Advocates for women who say they suffered injuries related to the permanent birth control device Essure say that the U.S. Food and Drug Administration (FDA) intentionally scheduled a panel meeting the same day as Pope Francis’ first-ever papal address. The agency announced the September 24th meeting at the end of June after receiving reports of injuries and clinical trial fraud.
FDA spokeswoman Deborah Kotz told the Catholic News Agency that there was no conspiring of the panel meeting date, pointing out that the FDA announced the meeting 6 days for the pope’s U.S. visit itinerary was released on June 30th. According to CNA, however, the Pope’s visit date was released as early as February 5th.
Angela Desa-Lynch, an administrator for the Facebook group “Essure Problems” told CNA that the coincidence was planned and intended to draw media attention away from the panel meeting. According to Fierce Medical Devices, Essure Problems has over 9,000 members and was spearheaded by famed activist Erin Brockovich. The group intends to launch a hunger strike after the meeting takes place, along with other advocacy groups.
Essure was approved in 2002 and initially marketed by Conceptus. Bayer took on the device when it acquired Conceptus in 2013. Since the device was approved, the FDA received over 5,000 complaints. Fierce Medical Devices reports that most of the complaints are from after Bayer’s acquired the device. The FDA said it would investigate complaints over Essure in April.
Essure contains two flexible metal springs placed in the fallopian tubes. Pregnancy is prevented as scar tissue grows around the springs. Bayer has claimed that only 7 percent of participants suffered from pelvic pain in a 5-year clinical trial. However, a New York Times article cited data from a long-term trial published in the Journal of Minimally Invasive Gynecology and pointed out that only 366 out of 518 participants were followed for the full 5 years. Additionally, NYT reported that many women who were followed still reported problems related to Essure, such as abnormally heavy periods and recurrent pelvic pain.