Bayer blocks non-US sales of Essure
Pharmaceutical company Bayer is halting the sales of its sterilisation implant Essure from all countries bar the US. It follows on from the temporary suspension of Essure implants sold within in the EU just a month ago.
The company has come under fire, with thousands of women having had to undergo hysterectomies, or further surgeries resulting from perforation of the uterus or fallopian tubes. In some cases, the non-hormonal coil implant has fallen out, and embedded itself on another part of the body.
The process incorporates the Insertion of the coil into a patients’ fallopian tubes, where it causes increased inflammation and scarring over the following months which closes off the tubes entirely. Known as a hysteroscopic sterilisation, the procedure is known to be un-invasive and done within local GP practices.
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However, made from nickel and polyester fibres (PET), the coil has been known to create acute and/or persistent pain, with many women suffering an allergic reaction from the nickel-titanium alloy or fibres as a result.
Sales in all countries except the US have now banned the use of Essure, yet Bayer has stated in French that "this decision is not linked to any problem of safety or quality of Essure.
“The safety and effectiveness of Essure is supported by more than 10 years of scientific research and real–life clinical settings."
The Food and Drug Administration has supported this claim, although it has received over 500 complaints in the US alone since the product’s approval in 2002.
Bayer is not seeking to reobtain its CE rating for the product, which would enable it to be distributed throughout the European Union. Doctors have now been advised to block any use of the implant going forward.