MIRENA COIL FOR HEAVY PERIODS

Transcription

1 MIRENA COIL FOR HEAVY PERIODS This page and its cntents are Cpyright 2010 the British Fibrid Trust Questins & Answers fr Patients Dr Nicki On, PhD, MRPharmS. Pharmacist Dr Rajesh Varma, MA, PhD, MRCOG. Cnsultant Obstetrician & Gynaeclgist. Website address: What is the Mirena IUS? 1. An IUS (intrauterine system), cmmnly knw as a cil, is a small T-shaped plastic device which slwly releases a prgestgen hrmne. This is similar t the natural prgesterne yur varies prduce. 2. In UK, the IUS is available as Mirena. In fact, Mirena cntains 52 milligrams f levnrgestrel, a hrmne used in many cntraceptive pills. The hrmne is hused within a substance called plydimethylsilxane. This is surrunded by a membrane (skin) als made f plydimethylsilxane. Levnrgestrel is released frm IUS at an initial rate f 20 mcg/day. 3. The T-shaped frame als cntains barium sulphate s that it can be seen n x-rays. 4. There are tw fine threads, made f irn xide and plyethylene, attached t the bttm f the frame. The fine threads allw easy remval and allw yu r yur gynaeclgist t check that the IUS is in place. What is the Mirena IUS used fr? It has three main licensed uses: Cntraceptin: This is the main use, which is an effective, lng term and reversible methd f cntraceptin. Once Mirena cil is placed inside the wmb, it slwly releases the hrmne levnrgestrel ver a perid f 5 years r until it is remved. Heavy menstrual bleeding (Menrrhagia): It reduces the menstrual bld flw. Prtects the uterine (wmb) lining frm verstimulatin in wmen wh have a uterus (wmb) and wish t use Oestrgen replacement therapy HRT Mirena has als been shwn t be effective in managing symptms f ther gynaeclgical cnditins, such as fibrids, endmetrisis, adenmysis, endmetrial hyperplasia and premenstrual syndrme. Hwever, Mirena is presently nt licensed t be used as a treatment fr these cnditins Hw des Mirena wrk? The hrmne in the Mirena cil reduces heavy menstrual bleeding by cntrlling the mnthly develpment f the lining f yur wmb, making it thinner. The hrmne in the cil prevents pregnancy by the fllwing actins: Picture f a Mirena Cil It makes the lining f yur wmb thinner and in ding s it makes the uterus lining less likely t accept a fertilised egg. It als thickens the mucus frm yur cervix, which makes it difficult fr the sperm t reach the egg. In sme cases, it stps vulatin and as the result yur perids stp and there are n eggs fr fertilisatin. Date f preparatin: 12 September 2010

2 Page 2 Mirena fr HMB Q&A Hw effective is Mirena fr heavy bleeding? There is strng scientific evidence shwing that it reduces the mnthly bld lss in 90% f wmen wh use the system. In 20% f wmen fitted with Mirena, perids may stp altgether with the reductin in bld lss being gradual ver a perid f time. Generally, yu see reductin in bld lss in 3 t 6 mnths after insertin. There is evidence shwing abut 86% reductin in bld flw at 3 mnths and 97% reductin at 12 mnths after fitting. Yu may have an increase in bleeding. hwever, usually in the first 2-3mnths, befre a reductin in bld lss is achieved. If a significant reductin in bld lss in nt achieved after 3-6 mnths, alternative treatments shuld be cnsidered. Many gynaeclgists nw believe that Mirena is an imprtant alternative t a hysterectmy and ther surgical treatments. What are the benefits f having a Mirena fr heavy bleeding? It is very effective in reducing menstrual bld lss therefre preventing anaemia. Once fitted, it lasts 5 years. Wmen wh are in their frties will require ne r tw Mirena IUS befre their menpause. Menpause brings abut a natural cure fr the heavy menstrual bleeding prblem, and decreases the need fr a hysterectmy. Yu get the benefit f cntraceptin in additin t treating heavy menstrual bleeding. Be warned, if cntraceptin is nt what yu want r unacceptable then Mirena cil is NOT fr yu Will Mirena affect my perid pain? Typically, abut half f the wmen wh suffer with heavy bleeding als cmplain f painful perids. Experience shws that Mirena significantly imprves perid pains in ver 96% f users, in additin t reducing the mnthly bld lss. What are the side-effects effects r risks f Mirena? Acne (usually less cmmn after 3 mnths f treatment, and may imprve if acne already exists). Breast pain, tenderness r swelling. Headaches r migraines (althugh headaches may lessen in many users; in thers, they may increase in number r becme wrse). Dizziness. Depressin. If yu have a histry f emtinal disturbances, it may be mre likely fr yu t have a recurrence while using the Mirena device Weight gain. Lss f fertility. Sme develp small fluid-filled cysts n the varies. Often, these cysts d nt cause symptms but sme wmen experience pelvic pains. These cysts are nt dangerus and usually d nt need t be treated and disappear withut treatment. Wmen using the Mirena cil are mre likely t develp benign simple varian cysts. The mst cmmn symptm f a simple cyst is abdminal pain that des nt reslve with simple painkillers. Such cysts usually disappear withut treatment in 2 3 mnths Pelvic infectin. The Mirena cil is designed t minimise the risk f infectin, but there is still a slight risk f develping a pelvic infectin while using the cil, particularly in the first 3 weeks after fitting. Such infectins are usually related t sexually transmitted diseases, and yu are mre likely t develp an infectin if yu r yur partner has several sexual partners. Overall, abut 1.5% f wmen will develp an infectin with 5 years use f the cil. Yu can reduce yur risk f develping an infectin by using a cndm when having sex with anybdy ther than yur lng-term sexual partner. Embedment f Mirena in the mymetrium may ccur. When this happens the Mirena shuld be remved. Embedment can result in difficult remval and, in sme cases surgical remval may be necessary. Date f preparatin: 12 September 2010

