The intrauterine device and the intrauterine system.

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Best Practice & Research Clinical Obstetrics and Gynaecology xxx (2014) 1e18

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Best Practice & Research Clinical Obstetrics and Gynaecology journal homepage: www.elsevier.com/locate/bpobgyn

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The intrauterine device and the intrauterine system

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E. Stephen Searle, FFRSH

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Sexual Health Services, Derbyshire Community Health Services, Chesterfield, S40 2AB, UK

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Keywords: intrauterine device IUD intrauterine system IUS cost-effectiveness of intra-uterine contraception training in intrauterine techniques intrauterine contraception in developing countries

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Introduction

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Intrauterine contraception is used by about 100 million women worldwide, making it the most popular form of fertility regulation. In UK community contraception clinics, however, long-acting reversible contraception has increased to 28% of users, and intrauterine contraception accounts for only 8% of methods used by women accessing these services. Potential exists to increase uptake of these more effective methods. In this chapter, we review the clinical advantages, disadvantages and cost-effectiveness of intrauterine contraception. We discuss the management of complications along with advice for trainers, and briefly consider issues in developing countries. © 2014 Published by Elsevier Ltd.

Intrauterine contraceptives (IUCs) are the most widely used contraceptive methods in the world. The two most common models currently in use are the 10-year banded copper intrauterine device and the levonorgestrel-releasing intrauterine system (LNG-IUS). National Guidance recommends greater use of long-acting reversible contraception (LARC) [1], as this would reduce unwanted pregnancies. The four LARC methods are the implant, the intrauterine device (IUD), the intrauterine system (IUS), and the injections. They are all more cost-effective than oral contraception even at 1 year of use. This is because although pills and condoms have low initial costs compared with the high ‘up-front’ costs of the IUS and implant, the much lower user failure rates of the LARC methods mean the costs of fewer unwanted pregnancies offset the cost of the drugs. These low failure rates are similar in women over and under the age of 21 years. They are safe, with few side-effects, have a high continuation rate, and can be used irrespective of age or parity. Many healthcare professionals discourage the use of these

E-mail addresses: [email protected], [email protected].

http://dx.doi.org/10.1016/j.bpobgyn.2014.05.004 1521-6934/© 2014 Published by Elsevier Ltd.

Please cite this article in press as: Stephen Searle E, The intrauterine device and the intrauterine system, Best Practice & Research Clinical Obstetrics and Gynaecology (2014), http://dx.doi.org/10.1016/ j.bpobgyn.2014.05.004

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E. Stephen Searle / Best Practice & Research Clinical Obstetrics and Gynaecology xxx (2014) 1e18

devices by adolescents, young women and nulligravidas, although the World Health Organization (WHO) makes no restrictions on the use of IUCs. They are an excellent tool for preventing unplanned pregnancy, and should be considered as a first-line contraceptive choice for any woman with no medical contraindications [2]. History Many stories have been documented of various objects being inserted into the uterus to prevent pregnancy. These include stones in the uteri or vaginae of camels, gold balls, wedding rings, rings made of silkworm gut, later wound with silver or silverecopper alloy being used for contraception. These are now made of coiled stainless steel and called a Grafenberg ring (Fig. 1c), which are widely used in China These usually have no thread, presumably as they were intended as a lifetime method not to be removed after the birth of the first child. They can be removed with a simple, small uterine hook. Wider acceptance of the method was eventually achieved with the Lippes Loop (Fig. 1b) in 1962. One of these inert devices could be left in situ until past the menopause, without replacement, and so was often popular with multiparous women. Modern bioactive devices have a licensed period of use, after which it is recommended that they are replaced, but they are smaller than the old inert devices, and so may cause less pain and bleeding problems. Modern intrauterine methods are much improved from the older devices. Early IUDs, such as the Dalkon Shield (Fig. 1a), were associated with severe pelvic inflammatory disease and tubal infertility. This was caused by infection spreading up the multi-filament threads into the uterus. Even though other IUDs do not have this problem, the Dalkon Shield litigation resulted in regions, especially in the USA, where women were denied IUDs for decades. Currently, around 150 million women worldwide use the newer IUDs and IUS, but potential still exists for much wider use if myths can be overcome and training is provided for health professionals. Types of devices Intrauterine methods include the framed copper-bearing devices (Cu-IUDs), which can be ‘banded’ (i.e. have extra Cu bands on the arms, or un-banded) (Fig. 2). In addition, frameless Cu intrauterine implants (Cu-IUIs) (Fig. 3), and the levonorgestrel-releasing system (LNG-IUS) (Figs. 4 and 5) are available. Copper-bearing devices (Cu-IUDs) can be ‘banded’ (i.e. have extra Cu bands on the arms) or un-banded. Only the copper devices are used for emergency contraception. Fertility resumes normally after removing THE Cu-IUD or LNG-IUS [3]. Clinical features, advantages and disadvantages of the intrauterine device compared with the intrauterine system Eligibility to use intrauterine contraception The IUD and IUS are effective and safe for most women, with a few exceptions, as detailed in the UK Medical Eligibility Criteria [2,4]: Postpartum, the normal policy is to delay insertion of the IUD and IUS until 4 weeks postpartum. This is to allow for involution of the uterus. Although immediate postpartum insertion up to 48 h after delivery has been suggested, this may result in high expulsion rates. Women with current venous thromboembolism who are taking anticoagulants need reliable contraception, as pregnancy would be particularly risky. Oestrogen-containing methods are clearly contraindicated, so LARC methods are a preferred choice. Intrauterine devices are a possibility but the anticoagulant may cause menorrhagia. The IUS should overcome this problem as no clinically significant interaction occurs between anticoagulants and the progestogen in the IUS. Known or suspected pregnancy is a contraindication, but that should not prevent ‘quick-starting’ [5] the intrauterine methods on the day of presentation or with emergency contraception, provided reasonable efforts are made to exclude pregnancy, and the woman is followed up in 3 weeks to confirm non-pregnancy. Please cite this article in press as: Stephen Searle E, The intrauterine device and the intrauterine system, Best Practice & Research Clinical Obstetrics and Gynaecology (2014), http://dx.doi.org/10.1016/ j.bpobgyn.2014.05.004

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Fig. 1. Various current and historical Intrauterine devices.

