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1.
J Gynecol Obstet Hum Reprod ; 50(3): 101939, 2021 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-33049363

RESUMO

OBJECTIVES: To evaluate patients' satisfaction and evolution of pre-operative symptoms at 6 months following laparoscopic cornuectomy for hysteroscopic sterilization implants removal. MATERIAL AND METHODS: Retrospective study including all patients undergoing laparoscopic cornuectomy for implants removal in a tertiary care setting from January 2017 to October 2018. All women suffered from persistent and treatment-resistant gynecologic and non-gynecologic complaints since sterilization procedure. Patents' satisfaction was evaluated with the PGI-I questionnaire at 2 and 6 months following surgery. RESULTS: Overall, 104 patients were enrolled. Main symptoms comprised asthenia (n = 80), chronic pelvic pain (n = 80), arthralgia (n = 70), abnormal uterine bleeding (n = 42) and headache (n = 40). Cornuectomy was feasible in all cases and led to complete devices removal in 101 women. Mean length of stay was 1.8 days, while outpatient management was feasible in 45.2 % of cases. One grade 3 complication occurred along the study period (hemoperitoneum requiring reoperation). Surgery was associated with a significant decrease in symptom occurrence, except for alopecia and weight loss. Patients' satisfaction was high: 91 % at 2 months and 97.6 % at 6 months reported an improvement in their health status compared to baseline situation. Satisfaction regarding each symptom was consistent with overall assessment, with most patients reporting significant improvement at both 2 and 6 months. CONCLUSION: Laparoscopic cornuectomy is feasible and associated with high mid-term satisfaction in patients suffering from adverse effects attributed to hysteroscopic sterilization implants.


Assuntos
Histerectomia/métodos , Laparoscopia/métodos , Satisfação do Paciente , Esterilização Tubária/efeitos adversos , Esterilização Tubária/instrumentação , Útero/cirurgia , Adulto , Artralgia/etiologia , Artralgia/cirurgia , Astenia/etiologia , Astenia/cirurgia , Feminino , Humanos , Histeroscopia , Pessoa de Meia-Idade , Dor Pélvica/etiologia , Dor Pélvica/cirurgia , Estudos Retrospectivos , Esterilização Tubária/métodos
2.
J Gynecol Obstet Hum Reprod ; 50(2): 101772, 2021 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-32442658

RESUMO

INTRODUCTION: Increasing reports of adverse effects have raised concerns about the Essure hysteroscopic sterilization method. Women suffering alleged complications of the Essure device often seek surgical removal. This study evaluated the quality of life (QoL) and postoperative outcomes in women undergoing Essure removal. MATERIAL AND METHODS: This observational case series included 95 women. Removal was performed by laparoscopic salpingectomy-cornuectomy, or hysterectomy with bilateral salpingectomy. QoL was assessed preoperatively and three months postoperatively by SF-36 questionnaires [correlated physical health score (PCS) and mental health scores (MCS)]. Symptoms evolution was collected at three months, and complications at one month. RESULTS: Sixty-four laparoscopic salpingectomy-cornuectomies, 33 laparoscopic hysterectomies, and eight vaginal hysterectomies were performed. Four intraoperative complications occurred (one conversion from cornuectomy to laparoscopic hysterectomy, one skin burn, two bladder injuries). Seven postoperative complications occurred (Clavien Dindo, grade 1 or 2). All components of the preoperative QoL scores were lower than those of the general population. PCS scores were lower preoperatively than postoperatively [37.6 versus 50.7; p<0.001]. MCS scores were lower preoperatively than postoperatively [29 versus 52.4; p<0.001]. 71% of patients showed an improvement of at least 10% in both PCS and MCS scores. Systemic and gynecologic symptoms were more frequent before than after surgery (98% versus 50%; p<0.001 and 77% versus 20%; p<0.001 respectively). CONCLUSIONS: Patients seeking Essure removal had an impaired preoperative QoL. They experienced a significant QoL improvement at three months post-operation. These findings will help clinicians to inform patients about their expected postoperative functional status and QoL.


Assuntos
Remoção de Dispositivo , Qualidade de Vida , Esterilização Tubária/instrumentação , Adulto , Feminino , Seguimentos , Humanos , Histeroscopia , Laparoscopia , Pessoa de Meia-Idade , Complicações Pós-Operatórias , Estudos Retrospectivos , Salpingectomia
3.
J Gynecol Obstet Hum Reprod ; 50(3): 101836, 2021 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-32590111

RESUMO

INTRODUCTION: The number of requests for Essure removal has grown continually over recent years. The objective is to describe the symptoms reported after Essure sterilization, methods of removal and results. MATERIAL AND METHODS: Retrospective and single-centre cohort (Regional university hospital of Lille, France) was conducted. All women, having consulted from December 2016 to February 2019 for symptoms related to Essure insertion, were included. All the symptoms were noted. A second group was created that included patients who underwent Essure removal to evaluate the benefits of surgery on these symptoms. RESULTS: The study included 98 patients. Most frequent symptoms were musculoskeletal pain (75 %), asthenia (63 %) and pelvic pain (55 %). Fifty-nine patients (60 %) underwent surgery. Surgery appeared beneficial with reduction of symptoms in 60 % of these patients, complete resolution in 33 % and no reduction of symptoms in 7%. Many symptoms were relieved by surgery with an overall decline of 96 % in menorrhagia, 94 % in metrorrhagia and 93 % in dyspareunia. However, other symptoms were not relieved by surgery like 100 % of sleep disorders, 70 % of abdominal pain cases and 57 % of memory impairment cases. CONCLUSION: Symptoms related to Essure insertion are numerous. Although surgery appears beneficial, some adverse effects remain. Therefore, a preoperative aetiologic assessment and information about risk of surgery failure are important.


