Following these changes, in April 2018, the Agency issued an order to restrict the sale and distribution of Essure after learning that some women were still not being adequately informed of the risks associated with the device before implantation.
The FDA's April action was a "unique type of restriction" in which it imposed additional requirements "to provide a reasonable assurance of the device's safety and effectiveness", Gottlieb said.
Essure consists of two sets of small metal coils that are inserted through the vagina and cervix into the fallopian tubes.
Bayer is facing numerous lawsuits over the device.
Healthcare company Bayer on Friday said it would discontinue the sale of its birth control product Essure in the United States, citing a decline in sales of the implantable device which made the business no longer sustainable.
February 2016: The FDA ordered Bayer to conduct a postmarket (522) study to better evaluate the safety profile of the device when used in the real world.
In a statement, Bayer attributed the decision to a "decline in USA sales of Essure in recent years and the conclusion that the Essure business is no longer sustainable". About 750,000 women have been implanted with the device since its approval.
But claims by users that Essure "migrated", causing pain or unintended pregnancies, have plagued the device, and sales have fallen by 40 percent over recent years, the Post said.
The agency is monitoring Essure in several clinical studies to gather more information on the device's safety.
In recent years, the ranks of women who claim harm from the device have ballooned, and more than 15,000 have filed "adverse event" reports with the FDA. 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.
"Those with Essure who suspect they may be having symptoms related to the device, such as persistent pain, should consult with their doctor on what steps may be appropriate for them to take", Gottlieb continued. "Instead, tens of thousands of women reported deeply troubling complications from using Essure, but the US was the last country where Essure continued to be sold". It also ordered the company to give doctors a three-page "patient decision checklist" to inform women about the risks.
Bayer, however, maintains that other factors are behind the product's drop in popularity.