In their press statement, Bayer notes that the "increased reliance on other birth control options, such as long-acting reversible contraceptives, and inaccurate and misleading publicity about the device" is what contributed to the decline in interest for Essure. As complaints mounted and demand slipped, it stopped Essure sales in Canada, Europe, South America, South Africa and the United Kingdom.
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.
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.
Based on that investigation, the FDA issued a black-box warning-the agency's most serious kind of warning-and ordered Bayer to conduct a post-market study to evaluate the safety of Essure. The views expressed therein are not necessarily those of stlucianewsonline.com, its sponsors or advertisers.
In recent years, thousands of women have claimed Essure caused serious health issues.
In 2016, the FDA ordered Bayer to label Essure packages with warnings of such potential injuries as well as the risk of its traveling into the abdomen or pelvic cavity.
Dr. Christopher M. Zahn, vice president of the American College of Obstetricians and Gynecologists, said in a statement Friday that the safety data on hysteroscopic sterilization, the fallopian tube procedure by which Essure works, "has not changed".
"Consumers rely on device manufacturers and goverment regulators to ensure that medical devices are safe and effective", says Dena Mendelsohn, senior staff attorney for Consumers Union, the advocacy division of Consumer Reports. Regarding the postmarket 522 study, Bayer will continue to enroll new participants.
I also want to reassure women who've been using Essure successfully to prevent pregnancy that they can continue to do so. Those who think it's causing problems, such as persistent pain, should consult with their doctors, Gottlieb added.
In a statement, Bayer attributed the decision to a "decline in US sales of Essure in recent years and the conclusion that the Essure business is no longer sustainable". Our Medical Device Safety Action Plan, issued in April, captures numerous efforts that we're undertaking. We'll share what we learn to help doctors and patients make informed decisions. 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.