Trends in Opioid Prescriptions after Laparoscopic Sterilization.

BACKGROUND AND OBJECTIVES: Examine trends in opioid prescriptions after laparoscopic sterilization over time, and identify any individual patient, provider, or procedural factors influencing prescribing. METHODS: A retrospective observational cohort analysis of laparoscopic sterilizations between January 1, 2016 and December 31, 2019 at Montefiore Medical Center. A review of the medical records was performed and information on patient demographics, comorbid conditions, and surgical characteristics were collected. The number of opioid pills prescribed postoperatively and any pain related patient calls, visits, or refills was recorded. RESULTS: Between January 1, 2016 and December 31, 2019, 615 laparoscopic sterilizations were performed. The median number of opioid pills prescribed was 10, ranging from 0 to 40. There was a significant decrease in the number of opioid pills prescribed (p < .0001) and refill incidence (p < .001) over time. Patients with a documented diagnosis of pelvic pain received significantly more opioid pills (p = .02), as did patients who underwent tubal occlusion versus salpingectomy (p = .01). There was no association between the number of opioid pills prescribed and other patient or procedural characteristics. Finally, the number of pills prescribed was not associated with urgent patient contact (p = .34). CONCLUSIONS: The overall number of opioid pills prescribed after laparoscopic sterilization decreased at our institution over time, which paralleled a decrease in refills and urgent postoperative patient contact. Further, few clinical characteristics influenced postoperative prescribing and there was no association between number of pills prescribed and urgent patient contact. These findings suggest excess prescribing and highlight the need to identify and adopt an evidenced-based approach to postsurgical opioid prescriptions.

Cats undergoing spay with medetomidine, ketamine and butorphanol develop arterial oxygen desaturation independent of surgical positioning and increased intraocular pressure in Trendelenburg position.

INTRODUCTION: This study observed the effects of three different surgical positions on arterial blood oxygenation measured noninvasively by pulse oximetry (SpO2) and on intraocular pressure (IOP) in anaesthetised cats undergoing spay. A total of 222 female feral cats were anaesthetised for a large-scale trap-neuter-return program with an intramuscular combination of medetomidine (0.03 - 0.05 mg/kg), ketamine (7 - 10 mg/kg) and butorphanol (0.4 mg/kg). Cats were randomly allocated to undergo spay in either Trendelenburg (70° downward head tilt), lateral or dorsal recumbency. SpO2 and pulse rate were measured at baseline, prior to surgical positioning, after one minute in surgical position and in one-minute intervals after surgical incision. Intraocular pressure was measured before positioning and at the end of surgery. At the end of surgery, all cats were placed into left lateral recumbency and all parameters were revaluated after five minutes. No significant differences between the three positions were found regarding SpO2, but an increase over time was observed. In total, 52 ± 10% (mean ± SD) of cats were hypoxaemic (SpO2 < 90%) at baseline. SpO2 improved over time, but 27 ± 3% (mean ± SD) of the cats remained hypoxaemic at the end of surgery. Trendelenburg position increased IOP during surgery (mean 31 ± 6 mmHg, individual max. 48 mmHg, versus 17 ± 4 mmHg in dorsal/lateral recumbency) but normalised after 5 mins in lateral recumbence. All cats recovered well from surgery and were released within 24 hours post-anaesthesia. Surgical position was shown to have no notable influence on SpO2 during anaesthesia in cats not receiving oxygen supplementation, whereas Trendelenburg position led to increased IOP. Oxygen supplementation is recommended with this anaesthetic protocol, as hypoxaemia is frequently observed.

INTRODUCTION: Dans cette étude, on a observé les effets de trois positions chirurgicales différentes sur l'oxygénation du sang artériel mesurée de manière non invasive par oxymétrie de pouls (SpO2) et sur la pression intraoculaire (PIO) chez des chattes anesthésiées subissant une stérilisation. Un total de 222 chattes sauvages ont été, dans le cadre d'un large programme de piégeage-castration-libération, anesthésiées avec une combinaison de médétomidine (0,03 à 0,05 mg/kg), de kétamine (7 à 10 mg/kg) et de butorphanol (0,4 mg/kg) par voie intramusculaire. Les chattes ont été réparties au hasard pour subir une stérilisation en Trendelenburg (inclinaison de la tête à 70 ° vers le bas), en décubitus latéral ou dorsal. La SpO2 et la fréquence du pouls ont été mesurées au départ, avant le positionnement chirurgical, après une minute en position chirurgicale et à des intervalles d'une minute après l'incision chirurgicale. La pression intraoculaire a été mesurée avant le positionnement et à la fin de la chirurgie. À la fin de la chirurgie, toutes les chattes ont été placées en décubitus latéral gauche et tous les paramètres ont été réévalués après cinq minutes. Aucune différence significative entre les trois positions n'a été constatée concernant la SpO2, mais une augmentation au fil du temps a été observée. Au total, 52 ± 10% (moyenne ± SD) des chattes étaient hypoxémiques (SpO2.

