The sale of a contraceptive implant has been suspended for three months across the European Union after an Irish regulator said it was temporarily withholding renewal of the device’s commercial licence.
The National Standards Authority of Ireland said it needed more information before renewing the licence for the Essure contraceptive device, its French counterpart told AFP.
As a result, the device “can no longer be sold in France or Europe during the temporary suspension period,” which runs to November, the French ANSM medical safety authority said.
Essure’s manufacturers Bayer say the device is a “minimally invasive” permanent birth control procedure.
“We would like to reassure the women who use Essure as their form of contraception and their healthcare professionals that the safety and efficacy of Essure continues to be supported by more than a decade of science and real world clinical experience,” the company said in a statement.
ANSM urged women to not use the Essure implant in the meantime “as a precaution”.
Brazil’s public health authority suspended the sale of the device in February pending further testing but lifted the ban last month.