Food and Drug Administration (FDA) Commissioner Scott Gottlieb, M.D., last month met with a group of women who claim to have been injured by the permanent birth control device Essure, and issued a statement updating the public on steps the agency has taken and plans to take in the future to better ensure patient safety.
Essure is a device that consists of two small, metal coils that are implanted in the fallopian tubes. The device is designed to prevent sperm from reaching the egg. It is a permanent form of birth control that has been used on more than 750,000 women worldwide.
Women have complained that the device can migrate and puncture the fallopian tubes or uterus and cause chronic pain, hemorrhaging, and permanent damage. They petitioned the FDA to remove the device from the market, but to no avail.
Essure is the only FDA-approved permanent birth control device. It is made by Bayer and was approved in 2002. Since then, the agency as continued to monitor the product’s safety and effectiveness by reviewing the medical literature, clinical trial information, post-approval study data and medical device reports submitted to the FDA.
“We convened a panel of medical experts in the fall of 2015 to provide us with advice on how we could better understand concerns about the device, such as patients who experienced abdominal pain, abnormal uterine bleeding, and device migration,” Dr. Gottlieb said.
In February 2016, the FDA ordered Bayer to conduct a post-marketing study to better evaluate the safety profile of the device when used in the real world. The agency also required a black box warning – its most serious type of warning – be added to its label.
“The aim is to help make certain a that a woman considering Essure receives and has full access to information about the benefits and risks of this type of device prior to undergoing treatment with this product,” Dr. Gottlieb said.
Currently, the FDA is reviewing nearly 12,000 medical device reports received in 2017 regarding Essure, the majority of which were sent to the FDA in the last quarter of last year. More than 90 percent of those reports mentioned issues involving the removal of the device, which the FDA is investigating.
“In short, we are actively working to gain more information on these new reports and to better understand reasons for device removal,” he said. The device is not intended to be removed. “The FDA will be following up on many of these individual reports to gather this additional information.”
Source: FDA News Release