FDA panel slated to weigh Bayer Essure safety after more than 5,000 complaints
|Essure--Screenshot courtesy of Bayer|
The U.S. Food and Drug Administration has further formalized its ongoing review of the controversial Essure permanent birth control implant from Bayer. The agency will review the safety and effectiveness of the device at a public Obstetrics and Gynecology Devices Panel on Sept. 24. After weighing feedback from presenters, panel members and the public, the FDA said it would later disclose the next steps for Essure.
Through May 31, the FDA has received more than 5,000 complaints about the device since it was approved in November 2002. Most of these were received since 2013 and have been voluntary reports from women who received the implants.
There are 11 complaints that report a death due to the device. Of these, 5 were fetal deaths of women who became pregnant after the placement of Essure. The remaining 6 deaths included four adults: "one death due to Group A Strep infection postprocedure, one death reportedly due to uterine perforation during device placement, one death related to an air embolism during device removal surgery and one death from suicide."
The most common reported problem is pain, particularly abdominal pain, and heavier or irregular menses. The agency had 3,353 reports of the former and 1,408 complaints about the latter. Headache, fatigue and weight fluctuations were also frequently reported. Specifically, complaints are concerned about patient/device incompatibility, migration of the device, different operation of Essure than expected, breakage and poor positioning of it.
|After three months, the body forms a natural barrier around Essure.--Courtesy of Bayer|
Essure consists of two flexible metal fiber coils that are placed in each of the fallopian tubes through the cervix in a 10-minute procedure. Over three months, a natural barrier then forms around them. Bayer acquired the device in its 2013 Conceptus acquisition for $1.1 billion; lawsuits and patient complaints have followed steadily since.
The frenzy peaked recently when the FDA disclosed in a March letter that it was reviewing Essure. Shortly after in May, The New York Times ran an article about 5-year data on Essure that Bayer had just released; it contained strong concern about the device and its history. Bayer felt obligated to retort in a letter that followed to the publication.
- here are the FDA documents
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