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Contraceptive methods

User Controlled Implantable Contraception: Baby, You Can Turn Me On

26 Jan, 16 | by shaworth

Over the course of this month, there has been quite a bit of press attention given to the Bimek SLV, a device purporting to be the first attempt to achieve user-reversible, surgical, male contraception.

Men have, for a considerable amount of time, been left behind in the field of contraception. Women have both hormonal and non-hormonal methods of which both short and long acting are available. Men, on the other hand, have the dichotomy of condoms or vasectomy, with no halfway option between instantly reversible and surgical permanence. Unsurprisingly, those who wish permanent contraception sometimes wish to have the procedure reversed, which is not guaranteed to be successful.

On the face of it, the Bimek SLV seems to be a good idea. Implanted into the vas deferens, the device contains an occluding valve, which can be changed from an open to a closed position by the user pressing a switch attached to it. However, there were some worrying gaps in the press reports about the device: what were its success rates so far, for example? It transpires that the device is beginning Phase I trials soon, and that the only person in which the device has been implanted is the inventor himself.

Further review of the product information reveals that so far, no animal testing has been performed for the device at all, and this is revealed as a selling point, so that the device can be used by vegan men. Yet despite the lack of objective evidence, the product literature, and website, contain references to the apparent safety of the device, and that the procedure is “low risk”. It’s easier to find information on investing in the project that it is to find information on trial participation.

Bimek himself is not a medical professional, and has brought the device to preliminary trials under his own steam. He is seeking further funding in order to proceed, hence the attempt to drum up media support. In the age of crowd-funding and peer-to-peer lending, traditional methods of research and development are being bypassed. Perhaps this is of value, and perhaps the drive to implantable technology without animal testing will revolutionise healthcare research as we known it, but given that earlier this week a Phase I trial in France resulted in the death of a participant and the hospitalisation of several others, perhaps Bimek would do well to tone down their claims of safety, in the face of scant supporting evidence.

Ultimately, for the time being, what the Bimek SLV has done well to showcase, is that sensationalist reporting without a full grasp of the facts, remains depressingly popular as a way of communicating new science developments to the masses. Here’s hoping that time, and further research, means that it can prove its claims.

Crowdsource, Contraception and No Small Potatoes

14 Sep, 14 | by shaworth

Contraception for men has been an area of dashed dreams for many years, so the ongoing trials of potentially reversible vas deferens occlusion by polymer injection represents an interesting development. Reported in the UK press as an “injectable contraceptive for men”, a description that seems grossly inaccurate in some respects as it’s not equivalent to the injectable contraceptives for women which work using high dose progestrogen; although it is injected into the vas itself, Valsagel is currently undergoing testing in animal models with hopes to begin trials in humans if this is deemed to be a success.

Valsagel is not the first polymer injected vas-affecting agent to be developed, and the work was inspired by the ongoing trials of RISUG in India, covered by Wired in 2010 in an extensive article that also details how Valsagel came to be and containing an account of a consenting process that seems less than entirely rigorous. RISUG was passed over by the WHO after phase II trials in 1997, due to production problems, but interest in the project was renewed in India in recent years and Phase III trials continue locally.

Valsagel works slightly differently to RISUG, by occluding the vas deferens using the polymer. Theoretically, the polymer can be subsequently dislodged using another injectable agent; although whether this is true in humans, only time will tell. Interested clinicians can follow the Valsagel trials through the Parsemus Foundation, who are partly funding the trials through crowdsourcing initiatives.

This is not the first crowd-sourced initiative in medial research discussed in the blog, and it also remains to be seen whether this will represent a useful source of funding for medical research in future, by bringing patients and small donors into contact with large-scale projects.

