ibusinesslines.com July 23, 2018

FDA restricts contraceptive Essure

10 April 2018, 09:20 | Melissa Porter

FDA Restricts Sales of Bayer's Essure Contraceptive Implant

Sale of Essure contraceptive restricted; women must be told of 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.

The step was taken to ensure that all women considering the device "are provided with adequate risk information so that they can make informed decisions", according to an FDA news release. USA health officials are placing new restrictions on a contraceptive implant that has been subject to thousands of reports of painful complications from women. Over ~3 months, as tissue forms around the inserts, a barrier is formed that prevents sperm from reaching the egg. Some patients implanted with Essure have experienced adverse events, including perforation of the uterus and/or fallopian tubes, migration of inserts to the abdominal or pelvic cavity, persistent pain and suspected allergic or hypersensitivity reactions. The FDA will review and monitor Bayer's plan to ensure the company complies with the restriction. FDA Commissioner Scott Gottlieb, MD, said, "Despite previous efforts to alert women to the potential complications of Essure, we know that some patients still aren't receiving this important information".

On April 9, 2018, the FDA restricted sales of the Essure device to only doctors and healthcare facilities who use the FDA-approved "Patient-Doctor Discussion Checklist - Acceptance of Risk and Informed Decision Acknowledgement".

The agency is now requiring that Bayer, the manufacturer of the device, only sell Essure to doctors who talk patients through a two-page checklist of possible risky side effects before implanting the device. Some women have also reported headache, fatigue, weight loss and depression, but whether those symptoms are linked to Essure "is unknown", the FDA said Monday. "This is a unique restriction, and it will help resolve the issue we brought up with Commissioner Gottlieb, that nearly 95 percent of women implanted after the FDA's guidance was issued were not getting the new warnings about Essure".

Sale of Essure contraceptive restricted; women must be told of risks

Agency officials said Monday that they would continue to evaluate new information about the device and "regulatory options" that balance risks and benefits. The company added that FDA evidence reviews have determined Essure to be "a safe and effective medical device that benefits women by providing them with a valuable contraception option". 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. The California case now focuses on whether Bayer adequately reported adverse events to the FDA.

In a financial statement on January 30, Bayer said it had been served USA lawsuits from approximately 16,100 users of Essure.

Further action may await completion of a postmarketing study the FDA ordered Bayer to conduct in 2016. The agency also mandated that a more extensive patient decision checklist be added to the product's labeling.

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