Bayer blocks non-US sales of Essure

By Catherine Sturman
Pharmaceutical company Bayer is halting the sales of its sterilisation implant Essure from all countries bar the US. It follows on from the temporary su...

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.  

Related stories

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.

Share

Featured Articles

UPS Healthcare Addressing Connected Logistics Needs

UPS Healthcare is meeting increased need for integrated, globally connected healthcare logistics services in Republic of Ireland, where pharma is booming

HPV Vaccine 'Protects Males from Cancers' - Global Report

As a new report shows the human papillomavirus vaccine can also protect men and boys, we take a look at HPV vaccines, and their impact on world health

Tata Consultancy Report Shows AI in Healthcare on Rise

Tata Consultancy Services AI for Business Global Study shows that three-quarters of healthcare leaders are deploying AI to drive innovation and efficiency

McKinsey: Consumers Demand Data-driven Wellness Products

Medical Devices & Pharma

SpaceX Starlink Launch Boost for Indonesia Healthcare

Technology & AI

J&J Targets Supplier Sustainability to Cut Healthcare GHGs

Sustainability