Those following developments in this field may also be interested in the attempt of an American woman, known only as Bailey, who attempted to crowd-fund her termination of pregnancy through the website GoFundMe (which the website subsequently revoked; although she did receive the funds allocated). Bailey was interviewed about her decision in the fashion and design magazine Vice*, where she discusses that her decision to crowd-fund donations was due to being unable to finance the procedure herself, and the use of crowd-funding to help people achieve their goals. She makes reference to the $50,000 raised to produce a single serving of potato salad, something that suggests the world has not yet run out of ways to waste money.

*This magazine contains content, including nudity and profanity, which is probably in violation of your work internet use policy, but you can read the interview here.

FSRH Welcomes Nurses at a one day conference

24 May, 14 | by shellraine, e-Media Editor

 

The FSRH is delighted that from January 2014 nurses are Eligible to become members of the FSRH and to undertake training for the Nurse Diploma in Sexual and Reproductive Health Care (NDFSRH), the Letters of Competence in both intrauterine devices and subdermal implants and the postgraduate qualification in medical education. The organising committee has planned this ‘one off’ meeting to update delegates on FSRH qualifications and to provide a general update on contraception, together with a motivational speaker on communication skills. This event is aimed at all nurses working in sexual and reproductive health in any setting, service managers and lecture practitioners.

Venue

Royal College of Obstetricians and Gynaecologists

27 Sussex Place, London, NW1 4RG

 Course Fee £130.

For Nurse Diplomate & Associate members £120

Please make cheques payable to FSRH and send to

Faculty of Sexual and Reproductive Healthcare, 27 Sussex Place, London, NW1 4RG

Full programme

 

 

 

ESC – 13thCongress and call for applications for project funding

16 Sep, 13 | by shellraine, e-Media Editor

Mark your calendar:

28 till 31 May 2014
Lisbon, Portugal

First announcement

Check out the first announcement including:

  • programme overview: 8 workshops, 21 congress sessions, 2 debates…
  • abstract submission instructions (deadline 1 December 2013)
  • registration form

Register now

Please find here an overview of the registration fees.
You can now register through the online registration form

General information / Programme overviewCall for abstracts (deadline = 1st December 2013)/ Registration

ESC newsletter

Call for project or course applications

The ESC provides funding to support a project within Europe

The available budget for applications received between 1 August and 31 December 2013 is 30,000 euro. Applications should meet the following minimal conditions:

  • The applicant must be a paid-up ESC member
  • The grant may be used to support an individual, group, institute or organisation with a project related to the aims of the ESC.
  • Examples of projects include: research, audit, review, needs assessment

Deadline for the application period:  31 December 2013

Application Form

 

 

World Contraception Day – 26 September 2013

16 Sep, 13 | by shellraine, e-Media Editor

WCD will be using an umbrella theme for this and future years: ‘Its your life; its your future’. This theme has been chosen as it is forward-looking, positive and empowering.

There are 3 sub-themes:

Your options: where young people can learn about all the contraceptive options available, using a reliable, unbiased source of information.

Your future:  understanding how unplanned pregnancies can happen and how the body changes during puberty

Your partner: learning to talk to your partner about contraception and how to build a trusting relationship based on reliable information

Organisations may choose whether to concentrate on one theme per year or cover all or some of the subjects this year.

A selection of materials are available in the form of a modular toolbox addressing each theme with background information and info graphics. Social media will be used more widely this year and suggested topics for Twitter and Facebook will be made available. There is also a countdown clock.

Campaign materials are available here: http://bit.ly/WCD2013

 

 

 

 

Faculty 20th Anniversary Celebration & McGonagall’s Ode!

19 Jul, 13 | by shellraine, e-Media Editor

At the event to celebrate the Faculty’s 20th anniversary, those gathered were regaled, by the invited after-dinner speaker Professor James Drife, with the following ode – available as a podcast for best effect:

The Editor felt the Journal’s readers might like to share the experience, although nothing could compare with seeing the performance ‘live’.

When not engaged in composing and reciting poetry, Professor Drife’s day job is Professor of Obstetrics and Gynaecology at the University of Leeds, Leeds, UK.