Associations between neutering and idiopathic epilepsy in Labrador retrievers and Border collies under primary veterinary care in the UK.

There are sparse published scientific data on associations between neutering and the severity and survival of dogs with idiopathic epilepsy. This study aimed to explore the timing of neutering with respect to onset of seizures in dogs with idiopathic epilepsy. Associations between neutering and both age of onset of seizures and the occurrence of cluster seizures or status epilepticus were examined. Survival analysis investigated the effects of sex-neuter categories. The median survival time of Border collies was compared with data previously reported in literature. The study included veterinary primary-care clinical data on 117 Labrador retrievers and 57 Border collies diagnosed with idiopathic epilepsy from the VetCompass project in the UK. The majority (74.2%; P≤0.001) of neutered cases were neutered before the onset of seizures. Age (years) at onset of seizures did not differ between dogs intact at time of onset and dogs neutered before onset of seizures (males 3.6 vs. 3.7; P=0.468 and females 3.4 vs. 4.1; P=0.154). Neuter status was not associated with the occurrence of cluster seizures (males P=0.947 and females P=0.844). Dogs intact at onset of seizures had longer median survival times than dogs neutered before onset of seizures (males, 1436 days vs. 1234 days; P=0.019; females, 1778.5 days vs. 1261 days; P=0.027). Median survival time of 1393 days for Border collies was longer than previously reported (P≤0.001). These results do not support recommendations to neuter dogs with idiopathic epilepsy within an evidence-based treatment plan.

Contraception.

Contraception counseling and provision are vital components of comprehensive health care. Unplanned pregnancy can be devastating to any woman but is particularly dangerous for those with chronic illness. Internal medicine providers are in a unique position to provide contraception, as they often intersect with women at the moment of a new medical diagnosis or throughout care for a chronic problem. A shared decision-making approach can engage patients and ensure that they choose a contraceptive method that aligns with their reproductive plans and medical needs.

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.

Infection prevention preparedness and practices for female sterilization services within primary care facilities in Northern India.

BACKGROUND: In 2014, 16 women died following female sterilization operations in Bilaspur, a district in central India. In addition to those 16 deaths, 70 women were hospitalized for critical conditions (Sharma, Lancet 384,2014). Although the government of India's guidelines for female sterilization mandate infection prevention practices, little is known about the extent of infection prevention preparedness and practice during sterilization procedures that are part of the country's primary health care services. This study assesses facility readiness for infection prevention and adherence to infection prevention practices during female sterilization procedures in rural northern India. METHOD: The data for this study were collected in 2016-2017 as part of a family planning quality of care survey in selected public health facilities in Bihar (n = 100), and public (n = 120) and private health facilities (n = 97) in Uttar Pradesh. Descriptive analysis examined the extent of facility readiness for infection prevention (availability of handwashing facilities, new or sterilized gloves, antiseptic lotion, and equipment for sterilization). Correlation and multivariate statistical methods were used to examine the role of facility readiness and provider behaviors on infection prevention practices during female sterilization. RESULT: Across the three health sectors, 62% of facilities featured all four infection prevention components. Sterilized equipment was lacking in all three health sectors. In facilities with all four components, provider adherence to infection prevention practices occurred in only 68% of female sterilization procedures. In Bihar, 76% of public health facilities evinced all four components of infection prevention, and in those facilities provider's adherence to infection prevention practices was almost universal. In Uttar Pradesh, where only 55% of public health facilities had all four components, provider adherence to infection prevention practices occurred in only 43% of female sterilization procedures. CONCLUSION: The findings suggest that facility preparedness for infection prevention does play an important role in provider adherence to infection prevention practices. This phenomenon is not universal, however. Not all doctors from facilities prepared for infection prevention adhere to the practices, highlighting the need to change provider attitudes. Unprepared facilities need to procure required equipment and supplies to ensure the universal practice of infection prevention.

