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| Monday 06 February 2012 |
| Independent midwifery in New Zealand |
| Author: Rae Leach Independent Midwife practising in New Zealand |
| Post-partum Bladder Care: Background, practice and complications |
| Authors: Mr Philip Rahmanou MRCOG Subspecialty Trainee in Urogynaecology John Radcliffe Hospitals NHS Trust, Oxford. p.rahmanou@imperial.ac.uk Mrs Louise Rahmanou MCSP SRP Women’s Health Physiotherapist University College London Hospitals Trust, London |
| The development of transdermal hormone replacement therapy |
| Authors: Dr Susie Weir MBChB MRCGP DRCOG MSC (Community Gynaecology) DPM General Practitioner The Surgery, MichinhamptonDr Weir is also a Hospital Practitioner at the Menopause Clinics in Stroud and Gloucester |
| Capsular synovial metaplasia mimicking silicone leak of a breast prosthesis: a case report |
| Authors: Sarah Krishnanandan1, Ali Abbassian2, Anup K Sharma3 and Giles Cunnick4
1SpR in Accidents and Emergency, Kingston Hospital, Kingston, Surrey, UK 2SpR in Trauma and Orthopaedics, Mayday University Hospital, Croydon, UK 3Department of Breast Surgery, St. George’s Hospital, Tooting, London, UK 4Wycombe General Hospital, Queen Alexandra Road, High Wycombe, Bucks, UK Journal of Medical Case Reports 2008, 2:277 doi:10.1186/1752-1947-2-277 © 2008 Krishnanandan et al; licensee BioMed Central Ltd. |
| Healthcare Improvement in Scotland |
| Author: Susan Downie Medical Rriter Healthcare Improvement Scotland |
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Independent midwifery in New Zealand
IntroductionAuthor: Rae Leach Independent Midwife practising in New Zealand Independent Midwifery in New Zealand became an autonomous profession in 1990.The midwife is known as a Lead Maternity Carer (L.M.C.) and works under section 88 of the New Zealand Public Health and Disability Act, 2000. It is a partnership with women and we work under defined codes of conduct and scope of practice. Evidence of our standards of practice is reviewed every two years by an independent panel. Student Midwives are also trained to eventually become independent midwives.  Methods of PracticeCare is classed as either primary or secondary and this seems to cause difficulties with definition and overlapping, depending where one works. Primary care is all normal midwifery and applies to antenatal, intra partum and post partum care. Secondary care would include complications across the board as well as Epidurals and Syntocinon administration in labour, for which the hospital could have an input. Some Midwives can opt-out of caring for their women with Epidurals and Syntocinon and yet the code of practice clearly states that Midwives are required to make a declaration of competence when applying for an Annual Practising Certificate, and remain competent to practise across all the scopes and skills of practice. This also includes induction of labour where some places may expect you to start off the induction. The midwife works independently and autonomously and our individual caseload is very variable. The average number would be 5-6 women a month although some midwives take up to ten a month. We usually work in a group partnership, but work in pairs. We have five midwives in our practice, and we find our own premises to work from. This is a business just like any other and we pay rent, taxes, G.S.T. web site promotion, signage etc. We are paid by the government in stage payments of the pregnancy and we are all paid the same regardless of experience. This is frustrating when we lose the majority of the birth payment if a woman has an Elective Caesarean i.e. breech presentation .We also have no holiday pay and have to pay for insurance cover and study days. We work in various ways with a partner to cover our practice when we have time off. This often means that we are on call 24 hours a day maybe seven days a week - you are free to work as you want. Some Midwives may work together, share the caseload and split the payment. When you are on annual leave your partner will cover your caseload and this has to be planned in advance and therefore most of us would not book women for delivery at that time. Prescribing Another difference from UK midwifery is that we are able to prescribe and this has been a learning curve for me. We can prescribe a variety of drugs within our scope of practice. Midwives from the UK now have to complete a pharmacology paper in order to practice in New Zealand. We are able to prescribe antibiotics and anything related to pregnancy. We are also able to prescribe nicotine patches and oral contraceptives. Equipment In order to practice independently each individual should have specific equipment available. An Ante-Natal box with B.P. cuff, Doppler, Urine testing sticks and all resource information for women leaflets etc; Post-Natal box with scales, stethoscope, ophthalmoscope, tape measure and again information about contraception etc in various languages. We also carry birth equipment in our car for home deliveries or emergency homebirths. We can hire oxygen for homebirths but we are not allowed to use Entonox at home! We are given an extra birth fee for home births. Means of obtaining clients Women can contact us from the early outset of pregnancy especially women whom we had delivered previously. They may ring us directly or some may have seen their G.P. first (if they have one). The G.P. may also refer and recommend Midwives as some practices work from Doctors rooms. Midwifery practices are in the local phone directory and also on the internet, with our own websites. Some women wish to meet the Midwife first to ascertain if she is suitable for her needs and we also can refuse a client if we wish. Women have our mobile numbers and this can be a problem as some do not consider our private times and we are contacted evenings, weekends even in the night with all sorts of problems which then may have to be addressed. Sometimes women change Midwives at