The Essure System for Permanent Birth Control will no longer be available in the United States after December 31, 2018, according to a press release issued by Bayer. In a statement released by the Agency, FDA Commissioner Scott Gottlieb, MD, said "I want to stress that, even when Essure is no longer sold, the FDA will remain vigilant in protecting patients who've already had this device implanted".
Essure consists of two sets of small metal coils that are inserted through the vagina and cervix into the fallopian tubes.
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.
In a statement, Bayer attributed the decision to a "decline in us sales of Essure in recent years and the conclusion that the Essure business is no longer sustainable".
Essure will gradually be phased out and US sales halted by the end of 2018.
In a Facebook message to NBC News on Friday, Firmalino hailed Bayer's decision and said all the years of "fighting to get Essure off the market has finally paid off".
February 2018: FDA officials met with women implanted with Essure and patient advocates to listen to their concerns and experiences with the device.
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Plaintiffs allege that Essure, which is implanted in a woman's fallopian tubes to permanently block an egg's passage to the uterus, could pierce the tubes.
For women who have received an Essure implant, the postmarket safety of Essure will continue to be a top priority for the FDA. They also claim that the device failed to prevent unwanted pregnancies and led to nickel allergies and depression.
"As a result, when thousands of women reported serious complications from Essure, there was no unbiased long-term research to refute or confirm those reports", Zuckerman said. Those who think it's causing problems, such as persistent pain, should consult with their doctors, Gottlieb added.
Early in 2016, the FDA put its strongest safety warning label on the device after thousands of complaints and asked the drugmaker to conduct a post-market study.
"Consumers rely on device manufacturers and goverment regulators to ensure that medical devices are safe and effective", says Dena Mendelsohn, senior staff attorney for Consumers Union, the advocacy division of Consumer Reports. Those problems are listed in the current FDA labeling for the device, with the qualifier: "It is unknown if these symptoms are related to Essure or other causes".
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