Essure Permanent Birth Control, Effectiveness and Safety: An Italian 11-Year Survey.

STUDY OBJECTIVE: To describe safety, tolerability, and effectiveness results through a minimum 2-year follow-up of patients who underwent permanent sterilization with the Essure insert. DESIGN: A retrospective multicenter study (Canadian Task Force classification II2). SETTING: Seven general hospitals and 4 clinical teaching centers in Italy. PATIENTS: A total of 1968 women, mean age 39.5 years (range, 23-48 years) who underwent office hysteroscopic sterilization using the Essure insert between April 1, 2003, and December 30, 2014. INTERVENTION: The women underwent office hysteroscopic bilateral Essure insert placement, with satisfactory device location and tube occlusion based on hysterosalpingography or hysterosalpingo-contrast sonography (HyCoSy). MEASUREMENTS AND MAIN RESULTS: Placement rate, successful bilateral tubal occlusion, perioperative adverse events, early postoperative (during the first 3 months of follow-up), and late complications were evaluated. Satisfactory insertion was accomplished in 97.2% of women and, in 4, perforation and 1 expulsion were detected during hysterosalpingography. Three unintended pregnancies occurred before the 3-month confirmation test. Two pregnancies were reported among women relying on the Essure inserts. Postprocedure pain was minimal and brief; in 9 women, pelvic pain became intractable, necessitating removal of the devices via laparoscopy. On telephone interviews, overall satisfaction was rated as "very satisfied" by the majority of women (97.6%), and no long-term adverse events were reported. CONCLUSION: The findings from this extended Italian survey further support the effectiveness, tolerability, and satisfaction of Essure hysteroscopic sterilization when motivated women are selected and well informed of the potential risks of the device. Moreover, the results do not demonstrate an increased incidence of complications and pregnancies associated with long-term Essure use. Patients with a known hypersensitivity to nickel may be less suitable candidates for the Essure insert.

A slowly reabsorbed, echogenic surgical thread provides a long-lasting ultrasound-detectable marker of grafted ovarian tissue.

This communication reports a novel technical solution for the orthotopic transplant of cryostored-thawed ovarian tissue. The described technique was applied to three young women with iatrogenic ovarian failure. An echogenic thread that is reabsorbed after 6 months was used to fasten the thawed ovarian small fragments before grafting them onto the atrophic ovary. This technical solution made it possible to avoid the loss of small tissue pieces during laparoscopic grafting as well as to precisely localize the grafted tissue by transvaginal ultrasound during the following months. The precise localization of the grafted tissue was particularly helpful when its revascularization and functional recovery were followed up using, respectively, colour Doppler and transvaginal follicle growth examination. In conclusion, the use of a slowly reabsorbed, ultrasound-detectable surgical thread as an ultrasound-detectable marker able to improve the localization of the exact site at which ovarian tissue was grafted is proposed.

Laparoscopic sacropexy and obstructed defecation syndrome: an anatomoclinical study.

INTRODUCTION AND HYPOTHESIS: Laparoscopic sacropexy (LSP) is associated with obstructed defecation syndrome (ODS) in 10-50% of cases. An anatomoclinical study was carried out to investigate whether there is any correlation between iatrogenic denervation during LSP and ODS. METHODS: Five female cadavers were dissected to identify possible sites of nerve injury during LSP. Subsequently, the videos of 18 LSP were blindly reviewed to assess the location of sacral dissection and tacks, the position and depth of the peritoneal tunnel, and another 4 variables. An anatomical triangle was defined on the right lumbosacral spine so as to clearly describe the sites of the surgical variables, which were then statistically correlated with the patients' postoperative outcome. RESULTS: The only variable associated with postsurgical ODS was dissection in the 90° angle of the anatomical triangle, where the superior hypogastric plexus was observed in all cadavers. CONCLUSIONS: Medial and midline dissection over the sacral promontory might be associated with postoperative ODS.

Sorafenib inhibits growth, migration, and angiogenic potential of ectopic endometrial mesenchymal stem cells derived from patients with endometriosis.

