Is There Still a Role for Sterilization by Tubal Ligation as a Contraceptive Method?

Tubal ligation has been used since the late nineteenth century to control undesired fertility in women. Over the years, there have been many improvements to the surgical technique, and the procedure has become a lot safer. Some recent developments, however, appear to make this procedure obsolete. In the first instance, there is now ample evidence that removing the Fallopian tubes rather than ligating them or closing them provides protection against developing ovarian carcinoma. The many surgical approaches and closure methods are therefore no longer appropriate. In the second instance, the use of long-acting reversible contraception has been shown to be as effective in preventing future pregnancy, more cost-effective and with even more health benefits than tubal ligation or tubectomy. This is especially true of the use of intrauterine levonorgestrel. The problem of regret and request for tubal ligation reversal, where that was performed, is eliminated as is the surgical concern of operating on older women with increased body mass index and medical co-morbidities.

The levonorgestrel-releasing intrauterine system 52 mg as a contraceptive versus a therapeutic: essential differences and perspectives.

BACKGROUND: It is 100 years since the discovery of oestrogen and nearly that since the discovery of progesterone. It is over 50 years since the concept of using intrauterine progesterone. Ten years after its synthesis, the research using levonorgestrel as an intrauterine agent was introduced. AREAS COVERED: The pharmacodynamics and pharmacokinetics of LNG-IUSs and the LNG-IUS 52 mg in particular explain why intrauterine LNG is so highly effective for contraception. When intrauterine LNG is used therapeutically it should ideally be based on clinical monitoring of the pathology being treated rather than a fixed time period While the LNG-IUS 52 mg is probably required for most medical conditions, consideration should be given for using the LNG-IUS 13.5 mg for hyperplasia and endometrial protection during oestrogen therapy and for older women who appear more prone to a low rate of LNG induced breast cancer, although there is not yet an official indication for this. CONCLUSION: The desire for fertility control, therapy for various genital pathological conditions and reduction of repeated endometrial decidualization and inflammatory breakdown and its consequences, and menopausal problems can be aided by intrauterine LNG. This review explains how a contraceptive also became a WHO listed essential medicine.

There are significant differences at many levels in the use of intrauterine levonorgestrel for contraception when compared to using it as a therapeutic.

The intrauterine device versus oral hormonal methods as emergency contraceptives: A systematic review of recent comparative studies.

Oral emergency contraceptives do not appear to be as effective as the copper IUD as an emergency contraceptive. There is as yet no estimation of the relative efficacy rates rather than the failure rates. The references for this study were obtained by entering the terms "intrauterine device" "and "emergency contraception" in Medline, PubMed, Popline, Global Health and ClinicalTrials.gov. Chinese references were obtained from the Wanfang database. For the short term study articles with a defined population who were followed up after the index cycle were eligible. Women who were adequately followed for at least 6 months were included in the long term study. There were 13(of 228) studies which met our selection criteria and were conducted between August 2011 and January 2019. There were 960 insertions of four types of copper IUD with a failure rate of 0.104%. There were 22 failures out of 1453 oral emergency contraception users with a failure rate of 1.51%. The relative risk of failure for an intrauterine device versus an oral method was 0.1376(95% CI -0.03-0.58). The 6 month to 12 month pregnancy rate was 0-6% for IUDs and 2.7-12% for oral methods. The copper IUD appears to be more effective than oral methods as an emergency contraceptive. The 6 to 12 month pregnancy rates after using either method is 4-10%. Emergency contraception is not a solution to unintended pregnancy.

Modern menstruation: Is it abnormal and unhealthy?

The menstrual cycle appears to have evolved in humans and some other species to improve reproductive efficiency by enabling progesterone production without the presence of the fetus. This phenomenon is termed spontaneous decidualization. Repeated menstruation is produced in modern women because of better general health and having fewer pregnancies later in life and limiting breast feeding. The repeated breakdown of a progesterone primed endometrium releases an inflammatory cascade which appears to have short and long term adverse consequences. Repetitive modern menstruation is no longer a sign of good general and reproductive health but a harbinger of possible future health problems. Cyclical menstruation has no intrinsic biological value or necessity in modern life. Spontaneous decidualization can be prevented by using estrogen-progestin combinations or progestins on their own. Newer and safer hormonal products are now available and should become even safer in the future. Hormonal suppression of spontaneous decidualization should be encouraged in adolescent and young women as a health promotional option.

