The Ministry of Health has made public this Tuesday an action guide for those affected by the malfunction of Essure contraceptive implant, marketed by Bayer until its ban last year, which includes the guidelines for its extraction. It is a demand of patients and is prepared by the Spanish Society of Gynecology and Obstetrics (SEGO) at the request of the Spanish Agency for Medicines and Health Products (AEMPS, dependent on Health).
On September 14, the Essure Free Platform had already met with AEMPS and SEGO to contribute to its drafting. Minister Maria Luisa Carcedo has presented the protocol in a meeting with that organization and with the Association of Affected by Essure. It is aimed at medical and professional centers, Gynecology and Primary Care.
The guide has the objectives of "providing adequate information and care" to all users that have adverse effects; "offer the maximum security guarantees" in the procedure of removal of the device as well as its follow-up in subsequent revisions; and guarantee "that patients receive adequate information related to the intervention".
There are 80,000 women carriers of the Essure in Spain, which Bayer marketed, of which the AEMPS reports 962 cases of complications, but the associations estimate some 1700 although "it is very difficult to know, every day there are women with symptoms and there are no records".
Susana Vázquez, from the Plataforma Libres de Essure and present at the meeting with Carcedo, values it as positive: "We have been asking for it for a long time, in hospitals and medical centers we do not know what the Essure is, they did not pay attention to us". She was told for example that her symptoms were due to her being "menopausal", aged 36. Among the side effects described "stomach inflammation, metal allergy, infections, hemorrhage, a lot of pain". In some cases complete sterilization is carried out when operating and the uterus and tubes are removed.
The next step according to Vázquez is "to meet with Bayer, but at the moment there is no planned meeting". Last July, the pharmaceutical company announced that it was withdrawing the Essure from the last country where it was still marketed, the United States. The company faces thousands of lawsuits all over the world from women who have suffered the consequences of that contraceptive, also in Spain, where the requests for compensation are "individual", specified Vázquez.
Angelica del Valle, of the Association of Affected by the Essure, also receives the guide well although at the end of the meeting she recognized that she still has to "review" it in a concrete way to see if her more specific demands are met. Highlights among these points, in addition to the training of doctors so that "family doctors knew what it was and knew to recognize their symptoms", allergy tests or medical monitoring after the removal of the implant.
Both she and Vázquez stressed the importance of radiographs – also ultrasounds and CT scans – before the intervention and also before leaving the operating room. All this to "see if fragments remain and a second operation is avoided," as in many cases. The document includes this type of evidence at different points in the process, and specifies that an x-ray and / or ultrasound be performed "if the doctor is not completely sure of the complete removal of the implant when inspecting the removed implant" in cases of laparoscopic extraction. when it is located in the fallopian tubes. The Ministry also emphasizes that the guide includes "performing CT scans and revisions if the device is not detected by transvaginal ultrasound and abdominal radiography."
According to the minister, the objective is that the guide "has the widest possible dissemination among specialists in Gynecology and Primary Care so that if a woman reports a complication she receives the appropriate attention and can be evaluated for referral to the specialist".
The National Court rejected the complaint
Del Valle has assessed that this guide is a "revision" of the one that was carried out in 2016, from which SEGO demanded changes "necessary" and with those that had insisted on the previous government and the autonomous communities. Bayer began to market Essure at the beginning of 2000 and in 2002 it was implanted to the first six women in the Reina Sofía Hospital in Córdoba, a city in which 10% of those affected are concentrated.
The method consisted in the implantation of two small metal springs-nickel and titanium-with polyethylene terephthalate (PET) fibers in the fallopian tubes through the uterus. In three months it generates fibrosis in the tubes, which adhere to the spring by contact with the PET and prevent the passage of sperm. The method is irreversible, so it was recommended for women with children who had the clear intention not to become pregnant again.
In July of this summer, a group of Spanish women tried to open the criminal court against Bayer with a lawsuit for the crime of injury and fraud which also included SEGO and AEMPS. The National Court refused to investigate for not having competences, and the Spanish Association of Affected by Essure presented a resource.