Assuntos
Histerectomia , Salpingectomia , Esterilização Tubária/efeitos adversos , Esterilização Tubária/instrumentação , Adulto , Astenia/etiologia , Astenia/cirurgia , Estudos de Coortes , Feminino , Humanos , Pessoa de Meia-Idade , Dor Musculoesquelética/etiologia , Dor Musculoesquelética/cirurgia , Dor Pélvica/etiologia , Dor Pélvica/cirurgia , Estudos Retrospectivos , Esterilização Tubária/métodos , Resultado do Tratamento
4.
Contraception ; 102(6): 430-432, 2020 12.
Artigo em Inglês | MEDLINE | ID: mdl-32866471

RESUMO

We report a case of severe systemic delayed dermatitis in a patient with nickel-titanium sterilization microinserts placement complicated by uterine perforation and polyethylene terephthalate (PET) exposure. We hypothesize that delayed dermatitis may be caused by the exposure of PET fibers in this patient with underlying autoimmune disorder. Further research on the use of PET and the potential of systemic dermatologic reactions when exposure occurs is needed, especially when considering the inclusion of PET in future implant device development.


Assuntos
Dermatite de Contato/diagnóstico , Níquel/efeitos adversos , Polietilenotereftalatos/efeitos adversos , Esterilização Tubária/efeitos adversos , Titânio/efeitos adversos , Perfuração Uterina , Útero/cirurgia , Adulto , Remoção de Dispositivo , Feminino , Humanos , Níquel/administração & dosagem , Esterilização , Esterilização Tubária/instrumentação , Esterilização Tubária/métodos , Titânio/administração & dosagem , Resultado do Tratamento
5.
Am J Case Rep ; 21: e923661, 2020 Jul 07.
Artigo em Inglês | MEDLINE | ID: mdl-32636354

RESUMO

BACKGROUND There is growing evidence suggesting that Filshie clip migration is a rare but significant late complication following tubal sterilization. Although most women are asymptomatic, clip migration can result in serious morbidity such as abscess formation and be a source of sepsis years later. CASE REPORT A 51-year-old woman presented with 2-week history of worsening right flank pain with fever and chills, unresponsive to oral antibiotics. CT imaging showed a 4-cm anterior bladder wall mass with a tubal ligation clip within, initially suspicious for a tumor, with secondary infection. Cystoscopy was unremarkable and tumor markers were negative. A subsequent CT urography confirmed the finding of right adnexal abscess with ligation clip within, suggesting a diagnosis of pelvic inflammatory disease. Due to failure of conservative management, she underwent a diagnostic laparoscopy, which was then converted to an exploratory laparotomy due to dense omental adhesions. A Filshie clip was found within the bladder wall abscess and removed. An inadvertent bladder dome perforation was repaired. Pain and fever resolved after the operation and she was discharged home on post-op day 4 with an indwelling catheter. A micturating cystogram a month later showed no extravasation of contrast and the catheter was removed. CONCLUSIONS This case report highlights the importance of considering Filshie clip migration as a differential diagnosis vs. pelvic inflammatory disease in women without other risk factors and who had previously undergone tubal ligation. Women should be made aware of this potential, rare late complication and its serious morbidity, which may occur years later.


Assuntos
Abscesso/etiologia , Migração de Corpo Estranho/complicações , Esterilização Tubária/instrumentação , Doenças da Bexiga Urinária/etiologia , Abscesso/cirurgia , Feminino , Migração de Corpo Estranho/cirurgia , Humanos , Pessoa de Meia-Idade , Doenças da Bexiga Urinária/cirurgia
6.
Fertil Steril ; 114(1): 187-188, 2020 07.
Artigo em Inglês | MEDLINE | ID: mdl-32622410

