August 7, 2017
The marketing of Essure sterilization implants, manufactured by the Bayer laboratory, is suspended in the European Union until November 2, 2017, due to the increase in reports of adverse reactions.
Essure sterilization implants withdrawn from sales for 3 months
Essure female sterilization implants, manufactured by giant Bayer, are an alternative to tubal ligation, performed under general anesthesia. 240,000 women in France use this contraceptive. But this device has been questioned by some women because of adverse effects and has been the subject of a class action lawsuit against Bayer.
The certification body chosen by the manufacturer Bayer to review its dossier, the National Standards Authority of Ireland (NSAI), has decided not to renew the certificate of marketing for the implant in the European Union, which expired on 3 last August, ” until all outstanding questions are answered “, According to Bayer. Their marketing was suspended in the European Union for a period of 3 months, i.e. until November 2, 2017..
Sometimes serious side effects involved
ANSM, the National Medicines Safety Agency, also asks the Bayer laboratory ” recall products in stock “In French health establishments and recommends” as a precaution not to implant any more This contraceptive for now. According to the ANSM, over 1,000 women have experienced device malfunction or adverse reactions, between early 2003 and February 2017.
The ANSM specifies, however, that the suspension of implants is not not likely to call into question at this stage the reassuring conclusions made in the spring by a committee of independent experts called upon by the ANSM. This committee nevertheless advised to better inform women considering this method of contraception on the risks of “ possibility of failure “. Case to be continued …
Aurélie Giraud
Take the test: Implant, pill, IUD… What do you know about hormonal contraception?
