Signs and symptoms: Adverse events associated with a sterilization device.

Sterilization is now the most common contraceptive method used by women of in the U.S., and sterilization devices have played an important role in its increased popularity. This mixed methods study examines a random sample of 2500 U.S. Food and Drug Administration (FDA) adverse event reports made between 2006 and 2017 about Essure, a sterilization device. Quantitative coding was used to examine patient problems; pain and bleeding were reported most frequently. Qualitative coding analyzed impacts of symptoms on patients' everyday lives and patients' healthcare experiences, including intimate relationships, mothering, and paid employment. Findings suggest that some patients struggled when their reported "subjective" symptoms didn't result in "objective" clinical signs of problems, and when physicians dismissed or deflected their concerns in diagnostic encounters. This paper raises important issues regarding the symptoms patients associated with Essure, the diagnosis of device-driven disease and injury, and the FDA's regulation of medical devices.

Seven-Year Outcomes After Hysteroscopic and Laparoscopic Sterilizations.

OBJECTIVE: To evaluate 7-year outcomes after hysteroscopic and laparoscopic sterilizations, including subsequent tubal interventions and hysterectomies. METHODS: This observational cohort study included women undergoing hysteroscopic and laparoscopic sterilizations in outpatient and ambulatory surgical settings in New York State during 2005-2016. We examined subsequent procedures (tubal ligation or resection, and hysterectomy not related to uterine leiomyomas or gynecologic tumors) after the index procedures. After propensity score matching, we used Kaplan-Meier analysis to obtain estimated risks of subsequent procedures within 7 years of index sterilization procedures, and Cox proportional hazard models to compare the differences between groups. RESULTS: We identified 10,143 and 53,206 women who underwent interval hysteroscopic and laparoscopic sterilizations, respectively, in New York State during 2005-2016. The mean age of the cohort was 34.2 years (range 18-80). The propensity score-matched cohort consisted of 10,109 pairs of women. The estimated risk of undergoing an additional tubal ligation or resection within 7 years was higher after hysteroscopic sterilization than it was after laparoscopic sterilization (3.9% vs 1.6%, HR 2.89, 95% CI 2.33-3.57). The difference was most pronounced within the initial year after attempted sterilization (1.5% vs 0.2%; HR 6.39, 95% CI 4.16-9.80). There was no significant difference in the risk of receiving a hysterectomy (0.9% vs 1.2%; HR 0.73, 95% CI 0.53-1.00) between women who underwent hysteroscopic and laparoscopic sterilizations. 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.

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.

Hysteroscopic Sterilization With Essure: Summary of the U.S. Food and Drug Administration Actions and Policy Implications for Postmarketing Surveillance.

In September 2015, the U.S. Food and Drug Administration (FDA) convened a meeting of the Obstetrics and Gynecology Advisory Board Committee to address the sudden increase of patient-reported adverse events surrounding Essure, a Class III device offering a less invasive method for permanent female sterilization. After a review of the premarketing and postmarketing data and existing scientific literature, the FDA concluded there was insufficient evidence to remove the device from the market. However, the FDA did release a new guidance document requiring a black box warning for the device and ordered a new postmarketing study comparing Essure's safety and efficacy with laparoscopic tubal sterilization. The device was first approved in 2002 based on nonrandomized, single-arm prospective clinical studies. Since its approval, the device has grown in popularity, particularly in the United States. The driving forces for the sudden increase in adverse event reporting starting in 2013 related to the device remain unclear. Until completion of the new postmarketing study, there will continue to be significant uncertainty of the technology's risk-benefit profile. The controversy with Essure underscores the need for obstetricians and gynecologists to be actively involved in the lifecycle of medical devices. This includes actively reporting adverse events associated with devices to the FDA, supporting the implementation of unique device identifiers enriched with clinical records and paired with insurance claims, and stewarding robust device-specific registries.

Evaluation of Nickel Allergic Reactions to the Essure Micro Insert: Theoretical Risk or Daily Practice?

