Bayer to withdraw contraceptive implants in US
GERMAN chemicals and pharmaceuticals giant Bayer will withdraw its controversial Essure contraceptive implants from sale in the United States, the last country where they are available, more than a year after they were discontinued in Europe.
Bayer’s dec i sion to stop sa les on December 31 “i s based on a decline in US sales of Essure in recent years,” the group said in a statement Friday, whi le i nsi st i ng on it s “safet y and ef f icacy”.
Essure, a non-hormonal coil implant used to sterilise women, has in some women caused chronic pain, perforation of the uterus and fallopian tubes and led to hysterectomies, news reports say.
Bayer blamed a number of factors for lower sales, including the “decreased use of permanent contraception overa l l , i ncrea se d rel ia nce on other birth control options . . . and inaccurate and misleadi n g pu bl i c i t y a b out t he dev ice.”
A tiny spring-shaped device, Essure is inserted under loca l a naest het ic into a woman’s f a l lopi a n t ube s , blo c k i ng t hem i n order to pre vent fer t i lisat ion.
It can be performed in the doctor’s office.
Its withdrawal from sale in Europe last year followed European Union authorities’ suspension of sales of the implant while they gathered more data on safety.
Risk checklist
But while the US Food and Drug Administration (FDA) required Bayer in April to limit sales of Essure to medical practitioners who agreed to run through a checklist of the risks with patients before selling them the implant, it did not at any point stop sales.
“T he F DA c ont i nue s t o bel ieve t hat t he benef it s of the device outweigh its risks,” t he federa l aut horit y says on its website.
It nevertheless adds that between November 2002 and Januar y 2018, there were 26,773 “adverse event and product problem reports” submitted about Essure according to its database.
The most common problems women reported were pain, heavier periods, headaches, fatigue and weight fluctuations, with most reports cataloguing multiple symptoms in a single patient.