Intrauterine contraception are only contraindicated in cases of pelvic inflammatory disease, septic abortion, purulent cervicitis, or puerperal sepsis until the infection is fully resolved. Thereafter, intrauterine contraception are a good choice with safer sex precautions. Unexplained vaginal bleeding should be investigated (as with all contraception) before inserting intrauterine methods. After gestational trophoblastic disease, beta hCG levels should have returned to normal before IUD or IUS insertion. Similarly, cervical cancer should have been treated before insertion. Please cite this article in press as: Stephen Searle E, The intrauterine device and the intrauterine system, Best Practice & Research Clinical Obstetrics and Gynaecology (2014), http://dx.doi.org/10.1016/ j.bpobgyn.2014.05.004

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Fig. 2. Examples of framed Copper bearing intrauterine devices available in the UK, from left to right: The unbanded Flexi-T; Multiload 375 and Nova-T 380 and the banded Gynae-T 380. (Alternative banded Cu-IUDs include the T-Safe 380.)

Anatomical abnormalities of the uterus, such as full or partial bicornuate uterus or fibroids, are relatively common. The IUS may help to treat heavy menses caused by fibroids but, where distortion of the uterine cavity has occurred, contraception may be compromised. Ischaemic heart disease, migraine with aura, breast cancer and severe liver disease are all UKMEC 1 (unrestricted use) for Cu-IUDs, but specialist advice should be sort for the IUS. In Wilson's disease, CuIUDs are probably not recommended, although little evidence is available. For all other medical conditions, the benefits of intrauterine methods outweigh any risks. This includes teenagers who

Fig. 3. The Intrauterine implant Gyne-fix330 shown in a foam model uterus, which is useful for training.


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Fig. 4. The Levonorgestrel Intra-Uterine System (LNG-IUS) Mirena.

especially need safe, effective, user-friendly contraceptive methods. Adolescent users of IUC have been shown to have low failure and high continuation and satisfaction rates. In the case of the LNG-IUS, adolescents can also benefit from a decrease in menorrhagia and dysmenorrhea. An evidence-based review in the USA concluded that IUDs are a safe and effective option for adolescents, and provide an additional contraceptive option for nurse practitioners as well as doctors to offer their patients to prevent unintended pregnancy and enhance adolescent sexual health and well-being [6]. In contrast, oral contraceptive pills, the patch, and the contraceptive vaginal ring have significantly higher contraceptive failure rates, and these rates are magnified in young women [7]. Therefore, LARC methods should be considered first-line options for teenagers seeking contraception.

Fig. 5. The Levonorgestrel Intra-Uterine System (LNG-IUS) Mirena.


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What clinicians need to assess when a woman is considering intrauterine contraception Sexual history should identify women at risk of sexually transmitted infections (STIs), for whom an infection screen is appropriate [8]. Many clinicians are reluctant to offer intrauterine methods to young or nulliparous women. This is due, partly, to concerns about infections and also about difficulty with insertion (addressed below). Although infection increases slightly in the first 20 days after insertion [9], thereafter the risk does not increase. It would be prudent for those at higher risk of STIs, such as women aged younger than 25 years, and those with a new sexual partner, to promote safer sex and encourage partners to be screened for STIs. These concerns should not be allowed to deny such women the choice of intrauterine methods. In asymptomatic women, other vaginal infections, such as candida, bacterial vaginosis, or Group B streptococcus do not need to be tested or treated. If results are unavailable when the woman presents for insertion, there is no need to delay insertion. Prophylactic antibiotics should be considered for women at high risk of STIs, such as rape victims or young teenagers with multiple partners. Such prophylaxis is no longer recommended for women with congenital heart defects, prosthetic heart valves, or a history of endocarditis. Women should undergo a bimanual vaginal examination to assess the pelvis. Information and counselling Clinicians should focus on the best clinical care of the patient while being mindful of the importance of clear medical records. Rather than overwhelm patients with information, it is better to concentrate on the concerns of the individual woman in the consultation. Mode of action Copper is toxic to ova and sperm. Hence, the primary action of Cu-IUDs is inhibition of fertilisation [10]. In addition, the endometrial inflammatory reaction inhibits implantation. As pregnancy does not begin until implantation, IUDs do not work by causing an abortion [11]. LNG-IUS works by releasing progesterone onto the endometrium, which prevents implantation [12]. In addition, within 1 month of insertion, the endometrium atrophies and sperm penetration through the cervical mucus is reduced. These two effects have the added benefits of reduced menstruation and lowered risk of pelvic inflammatory disease (PID), as pathogens as well as sperm are less likely to ascend into the uterus. Around 80% of women continue to ovulate with the LNG-IUS [13]. Contraceptive efficacy Banded Cu-IUDs (i.e. with copper bands on the arms as well as fine copper wire the stem) are more effective than non-banded IUDs [14]. The failure rate is 1e2% at 5 years. The most effective Cu-IUDs contain 380 mm [2] of copper [15]. The failure rate of the LNG-IUS is either similar or more effective than the best Cu-IUDs, at less than 1% at 5 years [9,16]. Duration of use Complications are associated more commonly with insertion and reinsertion. Therefore, to minimise the risks of expulsion, infection and perforation, IUDs with the longest duration of use are preferred. The banded devices (e.g. T-Safe Cu 380A QL or TT 380) are mostly licensed for 10 years. Other Cu-IUDs and the LNG-IUS are licensed for 5 years. The latter is also licensed for menorrhagia for 5 years and for endometrial protection with oestrogen-only HRT for 4 years. In the UK, it is accepted practice that a Cu-IUD inserted over the age of 40 years can be retained until the woman has passed the menopause [17]. Perimenopausal women are likely to be reassured when informed that if a LNG-IUS is inserted from the age of 45 years, they can continue with the same IUS until the menopause can be confirmed [6]. Please cite this article in press as: Stephen Searle E, The intrauterine device and the intrauterine system, Best Practice & Research Clinical Obstetrics and Gynaecology (2014), http://dx.doi.org/10.1016/ j.bpobgyn.2014.05.004