various stages of pregnancy and we also can ask them to find another midwife if the partnership does not work out. Some also move to another midwife; these changes do not help to maintain a stable salary. We are the first port of call regarding the pregnancy and have to be contacted first before sending into hospital. Ante-natal Midwifery care is from booking usually around 6-8 weeks and up to 4-6 weeks postnatally. We are able to organise blood tests and scans as necessary throughout the pregnancy. All women are offered a nuchal translucency scan and maternal serum screening integrated blood test between 11-13 weeks. We can refer for amniocentesis and chorionic villus sampling if required. During the pregnancy we can arrange for a range of blood tests if we so wish and also can contact various Pathologists to discuss results. The Pathologists lab people are very helpful and willing to share their expertise. We refer to the Obstetricians at the hospital and also have access to an Obstetric Physician regarding medical problems. Some Midwives attend the hospital appointments with their women. For most women they may never have contact with a doctor during the entire pregnancy. We also have access to Social workers, Physiotherapists and other professionals. Midwives work collaboratively with other health professionals when necessary to meet any additional, medical, health or social needs of mothers or babies (NZCOM). Labour The women contact us when they go into labour; we then can assess if they need to go to the hospital at that time. Some midwives may visit the women in their home at first to assess the labour before going into hospital. The women’s preferences would have already been discussed, with a care plan if she so wishes. The majority of Midwives would be happy to perform water births as well as home deliveries. If there are complications during the labour, Obstetricians are always available for advice and assistance. The Obstetricians are supportive of us and I am sure that this relationship has developed as the role of L.M.C. midwives has evolved. Midwives, as in any profession, are variable in their experience and the obstetricians would recognise this. There is also help on hand if required from the hospital staff although the core staff does not intervene unless asked. We are mainly the sole carers of the women in labour and this can mean being with the woman for several hours. It also means that one midwife manages the labour, taking into account the woman’s requests and needs. The epidural rate is probably the same as any large hospital but I am aware of more N.V.D. even with the epidural. Some would argue that this is a direct result of one to one care and that the partnership with the women greatly improves the outcome. The majority of women here would only see at the most two midwives during their pregnancy and I don’t know if they stay with the women throughout the labour. Before 1990 the midwifery care was just the same as private health care, whereby the obstetrician or G.P. would deliver your baby. These models of care are still an option for women as some G.P’S are still L.M.C’S with the core staff mainly doing the labour care. This does not seem the role of the G.P. anymore. There is private obstetric care either completely or shared with the Midwife for ante-natal and post-natal care; the women pay for private Obstetric care. For some of the older population they may question independent practice of a midwife for their children and often ask questions around this subject; they do not always have confidence in our abilities! Post natal care The continuity of care postnatally, 4-6 weeks after birth is a great advantage to the women especially regarding Breast feeding, we have a higher number of women exclusively breast feeding at discharge especially primigravida. There is a higher rate of breast feeding in New Zealand especially in the younger age group. We have to update regularly as part of our registration and produce statistics on our Breast Feeding rates. We are also responsible for the care of the newborn up to this period and we perform full baby checks at birth, one week and on discharge, any concerns that may arise we can refer to a Paediatrician or G.P accordingly. Another learning curve for me in Independent Midwifery has been treating Mastitis and Breast Abscesses, this is all part of the length of time we continue with care and seems to be more common at certain times of the year. My clientele range from European to Chinese, Koreans, Indians, Maori and Pacific Islanders. There may be language problems and we can resource help for this. It is interesting to notice how various races cope and accept pregnancy and labour. There are of course still lots of myths which are handed down from generation to generation mainly in the Asian population.  ComplicationsIn areas of low socio economic households there can be problems of obesity, diabetes, grandmultiparae also non attendingappointments and arriving in labour with no Ante-natal care. I have seen hardly any problems of Hypertensive disease of Pregnancy (P.E.T.) There are many private scanning places to choose from, some are free others charge about 12-15 on average. This is the woman’s preference. This is also the case if we recommend women to see a Physiotherapist, Chiropractor, Osteopath or Acupuncturist. There are many other available options for women but they would have to pay for these services. We care for women with medical problems as well. These problems are usually made aware at the booking visit and according to the problem would be seen by the obstetrician or obstetric physician at clinic. It is our responsibility to refer and make appointments for the women and some of us attend these appointments with the women. The caesarean section rate is a problem here as anywhere else and many factors are involved. One comment many experienced Independent Midwives that I work with make is that we see inexperienced registrars unable