RESUMO

OBJECTIVE: To study differences between robotic and laparoscopic approach in Essure device removal. DESIGN: Demonstration video of two different surgical approaches. SETTING: Clinico San Carlos University Hospital in Madrid, Spain. PATIENT(S): A total of 737 Essure devices were implanted until June 2017 in Clinico San Carlos Hospital. Nineteen of them were removed. Fourteen (73.7%) were removed using the laparoscopic approach, 4 (21%) using the robotic approach, and 1 (5.3%) using hysteroscopy. We show two cases, one performed using the robotic approach and one using the laparoscopic approach. The first patient was 49 years old and the indication for Essure removal was nickel allergy. The second patient was 52 years old and she had chronic pelvic pain. INTERVENTION(S): We performed two cases of Essure device removal and bilateral salpingectomy operated using the laparoscopic and robotic approaches to compare both procedures. The first step was coagulation of the antimesenteric edge of the fallopian tube with bipolar forceps 2 cm from the uterine horn. The second step was cutting of the coagulated tissue and dissection to visualize the metallic spiral. The third step was pulling gently to extract one of the spirals of the device. The fourth step was salpingectomy and extraction of the proximal part of the Essure. After Essure removal and bilateral salpingectomy, we performed X-ray of the pelvis to ensure complete removal of the device in both patients. MAIN OUTCOME MEASURE(S): We recorded intraoperative and postoperative complications, total operative time and blood loss. RESULT(S): We did not have intraoperative or postoperative complications in any of the surgical approaches. Total operative time was 30 minutes in the robotic surgery (total time in the operating room, 60 minutes) and 45 minutes in the laparoscopic approach (total time in the operating room, 65 minutes). Estimated blood loss was 10 mL in the robotic surgery and 25 mL in the laparoscopic surgery. Both patients were asymptomatic after 3 months of follow-up. The same results could be extrapolated to our series; we observed a median of total operating time of 45 minutes, no complications, length of stay of 2 days, and total resolution of symptoms after 3 months of follow-up. Our results are similar to the results reported by other authors who consider laparoscopic salpingectomy for removal of Essure inserts to be safe and feasible. CONCLUSION(S): Robotic and laparoscopic approaches allow complete removal of Essure devices in symptomatic patients without major complications. On the other hand, robotic surgery provides advantages to the surgeon, such as greater precision, elimination of tremor, three-dimensional visualization of surgical field, and ease of minimally invasive suturing. But robotic surgery has the disadvantages of increased cost and increased case time in some circumstances.


Assuntos
Dispositivos Anticoncepcionais , Remoção de Dispositivo , Laparoscopia , Procedimentos Cirúrgicos Robóticos , Esterilização Tubária/instrumentação , Feminino , Humanos , Pessoa de Meia-Idade , Salpingectomia , Esterilização Tubária/efeitos adversos , Resultado do Tratamento
7.
J Gynecol Obstet Hum Reprod ; 49(8): 101781, 2020 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-32492524

RESUMO

INTRODUCTION: Inserts Essure® were used as a definitive sterilization method from 2001 to 2017. They have been used for more than 750,000 procedures. Gynecological or extra gynaecological adverse events have been reported by patients. The objective of the study is to evaluate the resolution of symptoms attributed to Essure® micro-inserts after surgical removal. METHODS: Monocentric retrospective study. Patients who had surgical removal of Essure® micro-inserts between January 2017 and April 2019 were included. The removal was performed by bilateral salpingectomy with cornuectomy by laparoscopy or vaginal hysterectomy. Symptoms were reported preoperatively, 4-8 weeks after withdrawal (early assessment) and 6-24 months after withdrawal (later assessment). RESULTS: Ninety patients had a surgical removal of Essure® micro-inserts. Fifty-two vaginal hysterectomies and thirty-five laparoscopic salpingectomies were performed. The main symptoms reported are pelvic pain (70 %), fatigue (66.7 %) and heavy bleeding menstruations (53.3 %). One month after surgery, 46.7 % of patients have a major improvement of symptoms and 51.1 % a partial resolution. The major improvement rate is not significantly different between laparoscopic salpingectomy and vaginal hysterectomy (51.5 % versus 42.3 %) (p = 0.23). At 24 months, results improved with 83.3 % major improvement. CONCLUSION: Surgical removal may be effective for treating most women with attributed device symptoms. Vaginal hysterectomy and laparoscopic salpingectomy with cornuectomy seem to have an equivalent rate for the resolution of extra-gynecological symptoms.


Assuntos
Histerectomia Vaginal , Laparoscopia/métodos , Salpingectomia/métodos , Esterilização Tubária/efeitos adversos , Esterilização Tubária/instrumentação , Útero/cirurgia , Adulto , Feminino , Humanos , Pessoa de Meia-Idade , Dor Pélvica/etiologia , Dor Pélvica/terapia , Estudos Retrospectivos , Resultado do Tratamento
8.
JSLS ; 24(1)2020.
Artigo em Inglês | MEDLINE | ID: mdl-32206011

