2024-10-07 12:30:47
One million women worldwide and at least 80,000 in Spain have used it between 2002 and 2017 the Essure contraceptive method. At the time, it was presented as a non-surgical alternative to other permanent contraceptive options, such as tubal ligation. As time passed, serious side effects began to be reported which affected many of them, forcing them to cease marketing.
Last Sunday, the program Saved de laSexta gave voice to the women affected by these consequences. A group of 47 of them arrived also impose numerous complaints to the manufacturer, who are still awaiting a final decision from the Supreme Court.
What was Essure and what consequences does it cause?
THE Spanish Association of People Affected by Essure explains that the device in question is a barrier method of contraception; That is, it physically prevents the egg and sperm from meeting and conception occurs. It consists of a small titanium spring, which is inserted into the fallopian tubes to block them through an incisionless procedure called hysteroscopy.
Blockage of the pipes occurs because the device causes tissue growth in the area of placement (fibrosis). This is why in most cases it is considered irreversible; If for any reason you want to remove it, the surgery must be carried out under general anesthesia, with some risk of loss of the tubes or even the uterus.
According to the same source, l main adverse effects that appear to have something to do with Essure use are cramping, bleeding, and nausea during and after surgery; changes in the menstrual cycle, heavy bleeding, allergic reaction to any of the implant materials; perforation of the uterus, migration of the device; endocrine disorders (with consequences such as weight gain, menstrual irregularities or migraines), back and leg pain, digestive pain or pain during sexual intercourse.
The odyssey of the affected women
The device, designed by the Californian company Conceptus Inc, was approved for marketing in the United States in 2002 and in Europe in 2003 by the pharmaceutical company Bayer. At the start, It has been heralded as a safe, non-invasive alternative to procedures such as tubal ligation.
When the first women in Spain began to report symptoms after applying the method, many doctors They failed to see the connection between themselves and Essureas the documentation provided by the manufacturer did not adequately include them, as confirmed in the 2021 ruling. 263/2021 of the Court of First Instance n. 2 of Orihuela. However, as the number of women claiming to suffer from various health problems resulting from the device has increased, a group of affected women created the associated platform Essure-Free and the Association of Essure Affected People in 2015. These organizations brought together, at their peak, nearly 1,500 members.
Over the years, both entities have carried out a series of protests and events in addition to the others civil, criminal and conciliation cases that as many as 47 women have lodged complaints against Bayer, the Ministry of Health, the AEMPS (Spanish Agency for Medicines and Health Products) and the Spanish Society of Gynecology and Obstetrics. Ultimately, all this led the AEMPS to order Bayer’s distributor in Spain in 2017 to cease marketing and withdraw the Essure contraceptive implant from the market. Due to controversy in Europe and the United States, Bayer decided to permanently stop marketing the product at the end of 2018.
In the same year, AEMPS, SEGO, Essure Free Associated Platform and the Ministry of Health presented the Operation guide for a patient carrying the Essure devicethus correcting one of the manufacturer’s errors: the lack of information on how to proceed in case extraction is necessary or major complications occur. The document is mandatory for implementation in all Spanish health centers and hospitals.
Subsequently, in 2021, the Court of First Instance No. 2 of Orihuela issued the aforementioned sentence, in which he declared the product defective and agreed with the appellants. Currently, The matter is in the hands of the Supreme Courtwhich should give you a permanent solution.
References
Spanish Association of People Affected by Essure. Consulted online at https://www.afectadasessure.org/ on October 7, 2024.
Court of First Instance No. 2 of Orihuela, Judgment 263/2021 of 1 September 2021, Rec. 566/2020. Consulted online at on October 7, 2024.
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