NEW YORK (Reuters) – Life sciences company Bayer AG closed its sale of its anti-baby product Essure in the US on Friday, announcing a decline in implantable devices that will not make it sustainable.
FILE PHOTO: A logo from Bayer can be seen alongside dark clouds at the Cologne-Bonn airport
March 27, 201
The decision followed an announcement by the company in September 2017 to discontinue the sale of the disputed sterilizer in all non-US countries.
Bayer stated in a statement that the decision was not based on security concerns. The Leverkusen-based company faces 16,000 US court cases over Essure.
"The benefit-risk profile of Essure has not changed, and we remain committed to the safety and efficacy of the product, as evidenced by extensive research," said Bayer.
It said it had informed the US Food and Drug Administration of its decision and would bring health care providers up to date.
Essure will phase out and sales in the US will be discontinued by the end of this year. Doctors can perform Essure procedures until the end of next year when they are asked to return unused devices.
FDA Commissioner Scott Gottlieb said in a statement that the agency would continue to monitor the safety of Essure, adding, "We expect Bayer to meet its postal market obligations with respect to this device." In early 2016, the FDA has shown its strongest impact warning on the device after thousands of complaints and asked the drug maker to conduct a post-market trial.
The agency said it received nearly 12,000 Essure reports in 2017.
Bayer said extensive research by the company and independent medical researchers had shown that Essure was safe.
Women have alleged in court cases that Essure implanted in a woman's fallopian tube to permanently block the passage of eggs into the uterus could puncture the vessels and that metal parts of the device could loosen and migrate into other parts of the device Body, causing pain, injury and heavy bleeding.
They also claimed that the device did not prevent unwanted pregnancies, leading to nickel allergies and depression.
Bayer was accused in trials of knowing the risks associated with Essure and not warning sellers, doctors and regulators.
Marcus Susen, a Florida-based attorney representing a number of women who sued the company, has long since called his decision overdue and said it was up to a jury to decide if Bayer would sell Essure for trading or security reasons for it.
Bayer spokesman Steven Immergut said the company has sold around one million Essure devices worldwide since its launch in 2002.
Most of these sales in the US, according to the company, are an average annual decline in sales of 40 percent in the device since its launch.
In April, the FDA said some women were under-informed of the risks associated with Essure prior to implantation and restricted their sale to health care facilities that provided comprehensive information about their risks and benefits.
Bayer said in a statement that the decline in sales was due to a general decline in permanent contraception in the United States, an increasing reliance on other contraceptive methods and "inaccurate and misleading advertising about the device".
Reporting by Tina Bellon; Editing by Clive McKeef, Toni Reinhold