MONDAY, April 9, 2018 (HealthDay News) - To help curb complications tied to the permanent contraceptive implant Essure, the U.S. Food and Drug Administration on Monday slapped new restrictions on the sale of the device.
The federal agency announced it decided to immediately make changes after learning that some women were not being adequately informed of Essure's risks before getting the device implanted - despite significant efforts to educate patients and doctors.
With the change, the device can only be made available by healthcare providers and facilities that provide information to patients about the risks and benefits of this device.
After noticing an increase in side effects, the FDA added new warnings for Essure in 2016, including a checklist that doctors were supposed to go through with patients.
Since then, USA sales of Essure have fallen 70 percent, but "we know that some patients still aren't receiving this important [risk] information", FDA Commissioner Scott Gottlieb said in a statement.
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Essure, a flexible coil inserted through the vagina into the fallopian tubes that prompts obstructive tissue growth, is meant to be a minimally invasive option for permanent sterilization. In order for this device to meet reasonable assurance of safety and effectiveness, all women considering Essure should receive this important information.
Essure, which boomed in popularity when it first came on the market in 2002, has been billed as a convenient alternative to surgical sterilization, informally known as getting your tubes tied. In addition, women have also reported experiencing headache, fatigue, weight changes, hair loss and mood changes, such as depression.
Even the action declared on Monday will call for health practitioners to be certain individuals sign up a form with a record acknowledging they've been informed of their implants' dangers, and also also necessitate the physician's signature.
They've taken steps to require warnings, but now the federal agency is imposing a unique type of restriction involving sales and distribution--forcing manufacturer Bayer to only sell the device to doctors who can verify that they're telling patients about all the risks.
The Patient-Doctor Discussion Checklist, which was added to the Essure label in November 2016, now includes the sub-title "Acceptance of Risk and Informed Decision Acknowledgement" to emphasize the importance of this tool.
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That work must begin July 1, and any delays complicate the project, she said. The increase will give the superintendent position a salary of $186,110.
The agency said Bayer, which manufactures the device, will be responsible for implementing the restrictions immediately and for ensuring that providers comply.
Still, one expert in women's health said the FDA move can only be helpful to women.
Thousands of women have reported serious problems with what was once a popular choice for birth control. The FDA says failure to comply will lead to applicable criminal and civil penalties. Although Bayer's post-market study now has demonstrated adequate progress, including tripling of the total number of enrolled patients over the past six months, the FDA plans to require Bayer to increase the number of participating study sites to account for the declining sales volume.
For more on female sterilization, visit the U.S. Department of Health and Human Services.
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