The efficacy of intrauterine devices for emergency contraception and beyond: a systematic review update.

BACKGROUND: The copper intrauterine device (IUD) is a very effective form of emergency contraception. The failure rate is about 0.1%. IUDs are also very cost-effective when used as long acting-reversible contraception (LARC). The purpose of this review is to attempt to confirm these findings. METHODS: The references for this study were generated by entering the terms "intrauterine device" and "emergency contraception" in Medline, PubMed, Popline, Global Health and ClinicalTrials.gov. Chinese references were obtained from the Wanfang database. For the emergency contraception study, articles with a defined population who were followed up until outcome were eligible. Women who were adequately followed for at least 6 months were included in the long term arm of the study. RESULTS: There were 18 (of 228) studies which met our selection criteria and were conducted in five countries, between August 2011 and January 2018. There were 1720 insertions of seven types of copper IUD with a failure rate of 0.12%. The maximum time from intercourse to IUD insertion was 14 days. The discontinuation rate at 12 months was over 20% in the long term studies. CONCLUSION: There are now a combined total of 8550 reported insertions from two reviews with 8 pregnancies and a failure rate of 0.093%. Copper IUDs remain an effective form of emergency contraception, for which they are under-promoted. The major limitation of the studies is the lack of data relating unprotected intercourse to the day of the cycle.

Delivery of progestins via the subdermal versus the intrauterine route: comparison of the pharmacology and clinical outcomes.

INTRODUCTION: Subdermal and intrauterine progestin releasing systems are two types of long-acting reversible contraceptive systems (LARC). Their use has transformed current contraceptive practice management. There is not much objective evidence to help decide which method is preferable and in which particular circumstance using objective criteria. AREAS COVERED: MEDLINE, POPLINE, PubMed, and clinicaltrials.gov were searched using the terms "implant" vs "IUS" and then adding the terms "levonorgestrel" and "etonogestrel" to the implant arm and "levonorgestrel" to the IUS arm. This was done using commercial names as well for the terms "pharmacodynamics" and "pharmacokinetics" as well as for the term "therapeutic." Preference was given to comparative studies of the highest degree. EXPERT OPINION: Under normal circumstances, user satisfaction appeared marginally greater for intrauterine rather than subdermal progestin provision. However, after uterine events such as pregnancy or surgical evacuation of the uterus, implants performed better. Intrauterine progestin is preferable for therapeutic purposes.

Dimensional analysis of the endometrial cavity: how many dimensions should the ideal intrauterine device or system have?

BACKGROUND: The geometrical shape of the human uterus most closely approximates that of a prolate ellipsoid. The endometrial cavity itself is more likely to also have the shape of a prolate ellipsoid especially when the extension of the cervix is omitted. Using this information and known endometrial cavity volumes and lateral and vertical dimensions, it is possible to calculate the anteroposterior (AP) dimensions and get a complete evaluation of all possible dimensions of the endometrial cavity. These are singular observations and not part of any other study. METHODS: The AP dimensions of the endometrial cavity of the uterus were calculated using the formula for the volume of the prolate ellipsoid to complete a three-dimensional picture of the endometrial cavity. RESULTS: Calculations confirm ultrasound imaging which shows large variations in cavity size and shape. Known cavity volumes and length and breadth measurements indicate that the AP diameter may vary from 6.29 to 38.2 mm. These measurements confirm the difficulty of getting a fixed-frame intrauterine device (IUD) to accommodate to a space of highly variable dimensions. This is especially true of three-dimension IUDs. A one-dimensional frameless IUD is most likely to be able to conform to this highly variable space and shape. CONCLUSION: The endometrial cavity may assume many varied prolate ellipsoid configurations where one or more measurements may be too small to accommodate standard IUDs. A one-dimensional device is most likely to be able to be accommodated by most uterine cavities as compared to two- and three-dimensional devices.