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Side-effects Menstrual bleeding and pain Menstrual bleeding and pain are the most common reasons for discontinuation of IUC. Insertion can be uncomfortable or painful, although 50% of women experience no or little pain at insertion [18]. Spotting, light bleeding, heavier or longer menstruation is common in the first 3e6 months after Cu-IUD insertion. These patterns are not harmful and usually decrease with time. The LNG-IUS is typically associated with transient menstrual disturbance during the first few months of use, but this usually settles with continued use, with concomitant decrease in menstrual blood loss. Overall, the safety profile of the LNG-IUS has been well established across a wide population of women, and the available data do not suggest that the LNG-IUS adversely affects bone health or increases the risk of adverse cardiovascular events or breast and uterine cancers [19]. With the LNGIUS, complete amenorrhoea occurs in about 25% of users, whereas a further 40% have light periods. When a women experiences ongoing pain with a framed Cu-IUD, possibly owing to the arms in the uterine cornu, some clinicians try a frameless Cu-IUI. Trials have, however, failed to find statistical differences with different Cu-IUDs. Hormonal side-effects Although a few women report symptoms resulting from low systemic absorption of levonorgestrel, no significant differences in acne, headaches, breast tenderness, nausea, mood, libido or weight gain were observed between women using the LNG-IUS and the Cu-IUD [20]. Ovarian cysts No consistent evidence has shown that ovarian cysts are more common with the LNG-IUS compared with Cu-IUDs. Most ovarian cysts are asymptomatic and resolve spontaneously. Non-contraceptive benefits The endometrial protection offered by the LNG-IUS for women on oestrogen only hormone replacement therapy allows women to avoid the side-effects of systemic progestogen. In addition, the LNG-IUS is the most effective medical treatment for menorrhagia. Heavy menstrual bleeding is a common problem in women of reproductive age, and can cause irritation, inconvenience, self-consciousness, and fear of social embarrassment. The LNG-IUS consistently reduces menstrual blood loss in women with heavy menstrual bleeding, including those with underlying uterine pathology or bleeding disorders. The available data suggest that it reduces menstrual blood loss to a greater extent than other medical treatments, including combined oral contraceptives, oral progestogens (both short- or long-cycle regimens), tranexamic acid, and oral mefenamic acid [21]. In addition, the LNG-IUS and endometrial ablation seem to reduce menstrual blood loss to a similar extent. The adverse effects reported with the LNG-IUS in women with heavy menstrual bleeding are similar to those typically observed in women using the system for contraception. Expulsion rates may be higher in women with heavy menstrual bleeding than in the general population of LNG-IUS users. Overall, the LNG-IUS has a positive effect on most quality-of-life domains, at least comparable to those achieved with hysterectomy or endometrial ablation, and is consistently a cost-effective option across a variety of countries and settings. A significant reduction occurs in dysmenorrhoea as well as bleeding with the LNG-IUS compared with the Cu-IUD [22]. Some evidence shows that the LNG-IUS is effective in treating the pain of endometriosis as well as the heavy menstrual bleeding associated with uterine fibroids, endometriosis, adenomyosis, and endometrial hyperplasia [23]. In randomised-controlled trials, the LNG-IUS has shown comparable clinical efficacy to gonadotropin-releasing hormone analogues or progestins for the symptomatic treatment of endometriosis. Experience with LNG-IUS in adenomyosis is based on prospective cohort studies [23]. Uterine volume was seen to diminish in some studies. In the treatment of endometrial hyperplasias, including atypical hyperplasia, the LNG-IUS is equal or superior to treatment with systemic progestins. A systematic review of case-controlled studies found that use of a Cu-IUD reduced the risk of endometrial cancer (RR 0.51, 95% CI 0.3 to 0.8) [24]. An epidemiologic study of nearly 20,000 women Please cite this article in press as: Stephen Searle E, The intrauterine device and the intrauterine system, Best Practice & Research Clinical Obstetrics and Gynaecology (2014), http://dx.doi.org/10.1016/ j.bpobgyn.2014.05.004

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found that women who used Cu-IUDs had a 45% reduced risk for cervical cancer, compared with never users (OR 0.55; P < 0.0001) after adjustment for ‘relevant covariates.’ Those variables include the number of previous Pap tests that a woman has undergone [25]. Complications Perforation The rate of uterine perforation at 7 years is low, up to 2 per 1000 insertions, with all IUDs, Cu-IUIs or the IUS [26]. Expulsion Around one in 20 IUDs and IUSs are expelled [27] and, as this is most common in the first 3 months, women should be encouraged to check the threads especially after heavy menses. Early expulsions with the frameless intrauterine implant are common [28]; however, this may be related to the experience of the health professional who fitted the device. Ectopic pregnancy The absolute risk of ectopic with intrauterine methods is low (around 0.02 per 100 woman years), 20 times less than for women using no contraception [29]. When an intrauterine method fails, however, the chances of the pregnancy being ectopic are 10%. Because of the potential seriousness of this, a pregnancy with an IUD in situ is ‘an ectopic until proved otherwise’. A previous history of an ectopic pregnancy is not a contraindication to their use, although an IUS may be preferred to a Cu-IUD as the former inhibits sperm transport through the cervical mucus and so should be more effective at preventing fertilisation. During the appointment for IUD and IUS insertion, some basic questions must be asked, information given, and information documented. These are presented in Table 1. When the woman has been given the essential information and an opportunity to discuss any concerns or questions she may have, she will be in a position to give verbal informed consent to the pelvic examination and device insertion. All clinicians will appreciate the need to work within their limitations, and refer any difficult cases or insertions to specialist colleagues. Choice of device After checking the eligibility criteria, the woman may choose between a Cu-IUD or the LNG-IUS. This choice will usually be determined by the likely effects on menstrual bleeding pattern and possibly duration of use and cost. Some women are keen to avoid hormonal methods. If a Cu-IUD is chosen, then a device with the lowest failure rate should be the first line, in both parous and nulliparous women (e.g. a 10-year banded device such as the T-Safe380 or equivalent) (Fig. 6).

