FDA restricts sale, distribution of Essure to protect women

FDA restricts sale, distribution of Essure to protect women

The new Essure labeling, which will now be legally required when this product is offered to a patient, restricts the sale and distribution of the device to only health care providers and facilities that provide information to patients about the risks and benefits of this device.

It was welcome news to the Essure Problems community, though its members still would prefer that the device be taken off the market.

"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", said FDA Commissioner Scott Gottlieb, MD, in the agency's statement. 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 must be given the opportunity to sign an acknowledgment, which must be signed by the physician implanting the device.

The FDA is aware that some women have received the Essure device without being adequately informed of Essure's risks.

The Food and Drug Administration said Monday that it is restricting the sale and distribution of Essure, a controversial contraceptive device that some patient advocates want taken off the market. The agency notes that sales of Essure have fallen 70 percent since the previous FDA restrictions were announced.

In a statement after the announcement, Bayer said it will continue to tell health care providers about "the importance of appropriately counseling each patient on the benefits and risks of Essure".

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As the manufacturer, Bayer must ensure that providers comply with the new restrictions, the FDA said.

Essure, a flexible coil inserted through the vagina into the fallopian tubes that prompts obstructive tissue growth, is meant to be a minimally invasive option for permanent sterilization.

"This is the FDA's way of assuring that patients understand exactly what potential complications and problems can occur with Essure", said Dr. Mitchell Kramer, who directs obstetrics and gynecology at Huntington Hospital, in Huntington, N.Y. Tissue forms around the inserts over about three months, serving as a barrier that keeps sperm from reaching an egg. Two years ago, Essure got the FDA's strongest warning label. A patient brochure, titled "Patient-Doctor Discussion Checklist - Acceptance of Risk and Informed Decision Acknowledgement", must be reviewed with the prospective patient. That is simply unacceptable.

Further action may await completion of a postmarketing study the FDA ordered Bayer to conduct in 2016.

Bayer mentioned in a recent financial report that as of January 30, more than 16,000 Essure users had filed lawsuits against the company, alleging outcomes that included hysterectomies, perforations, depression and weight gain.

For Firmalino and her fellow Facebook group members, many of whom are now suing Bayer, the FDA's move could signal an even more drastic change: the possibility that the manufacturer would pull Essure from the market.

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