Medicine

FDA restricting sales of permanent birth control over risk concerns

FDA restricting sales of permanent birth control over risk concerns

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.

Now, the device, Essure, can only be sold in healthcare facilities that provide full information about the risks and benefits of the device.

"We have evidence to believe that some women are not getting access to this checklist before the device is being implanted", Deborah Kotz, a spokesperson for the FDA, told BuzzFeed News. Since then, Essure sales have gone down approximately 70-percent in the U.S. The FDA says that some women are still not receiving information about the known risks of Essure before implantation. It plans to enforce these requirements and will take action for a failure to comply, including applicable criminal and civil penalties.

Bayer emphasized that the risk-benefit profile of Essure had not changed and that communicating risks with patients was in keeping with its values as the device's manufacturer. The FDA is requiring a unique type of restriction, using its authority to restrict the sale and distribution of a device to impose additional requirements needed to provide a reasonable assurance of its safety and effectiveness. In a procedure that takes about 10 minutes, doctors insert two sets of tiny coils through the vagina and cervix and into a woman's fallopian tubes, which carry eggs from the ovaries to the uterus. Despite previous efforts to alert women to the potential complications of Essure, we know that some patients still aren't receiving this important information. "That is simply unacceptable", FDA Commissioner Scott Gottlieb said in a statement. Under the new restrictions, only doctors and health facilities that discuss those risks with all patients will be legally allowed to implant Essure, the FDA said. "Every single woman receiving this device should fully understand the associated risks".

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Initially approved in 2002, Essure is the only permanent birth control device that is implanted without a surgical incision. 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 have been reported in some women after Essure implantation.

Essure, approved by US regulators in 2002, was given the strongest safety warning label on the device in early 2016 following thousands of complaints. Bayer is deeply committed to providing women with safe and effective healthcare options that meet their individual needs, and is dedicated to ensuring the continued safe, effective and appropriate use of Essure as an important option for permanent contraception.

In the 16 years since approval, the FDA said it has received more than 26,000 reports of adverse events - nearly 12,000 last year alone - including miscarriages, fetal deaths, and other problems. It also includes a checklist of possible adverse effects that patients must individually initial, indicating that the physician had explained them.


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