JD

McGonagall’s ode to the Faculty of Sexual and Reproductive Health

 

O what a very exciting place this is to be,

On Thursday the sixth of June, in the year 2-0-1-3

The Royal College of Obstetricians and Gynaecologists’ Committee Room One,

Where over the years many mighty medicopolitical deeds have been done.

 

O what beautiful portraits there are on the walls,

Showing how the president’s face lights up when the portrait painter calls!

If only the Faculty also had presidential portraits, I think they would look very fine,

And when viewed as a group would not be so overwhelmingly masculine.

 

The rest of the RCOG is fully occupied with a course right now,

So if you want to run a busy labour ward, there are experts here to tell you how:

But if you prefer your labour ward to be under-occupied and have rooms to spare,

You should follow the guidance of the Faculty of Sexual and Reproductive Healthcare.

 

For the Faculty tells people what to do with their cap, pill, condom, LARC or coil

If they wish to avoid pregnancy and parenthood and all that worry and toil,

And instead continue their careers, travel to far-off lands,

And feel free to buy new furniture, use moisturiser and eat from non-stick frying pans.

 

Tonight we are here to celebrate the Faculty’s 20th anniversary,

Which is why we have come from many distant places to London, NW1 4RG.

I myself have travelled from Dundee, by the new railway bridge over the silver Tay,

Which unlike the old one, has stayed up and has not been swept away.

 

But Professor Johannes Bitzer has had an even longer journey than mine –

All the way from Basel, Switzerland, with its historic bridge over the silvery Rhine,

A bridge that, I believe, has a chapel halfway across so you can offer up a prayer –

A feature that our new railway bridge could have done with, but it isnae there.

 

Tonight we also have a Liverpool delegation, which is small but select:

Meera Kishen, an ex-president, and John Ashton and David Richmond, presidents-elect.

The first RCOG president was from Liverpool, and still today if you’re feeling presidential,

Residence in Merseyside evidently remains desirable if not essential.

 

But there are exceptions to every rule, are there not?

President Chris Wilkinson is a Londoner and President Tony Falconer is a Scot,

And the Faculty has had presidents from Bournemouth and Southwark and all over the place,

So clearly my comment about Liverpool is not evidence-based.
For the Faculty is an international organisation, when all is said and done,

With a membership that now stands at 16,271

(Stretching alphabetically from Australia to Zimbabwe, which is many a mile)

And with Honorary Fellows in many exotic places including, as of today, Carlisle.

 

And also in the House of Lords, one of London’s most exclusive addresses,

For our roll-call of Honorary Fellows includes two distinguished baronesses.

Long may the House of Lords continue to play its part in the great political game:

May all the plans for reform be limited to giving it a gender-neutral name.

 

O how grateful we all are for that historic day, Friday the 26th March 1993,

The date of the founding, twenty years ago, of the FFPRHC!

In that same week, there had already been another advance in science and scholarship,

With the launch, on Monday the 22nd March, of the Intel Pentium microchip.

 

So today, both the Faculty and the Intel Pentium microprocessor are 20 years old –

A characteristic they share with three members of One Direction, or so I am told.

How marvellous to share a birthday with a successful microchip and famous boy band,

Neither of which a man of my age is able to understand.

 

But what I do know is that the Faculty is a major force for good in sexual health,

And that its members, fellows and friends represented here are its real wealth.

Aye, of movers and shakers, the honorary Fellows’ list is a veritable encyclopaedia

Which now includes Dr Mike Smith, known as the Big Daddy of doctors in the media.

 

And one other new fellow, who has never joined Mike in front of the microphones

Because other men have already done a show with the title, “Alias Smith and Jones”.

Corin Jones has been with the Faculty, man and boy, since it was called NAFPAD,

And is now retiring, which makes everyone, except Corin, extremely sad.