to attempt forceps/ventouse deliveries and are more skilled with caesarean sections. Consultant backup is not always present to teach them. This for us as midwives can be frustrating and a challenge as we are the woman’s advocate. I feel my skills have been extended and my thinking widened as we become more experienced with early pregnancy problems including screening and miscarriages, S.T.D.’s as well as managing medical issues affecting pregnancy. You develop the skills to think outside the box. The decision making is a huge learning curve. If a midwife was newly qualified it would be important to pair her with a more experienced midwife. Students It is our choice to take on student midwives and there are always vacancies although sometimes they experience difficulties in finding midwives. But because we have to have a practising review every two years, most of us need the points that come withtaking on a student. They are with us nearly every day for about 8 weeks, but their experience would depend on the midwives caseload at that time. As Midwives our role is also as a teacher and we should impart our knowledge to others. Student midwives are trained to practise as Independent Practitioners and their training has been lengthened recently to include more practical hours, which is definitely necessary. Once qualified they can do a mentoring system for 18 months in the hospital but this is only if there are vacancies as there are more midwives than jobs. Some choose to be Independent Midwives. A.C.C. We have a system whereby one can sue; it is ACC (Accident Compensation Corporation). I do not know enough about how the system works for compensation regarding birth, but the individual is not sued. As Midwives, our college fees cover us re: insurance. This is also the system through which we can access physiotherapy treatment etc for an accidental injury this would include third and fourth degree tiers for future follow up and further surgery if necessary. In order to survive as an Independent Midwife, I think you have to have lots of stamina, well organised flexible work practices, good work ethic and a supportive relationship/family. My personal view would be it would be very difficult to do this job with a young family as the work is unpredictable in its timing! One does have great job satisfaction though. This is a very idealistic system of care for women a one to one relationship, but for midwives it can cause burn out. Midwives leave the system as they struggle to cope with the on calls, long hours and family commitments. This is not a job I feel one can do continuously for years; many midwives opt in and out of the system over their career span. Independent Midwifery is a challenging, yet rewarding way of working. Post-partum Bladder Care: Background, practice and complications
IntroductionAuthors: Mr Philip Rahmanou MRCOG Subspecialty Trainee in Urogynaecology John Radcliffe Hospitals NHS Trust, Oxford. p.rahmanou@imperial.ac.uk Mrs Louise Rahmanou MCSP SRP Women’s Health Physiotherapist University College London Hospitals Trust, London Bladder care is an important aspect of management in the postpartum period. Postpartum voiding dysfunction occurs in a significant number of women, which can potentially cause permanent damage to the detrusor muscle and long-term complications when left undetected or untreated. Hospitals have varying guidelines for postpartum bladder care. In the absence of a universal protocol, many cases are missed or mismanaged. It is important to consider the implications of poor bladder care in the puerperal period and to try and avoid such cases occurring as far as possible. Definitions Urinary retention is a complaint of the inability to pass urine despite persistent effort.1 Acute urinary retention is defined by the International Continence Society as a painful, palpable, or percussable bladder, with the patient unable to pass any urine when the bladder is full,2 although it should be recognised that pain may not be present in the post partum woman especially following epidural analgesia. Post-partum urinary retention (PUR) also known as insidious urinary retention after vaginal delivery or puerperal urinary retention is a relatively common condition. Traditionally post-partum urinary retention is described as the absence of spontaneous micturition within six hours of vaginal delivery,3 however, there is no research base to this definition. Acute, also know as overt, retention presents with ‘the sudden onset of the inability to void’ leaving a significant amount of residual urine in the bladder. Post-void residual (PVR) is ‘the volume of fluid remaining in the bladder immediately following the completion of micturition’.2 In the literature, varying volumes of residual urine are regarded as significant ranging from 40ml-200ml.4 These ranges may reflect the timing and methods used to measure PVR. They are most accurate if measured immediately, within 60 seconds of micturition.5 A recent study using transvaginal ultrasound as a method of measuring immediate PVR suggest an upper limit of normal of 30ml.6 An isolated finding of a raised PVR requires confirmation before being considered significant. Chronic retention of urine is defined as a non-painful bladder, where there is a chronic high PVR.6 Postpartum chronic, also known as covert, retention is considered when there is PVR of over 150mls or more. It is usually a self-limiting condition, which often resolves within a week. Patients with covert bladder retention may present with frequency, passing less than 150ml with feeling of incomplete emptying. Incidence The reported incidence of postpartum voiding dysfunction varies due to inconsistencies in the definitions and method of diagnosis. Furthermore, figures may also vary depending on whether studies focus on acute or chronic retention. Estimated ranges of incidence vary from 0.05% to 37%.7 It would be reasonable to quote that 10-15% of women have voiding dysfunction to some degree