3 Mirena fr HMB Q&A Page 3 Side Effects (Cntinued) Decreased libid (sex drive). This is nt fficially reprted but was raised by a number f wmen n health's frum. What situatins prevent me frm having Mirena IUS? Yu can nt have an IUS if yu have r in the past had the fllwing: Cancer f r presence f abnrmal cells in the wmb, cervix, vary r breast. Active liver disease r a liver tumur. Unexpected bleeding frm yur vagina between perids r after sex. Bld clt prblems (e.g. thrmbsis, DVT r PE) r leukaemia r ther cancers affecting the bld. A heart attack r strke r infectin f the heart valves. Pelvic infectin r untreated sexually transmitted disease. Inflammatin f the lining f the wmb r cervix. I am diabetic, am I nt suitable fr Mirena cil fr my heavy menstrual bleeding symptm? Levnrgestrel may affect glucse tlerance, and the bld glucse cncentratin shuld be mnitred in diabetic users f Mirena. Can I change my mind nce I have had Mirena fitted? Mirena can be remved at any time. Ideally it shuld be remved during the time f a perid, r anther reliable frm f cntraceptin used fr seven days leading up t the time f the Mirena remval. This ensures that there is n risk f an unplanned pregnancy. What are the risks assciated with the prcedure f inserting the Mirena cil? During 20 days after fitting, there is a small chance f getting an infectin. It is advisable t make sure there is n existing infectin befre fitting. The IUS can be expelled (pushed) ut by yur wmb r can mve. This is mre likely t happen sn after fitting, Yu may nt be aware f it. It is imprtant yu learn hw t check yur IUS threads every mnth. While fitting, there is lw risk f perfratin (puncture) f yur wmb r cervix. The risk f perfratin may be increased in lactating wmen, in wmen with fixed retrverted uteri, and during the pstpartum perid. The risk is lw when the cil is fitted by an experienced gynaeclgist r gynaeclgy practice nurse. Perfratin can cause pain but ften yu get n symptms. If perfratin ccurs, the IUS has t be remved by surgery. There is a small risk f ectpic pregnancy if yu fall pregnant while yu are n the IUS. What are the alternatives t Mirena fr heavy menstrual bleeding caused by fibrids? There are alternative medical r surgical ptins. The cmmn medical ptins include: The cmbined ral cntraceptive pill. Tranexamic acid. Prstaglandin synthetase inhibitrs (NSAIDs) such as Mefenamic acid r ibuprfen. Surgical ptins include: Endmetrial ablatin. Mymectmy f sub-mucsal fibrids. UAE/UFE. Hysterectmy t remve the fibrids and wmb. Date f preparatin: 12 September 2010

