The U.S. Food and Drug Administration (FDA) is joining famous environmental and consumer activist Erin Brockovich in its skepticism of Bayer’s popular birth control device, Essure. Bayer claims that the coil-like device is the only non-surgical permanent form of birth control on the market. The FDA announced last month that it will be conducting a public meeting of the Obstetrics and Gynecology Devices Panel on September 24th to discuss the safety and effectiveness of Essure devices, which are manufactured by German drug giant, Bayer. The FDA claims that Essure’s labeling does not properly warn consumers about a multitude of side effects, including weight gain, fatigue, and depression, and that no studies have been conducted regarding these side effects. In addition to these side effects, he FDA has also received complaints that the nickel-titanium alloy makeup of the device causes allergic reactions such as itching and hives. At least eleven deaths have been attributed in some degree to the device, although it is unknown if Essure was the sole cause of death for every case. The National Health Institute estimates that 17 percent of all women have some kind of allergy to nickel.
The most recent announcement follows another FDA announcement in March that it was launching an investigation into a citizens’ petition filed on behalf of over 2100 women. The petition listed complaints that the device causes painful side effects near the insertion point as well as failing to prevent unwanted pregnancies. Among the most alarming side effects included in the petition were bowel perforations, splintering, as well as having the device slip from its initial location, leading to the unintended pregnancies. Among the latter, former Essure spokesperson and champion skier Picabo Street was dismissed from that position after becoming pregnant while wearing the device. The petition also accused Bayer and the device’s original manufacturer, Conceptus, of producing incomplete and misleading results from pre and post-approval studies. Bayer bought Conceptus in 2013, however, the device was granted FDA Pre-Market approval (PMA) in 2002. Among the discrepancies include Conceptus’s only reporting 22 of the 168 actual adverse events occurring during the trials, misstating one patient’s age by 20 years, and reporting that only 4 unintended pregnancies occurred when evidence suggests that the actual number was 64.
In addition to complaints about the misreporting of known side effects, the forthcoming hearing will address two follow up studies in which Bayer claims that no conclusive evidence was found for new complications “definitely associated” with the devices. A Bayer spokesperson said that the company welcomes September’s meeting, adding that “Essure is supported by more than a decade of science and real world clinical experience.” The FDA has received over 5,000 complaints regarding chronic pain, fatigue, and depression from Essure users. In 2013, Brockovich launched “Essure Procedure,” on online forum in which users of the device can share stories and information regarding the alleged complications. Brockovich writes on the site’s home page, “It is a woman’s right to decide for herself if she wants a certain form of birth control but when they are NOT told of the devastating side effects, well that isn’t right.” In addition to the Bayer’s follow up studies, the non-profit National Center for Health Research is conducting an independent investigation of Essure. Center president Diana Zuckerman emailed a statement saying she is pleased by the FDA’s announcement adding that, “Our center is studying more than 900 women who have had problems with Essure permanent birth control, including chronic debilitating pain, abnormal bleeding, and pregnancy.”
Sources:
ABC News 10 – Associated Press
Lifesite – Mark Hodges
Yahoo Health – Amy Capetta
Join the conversation!