July 25, 2018 Source: MDDI Online 644
Bayer announced on last Friday that it would stop the sales of its Essure birth control system in the United States by the end of this year due to a steady decline in its sales making the product no longer justifiable. Bayer insisted that its decision to discontinue Essure sales is only for business reasons and not for any safety or efficacy concerns.
Jeremy Schulman, the husband of one patient advocate tweeted, "So proud of my wife and the work the Essure Problems teams has done over the many years to stop Bayer from selling this harmful product. Mission accomplished."
The FDA was emphasizing that the women who were considering this implantable contraceptive device should be adequately informed about its risks. The patients must be given a chance to sign an acceptance of risk, which should be further signed by the physician who implants the device. The FDA passed the rule to Bayer to implement the restrictions at once and ensure that this process results in healthcare provider compliance with the sales restriction.
But some women never received this information before having Essure implanted. Further actions were taken by the FDA to address the medical device reports of serious side effects associated with the device. At last, FDA Commissioner Scott Gottlieb acknowledged Bayer's decision to stop Essure sales.
Scott Gottlieb said, "For women who have received an Essure implant, the postmarket safety of Essure will continue to be a top priority for the FDA. We expect Bayer to meet its postmarket obligations concerning this device.”
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