Clarification of the role of the Jaydess(Skyla) LNG- IUS 13.5mg and Kyleena LNG-IUS 19.5mg as intrauterine contraceptive systems.

INTRODUCTION: Jaydess/Skyla and Kyleena are 'low dose' levonorgestrel releasing intrauterine systems(LNG-IUS). They differ from Mirena and other similar LNG-IUSs in terms of pharmacological properties and physical dimensions. There are currently no defined guidelines to decide when to use Jaydess or Kyleena or Mirena. Areas covered: MEDLINE, POPLINE, PubMed and clinicaltrials.gov were searched using the terms 'Jaydess', 'Skyla', LNG-IUS 13.5mg and 'Kyleena' LNG-IUS 19.5mg. Only clinical research articles as opposed to generalised reviews and opinion papers on the newer LNG-IUSs were considered for review. There were 10 clinical research articles and 11 clinical research abstracts relating to Jaydess/Skyla(LNG-IUS13.5mg) and Kyleena(LNG-IUS 19.5mg). All the studies were sponsored by the manufacturer. There were no independent clinical research studies. Expert commentary: The clinical research information from studies on Jaydess/Skyla and Kyleena does not adequately inform the clinician when and where these IUSs should be used in preference to other LNG-containing IUSs. The terminology used for describing the new low dose LNG-IUSs is inconsistent. The clinical differences between Jaydess, Kyleena and Mirena and the clinical differences in parity of subjects using Jaydess or Kyleena is used to generate an algorithm for helping clinicians choose between Mirena and Jaydess/Skyla or Kyleena.

Insertion of intrauterine devices after cesarean section: a systematic review update.

BACKGROUND: Women who undergo a cesarean section (CS) are in a unique position to receive the intrauterine contraceptive device (IUD). They may also want to use the IUD as a long-acting reversible contraceptive method provided the IUD is safe and effective in the presence of a CS scar. SEARCH STRATEGY: We researched and reviewed the MEDLINE, POPLINE, Google Scholar, and ClinicalTrials.gov databases from January 1968 to June 2015. SELECTION CRITERIA: Eligible studies reported event rates or practical problems relating to IUD usage in post-placental or interval insertion (>90 days) after CS. Studies with ≥20 subjects were included. DATA COLLECTION AND ANALYSIS: Analysis of eligible data collected from the search followed the PRISMA guidelines. MAIN RESULTS: Twelve eligible studies of post-placental IUD insertion after CS included four randomized controlled trials of post-placental versus delayed insertion. Women randomized to delayed insertion were less likely to receive a device. Six studies examined the problem of missing IUD threads at follow-up with only 30%-60% presence of strings observed. CONCLUSION: The IUD is a long-acting reversible contraceptive method that is suitable for use in all women undergoing CS. The problems of device expulsion, missing threads at follow-up, and the tendency of increased puerperal bleeding need to be solved. Solutions are proposed.

Intrauterine levonorgestrel delivery with frameless fibrous delivery system: review of clinical experience.

The concept of using a frameless intrauterine device (IUD) instead of the conventional plastic framed IUD is not new. Frameless copper IUDs have been available since the late 1990s. They rely on an anchoring system to retain in the uterine cavity. The clinical experience with these IUDs suggests that frameless IUDs fit better as they are thin and, therefore, do not disturb or irritate the uterus. High tolerance and continuation rates have been achieved as complaints of pain are virtually nonexistent and the impact on menstrual blood loss is minimal. Conventional levonorgestrel-releasing intrauterine systems (LNG-IUSs) are very popular as they significantly reduce menstrual bleeding and provide highly effective contraception. However, continuation of use remains problematic, particularly in young users. Total or partial expulsion and displacement of the LNG-IUS also occur too often due to spatial incompatibility within a small uterine cavity, as strong uterine contractions originate, attempting to get rid of the bothersome IUD/IUS. If not expelled, embedment ensues, often leading to chronic pain and early removal of the IUD/IUS. Several studies conducted recently have requested attention to the relationship between the LNG-IUS and the endometrial cavity. Some authors have proposed to measure the cavity width prior to inserting an IUD, as many uterine cavities are much smaller than the currently existing LNG-IUSs. A frameless fibrous drug delivery system fits, in principle, in all uterine cavities and may therefore be preferable to framed drug delivery systems. This review examines the clinical performance, acceptability, and potential of the frameless LNG-IUS (FibroPlant®) when used for contraception, treatment of heavy menstrual bleeding, dysmenorrhea, and endometrial suppression in women using estrogen replacement therapy, endometrial hyperplasia, and other gynecological conditions. The review concludes that FibroPlant LNG-IUS offers unique advantages in reducing side effects.

