A lengthy campaign by health advocates and thousands of women to remove Bayer’s birth control method Essure has proven successful. Bayer announced this past July that they would discontinue sales of Essure by the end of the year.
The implant has caused a myriad of problems for scores of women. The subject of an estimated 16,000 Essure lawsuits or claims filed by women, Essure has been reported to cause serious injuries such as perforation of the uterus and the fallopian tubes. A number of deaths, including infants, have been attributed to the birth control method.
Bayer said its decision to end sales of the device was not due to safety issues or heavy litigation, but to an organic drop in sales and use by women who chose other birth control options. Bayer has continued to deny that the implant is dangerous or has caused injuries.
The device had mounted several injury claims and sparked the forming of many advocacy groups who repeatedly demanded that the Food and Drug Administration ban the device, but the agency declined.
After meeting with members of these advocacy groups, the F.D.A required Bayer to restrict Essure sales to doctors’ offices and medical practices on the condition that they agreed to provide women with extensive information about the product’s risks.
Reported side effects from hair loss and tooth loss to chronic pain and severe bleeding, miscarriages and even death, did not match up to the reported benefits from Bayer. From 2002, when Essure was approved, through 2017, it had received 27,000 reports that the device had adverse effects.
The Essure implant is made up of two small coils made of a nickel alloy and a polyester-like fiber. It is placed into the fallopian tubes and is designed to create an inflammatory response, causing scar tissue to form and blocking the tubes.
The United States was the only country where Essure, considered a nonsurgical implant, was being sold. Sales had previously been discontinued in France, England, Canada, Brazil, and many other countries.
After the F.D.A ordered a warning be placed on the package that warned of the injury risk, sales of the device in the United States had declined by approximately 70 percent.
Bayer blamed “inaccurate and misleading publicity” as a factor in declining sales. The company said they continue to stand by Essure’s safety and efficacy demonstrated by an extensive body of research.
A Bayer spokesman said that as of mid-April, there were approximately 16,800 plaintiffs who have filed claimed regarding Essure.
NastLaw LLC is currently investigating lawsuits on behalf of individuals who have been injured by Essure. Contact NastLaw for more information.