The Food and Drug Administration (FDA) has scheduled a September meeting of a panel that will consider the safety of Bayer Pharmaceutical’s Essure birth control device.
The FDA has received complaints of clinical trial fraud and serious side effects associated with the device, to the product, FierceMedicalDevices reports.
The agency now faces complaints from women calling for the device’s removal from the market who claim the meeting date was chosen to coincide with Pope Francis’s U.S. visit, drawing media attention away from the panel meeting. The pope will give the first-ever papal address to Congress on September 24, the date of the FDA panel meeting. Angela Desa-Lynch, an administrator for the Facebook group Essure Problems told the Catholic News Agency that the agency was aware of the scheduling convergence. The Essure group has more than 9,000 members and is lobbying to have Essure removed from the market.
“[T]he meeting was not timed in any way with the Pope’s address to Congress,” agency spokeswoman Deborah Kotz told the news agency in an email. The meeting date was announced on June 24, while the pope’s itinerary was not released until June 30, FierceMedicalDevices reports. But the Catholic News Agency said the pope’s September 24 address to Congress was publicized as early as February 5.
Essure, a permanent birth control method, received FDA approval in November 2002. The device consists of small, nickel-titanium coils that are inserted through the vagina into the woman’s fallopian tubes. The implant procedure is done on an outpatient basis in a doctor’s office. The coils cause scar tissue to form, which blocks the tubes, preventing pregnancy. Once blockage is confirmed, the method is considered 99.83 percent effective, National Public Radio (NPR) reports. But women have reported a variety of injuries and side effects they say were caused by Essure. These include fatigue, migraines, joint pain, digestive issues, back pain, heavy periods, abdominal pain, unintended pregnancies, and ectopic pregnancies (where the embryo implants somewhere other than the uterus). In some instances, the device has migrated from the fallopian tube and in a few cases, has been expelled from the woman’s body.
In April, the FDA said it would investigate Essure following complaints of fraud during the clinical trial and reports of serious side effects. The FDA has received more than 5,000 complaints about Essure since its November 2002 approval. In May, Bayer released data from a long-term study to support the safety and efficacy of Essure. The device caused pelvic pain in only 7 percent of participants in the study. But an article in the New York Times called the company’s data into question, citing results from a long-term trial published in the Journal of Minimally Invasive Gynecology. Only 366 out of 518 original study participants were followed for the full five years, according to the Times. And women who were tracked cited a number of problems tied to the device, including unusually heavy periods and recurrent pelvic pain.
The FDA panel meeting will be open to the public, and the agency said interested persons may present material to the panel in writing or request to speak at the meeting.