and for some time following delivery. Up to 5% of these women may have significant and longer lasting dysfunction, which if not recognised in the early peripartum period, may lead to bladder distension and overflow incontinence with significant long-term bladder dysfunction. Current Practices There are no set national guidelines for the management of postpartum bladder care as yet. In the guideline for “Routine Postnatal Care of Women and their Babies” produced by the National Institute of Clinical Excellence (NICE), it is recommended that conservative measures be taken to encourage those women that have been unable to void within six hours of delivery. If unsuccessful, bladder volume should be assessed and the patient should be catheterised if necessary. In the Royal College of Obstetrics and Gynaecology (RCOG) Green Top Guidelines it is recommended that a woman who is post instrumental delivery and has had a spinal anaesthetic or an epidural that has been topped up for a trial, may be at increased risk of retention and should have an indwelling catheter for at least 12 hours post-delivery. There is little evidence on the management of postpartum urinary retention and many hospitals have implemented their own postpartum bladder care protocols. Zaki et al investigated postpartum bladder care by means of a postal questionnaire in 189 maternity units in England and Wales. The results of which showed huge variations in diagnosis, management and compliance with the RCOG recommendations on postpartum bladder care.8 Risk Factors Although it is not possible to accurately predict who will develop post partum urinary retention various risk factors are suggested.9, 10 Risk factors include:
The pathophysiology of postpartum urinary retention is not clearly understood but various mechanisms have been suggested. The bladder is a hormone-responsive organ and it’s functions may be subject to the fluctuation of hormones during pregnancy and in the postpartum period.4 The postpartum bladder is hypotonic, remaining so for a number of days post delivery. Pregnancy causes reduced muscle tone in the bladder from the third month with the bladder gradually increasing in capacity as the pregnancy progresses.11 This may be as a result of physiological hormonal changes such as elevated progesterone levels during normal pregnancy. In the absence of the weight of the pregnant uterus limiting the size of the bladder, as well as possible trauma to the bladder, pelvic floor muscles and nerves during delivery, the bladder becomes susceptible to retention. One of the most common causes of postpartum urinary retention is the use of regional anaesthesia due to afferent neural blockade which supresses the sensory stimuli from the bladder to the pontine micturition centre. As a result, the reflex mechanism that induces micturition is blocked which may result in reduced contractility of bladder and urinary retention.12 Urinary retention may also be the result of nerve injury during delivery. A number of studies have shown that the pudendal nerve, with afferent nerve branches (S2–4) supplying the bladder, is damaged during pelvic surgery and vaginal delivery. Using electrophysiological tests, some studies have shown the damaging effect of a vaginal delivery to the pudendal nerve. There is a significant increase in pudendal nerve terminal motor latencies, which may take a few months to recover post delivery.13-15 This is thought to be due to pelvic floor tissue stretching during delivery resulting in pudendal nerve damage. Both instrumental delivery and prolonged labour can be predisposing factors to this damage. Another possible explanation of postpartum urinary retention is a transient phenomenon caused by tissue oedema around the urogenital area, resulting in a transient mechanical obstruction to urine outflow. The tissue oedema could be due to a prolonged labour process with compression of the fetal presenting part onto the birth canal or other factors such as instrumental/assisted delivery or extensive vaginal and perineal laceration. Within days of delivery, as the tissue oedema improves, the urinary retention gradually returns to normal. It is well known that in a non-pregnant population, chronic changes in the detrusor muscle can result from a single episode of massive over-distension. The bladder can retain up to a litre of urine, although residual volumes of between 500ml and 800ml are enough to stretch the bladder walls and cause detrusor damage. Significant bladder over-distension can lead to denervation and detrusor atrophy. This may result in long-standing voiding dysfunction with persistent urinary retention and overflow incontinence. Symptoms Symptoms of acute retention are much more obvious as women are not able to void and suffer an associated painful bladder. However, the pain should not be misdiagnosed as caesarean wound pain. Symptoms of incomplete empting/ chronic retention of the bladder in post partum period include:
Diagnosis of postpartum urinary retention can be difficult especially if a woman is asymptomatic. In order to diagnose urinary retention, the post void residual volume needs to be determined. Initially women are asked to void and immediately after PVR should be measured. This is important as a long delay in measurements can give an inaccurate PVR due to renal diuresis. Bladder distension may be felt by abdominal palpation but this is inaccurate and bladder volumes of less than 300ml may not be identified. Catheterisation is the most accurate PVR measurement in the first few weeks of the post partum period. Catheterisation can be uncomfortable and potentially increases the risk of urinary tract infection. Most authors recommend in/out catheterisation as an ideal method. Bladder scanning is a popular non-invasive method of measuring PVR. Many question the accuracy of scanning in post-natal women. A standard bladder scanner may measure echogenic uterine debris as bladder volume. However, some authors believe that ultrasound assessment is accurate, even in the post partum period, as the bladder maintains an ellipsoid shape.16 It may be logical to use a bladder scanner as a guide for the amount of post-void residual. If a significant residue is measured by ultrasound then it should be confirmed with an in/out urethral catheter. Management The recommendations for management in the literature vary between different authors. Summarised below are the most common suggestions. 