RESUMO

STUDY OBJECTIVE: The objective of the study was to identify factors associated with negative patient experiences with Essure. DESIGN: This was a retrospective cohort study and follow-up survey. SETTING: The study was conducted in an academic setting. PATIENTS: Patients included women who had an Essure placed between 2002 and 2017. METHODS: The hospitals' database was queried to identify subjects and charts were reviewed to confirm medical information. Subjects were invited by mail, e-mail, or phone call to participate a survey regarding symptoms and satisfaction with Essure. A comparison was made between women who reported a negative experience with Essure versus those who did not. A multivariable logistic regression analysis was performed to identify subject or procedural characteristics associated with any negative experience with Essure sterilization. RESULTS: Two hundred eighty-four women underwent Essure sterilization between 2002 and 2017, 42.3% of whom responded to the follow-up survey. Satisfaction with Essure was reported by 61.9% of respondents. Thirty-three percent of the respondents have undergone removal or desire removal of the device. The most frequent symptoms attributed to Essure were pelvic pain, dyspareunia, and vaginal bleeding. Forty-eight percent of the respondents were identified as having any negative experience with Essure. Factors associated with negative experiences with Essure included young age at placement (odds ratio [OR] 0.86; 95% confidence interval [CI] 0.79-0.94; P < .001), high gravidity (OR 1.39; 95% CI 1.14-1.71; P = .002), and absent history of abdominal surgery (OR 0.35; 95% CI 0.12-1.00; P = .049). CONCLUSION: Young age at placement, high gravidity, and absent history of abdominal surgery are factors associated with negative patient experiences following Essure sterilization. A negative experience with Essure is common, although dissatisfaction with the device is not always attributable to symptoms. This information could be considered when counseling women who plan removal of Essure. IMPLICATIONS STATEMENT: Our study provides new follow-up data with respect to hysteroscopic sterilization. This research is the first to examine any cause for negative patient experiences with Essure. Understanding factors associated with negative patient experiences could improve patient counseling regarding the extent to which symptoms could be attributed to Essure as well as counseling women who want to undergo removal of the device. These factors could in turn prove to be predictors for successful resolution of symptoms after removal of Essure. Results of this study could also be used for developing future hysteroscopic sterilization techniques.


Assuntos
Histeroscopia/instrumentação , Satisfação do Paciente , Complicações Pós-Operatórias/epidemiologia , Esterilização Tubária/instrumentação , Adulto , Estudos de Coortes , Feminino , Humanos , Histeroscopia/efeitos adversos , Histeroscopia/métodos , Pessoa de Meia-Idade , Esterilização Tubária/efeitos adversos , Esterilização Tubária/métodos , Inquéritos e Questionários
9.
Ann Diagn Pathol ; 46: 151508, 2020 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-32199277

RESUMO

The introduction of the Essure (Bayer AG, Leverkusen, Germany) device made possible a less invasive approach for patients desiring sterilization. Following FDA approval in 2002, problems were reported in some patients with these devices including most commonly pain. Labeling changes were mandated in 2016, and as of late 2018, the devices are no longer being sold in the United States. A comprehensive description of Pathologic findings in patients with these devices has not been reported. This study characterizes pathologic findings in patients undergoing surgery who had Essure in place, regardless of the indication for surgery. 137 cases were found, 126 of which had submitted tissue, 121 of which had fallopian tube(s) submitted. Duration for coils being in place was available for 104/137 patients (mean 48 months; median 43 months, range 0-166 months). Cases ranged from 2009 to 19, with a peak in cases noted in 2016. A chief complaint relating to the phrase "pelvic pain" was the most common, noted in 72/137 cases. Obliteration, defined as loss of the fallopian tube epithelium with filling of the lumen with fibrotic material, was noted in 33/121 cases. Inflammation was noted in 59/126 cases, 31/59 showed with giant cells, chronic inflammation (lymphocytes and/or plasma cells) in 37/59 cases, and acute inflammation 19/59 cases, with 14/19 showing eosinophils. Acute inflammation was noted in those with a shorter duration of coil implantation, while chronic inflammation, including giant cells, were noted across the span. This study has expanded knowledge of patients with removal of Essure coil devices.


Assuntos
Tubas Uterinas/patologia , Esterilização Tubária/instrumentação , Adulto , Feminino , Hospitais , Humanos , Pessoa de Meia-Idade , Complicações Pós-Operatórias/patologia , Estudos Retrospectivos , Esterilização Tubária/efeitos adversos
10.
Dermatitis ; 31(2): 122-127, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32168143

RESUMO

BACKGROUND: Essure is an effective method for hysteroscopic sterilization. Reports of adverse effects, the underlying mechanisms of which are unknown, have increased in recent years. OBJECTIVE: The aim of the study was to determine whether there is a relationship between adverse events attributed to Essure and nickel sensitization. METHODS: Patients presenting alleged adverse reactions to Essure were referred for nickel patch testing before removal. Data regarding medical history of nickel sensitization and symptoms attributed to Essure were collected. Dimethylglyoxime spot tests were performed on the explanted Essure. There was a follow-up at 3 months to evaluate whether there is improvement of the symptoms after Essure removal. CONCLUSIONS: Nickel sensitization via the classic delayed hypersensitivity pathway did not seem to be responsible for adverse events attributed to Essure. Among systemic symptoms reported, extracutaneous symptoms had the highest prevalence. Systemic contact dermatitis to nickel could not be ruled out in one case.