4 Page 4 Hw is a Mirena cil put in? Usually, fitting is arranged within 7 days after the start f yur perid. Befre putting it in the gynaeclgist r nurse check fr: Pregnancy Existing infectin Psitin and size f yur wmb. Yu may be given antibitics at the same time f the prcedure. A pain killer r lcal anaesthetic may be given t make yu feel cmfrtable during the prcedure. The prcedure takes abut minutes. After fitting, what are the signs fr f immediate medical attentin? Seek immediate medical attentin if any f the fllwings ccurs: Abdminal r stmach pain (sudden, severe, r cntinuing) Signs f a bld clt in the leg (sudden unexplained pain in the leg, especially in the calf) Signs f a bld clt in the lungs (sudden r unexplained shrtness f breath; chest pain; cughing up f bld) Signs f a heart attack (pain r discmfrt in the chest r upper bdy; shrtness f breath; nausea; cld sweats; r light headedness) Signs f a strke (such as sudden slurring f speech; sudden unexplained weakness, numbness, r pain in the arm r leg; sudden lss f crdinatin; severe, sudden headache). My partner can feel the string(s) during sex, what shuld I d? If this is prblematic, see yur gynaeclgist. He/she may tuck the strings behind the cervix, cut the strings shrter, r in mre extreme cases cut the strings t level with the cervix. The disadvantages f cutting the strings even with the cervix include yur difficulty in checking the IUS in crrect placement, and the subsequent cmplicated remval at the later Mirena fr HMB Q&A Hw d I keep track t ensure the cil is in place? Visit yur gynaeclgist. Yu shuld visit yur gynaeclgist abut 6 weeks after having the Mirena cil inserted, and every 12 mnths thereafter. Check in place. In abut 5-6% f wmen, the muscular cntractins f the wmb push the cil ut f place r expel it frm the uterus. This is mst likely t ccur in the first few mnths after fitting. Each mnth, yu shuld check that the cil is in place. This can be dne by feeling the tw fine black threads hanging frm the IUS at the tp f the vagina. Yur gynaeclgist and/r gynaeclgy practice nurse in the clinic shws yu hw. Dn t ever pull n the threads, because yu may accidentally pull ut the cil. Hw can I tell if the Mirena cil has been disldged r felt ut? Signs f disldgment r expulsin: Yu may be able t feel the lwer end f the Mirena can be felt (this ften feels like a matchstick) r Yur partner experiences any discmfrt r pain during sexual intercurse r yu may experience persistent pain r abnrmal bleeding r In sme cases, yu may nt be aware f the expulsin initially, but later yu will prbably experience changes in yur bleeding pattern and eventually a return t yur previus bleeding pattern. If disldgement r expulsin happens, cntact yur gynaeclgist immediately. In the absence f the cil, yu lse the prtectin against pregnancy and it is advisable t use anther methd f cntraceptin until yu see yur gynaeclgist r dctr. stage. Date f preparatin: 12 September 2010

5 Mirena fr HMB Q&A What if I becme pregnant while I am n the Mirena cil? There is a small risk f yu becming pregnant (less than 0.2%). Hwever, if yu d, there is a small increased risk f yu having an ectpic pregnancy (develpment f fertilised egg utside the uterus) and yur gynaeclgist will have t remve the cil whether yu want t cntinue with the pregnancy r nt. If yu think yu might be pregnant r have a sudden r unusual pain in yur lwer abdmen, seek medical advice immediately. This might be the warning signs f an ectpic pregnancy. What medicatins are interacting with the hrmne in the Mirena? The fllwing medicatins may interact with Mirena: Anti-epileptics: Lamtrigine (Lamictal), What shuld I d if I get pelvic infectin while n the Mirena cil? If yu develp a pelvic infectin, it must be treated prmptly. Cntact yur dctr immediately if yu begin experiencing persistent lwer abdminal pain, fever, pain with intercurse r abnrmal bleeding as these symptms may indicate a pelvic infectin. If yu develp a pelvic infectin, the cil shuld be remved. carbamazepine (Tegretl), tpiramate (Tpimax), phenytin (Epanutin), primidne (Mysline), phenbarbital, rufinamide (Inveln). Immunsuppressants: mycphenlic acid, mycphenlate Mfetil (CellCept). Anti-fungals: grisefulvin. Chlesterl lwering drugs (statins): Rsuvastin (Crestr). Anxilytics (anti-anxiety): alprazlam. Vasdilatr anti-hypertensives (bld pressure medicines): bsentan (Tracleer). Anti-neplastics (anticancer):bexartene (Targretin). Anti-HIV: Nevirapine (Viramune). CNS stimulants: mdafinil (Prvigil). Acne medicatins: Istretinin Under what medical reasns, Hw is the Mirena cil remved? Generally, IUS remval is easiest if it is dne twards the end f yur perid. Yur gynaeclgist r gynaeclgy practice nurse Page 5 shuld the Mirena cil be remved? If yu experience any f the fllwing, check with yur gynaeclgist/dctr t see if yu shuld have yur IUS remved. Develpment f heavy menstrual bleeding (regular r irregular cycle lengths) r intermenstrual (between yur perids) bleeding, which persists after 6 mnths f cil insertin. Migraines r severe headaches. Cnfirmed r suspected breast r endmetrial cancer. Strke r heart attack. Significantly elevated bld pressure. Recurrent pelvic infectins. Recurrent inflammatin f the lining f the uterus. Jaundice. uses a pair f frceps t take hld f the IUS's thread and gently retract. If fr sme reasns, the cil is "lst" because the thread can nt be felt r seen n speculum examinatin. Yur gynaeclgist may use varius thread cllectr devices r simple frceps t try t grasp the IUS device thrugh the cervix. When this fails, which is rare, an ultrasund scan may be arranged t check the psitin f the cil and exclude its perfratin thrugh int the abdminal cavity r its unrecgnised previus expulsin. Hysterscpy is very rarely needed. Hw sn can I try fr a baby after remval f the Mirena cil? After remval, nrmal fertility returns within 3-6 weeks. Nearly 80% f wmen are able t cnceive within 12 mnths. This might nt be the case fr yu because the presence f fibrids may further cmprmise yur fertility ptential. Date f preparatin: 12 September 2010

