The maker of a permanent contraceptive implant subject to thousands of injury reports and repeated safety restrictions by regulators said Friday that it will stop selling the device in the USA, the only country where it remains available.
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. This is the last place in the world where Essure was still sold.
Essure is made of two inch-long flexible metal coils. 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.
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 US after December 31, 2018, Bayer announced in a statement.
"I also want to reassure women who've been using Essure successfully to prevent pregnancy that they can continue to do so", he said. This April, the FDA significantly restricted sales and distribution of Essure.
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.
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The news was welcomed by women who have advocated against the device. The Company states that the decision to discontinue Essure was based on declining U.S. sales and not on any changes to the benefit-risk profile of the product.
Bayer denies that Essure is unsafe or ineffective, and in Friday's statement said that women now using the product can "confidently" rely on it. Those who think it's causing problems, such as persistent pain, should consult with their doctors, Gottlieb added. In addition, the Company will continue to enroll patients in the Essure postmarket surveillance study, as requested by the FDA.
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. "Device removal has its own risks".
"Thousands of women have reported serious complications from Essure, and there has been no unbiased long-term research to refute or confirm those reports", Diana Zuckerman, president of the National Center for Health Research, told the New York Times. "Patients should discuss the benefits and risks of any operation or procedure with their health care providers before deciding on the best option for them". Our Medical Device Safety Action Plan, issued in April, captures numerous efforts that we're undertaking.
We're committed to continuing to communicate publicly on issues related to the safety of Essure and other medical devices.
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