Physicians who want to implant the controversial Essure sterilization device are now required to provide an FDA-approved informational brochure to patients, which includes a consent form, the agency announced Monday. In a procedure that takes about 10 minutes, doctors insert two sets of tiny coils through the vagina and cervix and into a woman's fallopian tubes, which carry eggs from the ovaries to the uterus.
But in the statement Monday, Bayer noted the FDA "has repeatedly determined - after a rigorous review of the scientific evidence - Essure.is a safe and effective medical device that benefits women by providing them with a valuable contraception option".
The agency said Bayer, which manufactures the device, will be responsible for implementing the restrictions immediately and for ensuring that providers comply. Since then, Essure sales have gone down approximately 70-percent in the U.S. The FDA says that some women are still not receiving information about the known risks of Essure before implantation.More news: Trump Berates 'Stupid Trade' Between China and United States
"One of our other large concerns is that women who got Essure had no idea there was a warning on the device, or a doctor-patient discussion checklist", said Holly Ennis, a lawyer who represents hundreds of women who are suing Bayer over the device. "We take the concerns of all women affected by Essure very seriously".
The warning label was added to the device in 2016 after thousands of adverse event reports were submitted to the FDA describing issues such as persistent pain, perforation of the uterus or fallopian tubes, abnormal bleeding, allergic reactions, and unplanned or ectopic pregnancies. "Every single woman receiving this device should fully understand the associated risk". So Essure will now be limited to facilities that provide full information about its pro's and cons.
Essure has been clouded with controversy after multiple women complained about complications from the device such as abdominal pain, hives and even hair loss. "While some women may continue to choose Essure as their birth control option based on current information, as new information becomes available, the FDA will continue to keep the public informed of the agency's evaluation and findings, and consider regulatory options that appropriately balance benefits and risks for Essure". Based on this review, in February 2016, the agency ordered Bayer to conduct a post-marketing (522) study to better evaluate the safety profile of the device when used in the real world. It also directed Bayer to add a more comprehensive patient-decision checklist to the label that doctors could use to discuss all relevant risks with patients. The FDA will review and monitor the company's plan and will enforce the requirements.More news: Death notices for April 11, 2018
Essure, approved by US regulators in 2002, was given the strongest safety warning label on the device in early 2016 following thousands of complaints.
In a statement, Bayer said it "will continue to reinforce the use of the checklist with healthcare providers and will inform them about this important label update".
"We really weren't expecting the FDA to do anything that actually benefited women, so this was a huge move for the commissioner to make", Firmalino said.More news: Russia's government to support companies hit by USA sanctions