6 Page 6 Shuld I have my Mirena cil remved befre my UAE /UFE prcedure edure? S far, the nrmal practice has been t remve the cil a mnth befre UAE prcedure, which is in accrdance t the jint RCR/RCOG guidelines. This cnservative apprach has nt been based n any rbust scientific evidence. N definite cnclusin can be drawn frm a recent investigatin by Smeets et al.(ref. 3). The final decisin whether t remve the cil befre UAE prcedure r nt rests slely n yur interventinal radilgist wh will carry ut the UAE/UFE, taking int cnsideratin yur symptms, the sizes and lcatins f yur fibrids. Medical Terms The fllwing is a list f medical terms used in this factfile, accmpanied by a brief definitin. CNS. Central Nervus System. DVT. Deep Vein Thrmbsis. Endmetrial. Related t lining f the wmb. Endmetrial ablatin atin. A prcedure t destry the lining f the wmb by using energy surce frm electrical current, heat, laser r micrwaves t stp menstrual bleeding. Fibrids. Nn-cancerus (benign) grwths n r in the muscle layer f the uterus (wmb). Mirena fr HMB Q&A References 1. NICE Guidance: Heavy menstrual bleeding 2. Nn-cntraceptive uses f levnrgestrel- releasing hrmne system (LNG-IUS) IUS)-A systematic enquiry and verview. Varma R, Sinha D, and Gupta JK. Eur J Obstet Gynecl Reprd Bil 2006;125(1): Is an Intrauterine Device a cntraindicatin fr Uterine Artery Emblizatin?. A Study f 20 Patients. A J Smeets, R J Nijenhuis, P F Bekki, H Vervest, W Jan van Rij, and P N Lhle. J Vasc Interv Radil. In Press. GMC & MHRA Risk Grading Lw risk <5% Very lw risk <1% Extremely lw risk <0.1% HMB. Heavy Menstrual Bleeding. Hyperplasia. Excessive prliferatin f cells. Endmetrial hyperplasia results in thickening f the lining f the wmb. IUS. Intrauterine system r a cil. Mymectmy. A surgical remval f fibrids. NICE. Natinal Institute fr Health and Clinical Excellence. PE. Bld clts in the lungs. UAE (Uterine Artery Emblisatin). A prcedure t blck the bld supply t the fibrids. UFE (Uterine Fibrid Emblisatin). See UAE. Uterus. A wman wmb. Disclaimer This FACTFILE prvides primarily infrmatin which is intended fr educatinal purpse nly. All cntents within this factfile shuld nt be treated as a substitute fr the medical advice f yur wn dctr r gynaeclgist r any ther health care prfessinal. British Fibrid Trust is nt respnsible r liable fr any diagnsis made by a user based n the cntent f ur factfile. c/ 141 Brkmill Rad Lndn SE8 4JH [email protected] Date f preparatin: 12 September 2010 Cpyright BFT 2010