Assuntos
Alérgenos/efeitos adversos , Hipersensibilidade Tardia/epidemiologia , Níquel/efeitos adversos , Próteses e Implantes/efeitos adversos , Esterilização Tubária/instrumentação , Adulto , Alérgenos/análise , Artralgia/etiologia , Remoção de Dispositivo , Dispareunia/etiologia , Eczema/etiologia , Tubas Uterinas/patologia , Fadiga/etiologia , Feminino , Cefaleia/etiologia , Humanos , Hipersensibilidade Tardia/diagnóstico , Hipersensibilidade Tardia/etiologia , Histeroscopia , Laparoscopia , Metrorragia/etiologia , Pessoa de Meia-Idade , Níquel/análise , Oximas , Testes do Emplastro , Dor Pélvica/etiologia , Salpingectomia , Dermatopatias/etiologia
11.
J Minim Invasive Gynecol ; 27(3): 697-703, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-31212073

RESUMO

STUDY OBJECTIVE: To evaluate the feasibility, efficacy, and morbidity of Essure® device removal via laparoscopic en bloc salpingectomy-cornuectomy resection (LSC) and the utility of confirmation of complete removal with an intraoperative X-ray of the removed specimen (IX-S). DESIGN: Retrospective observational cohort study. SETTING: Academic hospitals of La Conception, Marseille, and Arnaud-de-Villeneuve, Montpellier, France. PATIENTS: Women who were not seeking future fertility seeking Essure® device removal by salpingectomy, between February 2017 and August 2018. INTERVENTIONS: All women underwent LSC. An IX-S was performed to confirm complete Essure® device removal. In the case of an unsatisfactory IX-S, an intraoperative pelvic X-ray control of the patient (IX-P) was performed. If IX-P diagnosed residual Essure® fragments, an additional resection was performed, and the removed tissue was checked by IX-S. MEASUREMENTS AND MAIN RESULTS: We included 72 women, and a total of 140 Essure® devices were removed. The IX-S confirmed complete Essure® device removal in 131 of 140 cases (93.6%) in 63 of 72 women (87.5%). Out of the 9 women with unsatisfactory IX-S, 6 had no residual Essure® fragments at IX-P, and Essure® device removal was considered complete. Three women had a persistent Essure® fragment at IX-P: an additional resection allowed complete removal in 2 cases and resulted in failure in 1 of 140 case (0.7%). There were 2 of 72 women (2.8%) intraoperative complications and 4 of 72 women (5.6%) postoperative grade 1 complications according to the Clavien-Dindo classification. CONCLUSION: Essure® device removal by LSC appears to be an effective and safe procedure. IX-S is a useful method to evaluate whether the removal of Essure® device is complete during an LSC procedure.


Assuntos
Remoção de Dispositivo/métodos , Dispositivos Intrauterinos , Monitorização Intraoperatória/métodos , Pelve/diagnóstico por imagem , Salpingectomia/métodos , Esterilização Tubária/instrumentação , Adulto , Estudos de Coortes , Remoção de Dispositivo/efeitos adversos , Remoção de Dispositivo/estatística & dados numéricos , Estudos de Viabilidade , Feminino , França/epidemiologia , Humanos , Histeroscopia/efeitos adversos , Histeroscopia/métodos , Histeroscopia/estatística & dados numéricos , Dispositivos Intrauterinos/efeitos adversos , Laparoscopia/efeitos adversos , Laparoscopia/métodos , Laparoscopia/estatística & dados numéricos , Pessoa de Meia-Idade , Morbidade , Gravidez , Radiografia , Estudos Retrospectivos , Salpingectomia/efeitos adversos , Reversão da Esterilização/efeitos adversos , Reversão da Esterilização/métodos , Reversão da Esterilização/estatística & dados numéricos , Esterilização Tubária/efeitos adversos , Esterilização Tubária/métodos , Esterilização Tubária/estatística & dados numéricos , Resultado do Tratamento , Ultrassonografia , Raios X
12.
J Gynecol Obstet Hum Reprod ; 49(2): 101666, 2020 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-31811972

RESUMO

OBJECTIVE: To describe the feasibility and effectiveness of a novel technique for Hysteroscopic sterilization using the distal ends of a copper-T intrauterine device (Ostialoc). PATIENT AND METHODS: A pilot study included 11 cases selected and informed about the technique at a tertiary University hospital. Through hysteroscopy, the knobs with the distal 1 cm of Copper-T intrauterine devices (Ostialoc) were inserted into the interstitial part of both fallopian tubes for the tubal block. Patients were evaluated two weeks later by plain X-ray and ultrasound to ensure nonexpulsion of the Ostialoc, then every month for three successive months. The patients were scheduled for HSG at 3 months and one year after the Ostialoc placement to evaluate tubal occlusion. RESULTS: The mean age of cases was 39.20 ± 4.09 years, mean parity was 4.48 ± 1.00, and the mean BMI was 28.92 ± 4.31 Kg/m2. The mean operative time was 22.24 ± 5.63 min. The technique was feasible in all cases. The postoperative complications were present in one case suffered from pelvic pain. HSG demonstrated complete block of both fallopian tubes after three months and at one year in 100% of the cases. CONCLUSION: Hysteroscopic sterilization using Ostialoc technique seems to be a feasible and effective technique in low resources countries.


