The Food and Drug Administration has placed multiple restrictions on the device following patient reports of pain, bleeding, allergic reactions and cases where the implant punctured the uterus or shifted out of place.
In a notice in April, the FDA said it was "unknown whether these symptoms are related to Essure".
Essure consists of two sets of small metal coils that are inserted through the vagina and cervix into the fallopian tubes. We expect Bayer to meet its postmarket obligations concerning this device.
FRIDAY, July 20, 2018 (HealthDay News) - Amid lawsuits and plummeting sales for its Essure birth control device, drug giant Bayer announced Friday that it would cease USA sales of the product by the end of 2018.
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". Many women reported that the device had become dislodged or broken, migrating to other organs in their body. "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".
In recent years, thousands of women have claimed Essure caused serious health issues.
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Bayer attributed the Essure decision to declining sales, saying it still stands by its safety and efficacy.
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.
In a statement released Friday, agency Commissioner Dr. Scott Gottlieb said that "even when Essure is no longer sold, the FDA will remain vigilant in protecting patients who've already had this device implanted".
I also want to reassure women who've been using Essure successfully to prevent pregnancy that they can continue to do so. That includes monitoring "adverse event" reports and holding Bayer to its promise to conduct further safety studies.
"The device has been associated with serious risks including persistent pain, perforation of the uterus and fallopian tubes, and migration of the coils into the pelvis or abdomen", according to Gottlieb. Our Medical Device Safety Action Plan, issued in April, captures numerous efforts that we're undertaking.
Bayer, however, maintains that other factors are behind the product's drop in popularity.