FRIDAY, July 20, 2018 (HealthDay News) - Amid lawsuits and plummeting sales for its Essure birth control device, drug giant Bayer announced Friday that it would cease US sales of the product by the end of 2018.
Bayer spokesman Steven Immergut said the company had sold roughly one million Essure devices worldwide since the product came on the market in 2002.
The Food and Drug Administration said earlier this year that over a 15-year period - November 2, 2002, when Essure was approved, through December 2017 - the agency received more than 26,000 reports of problems, including pain, heavier periods and irregular bleeding, headaches and fatigue.
Marcus Susen, a Florida-based lawyer representing a number of women who have sued the company, called its decision long overdue, and said it would be up to a jury to decide if Bayer stopped the sale of Essure for commercial or safety reasons. The views expressed therein are not necessarily those of stlucianewsonline.com, its sponsors or advertisers.
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This method of permanent birth control, where coils are inserted into the fallopian tubes creating a blockage that prevents the passage of an egg from the ovary, has been associated with numerous adverse events that were reported to the FDA including a significant collection of recent reports that have mentioned issues involving surgery to remove the device.
In February 2016, the FDA required Bayer to conduct a post-marketing study which resulted in the addition of a Boxed Warning and patient decision checklist to the labeling 7 months later. The film includes the stories of some women who claim they suffered permanent, serious complications from Essure. And we'll communicate publicly on any new findings or concerns. In addition, the Company will continue to enroll patients in the Essure postmarket surveillance study, as requested by the FDA.
The FDA received almost 12,000 reports in 2017 related to Essure, the only permanent, nonsurgical birth control on the market in the U.S. Those who think it's causing problems, such as persistent pain, should consult with their doctors, Gottlieb added.
And earlier this year, the agency restricted sales of the device to healthcare providers who agreed to have patients sign paperwork acknowledging the device's risks and benefits. Those problems are listed in the current FDA labeling for the device, with the qualifier: "It is unknown if these symptoms are related to Essure or other causes". The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.