panel meeting and the many others who have expressed their viewpoints and shared their experiences with us,” the FDA announced. “Patient health and well-being is our first priority regarding this device and all medical devices.”

The adverse event reports mentioned injuries ranging from painful sex to organ perforation. Some women also reported having a severe allergic reaction due to the metal. More than 24,000 individuals have joined the Facebook group “Essure Problems”, founded by user Angie Firmalino. Some spoke at the FDA panel meeting, along with administrators, saying they were never informed about the possibility of these injuries. “I felt very betrayed and misled, not only by my doctor but by the manufacturer,” Firmalino said at the meeting. “I honestly had no idea that these devices could expel from our fallopian tubes and perforate organs or embed in other areas of the body.”

Woman are facing obstacles in trying to sue over Essure because was approved through premarket approval (PMA). Devices cleared through PMA are supposed to undergo rigorous testing, and are therefore protected against liability. During the panel meeting however, it was alleged that Bayer falsified clinical data to obtain the PMA. Essure users are calling for its PMA to be revoked. “Bayer can stand here today and tell you they have years of data and follow-up with thousands of women supporting the safety and efficacy of Essure,” said Amanda Dykeman, an administrator of Essure problems. “But the truth is none of it supports Essure as safe and effective because we have seen how patients’ concerns have been ignored during the clinical trials and passed off as not related to the device.” In fact, original participants in the clinical trials spoke out at the meeting and said their comments had been altered. Dykeman presented information indicating “alterations were made by the lead investigator of Essure, who also had equity positions with the company, providing serious financial conflict of interest.”

from Parker Waichman http://www.yourlawyer.com/blog/fda-decision-on-essure-expected-in-february/