Bayer, maker of the popular non-surgical permanent birth control device, announced it now plans to stop selling its controversial device. The company claims its decision is due to lagging sales, but others believe it is because of the aggressive public health campaign and ongoing criticism of the device.
To date, more than 16,000 lawsuits have been filed against the company related to Essure. Claims include injuries to the fallopian tubes and uterus, as well as a variety of other complications caused by the device.
The company continues to deny allegations related to the device.
What is Essure?
Essure is a birth control implant device. It is placed through the vaginal opening into the fallopian tubes. Once in place, coils on the device trigger an inflammatory response that creates scar tissue that eventually blocks an egg from traveling through the tubes and into the uterus.
Essure is a permanent birth control option and is considered a non-surgical sterilization implant.
FDA Action Slows Sale
Bayer claims that despite the device being safe, it has stopped making Essure because sales slowed after FDA warnings were upgraded.
In an unusual move, the FDA limited sales of the device to medical practices and doctors who agreed to fully inform patients about the risks of the device before placing it. The agency noted it had received at least 27,000 adverse event reports since the device was approved for sale in 2002.
The FDA then took further action to inform and protect the public in 2016 when it ordered the device to include a “black box warning” on its label. The warning included mention of the risk of device migration, which occurs when Essure travels from the uterus into the abdomen and pelvic cavity – an occurrence that more often than not requires surgery to correct.
In addition to the warnings and FDA safety measures, Bayer claims the decline in Essure sales is due to a combination of “misleading publicity” and the fact that American women are option for reversible birth control methods.
According to a statement issued by Bayer, “The benefit-risk profile of Essure has not changed and we continue to stand behind the product’s safety and efficacy, which are demonstrated by an extensive body of research.”
Despite the upgraded FDA warnings, the agency continued to support Bayer’s claim that the device did more good than harm.
Still, there is no denying the thousands of reports that have come into the FDA from women seriously injured by their Essure device. There is also a lack of data concerning Essure and health officials are concerned there have been no unbiased, long-term studies conducted to confirm or refute reports of danger. Post-market surveillance studies continue to occur, but have done little to prove the safety of the device.
Bayer Halts All Sales of Essure
In response to years of lagging sales, Bayer announced this week it will stop all sales of the Essure Device. The company continues to deny wrong-doing and stands behind the safety and effectiveness of its device.
Bayer had already pulled the device in other markets and the United States was the last market in which it was sold.
In conjunction with the announcement from Bayer, Scott Gottlieb, the commissioner of the FDA issued a statement reassuring women currently using Essure that they should continue use of their device if there are no problems. He reminded that removal of the device has its own risks and encouraged women experiencing problems to contact their doctors.