Federal Register: Labeling for Permanent Hysteroscopically-Placed Tubal Implants Intended for Sterilization, Draft Guidance for Industry and Food and Drug Administration Staff; Availability

The FDA is announcing the availability of the draft guidance entitled "Labeling for Permanent Hysteroscopically-Placed Tubal Implants Intended for Sterilization." This draft guidance addresses the inclusion of a boxed warning and a patient decision...
Source: Food and Drug Adminstration (FDA): CDRHNew - Category: Medical Equipment Source Type: news

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Over the past several years, the commercial status of the Essure Coil, a permanent hysteroscopic sterilization device, has switched from assured to pressured. In July 2018, the device's manufacturer, Bayer Healthcare, announced that it would halt sales in the United States (the last country in which the device has been offered) by year's end. This decision was prompted by years of declining sales revenue and came after thousands of women filed complaints of adverse events, including device expulsion, uterine and tubal perforation, intractable pelvic pain, and bleeding necessitating hysterectomy, device-related death, unint...
Source: Fertility and Sterility - Category: Reproduction Medicine Authors: Tags: Inklings Source Type: research
DiscussionClinicians and their patients seeking permanent contraception have several options, yet we were unable to find a systematic review or decision support tool helping to facilitate shared decision-making. This systematic review can inform patients, providers, and health policy decision-makers about which options of permanent contraception will meet different reproductive goals according to various outcomes, which can lead to better health, social, economic, and mental well-being for reproductive age women. This can also aid our understanding of resulting costs to the health care system.Systematic review registration...
Source: Systematic Reviews - Category: International Medicine & Public Health Source Type: research
Conclusion: Essure reversal is a feasible technique for removing the device and restoring tubal patency; however, more data are needed on pregnancy outcomes following this novel procedure. PMID: 30846897 [PubMed - in process]
Source: JSLS : Journal of the Society of Laparoendoscopic Surgeons - Category: Surgery Tags: JSLS Source Type: research
TUESDAY, Jan. 22, 2019 -- Hysteroscopic sterilization is associated with an increased risk for additional tubal intervention within seven years compared with laparoscopic sterilization, according to a study published online Jan. 8 in Obstetrics...
Source: Drugs.com - Pharma News - Category: Pharmaceuticals Source Type: news
CONCLUSION: Patients undergoing hysteroscopic sterilization have a higher risk of receiving an additional tubal resection or ligation than those undergoing laparoscopic sterilization, particularly within the first year of the index procedure. There is no difference in undergoing a subsequent hysterectomy between the two groups. With limited evidence of outcomes after hysteroscopic sterilization beyond 7 years and existing reports of removals years after initial implantations, continuous monitoring of long-term outcomes for women who received the device is warranted. PMID: 30633141 [PubMed - as supplied by publisher]
Source: Obstetrics and Gynecology - Category: OBGYN Authors: Tags: Obstet Gynecol Source Type: research
ConclusionTo conclude, preoperative embolization of the arteriovenous shunt improves surgery, avoiding excessive bleeding and permitting easier radical hysterectomy for deep pelvic endometriosis. Similar cases have been published [1], but to our knowledge, our video is the first regarding this subject. It appears that embolization can fail, but hysterectomy remains the gold standard treatment [2].
Source: Journal of Minimally Invasive Gynecology - Category: OBGYN Source Type: research
Publication date: Available online 11 November 2018Source: Journal of Minimally Invasive GynecologyAuthor(s): Marine Godfroy, Patrice Lopes, Claudine Le VaillantABSTRACTStudy ObjectiveTo show the feasibility of 2-dimensional (2D) ultrasound (US) imaging compared with 3-dimensional (3D) US to identify the location of implants and assess if the classification developed by Simorre et al in 2016 was applicable to the 2 types of US imaging (i.e., 2D and 3D).DesignA prospective study (Canadian Task Force classification II-2).SettingThe department of obstetrics and gynecology in a teaching hospital.PatientsOne hundred fifty patie...
Source: Journal of Minimally Invasive Gynecology - Category: OBGYN Source Type: research
Publication date: Available online 11 November 2018Source: Journal of Minimally Invasive GynecologyAuthor(s): Marine Godfroy, Patrice Lopes, Claudine Le VaillantABSTRACTStudy objectiveTo demonstrate the feasibility of 2-dimensional ultrasound (2DUS) imaging compared to 3-dimensionnal ultrasound (3DUS) to identify the location of implants and assess if the classification developed by Simorre et al described in 2016 was applicable to the 2 types of ultrasound imaging (2D and 3D).DesignA prospective study (Canadian Task Force classification II-2).SettingDepartment of obstetrics and gynecology in a teaching hospital.PatientsOn...
Source: Journal of Minimally Invasive Gynecology - Category: OBGYN Source Type: research
(Abstracted from Contraception 2018;97:428–433) The second most common form of contraception among reproductive-aged women in the United States is female sterilization, although trends suggest declining rates. Methods available for interval sterilization include laparoscopic tubal ligation (TL) and hysteroscopic sterilization (HS).
Source: Obstetrical and Gynecological Survey - Category: OBGYN Tags: GYNECOLOGY: CONTRACEPTION Source Type: research
Objective: To evaluate whether or not hysteroscopic sterilization with endometrial ablation compared to those women who have undergone endometrial ablation and traditional bilateral tubal ligation have a lower likelihood of having post ablation tubal sterilization syndrome (PATSS).
Source: The Journal of Minimally Invasive Gynecology - Category: OBGYN Authors: Source Type: research
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