Uretero-fallopian fistula after hysteroscopy fallopian tube embolization: a case report.

BACKGROUND: Uretero-fallopian fistula (UFF) is a very rare surgery complication which usually happens after surgeries of fallopian tube or ureter. There has been no report of interventional operations of fallopian tube causing UFF. CASE PRESENTATION: A 41-year-old female received fallopian tube embolization for birth control. After that she noticed "clear vaginal discharge". She neglected that symptom for 7 years, until a sudden onset of abdominal pain brought her to the ER. Retrograde ureterogram confirmed UFF and revealed severe hydronephrosis of the left kidney. She received left nephrectomy afterwards and recovered well, with no urine leakage from her vagina. CONCLUSION: UFF could be caused by interventional operations of fallopian tube, and could lead to severe consequences. The application of fallopian tube embolization should be carefully controlled.

Surgical Management After Hysteroscopic Sterilization: Minimally Invasive Approach Incorporating Intraoperative Fluoroscopy for Symptomatic Patients with >2 Essure® Devices.

OBJECTIVE: To describe a non-hysterectomy surgical technique for symptomatic patients with >2 Essure® (Bayer Healthcare, Whippany, New Jersey) devices. DESIGN: Patients (n=4) presented with sharp pelvic pain, irregular vaginal bleeding, dyspareunia, weight gain, hair loss, fatigue, and/or diffuse skin rash, all of which were absent before undergoing hysteroscopic sterilization (HS). Hysterosalpingogram obtained before surgical excision of contraceptive tubal implants confirmed more than two Essure® devices in all patients. Except for HS-associated complaints, all patients were in otherwise good general health and none had any history of prior pelvic pathology. Hysteroscopy was followed by 5mm triple-port laparoscopic cornual dissection, modified partial bilateral salpingectomy, and foreign body removal under fluoroscopy and/or radiographic guidance. RESULTS: In this group, mean±SD patient age was 41±8yrs and interval between HS and device removal was 6.4±2.7yrs. At the conclusion of each case (mean±SD operative time=179±11min), imaging studies were reviewed by an attending radiologist and verified no retained metal in the abdomen. Conversion to laparotomy, hysterectomy, or blood transfusion was unnecessary for any patients, and all were discharged home within three hours. Their postoperative course continues to be satisfactory. CONCLUSION: Patients with more than two Essure® devices comprise an unusual group with a complex pelvic foreign body presentation. This is the first report on surgical management for such patients, underscoring the importance of localizing these contraceptive devices with careful imaging before, during, and after surgery. Moreover, hysterectomy is not absolutely mandatory in this setting and intraoperative fluoroscopy/radiography can facilitate complete, safe removal of all implants on an out-patient basis. Creation of ICD-10 modifiers for various post-HS complaints would allow for improved surveillance of the Essure® phenomenon.

Laparoscopic ovariectomy in eastern grey kangaroos (Macropus giganteus) and red kangaroos (Macropus rufus).

OBJECTIVE: To develop a technique for permanent sterilisation of female eastern grey kangaroos (Macropus giganteus) and red kangaroos (M. rufus) as part of a large-scale macropod management program on an enclosed 1545-ha site in western Sydney. METHODS: Free-ranging female kangaroos (n = 1409: 1285 eastern grey kangaroos, 124 red kangaroos) were anaesthetised via remote anaesthetic drug delivery of tiletamine/zolazepam, medetomidine and acepromazine prior to inhalational anaesthesia using isoflurane-oxygen. A laparoscopic ovariectomy technique was developed using standard laparoscopic equipment to effect permanent sterilisation of the kangaroos. The technique described was also adapted for use on immature animals weighing as little as 1 kg. No direct post-surgical care was provided once the animals had recovered from the anaesthetic. RESULTS: The procedure was simple to perform and had a very high success rate, with an overall project mortality rate of 2.13% (n = 30). Seven kangaroos (0.05% of all operated kangaroos) were euthanased as a direct result of the surgical procedure. Surgical complications were rare but included inadvertent gastrointestinal tract puncture with the trocar, intraoperative haemorrhage and subcutaneous emphysema leading to pouch eversion following surgery. CONCLUSION: The procedure described is a rapid and effective method of permanent fertility control in macropods and carries a low mortality rate.

Interval Female Sterilization.