Results of a 5-year contraceptive trial in parous and nulliparous women with a new LNG-IUS.

OBJECTIVE: To report on the contraceptive performance and continuation of a new T-shaped LNG-IUS, releasing 20 µg of levonorgestrel/day, in both parous and nulliparous nulliparous women after 5 years of use. MATERIALS AND METHODS: An observational prospective contraceptive study conducted in parous and nulliparous women up to 48 years of age. RESULTS: The study was conducted in a sample size of 356 women of whom 67.1% were parous and 32.9% were nulliparous with mean age of 35.1 (range 15-48). The total cumulative observation period was 27 269 woman-months. Only one accidental pregnancy was observed and two expulsions were reported with no partial expulsions. There were 12.7% medical removals for abnormal bleeding, pain and other medical reasons, mostly not related to the use of the LNG-IUS, and 13.3% removals in women wishing to become pregnant. The discontinuation rate at 5 years amounts to 25.7% including women with pregnancy wish, who used the LNG-IUS for an average of 44 months. There were no serious adverse events (e.g. perforation, pelvic inflammatory disease). CONCLUSION: The LNG-IUS used in this study is highly effective and well tolerated resulting in a high continuation of use. The only two expulsions that occurred during the study is remarkable. The ease and safety of insertion together with optimal retention is considered an advance in intrauterine contraceptive device technology.

Current status of frameless anchored IUD for immediate intracesarean insertion.

Immediate postpartum intrauterine device (IUD) insertion deserves great attention as it can provide immediate, timely and convenient contraception plus the added benefit of preventing repeat unintended pregnancies. Although women post vaginal delivery can benefit from immediate post-placenta contraception, women undergoing Cesarean section clearly need contraception, as an inter-delivery interval shorter than 18 months places them at a high risk for uterine rupture. The main drawback of currently available framed IUD devices for immediate postpartum insertion of an IUD is their high expulsion and displacement rates when inserted immediately postpartum after both vaginal and Cesarean delivery. Current research suggests that a brief window of opportunity exists of 10 minutes for insertion of conventional IUDs after which time expulsion rates both immediately and over time are greatly enhanced. This paper summarizes the current research conducted to overcome the expulsion problems associated with conventional T-shaped devices as well as through the use of an anchored frameless device. In the 1970s and 1980s, attempts were made to solve the expulsion problem by modifying existing devices, such as adding absorbable sutures (Delta-T) or additional appendages. These attempts proved to be clinically unsuccessful as the catgut suture added to the transverse arms did not provide sufficient resistance to prevent downward displacement and expulsion. An anchoring technique to suspend a copper IUD to the fundus of the uterus was developed in Belgium in the 1980s and has been the subject of extensive ongoing clinical research since 1985. Recently the frameless copper releasing anchor IUD, GyneFix, has been tested for postplacental insertion. Initially, the anchor was modified by the inclusion of a biodegradable cone which was added below the anchoring knot. Clinical studies confirmed the adequacy of this approach suggesting that it was technically possible to anchor an IUD immediately following Cesarean section as well as after vaginal delivery with minimal incidence of expulsion. However, it was found that removal of the IUD was difficult in a number of women who requested early removal, due to the slow disintegration time of the cone. Based on these prior experiences, a new approach for anchoring of a frameless IUD immediately after delivery of the placenta was invented and developed specifically for use immediately post-Cesarean delivery. Beyond providing convenient and timely contraception the intended use allows a woman adequate time to recover from both the surgery and the burden of childbirth, while ensuring adequate future contraception. It is anticipated that it will also have an added benefit of allowing a greater number of women to have follow-on vaginal deliveries. The anchoring procedure is conducted under direct vision. It can be performed immediately after placental removal without the burden of timing restraints. It consists of the precise placement of the anchor of the frameless IUD immediately below the serosa of the uterus, followed by fixing the anchoring knot in place with a very thin absorbable suture. Early stage studies have confirmed the suitability and ease of use of this approach with additional clinical trials currently being conducted. The anchoring technique is easy, quick, safe and effective with no expulsions at 12 months. The method is considered a major advance, suitable for general use due to its simplicity requiring limited training.

