FDA: Essure sterilization device can't be sold without 'unique' warnings to patients
11 April, 2018, 12:32 | Author: Hope Soto
(Reuters) - The U.S. Food and Drug Administration (FDA) on Monday slapped restrictions on the sale of Bayer AG's implanted birth control device Essure, two years after the agency put a severe warning label on the product.
"We've been closely evaluating new information on the use of Essure, and based on our review of a growing body of evidence, we believe this product requires additional, meaningful safeguards to ensure women are able to make informed decisions about risk when considering this option", Scott Gottlieb, MD, FDA Commissioner, said in a statement. Under the new restrictions, only doctors and health facilities that discuss those risks with all patients will be legally allowed to implant Essure, the FDA said.
Since then, USA sales of Essure have fallen 70 percent, but "we know that some patients still aren't receiving this important [risk] information", FDA Commissioner Scott Gottlieb said in a statement.
After noticing an increase in side effects, the FDA added new warnings for Essure in 2016, including a checklist that doctors were supposed to go through with patients. "Every single woman receiving this device should fully understand the associated risks". Sale and distribution of Essure is limited to healthcare providers who agree to review this checklist with patients, and give them the opportunity to sign it, before Essure implantation. "It does look like it's going to restrict Bayer's sales until they are in compliance".
The agency said Bayer, which manufactures the device, will be responsible for implementing the restrictions immediately and for ensuring that providers comply. The FDA says failure to comply will lead to applicable criminal and civil penalties. Some women have reported headaches, fatigue, weight changes, hair loss, and mood changes (such as depression). The agency indicated that Essure's role in these symptoms is now unknown.
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Essure, which boomed in popularity when it first came on the market in 2002, has been billed as a convenient alternative to surgical sterilization, informally known as getting your tubes tied. The agency is now monitoring the company's progress.
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. USA regulators found that some doctors weren't always telling women about the Bayer's device's risks, which can include bleeding, pain and organ perforation.
Now, the device, Essure, can only be sold in healthcare facilities that provide full information about the risks and benefits of the device.
The FDA is committed to continuing to communicate publicly on this issue and will provide updates related to the safety of Essure when available. The agency also mandated that a more extensive patient decision checklist be added to the product's labeling.
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