Essure System for Permanent Birth Control to Be Discontinued


The FDA in April limited the sale of Essure to healthcare facilities that provide full information about the device's risks and benefits.

Bayer has said it doesn't know how many women have the implants, just that about a million Essure "kits" have been sold worldwide, most in the U.S. It consists of two-inch long coils that are implanted in the fallopian tubes during a minimally invasive procedure.

Bayer is facing numerous lawsuits over the device. "Several factors have contributed to declining interest in Essure among women in the USA, including decreased use of permanent contraception overall, increased reliance on other birth control options, such as long-acting reversible contraceptives (LARCs), and inaccurate and misleading publicity about the device", the company said in its statement.

Courtney Mallon, a spokeswoman for Bayer, said the "voluntary discontinuation" is not indicative of safety issues and added that the company is "working closely with the FDA and have planned a slow wind-down process to ensure patients and providers are appropriately supported".

Essure, a non-surgical sterilization device that is inserted into the fallopian tubes and prevents pregnancy by producing scar tissue that blocks sperm from fertilizing eggs, will no longer be available in the USA after December 31, 2018, Bayer announced in a statement.

The women claim that metal parts of the device can become loose and migrate into other body parts, causing pain, injuries and severe bleeding.

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"Seven long years of fighting to get Essure removed from the United States market has finally paid off", said Angie Firmalino, who formed a Facebook group in 2011 called Essure Problems and sparked a grass-roots movement of women advocating against the device.

The majority of those sales were in the U.S. Since then, the company has seen an average 40 percent annual decline in U.S. sales, Immergut said. A self-described "data advocate", she analyzed public data on Essure and presented her findings to hospitals, patients and attorneys to help argue against the product. That includes monitoring "adverse event" reports and holding Bayer to its promise to conduct further safety studies.

"I also want to reassure women who've been using Essure successfully to prevent pregnancy that they can continue to do so", Gottlieb said.

We're committed to continuing to communicate publicly on issues related to the safety of Essure and other medical devices.

In May, the FDA said doctors must show women a checklist of the device's risks before implanting it. Not one more woman will be harmed by this device. We'll share what we learn to help doctors and patients make informed decisions.