Bayer to stop sales of Essure birth control device tied to injuries

The logo of German pharmaceuticals and chemicals giant Bayer stands over Bayer corporate offices

The FDA said the product saw a 70 percent decline of sales in the USA after it added a boxed warning and patient decision checklist to the labeling. "Instead, tens of thousands of women reported deeply troubling complications from using Essure, but the USA was the last country where Essure continued to be sold".

The maker of a permanent contraceptive implant subject to thousands of injury reports from women and repeated safety restrictions by regulators says it will stop selling the device in the US. The device has been controversial for years due to women's reports of pain and a myriad of alleged medical issues, including potential damage to the fallopian tubes and uterus.

"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.

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The decision follows action the Food & Drug Administration (FDA) this year restricting Essure's sale and distribution to health-care facilities that provide full information about the device's risks.

Bayer reiterated Friday that "The benefit-risk profile of Essure has not changed, and we continue to stand behind the product's safety and efficacy, which are demonstrated by an extensive body of research, undertaken by Bayer and independent medical researchers, involving more than 200,000 women over the past two decades". About 750,000 women have been implanted with the device since its approval. At the time, Essure was manufactured and marketed by Conceptus Inc., which Bayer acquired in June 2013.

But many women have attributed other problems to the implant, including mood disorders, weight gain, hair loss and headaches. While Bayer has not publicly acknowledged a direct correlation between the decision and the film's impending release, the push to pull Essure is not a new one. 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. "We have won, we have finally won".



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