 

For Corin is the person who for this Faculty, and for over 20 years, has done the most,

And who, as this poem draws towards its end, deserves a toast!

So, to drink the health of Corin and the Faculty, let us rise, one and all,

With a big thank-you from everyone here, including your humble poetic servant, William McGonagall.

 

Jim Drife, with acknowledgments to the Great Bard of Dundee.

 

July Journal published as Impact Factor soars to 2.1!

20 Jun, 13 | by shellraine, e-Media Editor

The July edition of the Journal is now available online and includes:

Venous thromboembolism and COCs: an ongoing saga

This ongoing controversy recently resulted in the decision of the French authorities to withdraw the combined oral contraceptive (COC) containing ethinylestradiol (EE) and cyproterone acetate (i.e. Diane 35®) from the market. This consensus statement from 26 international experts in contraception concludes that “Both epidemiological data and clinical trials must be taken into account when best practice is defined. Regulatory restrictions of previously registered methods should only be made after careful assessment of all the available evidence”. See page 156

Serum CA125 for ovarian cancer screening

This timely commentary raises questions about the widespread use of screening women with non-specific symptoms by measuring serum CA125 levels, following the publication of the NICE guideline on ovarian cancer in 2012. The authors acknowledge that there are barriers that prevent women with symptoms associated with ovarian cancer from presenting to their general practitioner. However, the authors also point out that this will lead to increased use of CA125 in general practice and raise concerns about how women with raised CA125 in the absence of evidence of any disease should be managed. See page 160

Ovarian cancer symptom awareness and help-seeking behaviour

Ovarian cancer symptom awareness is low in the UK, and varies widely between symptoms. In this study, Low et al. identify variables that may be implicated in a longer time to help-seeking for possible ovarian cancer symptoms, and highlights the need for more in-depth research into the factors related to time to help-seeking in real-world situations. See page 163

Fertility preservation decisions faced by women with breast cancer

This article presents a contemporary summary of fertility preservation techniques available to women of reproductive age with breast cancer. It offers unique insights into the difficult treatment decisions coupled with the difficult fertility preservation treatment decisions that these women face. The article highlights a number of themes that influence the decision-making process for these women. Egg and embryo banking appear to be the fertility preservation treatment of choice. Finally, this work may assist health care commissioners when deciding funding priorities within a health economy such as the NHS in the UK. See page 172

Correlates of unprotected sex in drug-injecting women

This study demonstrates that despite the high risk for HIV acquisition or transmission and unintended pregnancy, condom use among women who inject illicit drugs or who have sexual partners who inject drugs in St Petersburg in Russia is low. Programmes to investigate and improve contraceptive use, including condoms, among this vulnerable group of women are needed and might benefit from addressing alcohol misuse. See page 179

Contraception in a university environment

This is a very simple real-life observational study of a cohort of young, nulliparous women in a university-based general practice choosing and continuing with long-acting reversible contraceptive methods (LARCs) as their first line method of contraception. This article urges the health professional reader to consider offering this ‘fit and forget’ method of contraceptive to our younger population as a matter of routine. See page 186

Impact of UKMEC on CHC prescribing

Briggs et al. have assessed the effect of the UKMEC on prescribing of combined hormonal contraceptives (CHCs). Sadly, although there has been a small decrease in the proportion of higher-risk women being prescribed CHCs, their results suggest that in 2010 7.3% of CHC users had UKMEC Category 3 or 4 risk factors, particularly BMI ≥35 kg/m2. The authors point out that it is likely many of these women were being placed at an unnecessarily high risk of cardiovascular events, given the availability of lower-risk alternatives. See page 190

Financial cost to patients of a suspected ectopic pregnancy

In this article, Unger and colleagues in Edinburgh report on their assessment of an area of patient experience that is not often considered when assessing medical interventions. The financial impact on patients’ lives of the need to seek medical attention can be considerable and may become more significant as economic hardship increases. This article describes a well-conducted questionnaire study on the costs that patients themselves incurred in attending their general practitioners and a hospital clinic with a suspected ectopic pregnancy. The authors argue that such costs need to be factored into decisions regarding the cost-effectiveness of medical procedures. See page 197