Intrauterine systems: a frameless future?

INTRODUCTION: Intrauterine devices (IUD) are viewed as important contraceptive methodologies to prevent unintended pregnancy. AREAS COVERED: This expert opinion examines the place of frameless devices for use in young women in order to minimize side effect, improve patient comfort and maximize continuation of use to help reduce unintended pregnancies. EXPERT OPINION: Frameless designed IUDs have the ability to be used in both small and large uterine cavities of varied shapes and can significantly reduce abnormal bleeding, pain, embedment and expulsion and likely account for higher continuation rates than that seen with framed IUDs.

Practical Advice for Emergency IUD Contraception in Young Women.

Too few women are aware of the very high efficacy of intrauterine copper devices (IUDs) to prevent pregnancy after unprotected intercourse. Women who frequently engage in unprotected intercourse or seek emergency contraception (EC) are at high risk of unplanned pregnancy and possible abortion. It is therefore important that these women receive precise and accurate information about intrauterine devices as they may benefit from using an IUD for EC as continuing contraception. Copper IUDs should be used as first choice options given their rapid onset of action and their long-term contraceptive action which require minimal thought or intervention on the part of the user. In the United States, there is only one copper IUD presently available which limits treatment options. There are numerous copper IUDs available for use in EC, however, their designs and size are not always optimal for use in nulliparous women or women with smaller or narrower uteruses. Utilization of frameless IUDs which do not require a larger transverse arm for uterine retention may have distinct advantages, particularly in young women, as they will be suitable for use in all women irrespective of uterine size. This paper provides practical information on EC use with emphasis on the use of the frameless IUD.

No-needle, single-visit adult male circumcision with Unicirc: a multi-centre field trial.

BACKGROUND: Voluntary medical male circumcision (VMMC) is a priority HIV preventive intervention. Current adult circumcision methods need improvement. METHODS: Field trial in 3 primary care centres. Minimally invasive VMMC using the Unicirc instrument following topical lidocaine/prilocaine anesthetic. Men were followed up at 1 and 4 weeks. RESULTS: We circumcised 110 healthy volunteers. Two men complained of transient burning pain during circumcision, but none required injectable anaesthesia. Median blood loss was 1ml and median procedure time was 9.0 min. There were 7 (6.3%) moderate complications (5 (4.5%) post-operative bleeds requiring suture and 2 (1.8%) post-operative infections) affecting 7 men. No men experienced significant wound dehiscence. 90.4% of men were fully healed at 4 weeks of follow-up and all were highly satisfied. CONCLUSIONS: Use of topical anaesthesia obviates the need for injectable anesthetic and makes the Unicirc procedure nearly painless. Unicirc is rapid, easy to learn, heals by primary intention with excellent cosmetic results, obviates the need for a return visit for device removal, and is potentially cheaper and safer than other methods. Use of this method will greatly facilitate scale-up of mass circumcision programs. TRIAL REGISTRATION: ClinicalTrials.gov NCT02091726.

Expulsion and continuation rates after postabortion insertion of framed IUDs versus frameless IUDs - review of the literature.