Table 1 Minimum information and documentation requirements for intrauterine device and intrauterine system insertion. Has the woman had the opportunity to discuss any side-effects and risks? Past obstetric, gynaecological and sexual history must be taken. Has an existing pregnancy been considered? Check that no unprotected sex has taken place since her last menses. Has the woman been given a Cu-IUD or an LNG-IUS leaflet (in the UK, leaflets issued by the Family Planning Association are the gold standard). Have any abnormalities have been found on pelvic examination. The position and sounding length of the uterus must also be documented. This is useful for clinicians performing subsequent insertions. Have the LNG-IUS or Cu-IUD been inserted with ease or with pain, and were any technical difficulties were experienced? Which device was inserted? When does it need to be removed or replaced? Has a follow-up appointment been offered (just one visit 3e6 weeks after insertion is recommended). Thereafter, the patient is encouraged to report any problems rather than attend for arbitrary yearly checks. Cu-IUD, copper intrauterine device; LNG-IUS, levonorgestrel-releasing system.


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Fig. 6. Cu T-Safe 380.

Sometimes the cervical orifice is too tight for this device, and another 380 mm [2] Cu-IUD, such as the Nova-T380 or equivalent, is appropriate. If the uterine length at sounding is less than 6.5 cm, first consider whether the internal orifice has been passed, because it is important to avoid releasing the device in the cervical canal. If the cavity is genuinely short, then short, framed Cu-IUDs or a short, frameless IUI may be used. When can intrauterine contraception be safely inserted? Clinicians should consider the woman's convenience as well as safety when timing insertion. Being overly cautious about delaying insertion to exclude infection and pregnancy may not be in the woman's best interests. A Cu-IUD can be inserted at any time if it is reasonably certain that the woman is not pregnant. The same applies to the LNG-IUS if the clinician is also reasonably certain no conception has taken place [8]. This means that the highly effective ‘post-coital’ effect of Cu-IUDs can be used for insertion any time up to 5 days after the earliest predicted date of ovulation or up to 5 days after the earliest unprotected sex (Fig. 7). The LNG-IUS can be inserted within the first 7 days of the onset of menstruation, and it will be effective Q 6 immediately. Any later in the cycle, the clinician needs to exclude unprotected sex since the last period. In this case, the LNG-IUS may be inserted with advice to use additional contraception for the first 7 days. Intrauterine devices have been studied for use as emergency contraception for at least 35 years. They are safe and highly effective for emergency contraception and regular contraception, and are extremely cost-effective as an ongoing method. A carefully conducted review of the evidence found 42 studies conducted in six countries between 1979 and 2011, and included eight different types of IUD and 7034 women [30]. The maximum timeframe from intercourse to insertion of the IUD ranged from 2e10 or more days (not just within the 5 days recommended). Results, however, showed that the pregnancy rate was still only 0.09%. The conclusion was that Cu-IUDs are a highly effective method of contraception after unprotected intercourse. They are safe for most women, highly effective, and costeffective when left in place as ongoing contraception [8]. A Cu-IUD or LNG-IUS can be inserted at any time after medical or surgical abortion if there is no suspicion that the pregnancy is ongoing [8]. Please cite this article in press as: Stephen Searle E, The intrauterine device and the intrauterine system, Best Practice & Research Clinical Obstetrics and Gynaecology (2014), http://dx.doi.org/10.1016/ j.bpobgyn.2014.05.004

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Fig. 7. Emergency contraception. The timing of Cu-IUD insertion after ovulation is shown (i.e. that a Cu-IUD can be inserted up to 5 days after the earliest estimated day of ovulation). Emergency contraception with Cu-IUD can also be effectively achieved any time of the cycle where the earliest unprotected sex was no more than 5 days before.

Intrauterine contraception can also be inserted any time if another method has been used correctly up until insertion. A Cu-IUD will then be effective immediately. An additional method of contraception will need to be continued for a week after insertion of LNG-IUS. Training Some evidence shows that clinicians fitting higher numbers of IUDs have lower complication rates. For example, clinicians fitting fewer than 10 devices over a 6-year period have a higher perforation rate than those fitting 10e100 devices [31]. Therefore, the recommendation in the UK is that clinicians should insert a minimum of one IUD per month, in unanaesthetised women, to maintain competence. Doctors and nurses should also attend regular updates in dealing with emergencies d normally a Q 7 resuscitation and anaphylaxisis training day annually (Figs. 8 and 9). One aspect of training that needs greater emphasis worldwide is the encouragement to offer IUCs to all women, including the nulliparous. They are highly effective and safe for use in women who are nulliparous. Many myths and barriers, however, prevent more widespread use. A recent study [32] explored healthcare provider, health system, and user issues that prevent more widespread use of IUC, particularly among nulliparous women, and presented the evidence supporting greater utilisation of these devices

Fig. 8. In-clinic training.


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Fig. 9. Model uterus for training.