1. Intrapartum The most important part of management of PUR is prevention which starts with the labouring woman. Voiding should be encouraged every three hours whilst in labour and if unable to void, there should be a low threshold for catheterisation. Women should also be catheterised if the bladder is palpable or there is a sensation of incomplete empting. Women who have had an epidural for normal labour, especially with a heavy block, should be offered an indwelling catheter that should remain insitu for a minimum of six hours postpartum or until full sensation has returned. A catheter balloon should be deflated or removed prior to pushing to reduce the risk of urethral damage with extrusion of the inflated catheter during delivery of the baby. Women who have had spinal anaesthesia or epidural anaesthesia that has been topped up for a trial of Instrumental delivery with or without Caesarean section are at increased risk of retention and should have an indwelling catheter which should be kept in place for at least 12 hours following delivery to prevent asymptomatic bladder overfilling. 2. Postpartum In the postpartum woman the timing and volume of the first voided urine should be monitored. Voiding should be encouraged every 2-3 hours in the immediate postpartum period. Women should not be left for over 6 hours without voiding or being catheterised post delivery. A fluid balance chart can be helpful in monitoring input and output, especially in the first 24 hours post delivery. Normal sensation, difficulty initiating micturition, sensation of incomplete emptying, volume voided and timing and frequency of voids needs to be documented in the clinical records and PUR diagnosed as explained previously. Measures to aid voiding Yip et al advocates conservative, ‘helping measures’, such as oral analgesia, helping the patient mobilise and offering them privacy as well as techniques such as bathing in a warm bath and immersing their hands in cold water.4 It is suggested that these practical measures, which hold low risk to the postpartum woman, may be attempted prior to less conservative management. The importance of preventing constipation should not be forgotten. What to do if PUR is suspected or confirmed? If the volume voided is less than 150ml or the residual volume assessed by ultrasound is more than 150ml the patient should be managed with in/out catheterisation. With the urine residue accurately measured, an arbitrary residual volume of 150ml may imply a degree of dysfunction. At this stage a fluid balance chart is mandatory. Most authors recommend that if the patient is not able to void well after a further six hours, an indwelling catheter, such as Foley’s catheter, should be inserted and remain so for 24/48 hours. Some even advocate for it to remain insitu for one week.7 A midstream or catheter sample of urine needs to be sent for microbiology to rule out an infection. If positive, the patient should be treated with appropriate antibiotics as per local guidelines. However, as there is high risk of infection prophylactic antibiotics is advocated.17 In the absence of infection and a failed trial without catheter or persistent high PVR, intermittent self-catheterisation (ISC) or another indwelling catheter is recommended. The volume of urine drained initially can be a predictor of repeat catheterisation. A study by Burkhart et al found that if the initial volume of PVR was less than 700 in their cohort of patients, none required repeat catheterisation. However, if there was over a litre PVR then 20% required repeat catheterisation.18 Some obstetric units support the use of suprapubic catheterisation rather than ISC. This is more justified for women who have had a repeated failed trail with an in/out catheter or massive retention of urine with possible irreversible bladder damage. There is no evidence that pharmacological interventions have any place in the management of PUR . Complications and long-term implications Early detection of urinary retention is very important as the over-distended bladder may result in irreversible bladder damage. There is very limited data on short sequelae of PUR. The data available suggests that the majority of PUR are self-limiting cases with a return to normality within the first week post partum. Postpartum urinary retention that remains unrecognised or poorly managed may lead to long-term voiding difficulty with recurrent urinary tract infection and ureteric reflux. This may lead to upper urinary tract damage and even renal failure. There are also case reports of bladder ruptures in a few unrecognised cases. As a result, long-term follow up for patients is always advisable. Conclusions Intrapartum bladder care and the prevention and management of postpartum urinary retention are of great clinical importance. It is far more beneficial to prevent acute bladder distension by taking reasonable measures, where possible, to avoid it, than to treat cases once symptoms have developed. The implementation of regular screening protocols is advisable as cases recognised, diagnosed and treated promptly can prevent long term, irreversible damage to the detrusor muscle that can have a permanent impact on a woman’s quality of life. References
The development of transdermal hormone replacement therapy
The perimenopause, the time leading up to the menopause or final menses, has been recognised through the ages as a time of significant change. Symptoms of gradual reduction in female hormone production are common and experienced by many women.