STUDY OBJECTIVE: To evaluate whether de novo development of nickel sensitization is related to placement of the Essure device, and to evaluate whether the grade of reaction to nickel increased after device placement in patients with a confirmed nickel allergy. DESIGN: Prospective cohort study (Canadian Task Force classification II-2). SETTING: Two nonacademic training hospitals in The Netherlands. PATIENTS: Healthy women of childbearing age desiring permanent sterilization. INTERVENTIONS: At least 72 hours before Essure sterilization, each patient received 2 patches, 1 patch with a nickel solution in 5% petrolatum and 1 control patch. In addition, the patient was asked to complete a questionnaire on allergy-related symptoms. The patch test was scored according to the criteria for contact dermatitis of Devos and Van Der Valk. At 3 months after Essure sterilization, the patch test and the questionnaire were repeated. MEASUREMENTS AND MAIN RESULTS: All 169 patients underwent Essure sterilization and completed the patch test cycle. There were no statistically significant changes in patch test results and allergy-related symptoms after sterilization. Before sterilization, 29% of the patients had a positive patch test and 1.8% also showed a positive reaction to the control patch. Only 20.7% of the patients had a history of allergic reactions to nickel. After sterilization, 29% had a positive patch test and 0.6% also showed a positive reaction to the control patch. Among the patients with a positive patch test before sterilization, the grade of reaction did not increase after sterilization. Moreover, these patients did not exhibit any increase in allergy-related symptoms. Among 4 patients with a previous negative patch test, 2 developed a grade 1 reaction and 2 developed a grade 2 reaction after sterilization. Two of these 4 patients had a history of allergic reactions to nickel before sterilization despite a negative patch test. After sterilization, these 4 patients exhibited no increase in allergy-related symptoms. CONCLUSION: There were no statistically significant changes in nickel patch test results and allergy-related symptoms after Essure sterilization. Furthermore, among the patients with a positive patch test before Essure sterilization, the grade of reaction did not increase after sterilization. These results indicate that Essure sterilization likely is not related to nickel sensitization.

Update on long-acting reversible methods.

PURPOSE OF REVIEW: The last several years have seen a number of important clinical and academic advances in long-acting reversible contraceptive (LARC) methods, such that many professional medical organizations now recommend these methods as first-line contraception for all women. RECENT FINDINGS: Recent data support the use of LARC in a variety of special circumstances including adolescents, nulliparous women and immediately postpartum and postabortion. Evidence also shows that traditional methods of pain control with intrauterine device (IUD) insertion and cervical preparation prior to insertion may not be warranted. Further, the extended use of IUDs is safer and more effective than previously realized. SUMMARY: The rising uptake of LARC methods in the United States has the potential to dramatically decrease undesired pregnancies and abortion rates, and should be considered an effective option in the majority of women.

Update on permanent contraception options for women.

PURPOSE OF REVIEW: Permanent methods are the most commonly used contraceptive options worldwide. Even with the increase in popularity and accessibility of long-acting reversible methods, there remains high demand for permanent options, especially among women in developing countries. RECENT FINDINGS: Traditional methods of permanent contraception, such as postpartum tubal ligation and interval surgical tubal occlusion or electrocautery by mini-laparotomy or laparoscopy are well tolerated and highly effective. Bilateral total salpingectomy for ovarian cancer risk reduction is currently being investigated. Hysteroscopic tubal occlusion reduces or eliminates the need for anesthesia, but requires surgical training and specialized equipment. Alternative permanent contraception methods are being explored including immediately effective hysteroscopic methods, and nonsurgical permanent contraception methods that have the potential to improve access and reduce cost. SUMMARY: Permanent contraception methods are an important part of the contraceptive methods mix designed to meet the needs of women who have completed desired family size or wish never to become pregnant. Current surgical approaches to permanent contraception are well tolerated and highly effective. The development of a highly effective nonsurgical approach could simplify the provision of permanent contraception.

Ovarian blood vessel occlusion as a surgical sterilization method in rats.

PURPOSE: To evaluate the female sterilization by occlusion of the ovarian blood flow, using the rat as experimental model. METHODS: Fifty-five females rats were divided into four groups: I (n=10), bilateral ovariectomy, euthanized at 60 or 90 days; II (n=5), opening the abdominal cavity, euthanized at 90 days; III (n=20), bilateral occlusion of the ovarian blood supply using titanium clips, euthanized at 60 or 90 days; and IV (n=20), bilateral occlusion of the ovarian blood supply using nylon thread, euthanized at 60 or 90 days. The estrous cycle was monitored by vaginal cytology. After euthanasia, the reproductive tissues were evaluated histologically. RESULTS: Ovarian atresia was identified macroscopically at 60 days after surgery in the rats in groups III and IV; however, most of the rats in group III maintained cyclicity. Histology of the tissues from group IV revealed that the ovarian tissue was replaced by dense fibrous connective tissue that was slightly vascularized and that intact follicles were absent by 90 days. CONCLUSION: Ovarian blood vessels occluded caused ischemia, leading to progressive tissue necrosis, and bilateral occlusion using a nylon ligature is a viable method for surgical sterilization.

