In its statement on Friday, Bayer said the "declining interest" in the device was attributable to the decreased use of permanent contraception overall, increased use of other birth control methods, and supposedly "inaccurate and misleading publicity about the device". Pharmaceutical giant Bayer says it will stop selling its permanent contraceptive implant Essure in the United States.
In a notice in April, the FDA said it was "unknown whether these symptoms are related to Essure".
Pharmaceutical giant Bayer announced this week that it will cease USA sales of the controversial birth-control implant Essure, which has been linked to a smattering of serious health problems.
FDA Commissioner Scott Gottlieb said Friday that ensuring the safety of Essure will continue to be a priority for the agency for women who still use the product. In April, when the FDA became aware that many patients were not being adequately counseled, we required a restriction which limits the sale and distribution of the device to only health care providers and facilities that provide information to patients about the risks and benefits of this device and gives patients the opportunity to sign an acknowledgement that they fully understood these potential risks before having the device implanted.
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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.
February 2018: FDA officials met with women implanted with Essure and patient advocates to listen to their concerns and experiences with the device.
While the agency has said that Essure's benefits outweigh its risk, it did slap a "black box" warning on the implant in 2016, and ordered more safety studies.
Women "will not be harmed by this device anymore", she said.
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Adverse events such as perforation of the uterus and/or fallopian tubes, migration of inserts to the abdominal or pelvic cavity, persistent pain, and suspected allergic or hypersensitivity reactions has been reported in some women after Essure implantation. They also claim that the device failed to prevent unwanted pregnancies and led to nickel allergies and depression.
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.
We're committed to continuing to communicate publicly on issues related to the safety of Essure and other medical devices.
Gottlieb noted that device removal "has its own risks".
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"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.