Emergency contraception algorithm based on risk assessment

Introduction of a standardised protocol for the provision of emergency contraception (EC) has significantly increased the proportion of women offered an intrauterine device (IUD) as postcoital contraception, particularly in women at high risk of conception. Introduction of ulipristal acetate as an alternative method of EC has resulted in a reduction in the uptake of the emergency IUD. McKay and Gilbert state that this is cause for concern, and further investigation into the reasons behind this decrease in IUD uptake is needed. See page 201

No need for water torture

Cameron and colleagues set out to answer a simple question, namely does a full bladder assist insertion of intrauterine contraception? In the world of assisted conception a full bladder had been shown to aid intrauterine catheter insertion for embryo transfer, but could this knowledge be transferred usefully to the world of contraception? This simple question was answered in a simple and elegant way with a properly constructed and conducted randomised trial, which showed that we needn’t ask our clients requesting IUD/IUS insertion to arrive bursting – a fact for which both they and clinic staff will be duly grateful. See page 207

New monophasic natural estradiol COC

Lee Shulman reviews a new monophasic natural estradiol COC, Zoely®. This COC benefits from the progestogen nomegestrol acetate (NOMAC), which appears to result in good cycle control, with a 24/4 regimen. Since it is monophasic, it also has potential for extended cycle use. The great hope is that natural estradiol COCs will have a lower risk of venous thromboembolism (VTE) than EE-containing pills, but it should be stressed that there is currently no actual evidence for this. Studies are ongoing, but at present these COCs should be treated just like any other from the point of view of VTE. See page 211

Brook/FPA UK Sexual Health Awards 2013

The Journal’s Consumer Correspondent writes about the recently awarded Brook/FPA UK Sexual Health Awards, and opines that awards of this type are a good thing for the SRH profession generally and so rightly should be regarded as a highlight of the sexual health year. See page 219

Plus

An obituary for Dr Alison Bigrigg by Dr Audrey Brown; an organisational factfile on Tommys; a conference report from the FSRH Annual Scientific Meeting at University of Warwick;

And last, but by no means least, the Journal Impact Factor has risen, once again, to 2.1. Many congratulations to Anne Szarewski and her team.

 

New injectable – Sayana Press and Dianette VTE update

17 Jun, 13 | by shellraine, e-Media Editor

Sayana Press®

is a progestogen-only injectable contraceptive licensed for subcutaneous use. It contains 104mg of medroxyprogesterone acetate (MPA) in 0.65ml suspension and is bioequivalent to IM depot medroxyprogesterone acetate. It is administered at intervals of 13 weeks +/- 7 days via a new delivery system (Unijet) – a single dose pre-filled injector.

Sayana

Although ideal for self-administration it is not currently licensed for use in this way.  The April issue of the Journal included a commentary on SC MPA by Sharon Cameron from Edinburgh.

Further information for professionals including a step-by-step administration guide will be available via MedIsis website.

Dianette® and cyproterone acetate products: strengthening of warnings, new contraindications, and updated indication

In agreement with the MHRA and European Medicines Agency (EMA) Bayer has written to health professionals about Dianette®, co-cyprindiol and cyproterone acetate products. This follows the outcome of a review of the known risk of thromboembolic events by the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC). There are no new data, but there has been a “scare” in France which led to this and other so-called third generation products being removed from the market leaving very limited options for women.