[4]. The conclusion was that efforts need to be made to disseminate the evidence, which shows that few contraindications exist to IUC use. Healthcare professionals need to be educated and trained to insert IUC confidently, particularly in nulliparous women. This could substantially affect use of IUC. How to facilitate safe insertion of intrauterine contraception Assistants and chaperones An appropriately trained assistant, who can monitor the condition of the woman and assist in any emergency, should be in attendance during insertion. This assistant could act as chaperone, and the woman may also request a friend or relative to be present. Pain relief Around 50% of women experience some degree of pain at insertion. Pain is likely to be greater in nulliparous women, and is likely to be less in women who have delivered a baby vaginally within the last 6 months [15]. Topical lidocaine gel may reduce pain [33]. This gel is most effective if instilled through the internal orifice and left for 5e10 minutes to work. Although randomised-controlled trials have failed to report significantly less pain with ibuprofen, such oral analgesics are often advised. The distraction of an empathetic assistant should reduce the expected pain of an anxious patient. Management of emergencies during intrauterine insertions Serious patient collapse is rare. It may occur as a result of anaphylactic response to drugs or latex gloves, needing intramuscular adrenaline. A women whose epilepsy is poorly controlled may rarely develop status epilepticus. A woman with known or unknown pre-existing cardiac problems could suffer cardiac arrest. Much more common is vaso-vagal syncope. Typically, during or after insertion, the woman feels ill, goes pale, feels faint, clammy or nauseous. She will develop bradycardia with hypotension. She may have impaired consciousness and may have a hypoxic convulsion: if the airway is maintained, this is usually followed by regaining consciousness and gradual recovery. With vasoevagal shock, often laying the woman flat, lowering the head, raising the legs, monitoring the pulse, blood pressure and level of consciousness is all that is required. If continuing pain is preventing recovery, it may be necessary to remove the intrauterine device. Rarely oxygen, intravenous atropine, and expert help may be required. Please cite this article in press as: Stephen Searle E, The intrauterine device and the intrauterine system, Best Practice & Research Clinical Obstetrics and Gynaecology (2014), http://dx.doi.org/10.1016/ j.bpobgyn.2014.05.004

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Practical procedures for intrauterine insertions First, a bimanual pelvic examination should be carried out to assess the position, size, and mobility of the uterus, and to exclude pathology. On speculum examination, cleansing of the cervix with antiseptic has no proven benefit [8], and may alter the natural colonisation of the vagina. Gloves are worn on both hands, but sterile gloves are not required if a ‘no-touch’ technique is used. That is where anything inserted into the uterine cavity is held only by the handle. Forceps are applied to steady the cervix. It is usually possible to hold the cervix with gently closed sponge holders, which are less traumatic and less painful than tenaculum or vulsellum forceps. Holding the cervix and gently sounding the length of the uterine cavity reduces the risk of perforation and helps to ensure fundal placement of the device. [34] The uterine fundus is sensitive to pressure, so gently measuring up to the fundus is important. Follow-up consultation In the UK, it is recommended practice to offer the woman a follow-up appointment typically 6 weeks after insertion, or 3 weeks after insertion for emergency contraception. The aim of this visit is to check the woman is happy with the device, that she is not pregnant or has any symptoms suggesting infection, expulsion or perforation. Rather than have a routine annual check-up, current advice is for the woman to be offered information about symptoms to report at any time, which may indicate a complication. Specifically, a change in bleeding pattern, pelvic pain, or vaginal discharge needs follow up. Women can be given instruction on how to check that the threads of the IUD or IUS are present. If she cannot feel them, or if the stem is felt, alternative contraception should be used until medical advice is sought. Reducing the risk of sexually transmitted infections Although the IUS may offer some protection against pelvic inflammatory disease, intrauterine methods should be considered as protection against sexually transmitted infections (STIs). Women at higher risk of STIs include those under 25 years of age, those with a new partner, or those with more than one partner in the last year, or if their regular partner has other partners. Such women should be encouraged to have tests for STIs before or at the time of insertion. They should also be advised to used condoms in addition to the intrauterine method, at least until the partner has an STI screen. Removal Women requesting removal but wishing to avoid pregnancy can have the device removed in the first few days of menstruation. Otherwise, they should abstain from intercourse or use another method for 7 days before removal. This is because of the chance of a fertilised ovum being present. Had the IUD been left in situ, it would have prevented the ovum from implanting. This is the safest advice even if the woman would like a new Cu-IUD or LNG-IUS replaced immediately. If, for any reason, the device must be removed when otherwise unprotected sex has occurred in the preceding 7 days, the need for emergency hormonal contraception at the time of removal should be considered. If the woman requests removal in order to become pregnant, the devise can be removed at any time together, and pre-conception advice given, including the use of folic acid. After the menopause, a Cu-IUD inserted after the age of 40 years can be removed from the age of 50 years after 1 year of amenorrhoea. It could also be removed after 2 years of amenorrhoea before the age of 50 years. The LNG-IUS can be used for contraception up to 7 years if inserted after the age of 45 years. If the LNG-IUS is being used for menorrhagia and not for contraception, it can be retained while it is controlling the bleeding, provided intrauterine pathology has been excluded until the menopause. Please cite this article in press as: Stephen Searle E, The intrauterine device and the intrauterine system, Best Practice & Research Clinical Obstetrics and Gynaecology (2014), http://dx.doi.org/10.1016/ j.bpobgyn.2014.05.004

