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Essure was a device for female sterilization. It is a metal coil which when placed into each fallopian tube induces fibrosis and blockage. Essure was designed as an alternative to tubal ligation. However, it was recalled by Bayer in 2018, and the device is no longer sold due to complications secondary to its implantation. The company has reported that several patients implanted with the Essure System for Permanent Birth Control have experienced and/or reported adverse effects, including: perforation of the uterus and/or fallopian tubes, identification of inserts in the abdominal or pelvic cavity, persistent pain, and suspected allergic or hypersensitivity reaction. Although designed to remain in place for a lifetime, it was approved based on short-term safety studies. Of the 745 women with

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  • Obstrucció tubàrica definitiva (ca)
  • Essure (en)
  • Essure (es)
  • Essure (fr)
  • Essure (it)
  • Essure (nl)
  • Essure (pt)
  • Essure (sv)
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  • Essure, método Essure o de obstrucción tubárica es un método anticonceptivo permanente, sin hormonas, basado en la inserción de un dispositivo intratubárico sin incisiones quirúrgicas, a través de la vagina de una mujer.​ El dispositivo produce una inflamación localizada en la trompa de tal manera que ocluye el paso de espermatozoides y la naturaleza de la inflamación hace que el procedimiento sea irreversible.​ Debido a las polémicas sobre los efectos secundarios adversos, Bayer decidió detener la comercialización del producto para finales del 2018.​ (es)
  • Essure é um procedimento de esterilização permanente para mulheres desenvolvido pela e aprovado para uso nos Estados Unidos em 4 de Novembro de 2002. (pt)
  • Essure är en permanent preventivmetod för kvinnor, som har utvecklats av Conceptus Inc, och metoden har varit CE-godkänd i Europa sedan 2001. Produkten förbjöds i Sverige i början av 2019. (sv)
  • L'obstrucció tubàrica definitiva, mètode Essure o dispositiu Essure és un mètode anticonceptiu d'esterilització, per tant permanent, femení, que es du a terme mitjançant una intervenció quirúrgica a la qual s'introdueixen dos dispositius d'uns quatre centímetres de llarg, un a cadascuna de les trompes de Fal·lopi, de manera que les obstrueixen definitivament. Això fa que augmenti el gruix del teixit de les trompes fins a obstruir-les de tal manera que els espermatozoides es veuen impossibilitats de passar-hi per viatjar cap als òvuls. Cal que sigui un cirurgià professional qui introdueixi el dispositiu per via vaginal en cada una de les trompes. (ca)
  • Essure was a device for female sterilization. It is a metal coil which when placed into each fallopian tube induces fibrosis and blockage. Essure was designed as an alternative to tubal ligation. However, it was recalled by Bayer in 2018, and the device is no longer sold due to complications secondary to its implantation. The company has reported that several patients implanted with the Essure System for Permanent Birth Control have experienced and/or reported adverse effects, including: perforation of the uterus and/or fallopian tubes, identification of inserts in the abdominal or pelvic cavity, persistent pain, and suspected allergic or hypersensitivity reaction. Although designed to remain in place for a lifetime, it was approved based on short-term safety studies. Of the 745 women with (en)
  • Essure est un dispositif médical implantable de contraception définitive pour les femmes, développé par la société française Conceptus et commercialisé en France entre 2002 et 2013, puis par la firme Bayer, jusqu'en août 2017 (date de la suspension du marquage CE). Il s'agit d'une méthode de stérilisation tubaire définitive posée par voie hystéroscopique. Le 3 août 2017, la suspension du marquage CE entraîne la perte de l'Autorisation de mise sur le marché et la pose de l'implant immédiatement. (fr)
  • Il sistema di contraccezione Essure era una procedura mini-invasiva di sterilizzazione femminile sviluppata dalla Conceptus Inc., un'azienda sussidiaria della Bayer. La procedura consiste dell'impianto di due micro-inserti che vengono poi ricoperti di tessuto fibrotico, bloccando il passaggio degli spermatozoi all'interno delle tube di falloppio ed impedendo l'inseminazione. Il dispositivo è stato approvato in Europa e negli Stati Uniti d'America nel novembre 2002. In Italia la procedura è rimborsata al 100% dal Servizio Sanitario Nazionale. (it)
  • Essure is een permanente sterilisatiemethode bij vrouwen. Het heeft de CE-markering in Europa sinds 2001 en wordt in de handel gebracht door een dochteronderneming van Bayer, maar is door de farmaceut in veel landen – waaronder Nederland – van de markt gehaald, aldaar aanvankelijk gemotiveerd "vanwege de teruglopende belangstelling". Later, in 2017, zou het 'product'– op de Verenigde Staten na – in alle ander landen door Bayer geheel van de markt worden gehaald. In de Verenigde Staten werd de methode goedgekeurd door de FDA op 4 november 2002. Het werd ontwikkeld als een alternatief voor het afbinden van de eileiders, de standaardprocedure voor chirurgische sterilisatie. Het afbinden is een vrij grote ingreep die anesthesie vereist en door een chirurg wordt uitgevoerd. Essure daarentegen k (nl)
