A study from researchers at Northwestern University’s Feinberg School of Medicine indicates that the Food and Drug Administration approval of the Essure birth control device may have been based on insufficient or flawed data.
The FDA approved Essure—a non-surgical permanent birth control device—in 2002. Essure consists of flexible metal coils that are inserted into the fallopian tubes in a procedure in a doctor’s office. The coils create scar tissue that blocks the tubes and prevents pregnancy. But since Essure came to market, thousands of women have reported serious side effects.
The Northwestern researchers reviewed gynecological devices that have received FDA approval in the last 15 years. They focused on devices that have been linked to high-risk complications. Among the 18 devices reviewed, the researchers found that only 11 of the 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 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, one of the devices in the study, has been controversial because of numerous reports of serious injuries and complications, including bloating, pelvic pain, rashes, allergic reactions to the metal in the coils, 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,” the study authors explain.
Device maker Bayer Healthcare is facing 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 has decided to require a boxed warning and a 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.
The study’s first author, Dr. Jessica Walter, a resident in obstetrics and gynecology at Northwestern, said, “Devices are a huge part of the medical care that we provide women on a daily basis,” adding, “there’s an opportunity to increase the burden of proof required for a device to be approved for public use.”