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Management of problems with intrauterine contraception Suspected perforation Suspected perforation is more likely to occur at the time of insertion. A previous caesarean section scar seems to be a risk factor [26]. Perforation may be suspected if the uterine sound or the device itself is inserted longer than expected, and the fundus is not felt. The procedure should be stopped and the blood pressure, pulse, and level of discomfort monitored. If the device has been released, an ultrasound, plain abdominal X-ray, or both, should be arranged as soon as possible to locate the position of the device. Meanwhile, alternative contraception may be needed. Admission to hospital should be considered. After uterine perforation, an interval of 6 weeks before another gentle insertion attempt should allow healing to occur. Missing threads, with no definite history of expulsion If the threads cannot be seen on speculum examination, the woman should use additional precautions until an ultrasound scan can be carried out. The need for emergency contraception should be considered. If the device is seen in the uterine cavity, it can be left there and relied upon without the threads being brought down. If the device is not seen by ultrasound, a plain abdominal X-ray should be requested to rule out perforation into the abdomen or pelvis, requiring laparoscopic removal. Rarely, laparotomy may be needed. If the threads are missing at the time of device removal, and the device has been shown to be in situ, a gentle attempt at removal can be done with fine, long-handled Spencer Wells forceps or a uterine hook. Thread retrievers and other instruments for difficult removals, with or without ultrasound guidance, have been used but, if unsuccessful, hysteroscopic removal is indicated. The intention is for devices to be inserted at the fundus. It is not known whether they remain effective if the device is in the cavity but not fundally placed. If the device can be felt in the cervical canal with a sound, it cannot be relied upon and should be replaced. A recent large study of missing threads in IUC users recommended one and possibly two annual ultrasound checks to confirm the device is still in situ [35]. Abnormal bleeding The different causes of abnormal bleeding should be considered. For example, STIs such as chlamydia should be excluded, particularly in women under 25 years, and in those who have changed sexual partner. Pregnancy and gynaecological pathology should be considered, and a pelvic and speculum examination performed if symptoms persist for 6 months. Women over 40 years, and especially if over the age of 45 years may need investigations, such as endometrial biopsy and ultrasound scan. Women presenting with a change in bleeding pattern should be investigated to exclude pregnancy, infection, and gynaecological pathology. If these causes have been excluded or treated, abnormal bleeding can be treated with non-steroidal anti-inflammatory drugs or antifibrinolytics (such as tranexamic acid). Persistent bleeding problems with a Cu-IUD can be treated by changing to a LNG-IUS. Pregnancy Because of the higher proportion of ectopic pregnancies among Cu-IUD failures, the site of the pregnancy should be urgently determined by ultrasound. With an intrauterine pregnancy and an IUD in situ, the woman may need support in deciding whether to terminate the pregnancy or to continue with it. If she chooses abortion, the IUD could be removed at the time of surgical termination. Advice should also be given in the case of symptoms of miscarriage or infection occurring while the woman is waiting for the termination. If she wishes to continue with the pregnancy, she should be advised of the increased risk of miscarriage with removal of the devise, but even greater risks of second-trimester miscarriage, preterm delivery, and sepsis by leaving the intrauterine device in situ. If the threads are Please cite this article in press as: Stephen Searle E, The intrauterine device and the intrauterine system, Best Practice & Research Clinical Obstetrics and Gynaecology (2014), http://dx.doi.org/10.1016/ j.bpobgyn.2014.05.004

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E. Stephen Searle / Best Practice & Research Clinical Obstetrics and Gynaecology xxx (2014) 1e18 Table 2 Direct health service costs of different contraceptive methods [36]. Contraceptive method

Cost of 1 couple-year of protection

Spermicides Cap/Diaphragm Depo injection Combined pill Implant (multi-rod) Intrauterine device

£249 £244 £229 £209 £151 £86

visible, or can easily be retrieved from the cervical canal, the IUC should be gently removed up to 12 weeks gestation. If the device has not been expelled or removed, and the device cannot be identified at delivery or termination, then a plain abdominal X-ray should determine if it is extrauterine. Suspected pelvic infection For women with an IUD who have signs and symptoms of possible pelvic infection, broad-spectrum antibiotics and metronidazole can be started while awaiting swab results. The device does not need to be removed unless symptoms fail to resolve after 72 h [8]. Women with confirmed pelvic inflammatory disease should be followed up to ensure resolution, safer sex advice, and treatment of partners. Presence of actinomyces-like-organisms Actinomyces israelii is a commensal of the female genital tract. Women who use IUDs with actinomyces-like-organisms (ALOs), for example on Pap smears, should be asked about symptoms suggestive of pelvic actinomyces. These include pelvic pain, intermenstrual bleeding, and vaginal discharge. If the woman is asymptomatic and has no signs, particularly of cervical excitation or uterine or adnexal tenderness, then she can be reassured and the intrauterine method left in situ. She can be advised that there is no need for routine follow up or additional vaginal examinations, but simply given information about symptoms to report. In the rare event of signs and symptoms developing, swabs, urgent high-dose antibiotics, with IUD and IUS removal and culture may be indicated.

Fig. 10. Cost per year of contraceptive provision plus costs of pregnancies resulting from method failures.


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Affordability and availability in developing countries Compared with hormonal methods, Cu-IUDs are relatively safer, more effective and inexpensive, and are the most widely used reversible contraception in the world; however, they are underused in developed countries. The effectiveness of interventions for improving uptake of copper-IUDs has been studied in a systematic review of randomised-controlled trials and controlled before-and-after studies. Electronic databases for eligible trials were searched. Nine studies representing 7960 women met the inclusion criteria, including seven randomised-controlled trials and two controlled before-and-after studies [36]. Meta-analysis from three studies showed contraceptive provision by community workers doubled uptake of IUD, and studies on antenatal contraceptive counselling showed similar increases. This study reported major increases in IUD uptake with postnatal couple contraceptive counselling. A study on postnatal home visits and two studies on post-abortion contraceptive counselling did not reach statistical significance. The conclusions were that community-based interventions and antenatal contraceptive counselling improved uptake of copper-IUD in studies mainly conducted in developing counties. Further research is needed on postabortion contraceptive counselling as well as longer-term effectiveness of interventions to improve use of copper-IUD. Women in developing countries with anaemia The search for an ideal contraceptive device most suited for women of developing countries with anaemia poses a challenge. A study was conducted to compare the effects of the LNG-IUS and Cu-IUD on body iron stores and menstrual bleeding patterns in women in India [37]. The results showed that menstrual bleeding days increased initially at 3 months for both the LNG-IUS and the Cu-IUD, but by 12 months, mean number of bleeding days reduced in the LNG-IUS group whereas in Cu-IUD group, the number of bleeding days remained higher at 12 months compared with the pre-insertion level. In the LNG-IUS group, 20% had amenorrhoea. The conclusion was that the LNGIUS reduced the number of menstrual bleeding days and increased the haemoglobin and serum ferritin levels, thus preventing loss of body iron. This may be especially important for women in developing countries, such as India, in which a decrease in blood loss may improve iron deficient situations. Cost-effectiveness When McGuire and Hughes calculated the direct health service costs of different contraceptive methods, they found that the intrauterine device was the most cost-effective [38] (Table 2)

Fig. 11. Cost of newer contraceptive methods per protected year.