A randomized, controlled, multicenter contraceptive efficacy clinical trial of the intravas device, a nonocclusive surgical male sterilization.

Because of unavoidable complications of vasectomy, this study was undertaken to assess the efficacy and safety of male sterilization with a nonobstructive intravas device (IVD) implanted into the vas lumen by a mini-surgical method compared with no-scalpel vasectomy (NSV). IVDs were categorized into two types: IVD-B has a tail used for fixing to the vas deferens (fixed wing) whereas IVD-A does not. A multicenter prospective randomized controlled clinical trial was conducted in China. The study was comprised of 1459 male volunteers seeking vasectomy who were randomly assigned to the IVD-A (n = 487), IVD-B (n = 485) or NSV (n = 487) groups and underwent operation. Follow-up included visits at the 3 rd -6 th and 12 th postoperative months. The assessments of the subjects involved regular physical examinations (including general and andrological examinations) and semen analysis. The subjects' partners also underwent monitoring for pregnancy by monthly interviews regarding menstruation and if necessary, urine tests. There were no significant differences in pregnancy rates (0.65% for IVD-A, 0 for IVD-B and 0.21% for NSV) among the three groups (P > 0.05). The cumulative rates of complications at the 12 th postoperative month were zero, 0.9% and 1.7% in the three groups, respectively. In conclusion, IVD male sterilization exhibits a low risk of long-term adverse events and was found to be effective as a male sterilization method, similar to the NSV technique. IVD male sterilization is expected to be a novel contraceptive method.

Analysis of adverse events with Essure hysteroscopic sterilization reported to the Manufacturer and User Facility Device Experience database.

STUDY OBJECTIVE: The Manufacturer and User Facility Device Experience database may be useful for clinicians using a Food and Drug Administration-approved medical device to identify the occurrence of adverse events and complications. We sought to analyze and investigate reports associated with the Essure hysteroscopic sterilization system (Conceptus Inc., Mountain View, CA) using this database. DESIGN: Retrospective review of the Manufacturer and User Facility Device Experience database for events related to Essure hysteroscopic sterilization from November 2002 to February 2012 (Canadian Task Force Classification III). SETTING: Online retrospective review. PATIENTS: Online reports of patients who underwent Essure tubal sterilization. INTERVENTION: Essure tubal sterilization. MEASUREMENTS AND MAIN RESULTS: Four hundred fifty-seven adverse events were reported in the study period. Pain was the most frequently reported event (217 events [47.5%]) followed by delivery catheter malfunction (121 events [26.4%]). Poststerilization pregnancy was reported in 61 events (13.3%), of which 29 were ectopic pregnancies. Other reported events included perforation (90 events [19.7%]), abnormal bleeding (44 events [9.6%]), and microinsert malposition (33 events [7.2%]). The evaluation and management of these events resulted in an additional surgical procedure in 270 cases (59.1%), of which 44 were hysterectomies. CONCLUSION: Sixty-one unintended poststerilization pregnancies were reported in the study period, of which 29 (47.5%) were ectopic gestations. Thus, ectopic pregnancy must be considered if a woman becomes pregnant after Essure hysteroscopic sterilization. Additionally, 44 women underwent hysterectomy after an adverse event reported to be associated with the use of the device.

3D ultrasound to assess the position of tubal sterilization microinserts.