The PRAC recommendations include:

  • Dianette® and other medicines containing cyproterone acetate 2mg/ethinylestradiol 35 mcg are indicated for the treatment of moderate to severe acne related to androgen-sensitivity (with or without seborrhea) and/or hirsutism, in women of reproductive age.
  • For the treatment of acne, Dianette® and other cyproterone acetate 2mg/ethinylestradiol 35 mcg products should only be used after topical therapy or systemic antibiotic treatment have failed.
  • Since Dianette® and all other cyproterone acetate 2mg/ethinylestradiol 35 mcg products are also a hormonal contraceptive, they should not be used in combination with other hormonal contraceptives.
  • To increase awareness of the risk and risk factors of thromboembolism in relation to the use of Dianette® and other cyproterone acetate 2mg/ethinylestradiol 35 mcg products (e.g. increasing age, smoking, immobility), the warnings and precautions regarding this risk have been strengthened.

 

 

Copenhagen Impressions

3 Jun, 13 | by shellraine, e-Media Editor

European Society of Contraception and Reproductive Health
First Global Conference

Global

Highlights of the Congress included:

Crown Princess Mary opening the Congress followed by the amazing Copenhagen drummers                          drummers

 

 

 

Green contraception – estrogen in water an issue, rating methods for their ‘greenness’: hormones, packaging etc.

Lidegaard / Shulman / Dinger – continuing debate on VTE, interpreting research, epidemiology and practical applications.

Emergency Contraception – confirmation that pills have no impact globally on unintended pregnancy rates only IUDs do.

Meeting friends, old and new, from wider across the globe than usual, especially from the Baltic states, Africa and the Far East.

In addition the Board voted to set up a working group to investigate and promote multidisciplinary working across Europe.

bella sky

The startling Bella Sky hotel & conference centre

– especially the, trompe l’oeil, walkway between the 2 towers on the 23rd floor. It goes uphill from Tower 1 to 2 but from a distance appears to go the other way.

 

 

oresund  The Oresund Bridge

– the 5 mile rail and road link between Copenhagen and Malmo

 

 

 

bikesBicycles, bicycles and more bicycles

and particularly proper, separate, dedicated cycle lanes – at times quite scary and felt like being in the middle of the Tour de France peloton without the lycra and wrap-around shades!,

Great open sandwiches (smorrebrod) but hardly any danish pastries.

Herrrings, steak & frites. Not brilliant for veggies.

Good beer but not wine – used by next years hosts in Lisbon as an enticement to go there.

Lisbon

 

 

Online First articles

2 May, 13 | by shellraine, e-Media Editor

Use of UPA, LNG and the copper IUD for EC following the introduction of new FSRH guidelines

This paper reports a notes review of emergency contraception (EC) prescription before and after the release of the Faculty guidelines in early 2012. It is interesting that Levonelle® remains a popular choice, possibly because there is less interference with using hormonal methods as a quick start for the remainder of the cycle. One finding of this study, namely the generally poor uptake of IUDs (4%), is of concern and merits further study. [Gillian Robinson]

The IUS is a relatively cheap form of contraception

This study presents an analysis of the cost of providing the intrauterine system (IUS) for contraception to a cohort of 283 women in a community sexual health clinic setting. The authors describe the costs associated with the use of the IUS over a 5-year period and compare it to the costs modelled by NICE. The authors conclude that the IUS is a relatively cheap form of contraception compared with the combined oral contraceptive pill, and make the case for not limiting access to the IUS in community sexual health services based upon financial decisions. [Scott Wilkes]

An innovative one-stop, hospital-based, outpatient acute gynaecology clinic: model for taking the service to community

Kumar and colleagues present an ideal way of transferring acute gynaecology care to the community through the development of an acute gynaecology clinic. The clinic in question handles all non-pregnancy-related gynaecological emergency referrals and can be implemented with low overheads and few changes to existing infrastructure within the community. It is an ideal way to save money and resources in the current economic climate. It is also a good opportunity for CSRH trainees and consultants in SRH to utilise their existing skills to manage a wider variety of clinical scenarios commonly seen in primary care. [Neelima Deshpande]

 

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