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More recently, economic modelling analysis looked at the relative costs of ‘older’ contraceptives [39]. Again, Cu-IUDs are confirmed to be the most cost-effective. Seemingly cheap barrier methods are found to be more than three times as expensive owing to their higher failure rates (Fig. 10). The same study [39] looked at most of the newer ‘more expensive’ (in terms of drug costs alone) methods. Here the higher ‘up-front’ cost of the LNG-IUS makes it relatively costlier (Fig. 11). However, as the UK National Institute for Health and Care Excellence found, all of these long-acting methods compare favourably with ‘cheaper’ methods, such as the contraceptive pills. The cost-effectiveness of the LNG-IUS compared with hysterectomy has been has been studied. A total of 236 women with menorrhagia in Finland were randomly allocated to the LNG-IUS or hysterectomy [40]. Analysis was carried out after 5 years of follow up. Although 42% of the women assigned to the LNG-IUS eventually underwent hysterectomy, the discounted direct and indirect costs in the LNG-IUS group ($2817 per woman) remained substantially lower than in the hysterectomy group ($4660 per woman). Satisfaction with treatment was similar in both groups. Q8

How to increase uptake of intrauterine contraception In developed countries IUDs are among the least common methods of contraception used. The effectiveness of interventions to improve uptake and continuation of the copper IUD has been evaluated [41]. Three studies on contraceptive counselling and referrals by community workers showed an increase in uptake of the IUD among intervention groups. Two studies on antenatal contraceptive counselling also favoured the intervention groups. One study on postnatal couple contraceptive counselling also showed an increase in IUD uptake compared with controls. The authors concluded that community-based interventions and antenatal contraceptive counselling improved uptake of copper IUD contraception. As the copper IUD is one of the most effective reversible contraceptive methods, primary care and family planning and practitioners could consider using these interventions.

Practice points When a woman presents for contraception, or if she simply requests the pill’, always discuss the more reliable LARC methods. Do not convey a negative image of Cu-IUDs or the LNG-IUS with young or nulliparous women. Always assess the risk of STIs, carry out tests for STIs before or during fitting for women under 25 years, and those with a new partner in the last year; consider advice on safer sex. During the consultation, concentrate on what is central to the needs of the woman; spend time on essential record keeping rather than slavish documentation. Make reasonable efforts to exclude pregnancy before insertion but quick-start the IUD rather than delay insertion until the next menses. Approach insertion in a relaxed and confident manner. Be firm but gentle when instrumenting the uterus. Use distraction and a friendly assistant to help relax the woman, and local anaesthesia when needed. With a no-touch’ technique, there is no need to change into sterile gloves. Follow up the woman 3e6 weeks after insertion; thereafter, the woman does not need to have annual vaginal examinations. She can simply be followed up at routine cytology intervals or if she has any problems. Nurses who wish to be trained to fit IUC should be supported. Ideally, train at least two clinicians in every family practice to fit IUCs, so that emergency Cu-IUDs are always available.


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Research agenda Clinicians need to find better ways to increase the uptake of these highly effective and costsaving methods. This needs to include improved methods of communicating and myth busting. Develop an IUC that combines the menstrual benefits of the LNG-IUS with a reduced chance of dysmenorrhoea and expulsion, possibly an implanted, frameless hormonal IUS.

Q9 Q 10

Q 11

References *[1] NICE Clinical Guideline 30, October 2005; www.nice.org.uk [last accessed 12.05.05]. [2] Bahamondes L, Bahamondes MV. Considering the risks and benefits of intrauterine devices: should clinician advice now be changed? Clin Pract 2013;10:2044e9038. [3] Wilson JC. A prospective New Zealand study of fertility after removal of copper intrauterine contraceptive devices for conception and because of complications: a four year study. Am J Obstet Gynecol 1989;160:391e6. [4] UKMEC under publications in www.fsrh.org.uk. [5] Faculty of Sexual and Reproductive Healthcare, Royal College of Obstetricians and Gynaecologists. Quick starting contraception. London: Faculty of Sexual and Reproductive Healthcare; 2010. http://www.fsrh.org/pdfs/ CEUGuidanceQuickStartingContraception.pdf [last accessed 12.05.14]. [6] Smith E, Daley AM. A clinical guideline for intrauterine device use in adolescents. J Am Acad Nurse Pract 2012;24:453e62. [7] McNicholas C, Peipert JF. Long-acting reversible contraception for adolescents. Curr Opin Obstet Gynecol 2012;24:293e8. [8] World Health Organization. Sexually transmitted and other reproductive health infections http://www.who.int/ reproductive-health/publications/rtis_gep/rts_gep.pdf; 2005 [last accessed 12.05.14]. [9] Farley TM, Rosenberg MJ, Rowe PJ, et al. Intrauterine contraceptive devices and pelvic inflammatory disease: an international perspective. Lancet 1992;339:785e8. [10] Dannemiller Memorial Educational Foundation. vol. 9, No 5. In: Grimes DA, editor. The contraception report, modern IUDs Part 2. Towowa, New Jersey: Emron; 1998. pp. 2e16. *[11] Faculty of Sexual and Reproductive Healthcare. Faculty of Sexual and Reproductive Healthcare Clinical Guidance. Intrauterine contraception, November 2007. Faculty of Sexual and Reproductive Healthcare; http://www.fsrh.org/pdfs/ CEUGuidanceintrauterineContraceptionNov07.pdf [last accessed 12.05.14]. [12] Stanford JB, Mikolajczyk RT. Mechanisms of action of intrauterine devices: update and estimation of postfertilisation effects. Am J Obstet Gynecol 2002;187:1699e708. [13] Ratsula K, Toivonen J, L€ ahteenm€ aki P, et al. Plasma levonorgestrel levels and ovarian function during the use of a levonorgestrel-releasing contraceptive device. Contraception 1989;39:195e204. *[14] Kulier R, et al. Copper containing, framed intra-uterine devices for contraception. Cochrane Database Syst Rev 2006;3: CD005347. *[15] National Institute for Health and Clinical Effectiveness (NICE). Long acting reversible contraception: the effective and appropriate use of long-acting reversible contraception http://publications.nice.org.uk/long-acting-reversiblecontraception-cg30; 2005 [last accessed 12.05.14]. [16] French R, van Vliet H, Cowan F, et al. 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Obstet Gynecol 2009;113:1104e16. [22] Nilsson CG, Luukkainen T, Diaz J, et al. Clinical performance of a new levonorgestrel ereleasing intrauterine device. A randomised comparison with a Nova-T Cu-IUD. Contraception 1982;25:345e56. *[23] Heikinheimo O, Gemzell-Danielsson K. Emerging indications for the levonorgestrel-releasing intrauterine system (LNGIUS). Acta Obstet Gynecol Scand 2012;91:3e9. *[24] Hubacher D, Grimes DA. Noncontraceptive health benefits of intrauterine devices: a systematic review. Obstet Gynecol Surv 2002;57:120e8. X, Díaz M, Vaccarella S, et al. Intrauterine device use, cervical infection with human papillomavirus, and risk [25] Castellsague of cervical cancer: a pooled analysis of 26 epidemiological studies. Lancet Oncol 2011;12:1023e31. [26] Harrison-Woolrych M, Ashton J, Coulter D. Uterine perforation on intrauterine device insertion: is the incidence higher than previously reported? Contraception 2003;67:53e6. [27] World Health Organization. Mechanism of action, safety and efficacy of intrauterine devices.WHO Technical Report Series 753. Geneva: WHO; 1987. pp. 1e91. http://whqlibdoc.who.int/trs/WHO_TRS_753.pdf [last accessed 12.05.14]. [28] Wu S, Wildermeersch D. Performance of the frameless Gynefix and the TCu380A IUDs in a 3-year multicentre, randomised, comparative trail in parous women. Contraception 2000;61:91e8.