For some these, symptoms can be debilitating, affecting all aspects of daily living. There is little reference to early remedies in the literature; indeed menopause has only become a concern with the increase in lifespan associated with better nutrition and improved healthcare over the past two centuries.
The average age of menopause has been consistently around age 51 whilst average age of death has increased from mid 20s in medieval times to 84 years today. Even when menopausal problems were apparent, there was little help available. Thomas Graham wrote in his book published in 1837, “The
Diseases of Females”, that with the exception for attention to diet and exercise, “little or nothing is required for the management of ordinary cases”.
Women were thought to be ruled by their hormones, and thus inferior to men, making menopause a shameful secret. It was only in the later 19th century that scientists began experimenting with various animal extracts in the search for the ”fountain of youth”. The Merck Manual of 1899 describes a preparation known as “Ovariin” which was a coarse brown powder taken orally, essentially the dried and pulverised ovaries of a cow. Research continued; notably Drs Allen and Doisy.
Working together between 1923 and 1938 they identified oestrogen and its effects, followed by the other female hormones and their relationship to each other. Pharmaceutical companies were quick to spot possible market opportunities in menopause, menstruation problems, infertility and contraception and also hoped to address problems such as wrinkles and thinning hair! Scientists were recruited by the drug industry and the first commercial oestrogen was available in 1930. This was “Emmenin”, produced from urine obtained from late-pregnant women in Canada. Although marketed as the first effective oestrogen, an alternative source was quickly required as there were problems with high cost, taste and odour!
A better source was found in pregnant mares urine and this was marketed by the company Ayerst (which became Wyeth) as Premarin, its name derived from the source. This has been available for nearly 70 years now.
Other oestrogens followed with ethinyl oestradiol being synthesised in Germany by the company Schering in 1938, still the leading oestrogen used in contraception, and diethylstilbestrol synthesised in the same year in the UK by Charles Dodds. He made the formulation available freely, believing that pharmaceutical companies should not profit from scientific work. Many companies applied to manufacture DES (diethylstilbestrol) as it was off patent even thought Dodds himself already had concerns about possible cancer and miscarriage risks.
All these preparations to date had been oral formulations with no consideration of alternative delivery methods. Although effective HRT had really been made available in 1941 with DES, prescribing was not widespread until the 1960s when the change in womens role in society brought the menopause and hence the benefits of HRT to the fore.
Several books were written at that time which highlighted the improvement in both emotional and physical wellbeing for middle-aged women, indeed HRT was regarded as a panacea for all midlife issues. The prominent American gynaecologist, Dr Robert Wilson, promoted the use of oestrogen in his book “Feminine Forever” as a means of combating the “living decay” of menopause and advocated the use of oestrogen from “puberty to the grave”, advice which is not recommended now. Drug prescriptions increased steadily with Premarin being the number one drug in the US by 1992 . The use of HRT remained popular despite a significant scare in the 1970s in the USA when the link between unopposed oestrogen and endometrial cancer was demonstrated.
Despite providing an excellent treatment for many women, oral preparations are not without drawbacks. Daily dosing is required, which is a disadvantage for some menopausal women with memory problems! Any oral preparation must be absorbed from the digestive tract, then passes to the liver via the portal system and is metabolised before reaching the target organs. This increases the workload on the liver and affects the dose eventually delivered. The higher total dose required may give rise to oestrogenic side-effects including nausea, breast tenderness, headaches and leg cramps. Women with malabsorption problems may simply not absorb sufficient drug doses to achieve an adequate response.
Other routes of administration have become possible, but obviously need to be convenient and confer advantages over the oral route in order to be worthwhile. Research into transdermal administration had been going on throughout the 1970s but had several difficulties to overcome. Earlier, skin had been thought of as an impermeable protective barrier. However it has been shown that many drugs can diffuse through the thin layer of tissue separating the outside world from the capillary network lying just below the skin surface.
The first transdermal delivery systems were launched in 1979 and the next decade saw the development of ten further transdermal delivery systems (TTDS) containing different drugs. The drug company ALZA in the US led the market with brands including Estraderm, Duragesic, and Transderm-Nitro. They also produced patches for delivery of nicotine and analgesics, and anti-nausea drugs.
The main advantage of transdermal delivery relates to the controlled absorption rate giving predictable, uniform plasma levels, and improved bioavailability. The lower overall dose tends to result in fewer side effects. A transdermal patch is easy and painless to apply and equally simple to discontinue by removing the patch, should administration no longer be required, for example prior to surgery. A simple system tends to improve patient compliance particularly with weekly patches.