Assuntos
Histeroscopia , Dispositivos Intrauterinos Medicados , Esterilização Tubária/instrumentação , Esterilização Tubária/métodos , Adulto , Cobre , Estudos de Viabilidade , Feminino , Humanos , Pessoa de Meia-Idade , Projetos Piloto , Estudos Prospectivos , Resultado do Tratamento
13.
Fertil Steril ; 112(6): 1144-1149, 2019 12.
Artigo em Inglês | MEDLINE | ID: mdl-31843091

RESUMO

OBJECTIVE: To evaluate long-term patient satisfaction and symptoms after successful Essure sterilization and the influence of negative publicity on patients' opinion. DESIGN: Survey study. SETTING: Two nonacademic hospitals. PATIENT(S): All 924 women who underwent successful Essure sterilization between 2003 and 2009. INTERVENTION(S): A questionnaire was sent between 2008 and 2010 and in 2018. MAIN OUTCOME MEASURE(S): Patient satisfaction, symptoms, and the influence of negative publicity on patients' opinion of Essure sterilization. RESULT(S): After a median follow-up of 29 months, 689 of 924 women (74.6%) responded to the first questionnaire. Of these women, 673 of 689 (97.7%) was satisfied with their Essure sterilization and 607 of 689 (88.1%) recommended Essure sterilization to other women. Of the 689 women, 71 (10.3%) reported having symptoms after Essure sterilization for which they had to consult a physician. Most reported symptoms were menstrual and abdominal pain. After a median follow-up of 144 months, 317 of 577 women (54.9%) responded to the second questionnaire. A total of 157 of 317 (49.5%) women reported having symptoms and in 51 (16.1%) women the Essure devices were surgically removed. Among these women, 29 (57%) reported that their symptoms disappeared afterward and 33 of 51 (65%) women reported that negative publicity had somehow affected their decision to undergo surgery. CONCLUSION(S): After a follow-up of 144 months, approximately 50% of the women reported having symptoms and 16% underwent Essure removal surgery. Publicity had a negative influence on patients' opinion of Essure sterilization, as well as an effect on the decision-making process regarding Essure removal. These data are important when facing women with possible Essure-related complaints.


Assuntos
Histeroscopia , Satisfação do Paciente , Opinião Pública , Esterilização Tubária , Adulto , Comportamento de Escolha , Feminino , Seguimentos , Pesquisas sobre Atenção à Saúde , Conhecimentos, Atitudes e Prática em Saúde , Humanos , Histeroscopia/efeitos adversos , Histeroscopia/instrumentação , Pessoa de Meia-Idade , Países Baixos , Complicações Pós-Operatórias/etiologia , Esterilização Tubária/efeitos adversos , Esterilização Tubária/instrumentação , Fatores de Tempo , Resultado do Tratamento , Adulto Jovem
15.
Minerva Ginecol ; 71(6): 404-411, 2019 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-32064824

RESUMO

BACKGROUND: Most of the clinical adverse events associated with the Essure® sterilization device have been attributed to incidents during and immediately after device placement (perforation, infection, expulsion). The aim of this study was to prospectively evaluate the prevalence and severity of non-gynecological clinical symptoms (e.g. memory disorders, muscle pain, and impaired vision) in patients before device placement and after device removal. METHODS: Women who presented at least four non-gynecological clinical symptoms with the Essure® filled out a questionnaire before surgical removal of the device and then 1, 3 and 6 months afterwards. Patients with bleeding (metrorrhagia and menorrhagia) or tube perforation were excluded. RESULTS: Fifty-two symptomatic women were included in the study and followed up for 6 months. The median (range) time interval between Essure® placement and the first clinical symptom was 13 months (1-60), and the median time interval between Essure® placement and removal was 38 months (12-72). The prevalence of clinical symptoms prior to device removal ranged from 26% (for urinary tract disorders) to 96% (for weakness). The mean±standard deviation intensity (on a 0-to-10 scale) of the symptoms before removal of the Essure® was 8.4±0.4; at 1 month, 3 months and 6 months post-removal, the values had fallen significantly to 4.2±0.6, 4±0.8, and 4.1±1, respectively (P<0.0001 for all the symptoms). CONCLUSIONS: The observed decrease in symptom frequency and severity following Essure® removal and the persistence of this effect at 6 months suggest that the device should be removed in all symptomatic women.


Assuntos
Remoção de Dispositivo , Esterilização Tubária/efeitos adversos , Adulto , Feminino , Seguimentos , Humanos , Pessoa de Meia-Idade , Prevalência , Estudos Prospectivos , Índice de Gravidade de Doença , Esterilização Tubária/instrumentação , Inquéritos e Questionários , Fatores de Tempo
16.
J Minim Invasive Gynecol ; 26(6): 1157-1163, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-30508652

