Essure sterilisation implants withdrawn from the US market



The pharmaceutical group, Bayer, has announced the withdrawal of its contraceptive implants, Essure, from the market amidst accusations of significant side effects. These small permanent sterilisation implants in the form of coils were considered an alternative to tubal ligation, especially because they could be implanted without a general anaesthetic.

 

In September 2017, Essure was withdrawn from the market in every country except the United States. The implant was linked to numerous side effects: gynaecological problems, bleeding, pain, considerable fatigue, allergic reaction and depression, etc.

 

In France, ANSM[1] issued an announcement last year, stating that the coil "should no longer be implanted, as a precautionary measure" and "recalling all products currently in stock".

 

In April 2018, the US Food and Drug Administration (FDA) instructed Bayer to restrict the sale of this device to practitioners monitoring their patients for the high risk of side effects.

 

The Bayer multinational company has just announced its decision. In a press release, it explained that, due to "the fall in sales in recent years", the group would no longer be selling its Essure contraceptive implants in the US.

 

For further reading:

Marketing of Essure sterilisation implants halted in Europe

New restrictions on Essure sterilisation device in the United States, but no recall

 

[1] French National Agency for the Safety of Medicines.


Sources: 

Libération (24/07/2018), Journalisme et Santé publique, Jean-Yves Nau (21/07/2018)