FDA to Announce Essure Action in FebruaryDec 14, 2015
The U.S. Food and Drug Administration (FDA) will announce its decision on Essure, Bayer's permanent birth control device, in February 2016. The agency's action will be based on a review of information gathered from its Obstetrics and Gynecology Devices panel, which was held in September following thousands of injury reports related to the device. The FDA will also evaluate studies on Essure and other data.
Essure is composed of two metal coils, each inserted into a fallopian tube. The system is supposed to essentially sterilize women when scar tissue grows around the coils, preventing eggs from meeting sperm. More than 5,000 adverse events have been linked to the use of Essure, fueling the panel meeting. Injuries ranged from painful sex to organ perforation. Some women reported having severe allergic reactions to the metal. The FDA has classified Essure as a "high priority issue".
"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 Facebook group "Essure Problems", founded by user Angie Firmalino, has over 24,000 members. Some spoke at the FDA panel meeting, along with administrators, saying they were never warned about the risks. "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."
The device was approved through premarket approval (PMA), which is supposed to involve rigorous testing because no equivalent device exists. These devices are therefore protected from liability. However, it has been alleged that Bayer falsified clinical data to obtain the PMA and individuals are calling for its revocation. "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 responses involving complications were fabricated. 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."