Or Is This Really An Essure Recall Due To High Numbers Of Adverse Events Reported To FDA And Related Essure Lawsuits
We have reported developments concerning Bayer's Essure birth control device a few times over the past couple of years:
- The Essure Birth Control Product: Safety, Regulatory, And Legal Developments Over The Past Several Months (September 2016)
- Bayer Fails to Warn About Serious Complications from Essure (November 2016)
- FDA Restricts Sales of Essure Permanent Birth Control Device (April 2018)
But this article may be our final article about the Essure birth control device, due to the fact that Bayer recently announced that it will be pulling this product from the market at the end of 2018.
As for why there is this arguable "Essure recall", we will start with Bayer's spin on the situation. From this July 20, 2018 Washington Post news report, "Sales of Essure birth control implant to be halted by Bayer; U.S. last to sell controversial device":
The company said Essure's removal from the market was "business decision" prompted by precipitous declines in sales in recent years. It said in a statement that it stands by the safety and effectiveness of the device, and added that women who currently have Essure in place can continue to “confidently” rely on it.
The United States is the last country where Essure is being sold. Last September, citing "commercial reasons,” Bayer announced it was ending sales outside the United States....
Bayer said Essure sales in the United States have plummeted by about 40 percent a year in recent years. On Friday, the company attributed the decrease to several factors: a decline in the number of women using permanent contraception; increased reliance on long-acting contraceptives that are reversible, such as intrauterine devices, and “inaccurate and misleading publicity” about the implant.
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For some background and so as to put this Bayer action regarding Essure in perspective, we get this timeline from another item issued July 20, 2018, "Statement from FDA Commissioner Scott Gottlieb, M.D., on manufacturer announcement to halt Essure sales in the U.S.; agency’s continued commitment to postmarket review of Essure and keeping women informed":
When [the FDA] first became aware of an increase in adverse events submitted to our database concerning [the Essure permanent birth control device], we launched an ongoing effort to review these reports to better understand concerns.
September 2015: The FDA convened a panel of experts to get their input on how we should investigate patient complaints that included abdominal pain, abnormal uterine bleeding and device migration.
February 2016: The FDA ordered Bayer to conduct a postmarket (522) study to better evaluate the safety profile of the device when used in the real world. The agency announced that it intended to require labeling changes to help patients better understand the potential risks of the device.
October 2016: The FDA issued the final guidance, “Labeling for Permanent Hysteroscopically-Placed Tubal Implants Intended for Sterilization” and in November 2016, the FDA approved updated labeling for Essure consistent with the guidance that added a boxed warning and a Patient Decision Checklist.
February 2018: FDA officials met with women implanted with Essure and patient advocates to listen to their concerns and experiences with the device.
March 2018: The FDA reported on a rise in new medical device reports submitted to the agency’s public database in 2017 with more than 90 percent of the reports involving potential device removal.
April 2018: In order to address concerns that not every patient was receiving adequate risk information, the FDA restricted the sale and distribution of the Essure device.
One last observation and nothing more: Thousands of Essure products liability lawsuits have been filed against Bayer in U.S. courts during the past few years.
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