Female sterilization is relied on by nearly one in three women aged 35-44 years in the United States. Sterilization procedures are among the most common procedures that obstetrician-gynecologists perform. The most frequent sterilization procedures include postpartum tubal ligation, laparoscopic tubal disruption or salpingectomy, and hysteroscopic tubal occlusion. The informed consent process for sterilization is crucial and requires shared decision-making between the patient and the health care provider. Counseling should include the specific risks and benefits of the specific surgical approaches. Additionally, women should be counseled on the alternatives to sterilization, including intrauterine contraceptives and subdermal contraceptive implants. Complications, including unplanned pregnancy after successful female sterilization, are rare. The objectives of this Clinical Expert Series are to describe the epidemiology of female sterilization, access to postpartum sterilization, advances in interval sterilization techniques, and clinical considerations in caring for women requesting sterilization.

"Forgotten" Chapters in the History of Transcervical Sterilization: Carl Clauberg and Hans-Joachim Lindemann.

Transcervical sterilization is a non-surgical method of permanent female sterilization that is widely used and critically discussed. A review of the historiography of the method reveals that instances of its coercive use are not included in the historical account. This study offers a reexamination of the work of Carl Clauberg and Hans-Joachim Lindemann, to more deeply contextualize within the framework of current usage the coercive use of transcervical sterilization during the Third Reich and in postwar Germany. This inquiry is based on postwar criminal trial records on Clauberg, and on archival documents detailing Lindemann's activities in 1979. A comparative analysis examines arguments by medical historian Karl-Heinz Roth, and identifies shared characteristics and differences between Clauberg and Lindemann, their methods and scientific connections. The results demonstrate that the technique of transcervical sterilization has an abusive potential that may be explained as a function of the person of the physician, of the scientific method itself, and of societal and political influences. The analysis supports the argument that insights from the cases of Clauberg and Lindemann are transferrable geographically and over time, and have the potential to inform current medical practice, such as transcervical sterilization with the Essure device, whose historiographic exploration remains a desideratum.

Current techniques and outcomes in hysteroscopic sterilization: current evidence, considerations, and complications with hysteroscopic sterilization micro inserts.

PURPOSE OF REVIEW: To describe the current data regarding effectiveness, complications, postoperative evaluation, and surgical interventions associated with Essure hysteroscopic sterilization. RECENT FINDINGS: Hysteroscopic sterilization is a commonly performed procedure that is offered as a well tolerated, effective, outpatient method of permanent sterilization. Over the past several years, concerns have been raised regarding correct placement and postoperative complications. This has led to statements by both the Food and Drug Administration (FDA) in October, 2016 and American Association of Gynecologic Laparoscopists in February, 2017, as a significant portion of women seek removal of these devices. A current black-box warning issued by the FDA in 2016 recommends discussion of 'the probabilities of rates or events' of adverse outcomes associated with Essure placement. SUMMARY: Although hysteroscopic sterilization is usually a safe, effective option for permanent contraception, new evidence regarding complications has emphasized the need for proper education and counseling. Appropriate patient selection and knowledge of potential complications is paramount to ensuring patients, and medical providers are well informed and have realistic expectations regarding potential placement and postoperative issues.

Outcomes of Elective Outpatient Hysteroscopic Sterilization in Undocumented Women: A Retrospective Analysis.

OBJECTIVE: To determine the feasibility of hysteroscopic sterilization in low-income and unauthorized immigrant women when financial barriers to care are removed. METHODS: Outpatient hysteroscopic sterilization for low-income women at an urban clinic was made possible by grant funding. All procedures were performed by obstetrician/gynecologist attending physicians or supervised trainees. Electronic records were reviewed for cases performed from June 2010 to December 11, 2013. Outcome incidences and complications were determined. Subgroup analyses using demographic and clinical factors were performed. RESULTS: Hysteroscopic sterilization was attempted in 197 patients. Most were Hispanic (93%) and undocumented immigrants (83%). Bilateral placement was achieved on first attempt in 92% (181/197). Successful placement was ultimately achieved in 96% (190/197), and 88% (168/190) returned for hysterosalpingogram (HSG). Appropriate tubal occlusion was documented on 96% (161/168) of HSGs with mean time of 3.5 ± 1.3 months. Repeat HSG at 6 months showed 100% occlusion (7/7). Of the initial cohort, 85% (168/197) could ultimately rely on Essure for contraception. One pregnancy was self-reported 9 months after the procedure; the patient had not followed up for HSG. There were no pregnancies among those who completed follow-up. There were no cases of procedural complications. Successful Essure placement was not associated with age, parity, immigration status, or clinical characteristics (analgesics administered, history of cesarean section, vaginal delivery, cervical surgery, ectopic, fibroids, or pelvic inflammatory disease). The only factor positively associated with HSG follow-up was age 35 years or younger (53% vs. 47%; p = .03). CONCLUSIONS: Successful hysteroscopic sterilization can be achieved in an undocumented, low-income population. Rates of confirmatory HSG follow-up were found to be higher than in the general population. Public funding of programs could decrease unintended pregnancies and pregnancy-related costs.

