The intrauterine device and the intrauterine system




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.


Introduction


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) , 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 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 .




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 silver–copper alloy being used for contraception. These are now made of coiled stainless steel and called a Grafenberg ring ( Fig. 1 c), 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. 1 b) 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.




Fig. 1


Various current and historical Intrauterine devices.


Modern intrauterine methods are much improved from the older devices. Early IUDs, such as the Dalkon Shield ( Fig. 1 a), 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.




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 silver–copper alloy being used for contraception. These are now made of coiled stainless steel and called a Grafenberg ring ( Fig. 1 c), 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. 1 b) 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.




Fig. 1


Various current and historical Intrauterine devices.


Modern intrauterine methods are much improved from the older devices. Early IUDs, such as the Dalkon Shield ( Fig. 1 a), 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 ).




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 .)


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 .




Fig. 3


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



Fig. 4


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



Fig. 5


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




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 :


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’ 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.


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.


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, Cu-IUDs 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 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 .


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 . Therefore, LARC methods should be considered first-line options for teenagers seeking contraception.


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 . 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 , 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 . In addition, the endometrial inflammatory reaction inhibits implantation. As pregnancy does not begin until implantation, IUDs do not work by causing an abortion .


LNG-IUS works by releasing progesterone onto the endometrium, which prevents implantation . 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 .


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 . The failure rate is 1–2% at 5 years. The most effective Cu-IUDs contain 380 mm of copper .


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 .


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 .


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 .


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 .


Spotting, light bleeding, heavier or longer menstruation is common in the first 3–6 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 . With the LNG-IUS, 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 .


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 . 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 . 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 . 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 . 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) . An epidemiologic study of nearly 20,000 women 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 .


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 .


Expulsion


Around one in 20 IUDs and IUSs are expelled 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 ; 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 . 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 .


Nov 8, 2017 | Posted by in OBSTETRICS | Comments Off on The intrauterine device and the intrauterine system

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