More Essure Problems For Bayer as Essure Discontinued In Finland and the Netherlands
May 31, 2017
Essure keeps turning up like a bad penny for Bayer, who can't escape the negativity surrounding the device. Controversy concerning the permanent sterilization device continues to ramp up following Brazil's recent ban of the Essure device and nationwide protest rallies against Essure across America on May 6, 2017. Today, Bayer announced it would discontinue the sale and distribution of Essure in Finland on June 25, 2017 due to plummeting demand for the device. According to a medical source in the Netherlands, Essure sales will also be discontinued in the Netherlands next month as well, due to declining sales and profitability.
Despite discontinuing sales, Bayer still maintains that the product is safe and the risk-benefit profile is still positive. Tens of thousands of women would beg to differ, however, as thousands of women world-wide have undergone otherwise unnecessary hysterectomies to have the defective devices removed. Essure consists of two sets of tiny coils-one of stainless steel, wound with polyethylene terephthalate polyester fibers, nestled in a larger nickel-titanium coil-that are implanted in a woman's fallopian tubes. Scar tissue is supposed to form around them, securing the coils and blocking the tubes so that eggs cannot be fertilized.
Researchers in Finland published an article in the journal Fertility and Sterility in 2010,and noted that long-term data on Essure's safety and efficacy were still unavailable, and there were no randomized controlled studies of the device. The researchers also noted that most studies on Essure have been funded by Bayer. The FDA has recently ordered Bayer to conduct a new study of Essure's benefits and risks that it hopes will shed light on the complications that afflict women who have Essure, compared to those who have tubal ligation.
The newly drafted surveillance study will look at two groups of 1,400 women who chose to undergo either the implantation of the Essure device or laparoscopic tubal sterilization and have not been pregnant within the six weeks prior. Each group will be closely monitored for the side effects that keep being reported to the FDA. Some of the main focuses of the study will include chronic abdominal and pelvic pain, abnormal bleeding, allergic reactions to nickel, and reasons for Essure device removal. However, the study, which was supposed to have commenced months ago only had ONE patient enrolled as of May 3, 2017.
It is abundantly clear that Essure is on its way off the market in other European countries and hopefully the United States as well. It is hoped that all countries where Essure is sold will follow the lead of Brazil and either ban Essure from the market or that the demand for the defective product will be so low as to force Bayer to remove it from the market. Women injured by the device need to continue to speak up and out against the product to their Congressmen, the FDA and the manufacturer.
If you or a loved one have questions concerning the Essure device, contact attorney Holly Ennis at Ennis & Ennis, P.A. visit us online at www.ennislaw.com.