Medicolegal Review: Essure Lawsuits and Legal Strategies Adverse to Gynecologists.

The minimally invasive Essure procedure for hysteroscopic sterilization is an ongoing target for litigation. Although efficacious, this device has been scrutinized by the US Food and Drug Administration (FDA) owing to alleged complications. Patients affected by these potential complications are filing lawsuits against Bayer, the manufacturer of Essure. Many of these lawsuits have been barred by preemption, a legal doctrine that limits what can be required of a product by state lawsuits once the FDA approves it; however, in the lawsuits that have been allowed to proceed, the manufacturer has used a legal strategy termed the "learned intermediary doctrine" in an effort to shift blame to the gynecologist to absolve itself of liability. The learned intermediary only requires that a manufacturer inform the gynecologist of the risks associated with the device, and the gynecologist, in turn, must notify the patients through adequate informed consent. To incorporate the necessary components of informed consent, a gynecologist should include what a reasonable practitioner would consider pertinent to the discussion, as well as what a prudent patient would want to know to make a treatment decision. This disclosure entails explaining the risks, benefits, and alternatives, which should be clearly documented in the medical records. Understanding the importance of proper documentation and the legal strategies used in suits will help gynecologists lessen liability exposure when using a medical device, such as Essure, that is being targeted for litigation.

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.

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.

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.

Systemic Lidocaine Fails to Improve Postoperative Pain, But Reduces Time to Discharge Readiness in Patients Undergoing Laparoscopic Sterilization in Day-Case Surgery: A Double-Blind, Randomized, Placebo-Controlled Trial.

BACKGROUND AND OBJECTIVES: Perioperative systemic lidocaine provides postoperative analgesia, decreases opioid consumption, and facilitates rehabilitation in abdominal surgery. We hypothesized that systemic lidocaine has analgesic effects in women undergoing day-case laparoscopic sterilization. METHODS: Eighty women were randomized in this prospective, double-blind trial to receive either lidocaine (intravenous bolus of 1.5 mg/kg at induction of anesthesia, followed by an infusion of 1.5 mg · kg · h, which was continued until 30 minutes after arrival at the postanesthesia care unit [PACU]) or placebo. The primary end point was the proportion of patients with a numeric rating scale (NRS) of greater than 3, 30 minutes after arrival at the PACU. Secondary outcomes included total opioid consumption, postoperative pain scores, incidence of postoperative nausea and vomiting, and time to readiness for discharge. This clinical trial was registered (Eudra CT 2011-001315-31). RESULTS: Thirty minutes after PACU admission, the proportion of patients with an NRS score of greater than 3 did not differ between the groups (lidocaine group: 59% vs placebo group: 58%). The postoperative NRS for pain over the entire observation period was not significantly different between lidocaine and placebo groups (mean, 3.1 [SD, 0.7] vs 2.8 [SD, 0.6]; P = 0.4). Groups did not differ with respect to perioperative opioid consumption. Patients in the placebo group suffered significantly less from nausea (NRS: 0.1 [SD, 0.1] [placebo] vs 0.3 [SD, 0.1] [lidocaine]; P = 0.02) and required less postoperative nausea and vomiting rescue medication (1 patient in the placebo group vs 7 in the lidocaine group; P = 0.03). The time to meet hospital discharge criteria was significantly lower in the lidocaine group (median, 177 minutes [range, 96-408 minutes] vs 221 minutes [range, 121-420 minutes]; P = 0.02). The mean lidocaine plasma levels at the end of IV lidocaine infusion was 2.5 (SD, 1.1) µg/mL. CONCLUSIONS: In laparoscopic sterilization, systemic lidocaine reduces time to readiness for hospital discharge.