According to a just-published study, the Essure birth control implant may have received initial Food and Drug Administration (FDA) approval based on insufficient or flawed data.
The FDA approved the Essure non-surgical permanent birth control device in 2002, but since then, thousands of women have reported extreme and debilitating side effects.
Researchers at Northwestern University’s medical school studied gynecological devices like Essure that have been approved in the last 15 years. The researchers focused on devices that have been linked to high-risk complications. The study was published in the June 2016 issue of Obstetrics and Gynecology. The researchers reviewed a total of 18 devices, and discovered that only 11 of these 18 devices had undergone random controlled trials to establish their safety and efficacy. Only 12 of the 18 were required to undergo post-market surveillance so that manufacturers could assess any complications that may occur in women after the initial approval.
According to a news release from Northwestern, the researchers “looked at the class of devices with the highest potential risk to patients — the devices that had to go through the most rigorous pre-market approval process,” said senior researcher Dr. Steve Xu. “Despite this being the most stringent pathway, and despite the fact that we’ve had multiple safety issues connected to OB-GYN devices affecting millions of women worldwide, the evidence leading to approval has a lot of weaknesses.”
Essure was one of the devices examined in the study. Essure has been controversial because of numerous reports of serious complications, including bloating, pelvic pain, rashes, allergic reactions to the metal in the implant, excessive bleeding, organ perforation, unintended pregnancy, miscarriage, and ectopic pregnancy. “The device, meant to last a lifetime, was approved based on short-term evidence and insufficient post-market follow-up,” explain the study authors.
Bayer Healthcare, the manufacturer, faces a steadily increasing number of Essure lawsuits alleging that research and testing on Essure was insufficient to determine the safety and efficacy. Many of the lawsuits also allege that the manufacturer failed to adequately warn the public and the medical community about the serious risks linked to Essure.
The large number of complaints about Essure led the FDA to open an investigation in 2015 and convene the Obstetrics and Gynecology Devices Panel to gather scientific and clinical information about Essure and to hear women’s accounts of their experiences with the device. The FDA announced that it will require a boxed warning and Patient Decision Checklist be added to the Essure labeling to help ensure that women understand the risks and benefits and risks of Essure. Many of the injured women are calling for Essure to be removed from the market altogether.
“Devices are a huge part of the medical care that we provide women on a daily basis,” said study first author Dr. Jessica Walter, a resident in obstetrics and gynecology at Northwestern University Feinberg School of Medicine. “We found that there’s an opportunity to increase the burden of proof required for a device to be approved for public use.”