Clinical Articles
Let us imagine that there has been a significant side-effect from a contraceptive choice occurs and a patient suffers harm. It is a known but very rare side-effect.
How much legal and ethical responsibility lies with the doctor who prescribes the contraceptive, how much lies with the medical experts advocating this form of contraception as reasonable and safe, and how much lies with the pharmaceutical company who researched this product? Should this contraceptive be withdrawn from use, and if so, why would it be still available and advised for use in other countries around the world?
A reasonable response to this question would include an assessment of the incidence of this particular complication among all users of this contraceptive, the incidence of any other significant complications, and the outcome for the patients of these complications.
However, let us imagine the media finds this story and runs with it, giving widespread coverage of this single case and highlighting the contraceptive as the cause.
This is the situation at present with the progestogen IUD, Mirena® in the United States. It is also the case with oral contraceptive pills that contain cyproterone acetate (such as Diane-35®) in Australia.
Contraceptive pills like Diane-35® are more oestrogenic in their balance and this could potentially increase their risk of venous-thromboembolism (VTE), although this still remains somewhat controversial. It was temporarily banned in France because of this in 2013. However, the risks need to be put in perspective. Even if the worst case-scenario is accepted, the actual increased risk of VTE for these newer pills over older types is an extra four to six VTEs per 10,000 Pill users per year.1
“The risk of death from a VTE induced by a combined oral contraceptive is approximately one in 100,000, significantly less than the risk during pregnancy,” said Dr Foran.
It is known that oral contraceptive pills containing 35ug ethinyl oestradiol and cyproterone acetate are being prescribed in Australia for indications beyond contraception, namely androgenising signs in women. It is also known, that for some women these pills provide the best control of their symptoms.
In Europe, the regulatory authorities decided that the benefits outweighed the rare risks for properly selected patients and this OCP was quickly reintroduced to the market after only six months. However, in Australia there have recently been calls for the banning or restriction of this product in Australia following the diagnosis of a VTE in a young woman.
How reasonable is it in our society to allow the traumatic stories of individuals to override medical opinion and determine regulation?
The public needs to be made to realise that not only are these products very safe for the overwhelming majority of women, when prescribed appropriately, but they are also so much safer for women than an unplanned pregnancy would be.
It might be valid to argue that there are other combined oral contraceptives that are ‘safer’ than those containing 35ug ethinyl oestradiol and cyproterone acetate, or that cyproterone acetate is available separately for use.
However, what happens when one of these other oral contraceptive choices causes a major medical event in a different woman? In the UK, doctors have been advised to warn patients that there is an increased risk of VTE with Femodene®, Marvelon® and Yasmin® named as some examples. The Daily Mail UK1 had a massive heading to this effect:
“Deadly risk of pill used by one million women: Every GP in Britain told to warn about threat from popular contraceptive”
If media and legal pressure is allowed to result in the withdrawal of these medications, at some stage, there will be no oral contraceptive choices left.
The seriousness of the situation is highlighted in the case of the Mirena® IUD, since there is no similar alternative to this product in Australia. In the United States, this contraceptive device has been under a cloud of bad publicity since 2009, due to US Food and Drug Administration warnings relating to migration and perforation. Since then, the Mirena® IUD has been scrutinised by patients with side-effects and, of course, lawyers.
“The real question here is whether hysterectomy or endometrial ablation is a safer option than the Mirena® IUD for women with heavy menstrual bleeding.” Dr Foran.
The maintenance of a range of choices is important and women should have the right to make these decisions for themselves in consultation with their doctors. The Mirena IUD is also a safe form of contraception, especially for women who have thrombophilias and for older premenopausal women, most of whose other choices are less safe.
Is it still enough for doctors to fully inform women of the side-effects and complications of their contraceptive options and to let them decide, or is modern contraception becoming a very personal, public and legal battlefield, the main casualties of this being expert medical advice and a woman’s choice? …and in the end, who is left holding the baby?
- Bitzer J et al. Statement on combined hormonal contraceptives containing third- or fourth-generation progestogens or cyproterone acetate and the associated risk of thromboembolism. J Fam Plann Reprod Health Care. doi: 10. 1136/ jfprhc-2013-100624 http://srh.bmj.com/content/familyplanning/early/2013/04/10/jfprhc-2013-100624.full.pdf
- Daily Mail, UK, 22nd Feb 2018 http://www.dailymail.co.uk/news/article-2550216/Deadly-risk-pill-used-1m-women-Every-GP-Britain-told-warn-threat-popular-contraceptive.html
This article is based on an interview with Dr Terri Foran, Sexual Health Physician, Lecturer with the UNSW’s School of Women’s and Children’s Health and Director of Master Women’s Health Medicine on Saturday 17th February 2018 at the Annual Women’s and Children’s Health Update, Sydney
Expert/s: Dr Vivienne Miller