Authors: Dr Susie Weir MBChB MRCGP DRCOG MSC (Community Gynaecology) DPM General Practitioner The Surgery, MichinhamptonDr Weir is also a Hospital Practitioner at the Menopause Clinics in Stroud and Gloucester
Capsular synovial metaplasia mimicking silicone leak of a breast prosthesis: a case report
IntroductionAuthors: Sarah Krishnanandan1, Ali Abbassian2, Anup K Sharma3 and Giles Cunnick4 1SpR in Accidents and Emergency, Kingston Hospital, Kingston, Surrey, UK 2SpR in Trauma and Orthopaedics, Mayday University Hospital, Croydon, UK 3Department of Breast Surgery, St. George’s Hospital, Tooting, London, UK 4Wycombe General Hospital, Queen Alexandra Road, High Wycombe, Bucks, UK Journal of Medical Case Reports 2008, 2:277 doi:10.1186/1752-1947-2-277 © 2008 Krishnanandan et al; licensee BioMed Central Ltd. Synovial metaplasia around prostheses is regarded as a transitional phenomenon1. We describe the case of a patient in whom, at the time of removal of a prosthetic port, the quantity of viscous fluid produced as a result of metaplasia caused us to suspect that a silicone bleed had occurred. This resulted in what later appeared to have been the unnecessary explantation of her implant. Case presentation A fit and healthy 25-year-old Caucasian woman presented with asymmetry and gross bilateral tubular deformity of the breasts. Subsequently, a bilateral breast reconstruction with 350 cc Becker™ (Mentor, UK) implants was performed. At the time of surgery, 200 ml of saline was used to inflate both implants. The left implant was further inflated one and five months later using 80 ml of normal saline on both occasions, to optimise symmetry. One year later, both ports were removed as a day case procedure. At that time, the right port was removed without complication. However, the left port was surrounded by a viscous fluid simulating implant rupture. A silicone gel bleed was suspected and another operation was planned where the left prosthesis was replaced with another permanent implant. The fluid and a sample of the periprosthetic capsule were sent for histological review. Histological examination revealed that the fluid was synovial fluid. The sample of capsule was found to be fibroadipose tissue, composed of fibrin-organising histiocytes, lymphocytes and multinucleate giant cells. The capsule had undergone synovial metaplasia, which explained the presence of synovial fluid around the left implant. A typical histological appearance of synovial metaplasia is shown in Figure 1. Capsular synovial metaplasia. Sections from the cavity show the surface of the capsule lined by fibrohistiocytic cells. The nuclei of these cells are basally oriented and are polarised perpendicular to the cavity surface. The interface between the capsule and implant space is smooth. The overall features are indicative of synovial metaplasia.
Synovial metaplasia was first described by Brody and White2 following their studies on implanted silicone joints in chickens. Another study of 85 patients with breast prostheses showed that the incidence of synovial metaplasia was 40% and that this condition was not as rare as had been previously suspected1. A number of theories have been suggested to explain this phenomenon. One study suggested that the tissue reaction was a response to implants with a textured surface rather than a smooth surface3. In contrast, Ko et al.1 suggested that the occurrence of synovial metaplasia did not correlate with the implant type. Instead they postulated that implant age may be a significant factor. The incidence had been shown to decrease with the age of the implant, suggesting that it may be a transitional finding in capsular maturation. This is in contrast to one report of synovial metaplasia that had presented with breast firmness and pain 26 years following implantation4. Another hypothesis suggests that mechanical stress may influence the development of synovial metaplasia. In one study5, the bone-cement interface of loose hip prostheses, which is under considerable mechanical stress, was shown to undergo synovial metaplasia. Mechanical interference has also been associated with its development in the skin6. Mechanical stress may influence the development of synovial metaplasia in breast implants because of repeated surgery, expansion of the implants, the pendulous movement of the breasts or with chest wall muscle activity. Synovial metaplasia secretes lubricating factors and this may be beneficial for the reduction of capsular contracture. In one report, synovial metaplasia occurred after multiple manipulations and tissue expansions7. The investigators believed that this played an important role in the development of the metaplasia. The mechanical interference theory may explain the findings in our patient. The left prosthesis was expanded on two occasions, whereas the right prosthesis was not expanded at all. Synovial fluid was only macroscopically evident on the left side. Conclusion Silicone breast implants that are suspected of a leak should be assessed by histological examination of the fluid to rule out synovial metaplasia. This is particularly important if the implant has been subjected to expansions or manipulations. The clinical significance of synovial metaplasia is uncertain, however, increased awareness of this phenomenon by surgeons may reduce the unnecessary explantation of perfectly intact prostheses. If a leak is found to be due to synovial metaplasia, a period of observation and delay in explantation is advised as this may well be a transitional phenomenon. Consent Consent could not be obtained as the patient was untraceable. However, we believe the article contains a worthwhile clinical lesson which could not be made as effectively in any other way. The risk of identification of the patient is minimised by measures designed to prevent the identity of the patient being revealed either to others or to the patient’s relatives. We expect the patient and their next of kin would not object to the publication of this case. Competing interests The authors declare that they have no competing interests. Authors’ contributions SK and AA were involved in the literature search, writing up of the case and preparing the revision. AS and GC managed the clinical care of the patient as well as assisting in writing the manuscript. Acknowledgements We acknowledge the help and expertise of the histopathology department at St. George’s Hospital, particularly Dr V. Thomas for the diagnosis and preparation of histological slides. References
