Marketing of Essure sterilisation implants halted in Europe



On Monday, the pharmaceutical company, Bayer, announced that Essure[1] sterilisation implants will no longer be marketed in Europe. The device, which has been "challenged for alleged adverse reactions", has been withdrawn from the European market "for commercial reasons". A similar temporary decision was taken in August concerning a certification issue (see Essure sterilisation implants: marketing suspended for three months; Essure: experts believe that "there is no need to change the legislation).

 

Furthermore, CE labelling for Essure in Iceland, Liechtenstein and Norway will not be continued. However, the implants will still be marketed in the United States where the FDA (Food and Drug Administration) deemed that the benefit/risk ratio with this method was "favourable".

 

The laboratory explained that, “over the last few months, an unfavourable climate has emerged concerning the prescription [of Essure] leading to a constant decline in demand in France”. This scenario has intensified since August. However, the Resist association representing female patients who have experienced adverse reactions with the device are not "satisfied with the economic reasons put forward": "We are still convinced that this decision is not unrelated to other reasons which directly involve product safety". Moreover, "numerous women [2] (…) are still using this device", and "need explanations now". Despite its initial "victory", the association will not stop there and is "disappointed that the authorities have not exercised caution" (see Essure: group legal action against Bayer scheduled for September).

 

[1] sterilisation (or "permanent birth control") with the Essure implant - a method essentially recommended in France in recent years - involves the insertion of a small metallic coil into the fallopian tubes where it prevents sperm from reaching the egg by the formation of scar tissue".

[2] According to Bayer, approximately 1 million Essure medical devices have been sold worldwide since 2001. In France, between 2003 and early February 2017, 1,087 women experienced adverse reactions or the device failed to function, according to the Agence nationale de sécurité du médicament (French National Agency for Medicines and Health Products Safety). 


Sources: 

AFP (18/09/2017)