RESUMO

OBJECTIVE: To investigate the effectiveness of Tornado and Hilal (Cook Medical, Bloomington, IN) hysteroscopic proximal tubal occlusion (HPTO) for hydrosalpinx (HX) treatment before in vitro fertilization (IVF) and embryo transfer (ET) in patients with dense pelvic adhesions or low ovarian reserve. DESIGN: A retrospective study of patients treated between May 2014 and May 2016 (Canadian Task Force classification III). SETTING: A university-affiliated center. PATIENTS: One hundred fifty women with unilateral or bilateral HX who were not candidates for laparoscopic surgery. INTERVENTION: Tornado or Hilal HPTO before IVF-ET and/or frozen ET. MEASUREMENTS AND MAIN RESULTS: The main outcome was the cumulative live birth rate. Tornado or Hilal placement was successful for 143 (95.3%) patients. Of the 132 patients who underwent 204 ET cycles, 86 (65.2%) conceived, and 78 (59.1%) resulted in live births. The overall early and late miscarriage rates per clinical pregnancy were 12.8% and 1.1%, respectively. The ectopic pregnancy rate was 2.3%. No major complications occurred. CONCLUSION: Tornado or Hilal HPTO is an effective alternative for treating HX before IVF-ET/frozen ET in patients with dense pelvic adhesions or low ovarian reserve.


Assuntos
Transferência Embrionária , Doenças das Tubas Uterinas/cirurgia , Fertilização In Vitro , Histeroscopia/métodos , Infertilidade Feminina/terapia , Dispositivos Intrauterinos , Implantação de Prótese/métodos , Esterilização Tubária , Adulto , Terapia Combinada , Doenças das Tubas Uterinas/complicações , Doenças das Tubas Uterinas/epidemiologia , Feminino , Fertilização In Vitro/métodos , Humanos , Histeroscopia/efeitos adversos , Infertilidade Feminina/complicações , Infertilidade Feminina/epidemiologia , Infertilidade Feminina/cirurgia , Dispositivos Intrauterinos/efeitos adversos , Laparoscopia/efeitos adversos , Laparoscopia/métodos , Platina/química , Gravidez , Resultado da Gravidez/epidemiologia , Implantação de Prótese/efeitos adversos , Estudos Retrospectivos , Esterilização Tubária/instrumentação , Esterilização Tubária/métodos , Fatores de Tempo , Resultado do Tratamento
17.
J Minim Invasive Gynecol ; 26(4): 603, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-30064007

RESUMO

STUDY OBJECTIVE: To describe 2 different surgical techniques for Essure removal on the same patient: the hysteroscopic and laparoscopic techniques. DESIGN: An educational video approved by the local institutional review board (Canadian Task Force classification III). SETTING: A university hospital (University Hospital of Strasbourg, Strasbourg, France). PATIENT: A 46-year-old woman with many symptoms after Essure device implantation. An ultrasound found a right implant in the uterine cavity and a left intratubal implant. INTERVENTIONS: The first step was the hysteroscopic removal of the right implant. We viewed the 2 internal and external spirals, allowing the gripping of the whole device without risking any fragmentation or tubal lesion. The second step was bilateral salpingectomy with resection of the left interstitial tubal portion. We longitudinally incised the antimesial edge of the fallopian tube 2 to 3 cm from the tubal serous to the implant contact. A circumferential incision was performed at the uterine horn to circumscribe the interstitial tubal portion. The implant was released from the surrounding tissue. It was gently pulled to completely extract it and avoid spiral fragmentation. Then, we performed a bilateral total salpingectomy. An X-ray of the implants and pelvis was performed to ensure complete removal of the device. We made an X-stitch in the uterine horn to avoid the risk of fistula. CONCLUSION: More and more patients are asking for the removal of their implants. The surgical technique has to be adapted to the location of the implants and has to allow their complete removal to avoid leaving fragments that can cause the persistence of side effects.


Assuntos
Remoção de Dispositivo/métodos , Histeroscopia/instrumentação , Salpingectomia/instrumentação , Esterilização Tubária/instrumentação , Tubas Uterinas/cirurgia , Feminino , França , Procedimentos Cirúrgicos em Ginecologia/métodos , Humanos , Histeroscopia/métodos , Laparoscopia/instrumentação , Laparoscopia/métodos , Pessoa de Meia-Idade , Pelve , Salpingectomia/métodos , Esterilização Tubária/métodos , Ultrassonografia , Útero/cirurgia
18.
J Ultrasound Med ; 38(2): 289-297, 2019 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-30051486

RESUMO

The current reference standard to check the position of a tubal sterilization microinsert device after its insertion is hysterosalpingography. The objective of this study was to evaluate the accuracy of 2-dimensional (2D) and 3-dimensional (3D) ultrasonography (US) in the positioning of the tubal sterilization microinsert for definitive contraception. We searched MEDLINE, Embase, Cochrane, and Scopus databases through October 2017. Selection criteria included studies that analyzed the accuracy of 2D or 3D US, or both, with respect to the positioning of the microinsert. Data were displayed as forest plots and a summary receiver operating characteristic curves. Values for sensitivity, specificity, and positive and negative likelihood ratios (LRs) were calculated. The pooled analysis produced sensitivity and specificity values for 2D US in the positioning of the microinsert of 0.88 (95% confidence interval [CI], 0.47-1.0) and 0.92 (95% CI, 0.88-0.95), respectively, with positive and negative LRs of 8.68 (95% CI, 1.63-46.1) and 0.35 (95% CI, 0.11-1.11), respectively. Three studies analyzed the performance of 3D US, showing sensitivity, specificity, and positive and negative LRs of 0.75 (95% CI, 0.35-0.97), 0.82 (95% CI, 0.77-0.87), 3.65 (95% CI, 2.31-5.75), and 0.46 (95% CI, 0.2-1.09). In conclusion, 2D and 3D US are methods that show good accuracy in tubal sterilization microinsert positioning.


