FDA restricts contraceptive Essure

FDA restricts contraceptive Essure

(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.

The federal agency announced it chose to immediately make changes after learning that some women were not being adequately informed of Essure's risks before getting the device implanted - despite significant efforts to educate patients and doctors. 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.

"Among the additional significant concerns is the fact that females who got Essure had no thought there has been a warning to the apparatus, or even a doctor-patient argument checklist, " stated Holly Ennis, a lawyer who represents hundreds of ladies that are suing Bayer over the device".

"Bayer has educated and continues to educate healthcare providers about the importance of appropriately counseling each patient on the benefits and risks of Essure", Bayer spokesperson Courtney Mallon said in a statement.

Bayer's device, Essure, is a permanent contraceptive developed by the German drugmaker as an alternative to surgical techniques like tying or severing the fallopian tubes. "Every single woman receiving this device should fully understand the associated risk".

Additionally, women have reported headache, fatigue, weight changes, hair loss and mood changes like depression, however, it's unknown whether these are related to Essure. The patient brochure must be reviewed with the prospective patient with their health care provider to ensure the patient understands the risks, benefits and other information about Essure implantation. 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.

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Bayer is required to implement the FDA's restrictions immediately.

Essure, approved by US regulators in 2002, is a non-surgical and non-hormonal permanent birth control device.

Still, one expert in women's health said the FDA move can only be helpful to women. 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.

CNN reports that thousands of women have filed complaints with the FDA about the device since it went on the market in 2002. The agency is now monitoring the company's progress.

The FDA's actions are meant to "ensure that all women considering use of the permanent contraception device are provide with adequate risk information so that they can make informed decisions", according to a statement by the FDA. US health officials are placing new restrictions on a contraceptive implant that has been subject to thousands of reports of painful complications from women. It also includes a checklist of possible adverse effects that patients must individually initial, indicating that the physician had explained them. The FDA will review and monitor the company's plan and will enforce the requirements.

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