OBJECTIVE: To characterize the proliferation, migration, and angiogenic properties of mesenchymal stem cells (MSC) from ectopic and eutopic endometrial tissue and to investigate the effect of the tyrosine kinase inhibitor sorafenib. DESIGN: In vitro studies. SETTING: University hospital and research center. PATIENT(S): Patients receiving surgical treatment of endometriosis (n = 4) and control patients without endometriosis (n = 2) undergoing surgery for benign gynecologic diseases. INTERVENTION(S): Mesenchymal stem cell lines were isolated from ectopic and eutopic endometrial tissue, and sorafenib was administered to them. MAIN OUTCOME MEASURE(S): Proliferation, migration, invasion of endometrial MSC, and expression of ezrin, vascular endothelial growth factor, and hypoxia-inducible factor-1α (HIF-1α) were measured. RESULT(S): Ectopic endometrial MSC from patients with endometriosis showed a higher proliferation, migration, and angiogenic ability than eutopic MSC from the same patient or control MSC from patients without endometriosis. Sorafenib reduced the proliferation, motility, ezrin phosphorylation, vascular endothelial growth factor release, and HIF-1α expression of ectopic MSC. CONCLUSION(S): The increased proliferative, migratory, and angiogenic phenotype of ectopic MSC may be reverted by treatment with sorafenib. Targeting of the MSC population involved in sustaining the ectopic lesions might be useful in eradicating endometriotic implants.

Laparoscopic stripping of endometriomas negatively affects ovarian follicular reserve even if performed by experienced surgeons.

In order to estimate the impact of laparoscopic stripping of endometriomas on the ovarian follicular reserve, 43 normo-ovulatory women were studied by endocrine (anti-Müllerian hormone (AMH), FSH, LH, inhibin B, oestradiol) and ultrasonographic (antral follicle count (AFC)) methods before surgery, and 3 and 9 months after surgery. The operation was performed by experienced laparoscopists, particularly aware of the need to avoid damaging the healthy part of the ovary. Serum AMH concentrations significantly decreased after the operation (1.4±0.2 ng/ml after 3 months and 1.3±0.3 ng/ml after 9 months versus 3.0±0.4 ng/ml before surgery; P<0.0001), whereas basal FSH, LH, oestradiol and inhibin B concentrations remained unchanged. The volume of the operated ovary significantly diminished after surgery (P<0.0001), whereas the AFC was not significantly altered. Overall, the data show that laparoscopic stripping of endometriomas reduces ovarian reserve. The significant decrease of AMH after surgery confirms that part of the healthy ovarian pericapsular tissue, containing primordial and preantral follicles, is removed or damaged despite all the surgical efforts to be atraumatic. This must be carefully considered when laparoscopic cystectomy surgery is scheduled for patients with no relevant symptoms besides infertility or with already small ovarian reserve.

Diagnosis of pelvic endometriosis with use of macroscopic versus histologic findings.

OBJECTIVE: To obtain histologic confirmation of lesions suspected of endometriosis at laparoscopy. DESIGN: Prospective clinical study. SETTING: Patients in an academic hospital. PATIENT(S): Women of reproductive age who complained of chronic pelvic pain. INTERVENTION(S): A total of 122 biopsies were obtained from 54 patients undergoing laparoscopy, after exclusion of other potential causes of pelvic pain. MAIN OUTCOME MEASURE(S): Lack of consistency between laparoscopic and histologic diagnosis of endometriosis, in particular for minimal/mild stages. RESULTS: Endometriosis was confirmed by histology in 54% of the excised lesions. Diagnosis was more often confirmed among classic lesions than for all atypical lesions considered together. The histologic diagnosis of fibrosis was the most common among those biopsies, which lacked the presence of endometriosis. The revised American Fertility Association (AFS) scores before and after histologic confirmation differed significantly. In particular, 20 patients in either revised AFS class I or II were down-graded to stage 0. No single anatomical site turned out to be particularly prone to misdiagnosis at laparoscopy, in comparison to the other sites. CONCLUSION(S): These results confirm the need of histologic confirmation to obtain a diagnosis of endometriosis. However, the clinical impact of such findings remains a matter of debate.