Codacons filed a complaint with the public prosecutor of Rome regarding the alleged side effects of the Essure device, a permanent contraceptive system already withdrawn from the market (for commercial reasons) by Bayer last year. The consumer association will provide medico-legal assistance to women who have performed the implant.
Already withdrawn from the market, the permanent contraceptive "Essure" ended up in the sights of Codacons, who presented a complaint to the public prosecutor's office in Rome and made himself available to provide medico-legal assistance to the Italian women who implanted it. It is estimated that there are 7 in all. The action of the consumer association is only the last piece of a flood of controversy and initiatives that has literally invested the device produced by Conceptus Inc., a subsidiary of the pharmaceutical giant Bayer.
The Essure, approved in 2002 in Europe and the United States following scientific studies that have certified its safety, is a minimally invasive and permanent female contraception system, designed as an alternative to surgical interventions that have the same objective (as the ligation of the fallopian tubes under anesthesia). These are two small devices in stainless steel and nickel and titanium alloy that are inserted into the tubes through a catheter passing through the vagina (therefore without abdominal incisions). Once in position, they induce inflammation of the surrounding tissue which thickens, occluding the lumen of the tubes, effectively preventing the possibility of becoming pregnant. In practice, spermatozoa are prevented from reaching the egg.
As indicated, the safety of the device has been supported by scientific investigations that have convinced the American Food and Drug Administration (FDA) and the European authorities to authorize its marketing. Nonetheless, some subsequent investigations and the complaints of many women who performed the implant made the Essure end in a real storm of controversy. Just think that in 2017 the Ministry of Health ordered its recall on the whole national territory. In the same year Bayer decided to withdraw it from the European market for commercial reasons, a decision also extended to the United States in the summer of 2018 (it will be operational at the end of the year). In practice, Essure is no longer available, but being a permanent treatment, hundreds of thousands of women have implanted it in about 20 years.
A 2015 research published in the authoritative British Medical Journal has revealed that the Essure would present a 10 times higher risk of leading to a second (surgical) intervention compared to those who undergo laparoscopic sterilization procedures. It is no coincidence that many women gathered in Facebook groups, blogs and websites (such as the one managed by Erin Brockovich in the USA) to report serious side effects, such as perforation of the tubes and pitching pains, which forced them to undergo a new surgery to remove the Essure. Not to mention the complaints about "minor" effects such as nausea, joint pain, dizziness, loss and even numerous unwanted pregnancies, which would be higher than expected by the statistics. In a 2009 study, Professor Roger D. Smith from the Department of Obstetrics and Gynecology at the University of Michigan found an 11 percent risk of device failure. As indicated, Bayer said it had removed its device from the market for purely commercial reasons, but there are possible class actions on the horizon by women who claim to have suffered damage. The Italian ones now have a very valuable ally in the Codacons.