Assuntos
Tubas Uterinas/diagnóstico por imagem , Esterilização Tubária/instrumentação , Esterilização Tubária/métodos , Ultrassonografia/métodos , Feminino , Humanos , Imageamento Tridimensional , Reprodutibilidade dos Testes , Sensibilidade e Especificidade , Resultado do Tratamento
19.
J Minim Invasive Gynecol ; 26(4): 695-701, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-30077005

RESUMO

STUDY OBJECTIVE: To evaluate the feasibility of an en-bloc salpingectomy at the time of vaginal hysterectomy for removal of Essure inserts. DESIGN: Prospective observational study (Canadian Task Force classification II-1). SETTING: Monocenter study at the Conception University Hospital Center, Marseille, France. PATIENTS: Women seeking removal of the Essure device and candidate for vaginal hysterectomy from January 1, 2017 to January 31, 2018. INTERVENTIONS: Patient underwent a total hysterectomy and bilateral salpingectomy by the vaginal route (VH-S) with en-bloc removal of each hemiuterus with the ipsilateral fallopian tube, thereby allowing for removal of the Essure inserts without fragmentation. MEASUREMENTS AND MAIN RESULTS: Twenty-six VH-S were performed. There was no converted case to laparoscopy or laparotomy because of issues regarding feasibility or complications. Removal of each hemiuterus with the ipsilateral tube as a single unit was feasible in all cases. There was 1 Clavien-Dindo grade 1 perioperative complication: a bladder injury that required 10days of urinary catheterization. There were 2 grade 2 postoperative complications: 1 case of metrorrhagia of a granuloma on the vaginal fundus that was treated with silver nitrate and 1 case of acute urinary retention that required urinary catheterization for 24hours. CONCLUSION: Performing a VH-S with en-bloc removal of the hemiuterus with the ipsilateral tube without fragmentation orsectioning of the Essure inserts appears to be feasible. The vaginal route can hence be an approach for women who undergo hysterectomy during Essure insert surgery removal.


Assuntos
Histerectomia Vaginal/métodos , Salpingectomia/métodos , Esterilização Tubária/instrumentação , Adulto , Remoção de Dispositivo/métodos , Tubas Uterinas , Estudos de Viabilidade , Feminino , Humanos , Pessoa de Meia-Idade , Estudos Prospectivos , Esterilização Tubária/efeitos adversos , Útero
20.
J Minim Invasive Gynecol ; 26(6): 1117-1124, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-30428382

RESUMO

STUDY OBJECTIVE: To 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). DESIGN: A prospective study (Canadian Task Force classification II-2). SETTING: The department of obstetrics and gynecology in a teaching hospital. PATIENTS: One hundred fifty patients who had undergone hysteroscopic sterilization with Essure (Bayer Pharma AG Laboratory, Lyon, France) fallopian tube pregnancy prevention implants were invited by letter to participate in the study; 50 replied positively between January and August 2017. INTERVENTIONS: An initial 2D US was performed followed by 3D US reconstruction. The primary end point was to compare the identification of device placement with 2D and 3D US imaging procedures according to this new classification. Secondary considerations were to evaluate the difficulty of attaining images, the quality of implant curvature, the duration of each imaging procedure, and the number of images performed for each technique. MEASUREMENTS AND MAIN RESULTS: Ninety-six percent of tubal implants were observed via 3D US compared with 100% via 2D US. The mean time of 2D US was 14.64 seconds for the right fallopian tube and 15.25 seconds for the left fallopian tube compared with 25.11 seconds for the right and 31.57 seconds for the left fallopian tube in 3D US (p <.01). The mean number of image acquisitions per patient was 1.02 (±0.14 standard deviation) for 2D US compared with 1.37 (±0.64 standard deviation) for 3D US (p <.01). The sonographer had no difficulty performing 2D US in 88% of cases compared with 58% of 3D US cases. CONCLUSIONS: Two-dimensional ultrasound appears to be an acceptable alternative to 3D US. We propose a 2D classification for cross section device localization to facilitate image interpretation.


Assuntos
Tubas Uterinas/diagnóstico por imagem , Dispositivos Intrauterinos , Implantação de Prótese/métodos , Esterilização Tubária , Ultrassonografia/métodos , Adulto , Tubas Uterinas/cirurgia , Estudos de Viabilidade , Feminino , França , Humanos , Histeroscopia/métodos , Imageamento Tridimensional/métodos , Migração de Dispositivo Intrauterino/etiologia , Projetos Piloto , Gravidez , Prognóstico , Implantação de Prótese/efeitos adversos , Implantação de Prótese/normas , Estudos Retrospectivos , Esterilização Tubária/instrumentação , Esterilização Tubária/métodos
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