Healthcare Improvement in Scotland
On 1 April 2011, Healthcare Improvement Scotland was launched as a new health body, marking a change in the way the quality of healthcare in Scotland is supported nationally. The purpose of Healthcare Improvement Scotland is to improve the quality and safety of healthcare for the people of Scotland by:
Author: Susan Downie Medical Rriter Healthcare Improvement Scotland
Healthcare Improvement Scotland collaborates with national and international experts to identify, create, synthesise and share evidence for improvement. It provides advice and guidance on effective clinical practice by developing national standards, evidence notes, health technology assessments and systematic reviews. Healthcare Improvement Scotland assesses new technologies in healthcare through the SHTG and advises on the cost effectiveness of newly licensed medicines through the SMC. All evidence is accessible to healthcare professionals to support them in providing safe and effective care, and to the public to inform them of the quality of care they can expect to receive. Currently, the evidence on postnatal depression is being revisited to update the SIGN guideline on postnatal depression. Aspects of the guideline undergoing revision include diagnosis, screening, pharmacological and psychological interventions. The updated guideline and an associated patient version will be available in spring 2012. Improvement Healthcare Improvement Scotland facilitates improvements in healthcare practice and patient safety through use of evidence; offers clinical governance support; and encourages NHS boards to promote public involvement and equal opportunities. Many of the organisation’s improvement initiatives that are currently ongoing stem from the reproductive, maternal and child health work programme. As part of its core continuous work, this programme co-ordinates the assessment of maternal deaths in Scotland and thus contributes to the triennial Saving Mothers’ Lives Report which is overseen by the Centre for Maternal and Child Enquiries (CMACE). The most recent report containing data from 2006- 2008 was published in March this year. In June, Healthcare Improvement Scotland, in collaboration with NHS Education and NHS Health, held a series of roadshows to launch the Scottish Antenatal Parent Education Pack. The pack was developed to prepare professionals to deliver consistent parent education, which respects and reflects the individual needs of pregnant women and their partners. It includes a national syllabus, a resource pack and a training element. In November this year, a revised Scottish Woman-Held Maternity Record (SWHMR) will be made available. The SWHMR is an innovative development led by Healthcare Improvement Scotland on behalf of the Scottish Government. Scotland was the first of the UK countries to have a single national unified handheld record for women during their maternity care. Following evaluation in 2010, the SWHMR is currently being refreshed and a national consultation has been undertaken. Scrutiny HEI inspects the NHS to ensure hospitals are safe and clean, assesses the performance of NHS and independent healthcare services, and publishes findings. Healthcare Improvement Scotland also scrutinises compliance with national standards. The national standards for sexual health services were published in March 2008 and peer review visits to each NHS board in Scotland to assess performance against these standards will be complete this summer. An overview of national performance will be published later this year. A new model for scrutiny is being developed that will apply to both the independent sector and the NHS in future years. Measures of success The effectiveness of Healthcare Improvement Scotland will be judged on the following criteria:
There are several factors that will help the new health body improve the quality of care and experience of every patient in Scotland every time they access healthcare. The Healthcare Improvement Scotland work programme supports Scottish Government priorities, particularly those arising from the Healthcare Quality Strategy. The organisation also has the freedom to determine how it works and publishes it findings and recommendations. Within the organisation there is a wealth of knowledge, including senior staff with extensive experience in leading change to improve services at all levels of the NHS. However it is only by working in partnership with patients, the public and health professionals and maintaining strong links with UK regulatory and professional bodies, and other UK organisations that Healthcare Improvement Scotland will ensure its work has credible clinical quality and is robustly evaluated. In this way, Healthcare Improvement Scotland will strive to build a reputation as a centre of excellence for healthcare quality improvement. Further information is available at www.healthcareimprovementscotland.org. |
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