BACKGROUND: Early intrauterine device (IUD) discontinuation after insertion immediately following aspiration abortion or after early medical abortion occurs as a consequence of expulsion of the IUD or removal due to side effects. These are often the consequence of the uterine forces impacting on the IUD due to spatial discrepancy with the uterine cavity causing pain, abnormal bleeding, and eventually, removal of the IUD. These women are candidates for repeat pregnancy as they often select less-effective methods or no contraception at all. Repeat abortion could be reduced by giving attention to these factors. STUDY DESIGN: In order to have an indication on the magnitude of the problem of IUD expulsion or discontinuation, we searched the MEDLINE database for clinical trials, randomized controlled trials, and prospective observational studies related to immediate postaspiration termination of pregnancy (TOP) and early medical abortion IUD insertion studies that reported IUD expulsion and IUD continuation rates. RESULTS: The search identified 17 clinical trials that were suitable based on the data they presented. The majority concerned T-shape IUDs, inserted immediately following surgical (aspiration) pregnancy termination. Two studies were conducted after medical TOP, and four studies were conducted with the frameless IUD inserted after surgical (vacuum aspiration) TOP. The results showed expulsion rates between 0.8% and 17.3% at 8 weeks, up to 5 years after insertion, respectively. In four studies with the frameless IUD, totaling 553 insertions, the expulsion rate was 0.0% in three of them. Follow-up in the latter studies varied between 5 weeks and 54 months. Reported continuation rates with conventional (framed) IUDs were between 33.8% and 80% at 1 year for studies providing 1 year rates and between 68% and 94.1% for studies reporting continuation rates at 6 months. Studies utilizing frameless IUDs reported 1 year continuation rate over 95%. CONCLUSION: Frameless IUDs, due to their attachment to the uterine fundus, appear to be better retained by the postabortal uterus when compared with conventional framed IUDs. The absence of a frame ensures compatibility with uterine cavity anatomical dimensions, and may therefore result in improved acceptability and continuation rates in comparison with framed IUDs. Both these characteristics of the frameless IUD could help reduce the number of repeat unwanted pregnancies and subsequent abortions in some cases.

Role of uterine forces in intrauterine device embedment, perforation, and expulsion.

BACKGROUND: The purpose of this study was to examine factors that could help reduce primary perforation during insertion of a framed intrauterine device (IUD) and to determine factors that contribute in generating enough uterine muscle force to cause embedment and secondary perforation of an IUD. The objective was also to evaluate the main underlying mechanism of IUD expulsion. METHODS: We compared known IUD insertion forces for "framed" devices with known perforation forces in vitro (hysterectomy specimens) and known IUD removal forces and calculated a range of possible intrauterine forces using pressure and surface area. These were compared with known perforation forces. RESULTS: IUD insertion forces range from 1.5 N to 6.5 N. Removal forces range from 1 N to 5.8 N and fracture forces from 8.7 N to 30 N depending upon device. Measured perforation forces are from 20 N to 54 N, and calculations show the uterus is capable of generating up to 50 N of myometrial force depending on internal pressure and surface area. CONCLUSION: Primary perforation with conventional framed IUDs may occur if the insertion pressure exceeds the perforation resistance of the uterine fundus. This is more likely to occur if the front end of the inserter/IUD is narrow, the passage through the cervix is difficult, and the procedure is complex. IUD embedment and secondary perforation and IUD expulsion may be due to imbalance between the size of the IUD and that of the uterine cavity, causing production of asymmetrical uterine forces. The uterine muscle seems capable of generating enough force to cause an IUD to perforate the myometrium provided it is applied asymmetrically. A physical theory for IUD expulsion and secondary IUD perforation is given.

Contraceptive needs of the adolescent.

The provision of contraception to adolescents requires specific attention. Adolescents require contraceptive methods which are safe, effective and simple to use. While long-acting reversible contraceptive methods are preferable, they should have a choice and not be forced or mandated especially in situations where this may compromise safety. After counselling they should have the ability to choose any method of contraception. Under the appropriate circumstances, each method of contraception may have a place. This chapter will be devoted to evaluating the most current scientific rationale for the indication for use of each method of contraception in adolescents.