BACKGROUND: The aim of this study was to assess the diagnostic accuracy of three-dimensional ultrasound (3D-US) for determining the position of Essure microinserts and the success of sterilization by the Essure method. METHODS: This retrospective observational study examined the case records of 311 women who underwent hysteroscopic sterilization from October 2002 through October 2008. Imaging with 3D-US or pelvic X-radiography or both was performed 3 months after the procedure to verify device position. Hysterosalpingography (HSG) was performed when a bilateral procedure was not completed because of a history of salpingectomy or blocked tube, when doubt persisted after 3D-US or pelvic radiography, or for comparative purposes in a prospective study. The positions seen on 3D-US were classified in four categories according to a specific scale we devised. RESULTS: The insertion procedure was completed in 94.2% patients. Only 90.5% underwent imaging verification of the device 3 months afterwards. In all, 227 3D-US, 175 pelvic radiography and 64 HSG imaging procedures were performed. Visualization of the device was possible in 99.6% of the 3D-US images. According to our classification, 3D-US was appropriate for assessing device position for 195 (85.9%) patients. The need for HSG confirmation was significantly lower with 3D-US than radiographic imaging (14.1 versus 26.8%, P = 0.001). 3D-US examinations, compared with the results of HSG as the reference test, had a sensitivity of 100% and a specificity of 76.6%. Neither pregnancy nor early expulsion occurred when 3D-US found that the devices were correctly placed. CONCLUSIONS: 3D-US is a simple technique for assessing the position of Essure(®) microinserts, even after concomitant endometrial surgery. The 3D-US classification presented here appears to make it possible to use HSG for back-up confirmation only when the microinsert is found in a very distal position on 3D-US and thus to protect the majority of women from the negative effects of pelvic radiography and HSG.

[The comparison of efficacy of female sterilization by modified Uchida technique and silver clips in China].

OBJECTIVE: To compare efficacy of female sterilization by modified Uchida technique and silver clips and to evaluate the influence on operation procedure and clinical effect with or without surgery training of service providers. METHODS: A comparative, multicenter clinical trial was performed in 18 county and township-level service centers. Totally 2198 women underwent sterilization from these 18 study center were divided into 1116 women sterilized by modified Uchida technique and 1082 women by silver clips. Those 18 centers were classified into 9 training groups which provide surgical skills of sterilization and other contents and 9 non training groups. Clinical documents of sterilization were recorded. All women were follow-up at 3, 6 and 12 months after surgery. RESULTS: There were no complications during surgery by both sterilization. The failure rate was 2.03% (22/1082) in silver clip method and the mean operative time were (12.4 ± 6.4) minutes in training group and (14.4 ± 8.1) minutes in non training group. In modified Uchida method, the failure rate was 0.18% (2/1116) and the mean operative time were (16.2 ± 4.9) minutes in training group and (19.0 ± 8.6) minutes in non training group. The mean operative time between two groups reached statistical difference (all P < 0.05). Total ended rate in modified Uchida technique were 2.2/hundred women year in training group and 2.5/hundred women year in non training group, and the rate of silver slips were 3.9/hundred women year and 4.8/hundred women year, which did not show significant difference (all P > 0.05). There was no significant difference in acceptability and side effects of all women between two methods (P > 0.05). The training of service providers could influence acceptability of women (P < 0.05). CONCLUSIONS: Clinical efficacy was not influenced by those two methods. The operative time and acceptability were improved by training surgeons in silver clips method.

Confirmation of Essure placement using transvaginal ultrasound.

STUDY OBJECTIVE: To evaluate the protocol for confirmation of satisfactory Essure placement using transvaginal ultrasound. DESIGN: Prospective multicenter cohort study (Canadian Task Force classification II-2). SETTING: Outpatient departments of 4 teaching hospitals in the Netherlands. PATIENTS: Eleven hundred forty-five women who underwent hysteroscopic sterilization using the Essure device between March 2005 and December 2007. INTERVENTION: Transvaginal ultrasound examination 12 weeks after uncomplicated successful bilateral placement or as indicated according to the transvaginal ultrasound protocol after 4 weeks, and hysterosalpingography (HSG) at 12 weeks to confirm correct placement of the device after 3 months. MEASUREMENTS AND MAIN RESULTS: The rate of successful placement was 88.4% initially. In 164 women (15%), successful placement was confirmed at HSG according the protocol. In 9 patients (0.84%), incorrect position of the device was observed at HSG. The cumulative pregnancy rate after 18 months was 3.85 per thousand women. CONCLUSION: Transvaginal ultrasound should be the first diagnostic test used to confirm the adequacy of hysteroscopic Essure sterilization because it is minimally invasive, averts ionizing radiation, and does not decrease the effectiveness of the Essure procedure.

A comparative study of female sterilization via modified Uchida and silver clip techniques in rural China.

OBJECTIVE: To compare the specific effects of 2 female sterilization methods: the modified Uchida technique and the application of silver clips. METHODS: A total of 2198 women living in rural areas who were still of reproductive age but opting for sterilization were enrolled. The participants were randomly divided into 2 groups, and underwent sterilization by either modified Uchida technique or silver clips. Information on acceptability, operation conditions, effectiveness, adverse effects, and complaints was collected 3, 6, and 12 months after the procedure. RESULTS: No significant difference in effectiveness, adverse effects or chief complaints between the 2 procedures was found. Differences in operative outcome, bleeding volume during the procedure, and operation time were found. CONCLUSION: A shorter operation time and less bleeding for the silver clip method indicated that female sterilization by this technique was as safe as that by modified Uchida technique.