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Q 13


[29] World Health Organization. A multinational case-control study of ectopic pregnancy. Clin Reprod Fertil 1985;3:131e43. [30] Cleland K, Zhu H, Goldstuck N, et al. The efficacy of intrauterine devices for emergency contraception: a systematic review of 35 years of experience. Hum Reprod 2012;27:1994e2000. [31] Harrison-Woolrych M, Zhou L, Coulter D. Insertion of intrauterine devices: a comparison of experience with Mirena and Multiload Cu 375 during post-marketing monitoring in New Zealand. N Z Med J 2003;116:U538. [32] Black K, Lotke P, Buhling KJ, et al. Intrauterine contraception for Nulliparous women: translating Research into Action (INTRA) group. A review of barriers and myths preventing the more widespread use of intrauterine contraception in nulliparous women. Eur J Contracept Reprod Health Care 2012;17:340e50. [33] Rabin JM, Spitzer M, Dwyer AT, et al. Topical anesthesia for gynecologic procedures. Obstet Gynecol 1989;73:1040e4. [34] International Planned Parenthood Federation. International Medical Advisory Panel. Statement on intrauterine devices. IPPF Med Bull 1995;29. [35] Marchi NM, Castro S, Hidalgo MM, et al. Management of missing strings in users of intrauterine contraceptives. Contraception 2012;86:354e8. [36] Arrowsmith ME, Aicken CRH, Majeed A, et al. Interventions for increasing uptake of copper intrauterine devices: systematic review and meta-analysis. Contraception 2012;86:600e5. [37] Rana M, Saxena P, Firdous N. Comparison of levonorgestrel and copper releasing intrauterine contraceptive device on body iron stores and menstrual bleeding patterns: experience on Indian women. Eur Rev Med Pharmacol Sci 2012;16: 230e4. [38] McGuire A, Hughes D. The economics of family planning services: a report prepared for the Contraceptive Alliance. London: Family Planning Association; 1995. http://www.fpa.org.uk/resources/research-reports [last accessed 12.05.14]. [39] Phillips CJ. Economic analysis of long term reversible contraceptives. Pharmacoeconomics 2000;17:209e11. [40] Hurskainen R, Teperi J, Rissanen P, et al. Clinical outcomes and costs with the LNG-IUS or hysterectomy for treatment of menorrhagia: randomised trail 5-year follow-up. JAMA 2004;291:1456e63. [41] Arrowsmith ME, Aicken CR, Saxena S, et al. Strategies for improving the acceptability and acceptance of the copper intrauterine device. Cochrane Database Syst Rev 2012;3:1469493X.


The intrauterine contraceptive device.

Self-checking the intrauterine device.

Efficacy of intrauterine device in the treatment of intrauterine adhesions.

The AiMu MCu Intrauterine Device.

The intrauterine device and primary tubal infertility.

The intrauterine device and ovarian pregnancy.

The intrauterine device and ectopic pregnancy.

Levonorgestrel-releasing intrauterine device.

Levonorgestrel-releasing intrauterine device.

Pelvic actinomycosis: beware the intrauterine contraceptive device.

Intrauterine device and ectopic pregnancy.

Update on the intrauterine contraceptive device.

Outcome of intrauterine pregnancies with intrauterine device in place and effects of device location on prognosis.

Intravesical migration of intrauterine device.

The copper intrauterine device and its mode of action.

Accuracy of information about the intrauterine device on the Internet.

Letter: Progesterone-releasing intrauterine contraceptive device.

Hematochezia caused by intrauterine device perforation.

Primary unruptured ovarian pregnancy with intrauterine device.

Editorial: pregnancy with an intrauterine contraceptive device.

Sigmoid colon migration of an intrauterine device.

Forgotten intrauterine device contributing to infertility.

Vasovagal shock after insertion of intrauterine device.

Urticaria secondary to a copper intrauterine device.