For those who aren't too put off by a few facts now and then, here's the chronology:
Essure was approved in 2002.
By 2010, everyone who pays attention to these things was painfully aware of the growing number of reports of safety issues associated with the device, and problems with other implants were also getting attention.
The head of FDA's Office for Device Evaluation resigned in 2010. A number of other top FDA medical device officials resigned in the 2009-2012 time period.
The Institute of Medicine did an extensive evaluation of the 510(k) process and, in July 2011, released a 245-page report with criticisms and recommendations.
Congress took the IOM recommendations to heart and, in July 2012, the Food and Drug Administration Safety and Innovation Act was enacted into law. It including the most significant legislation affecting the regulation of medical devices since the 1976 legislation that first gave FDA authority over the safety and efficacy of these products.
Whether the extensive changes that were included in the 2012 legislation will be effective in reducing the number of medical devices that are associated with safety issues post-market, only time will tell. But FDA oversight of medical devices has been under new management and new regulations for over five years now.
In 2016, FDA required Bayer to include a "black box warning" on Essure. A black box warning is also known in the industry as the "kiss of death," because of its typical impact on sales. So it came as no surprise to anyone, when, on July 20, Bayer announced it was withdrawing the product from the US market, due to declining sales.
The documentary was released on Netflix one week later. Hmmm. I wonder if Netflix might have held it for release because, in order for Bayer to sue for libel, it would have had to show that it incurred damages as a result of the libel. Now that there are no sales to be lost, no damages can be incurred.