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  • Essure (en)
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  • http://commons.wikimedia.org/wiki/Special:FilePath/Essure_Permanent_Birth_Control_device.jpg
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  • L'obstrucció tubàrica definitiva, mètode Essure o dispositiu Essure és un mètode anticonceptiu d'esterilització, per tant permanent, femení, que es du a terme mitjançant una intervenció quirúrgica a la qual s'introdueixen dos dispositius d'uns quatre centímetres de llarg, un a cadascuna de les trompes de Fal·lopi, de manera que les obstrueixen definitivament. Això fa que augmenti el gruix del teixit de les trompes fins a obstruir-les de tal manera que els espermatozoides es veuen impossibilitats de passar-hi per viatjar cap als òvuls. Cal que sigui un cirurgià professional qui introdueixi el dispositiu per via vaginal en cada una de les trompes. El dispositius produeixen una inflamació localitzada de les trompes de tal manera que es clou el pas dels espermatozoides, i la naturalesa de la inflamació fa que el procediment, igual que ocorre amb la lligadura de trompes, sigui irreversible: una dona sotmesa a aquesta mena de cirurgia no podrà mai més engendrar fills, encara que més endavant canvïi d'opinió i en vulgui. La seva eficàcia és del 99,8%, és a dir que de cada cent dones amb lligadura de trompes, hi ha 0,2 embarassos en un any. Hi ha milers de casos a tot el món de dones que després de l'implant sofreixen múltiples problemes de salut: forts dolors abdominals, mals de cap severs, sagnats... El cos, en molts d'aquests casos, reacciona de forma autoimmune, rebutjant l'implant. I l'extracció de l'implant és molt complex, ja que en molts casos la molla es trenca durant el procediment quirúrgic. Es pot trobar més informació sobre aquests problemes al documental de Netflix "El lado oscuro del bisturí" (2018). (ca)
  • Essure was a device for female sterilization. It is a metal coil which when placed into each fallopian tube induces fibrosis and blockage. Essure was designed as an alternative to tubal ligation. However, it was recalled by Bayer in 2018, and the device is no longer sold due to complications secondary to its implantation. The company has reported that several patients implanted with the Essure System for Permanent Birth Control have experienced and/or reported adverse effects, including: perforation of the uterus and/or fallopian tubes, identification of inserts in the abdominal or pelvic cavity, persistent pain, and suspected allergic or hypersensitivity reaction. Although designed to remain in place for a lifetime, it was approved based on short-term safety studies. Of the 745 women with implants in the original premarket studies, 92% were followed up at one year, and 25% for two years, for safety outcomes. A 2009 review concluded that Essure appeared safe and effective based on short-term studies, that it was less invasive and could be cheaper than laparoscopic bilateral tubal ligation. About 750,000 women have received the device worldwide. Initial trials found about 4% of people had tubal perforation, expulsion, or misplacement of the device at the time of the procedure. Since 2013, the product has been controversial, with thousands of women reporting severe side effects leading to surgical extraction. Rates of repeat surgery in the first year were ten times greater with Essure than with tubal ligation. Campaigner Erin Brockovich has been hosting a website where women can share their stories after having the procedure. As of 2015 many adverse events, including tubal perforations, intractable pain and bleeding leading to hysterectomies, possible device-related deaths, and hundreds of unintended pregnancies occurred, according to the US FDA adverse events database and other studies. It was developed by Conceptus Inc. and approved for use in the United States in 2002. Conceptus was acquired by Bayer AG of Germany in June 2013. In 2017, the CE marking in the European Union, and thus the commercial license for Essure was suspended for at least three months. Authorities in France and Ukraine recalled the implants, and the manufacturer withdrew the product voluntarily in Canada, the UK, Finland, and the Netherlands. In April 2018, the FDA restricted sale and use of Essure which resulted in a 70% decrease in sales. In July 2018 Bayer announced the halt of sales in the U.S. by the end of 2018. The device is featured in the 2018 Netflix documentary The Bleeding Edge. (en)
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