[Ambulatory Essure implant placement sterilization procedure for women: prospective study comparing general anesthesia versus hypnosis combined with sedation]. / Étude prospective comparant l'hypnosédation et l'anesthésie générale pour la pose de dispositif de stérilisation intratubaire en ambulatoire.

OBJECTIVE: implant placement Essure, sterilization procedure for women, were performed under hypnosedation (HYP) and compared to the operative anxiety and analgesia of 12 patients operated-on under general anesthesia (GA). STUDY DESIGN: prospective and comparative group study. PATIENTS AND METHODS: two groups of twelve patients were matched and compared based on the choice of anesthetic technique: hypnotics (HYP) with possible additional sedation by propofol and remifentanil or GA involving propofol, sevoflurane and remifentanil. The assessment of anxiety and pain based on a visual analogy scale (0-10) and use of analgesics were studied in the recovery room and at discharge of hospital. The statistical analysis relies on nonparametric tests for paired data (Wilcoxon test). RESULTS: all patients were operated. The two groups are statistically comparable. The preoperative anxiety before premedication is lower in the HYP group (p<0.05). No conversion to general anaesthesia is necessary in the HYP group, but five patients were using sedatives drugs but doses are very low compared to general anaesthesia. The analgesic consumption was equivalent in both groups. CONCLUSION: we conclude that hypnosedation is a valuable alternative to traditional anesthetic techniques for ambulatory Essure implant. The use of hypnotic tool is an interesting alternative for the management of patients during invasive medical procedures or surgical, providing psychological benefits to the patient.

Efficacy of a novel educational curriculum using a simulation laboratory on resident performance of hysteroscopic sterilization.

OBJECTIVE: To assess whether a novel educational curriculum using a simulation teaching laboratory improves resident knowledge, comfort with, and surgical performance of hysteroscopic sterilization. DESIGN: An educational prospective, pretest/posttest study. SETTING: The Montefiore Institute of Minimally Invasive Surgery Laboratory. PATIENT(S)/SUBJECT(S): Thirty-four OB/GYN residents in an academic medical center. INTERVENTION(S): Hysteroscopic sterilization simulation laboratory and a brief didactic lecture. MAIN OUTCOME MEASURE(S): Differences in scores on validated skill assessment tools: Task specific checklist, Global Rating Scale (GRS), pass fail assessment, and a multiple-choice examination to evaluate knowledge and attitude. RESULT(S): In the entire cohort improvements were observed on all evaluation tools after the simulation laboratory, with 31% points (SD+/-11.5, 95% confidence interval [CI] 27.3-35.3) higher score on the written evaluation; 63% points (SD+/-15.7, 95% CI 57.8-68.8) higher score on the task specific checklist; and 54% points (SD+/-13.6, 95% CI 48.8-58.3) higher score on the GRS. Higher PGY status was correlated with better pretest performance, but was not statistically significant in posttest scores. Residents reported an improvement in comfort performing the procedure after the laboratory. CONCLUSION(S): Simulation laboratory teaching significantly improved resident knowledge, comfort level, and technical skill performance of hysteroscopic sterilization.

Subserosal misplacement of Essure device manifested by late-onset acute pelvic pain.

OBJECTIVE: To increase awareness of the potential to present with late-onset acute pelvic pain secondary to subserosal misplacement of an Essure device (Conceptus Inc., Mountain View, CA). DESIGN: Case report. SETTING: University-affiliated teaching hospital. PATIENT(S): A 30-year-old woman who was seen with severe left lower quadrant pain 4 months after elective sterilization with an Essure device placed under local anesthesia. Mild to moderate resistance was encountered in the placement of the device in the left fallopian tube. INTERVENTION(S): Hysterosalpingogram showing patency of the left fallopian tube and operative laparoscopy. MAIN OUTCOME MEASURE(S): Laparoscopic removal of the Essure device with left salpingectomy. RESULT(S): The patient was free of pain and was discharged home the same day of the laparoscopic procedure. CONCLUSION(S): This report reinforces the need to consider a misplaced Essure device in the differential diagnosis of late-onset acute pelvic pain in women who had difficult placement of the device.