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Ultrasound-Guided Intervention in Assisted Reproductive Technology
Published in Arianna D'Angelo, Nazar N. Amso, Ultrasound in Assisted Reproduction and Early Pregnancy, 2020
Proximal occlusion of the fallopian tube isolates the hydrosalpingeal fluid from the uterine cavity and is an alternative to salpingectomy. It is technically faster and easier to perform and theoretically does not compromise the ovarian blood supply [6]. It can be done laparoscopically, or more recently, hysteroscopic occlusion has been introduced with the use of Essure with promising results [17].
Female sterilisation
Published in Suzanne Everett, Handbook of Contraception and Sexual Health, 2020
Using hysteroscope a guide wire places a flexible microinsert into each fallopian tube. The microinsert causes scar tissue to form and occlusion of the fallopian tube; this process can take three months, so alternative contraception is advised for three months following the procedure. The procedure is performed under local anaesthetic and takes ten minutes by a specially trained doctor. Occlusion of the fallopian tubes should be confirmed by ultrasound or X-ray (some women may need a hysterosalpingogram) before this method can be relied on to prevent conception (NICE, 2009). Essure is a small titanium metal coil that can be fitted this way and available in the UK (Figure 15.1).
Current and Future Trends:
Published in Miner Gary, Miner Linda, Dean Darrell, Healthcare’s Out Sick – Predicting A Cure – Solutions That Work !!!!, 2019
Miner Gary, Miner Linda, Dean Darrell
Money can be made both by developers bringing out new medication and then by law firms suing companies after further problems with the medications develop. How do we know what to take and what to think? All medications have adverse events, and all those known at the end of the clinical trials are mentioned in the medication inserts. How do we know, as patients, if the medication is safe for us to take? Device Example: One such example is a contraceptive device. The FDA in 2016 issued a “black box” warning on the implantable device in order to encourage more discussion between doctors and women who are considering the device (https://www.healthline.com/health-news/fda-warning-essure-contraceptive-device#1), due to women having device migration problems, resultant hysterectomies, pain, perforation of organs, and so on (Sara Joan Swann, 2016, https://www.healthline.com/health-news/fda-warning-essure-contraceptive-device#1).
Comparison of the ongoing pregnancy rate of in vitro fertilisation following tubal occlusion by microcoil placement versus laparoscopic tubal ligation for hydrosalpinges
Published in Human Fertility, 2022
Zhi Qin Chen, Ernest Hung Yu Ng, Miao Xin Chen, Mei Zhao, Jia Ping Pan, Hong Chen, Xiao Ming Teng
Since 2005, several case reports have described the treatment of hydrosalpinges by placing Essure under hysteroscopy prior to IVF in women who had high surgical risks because of dense pelvic adhesions (Galen, Khan, & Richter, 2011; Hitkari, Singh, Shapiro, & Leyland, 2007; Matorras et al., 2013; Mijatovic, Veersema, Emanuel, Schats, & Hompes, 2010; Ozgur, Bulut, Berkkanoglu, Coetzee, & Kaya, 2014; Rosenfield, Stones, Coates, Matteri, & Hesla, 2005; Thebault, Broux, Moy, & Vialard, 2012). A meta-analysis demonstrated that the Essure placement was feasible in these women and resulted in a 39% pregnancy rate, and 28% live birth rate per transfer (P. Arora, Arora, & Cahill, 2014). One randomised trial demonstrated that hysteroscopic tubal occlusion with Essure device (26.2%; 11/42) was associated with a significantly lower ongoing pregnancy rate following IVF compared to laparoscopic salpingectomy (Dreyer et al., 2016).
Reducing FDA regulations for medical devices: cutting red tape or putting patients’ lives at risk?
Published in Expert Review of Medical Devices, 2018
Timothy M. Janetos, Rebecca S. Xu, Jessica R. Walter, Shuai Xu
For high-risk devices, the FDA is mandated to require the ‘least burdensome’ level of clinical evidence for PMA approval. Essure, a Class III device for permanent female sterilization, was approved in 2002 based on a nonrandomized, single-arm prospective study [11]. The device has since been implanted in hundreds of thousands of women worldwide. In 2016, the FDA responded to a surge in voluntary patient-reported adverse events by requiring a black-box warning and mandating a large post-approval study of 2800 women. The manufacturer (Bayer) has voluntarily halted sales of Essure as of 2018. Indeed, across multiple specialties, high-risk devices are often approved based on clinical data that lack power or comparator arms, or have short follow-up times [12–15]. Ultimately, there is no replacement for rigorous, well-designed clinical studies with well-validated primary clinical endpoints to ensure device safety and efficacy.
Safety and patients’ satisfaction after hysteroscopic sterilisation
Published in Journal of Obstetrics and Gynaecology, 2018
María Nieves Cabezas-Palacios, Antonio Jiménez-Caraballo, Sara Tato-Varela, Alicia Sánchez-Sánchez, Carlos Romero-Díaz, Antonio Carrasco-Gallego, Ignacio Zapardiel-Gutiérrez
The prospective study was conducted in the Hysteroscopy Unit of ‘Virgen de la Macarena’ University Hospital of Seville between April 2007 and December 2015 after Institutional Review Board (IRB) approval was obtained. A total of 1068 women were referred to this unit for the insertion of the Essure® device. The exclusion criteria were a delivery or miscarriage in the previous 6 weeks, presence of abnormal uterine bleeding and suspected active pelvic infection. The patients received information about different contraceptive methods and were provided a written informed consent about the Essure® device and about their participation in this study. The Essure® was inserted in follicular phase of the cycle or at any given time if the patient used a hormonal contraceptive, after warning her not to interrupt its use.