Federal Register: Labeling for Permanent Hysteroscopically-Placed Tubal Implants Intended for Sterilization, Draft Guidance for Industry and Food and Drug Administration Staff; Availability

The FDA is announcing the availability of the draft guidance entitled "Labeling for Permanent Hysteroscopically-Placed Tubal Implants Intended for Sterilization." This draft guidance addresses the inclusion of a boxed warning and a patient decision...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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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
ConclusionThe present study suggests that routine antibiotic prophylaxis is not necessary before hysteroscopy because the prevalence of infections following in-office hysteroscopy is low (0.06%).
Source: Journal of Minimally Invasive Gynecology - Category: OBGYN Source Type: research
ConclusionThe present study suggests that routine antibiotic prophylaxis is not necessary prior to hysteroscopy because the prevalence of infections following in-office hysteroscopy is low (.06%).
Source: Journal of Minimally Invasive Gynecology - Category: OBGYN Source Type: research
CONCLUSION: This case series suggests that laparoscopic salpingectomy for removal of Essure inserts is safe and feasible. We acknowledge that the numbers were small. However, consistent use of a laparoscopic approach in these eight patients indicates that this procedure is a feasible and suitable alternative to hysterectomy. PMID: 29842838 [PubMed - as supplied by publisher]
Source: The European Journal of Contraception and Reproductive Health Care - Category: Reproduction Medicine Authors: Tags: Eur J Contracept Reprod Health Care Source Type: research
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