The elastic ball that could save thousands from pain of the coil
APIONEERING contraceptive ball is being hailed as a safe and comfortable alternative to metal c o i l s for thousands of British women. For the first time in 50 years, the i ntrauterine device (IUD) has been re-imagined in a new device that could remain effective for up to ten years.
The hormone- free Ballerine is shaped like a ball, as opposed to the standard T-shape coil in common use, and it is said to reduce the risk of complications in the uterus.
IUDs are either non- hormonal devices made of copper or those that release a tiny amount of progesterone, and are a popular form of contraception for more than 120,000 UK women.
Once inserted into the uterus, either the copper or the hormones prevent sperm and egg surviving by interrupting the process that allows a fertilised egg to implant.
While all intra-uterine contraceptives are between 90 and 100 per cent effective, the T-shaped design means it can be dislodged when the uterus contracts.
According to gynaecologist Dr Ilan Baram, who developed the Ballerine, this can lead to ‘digging in’ of the uterus, causing pain and increased bleeding in more than 25 per cent of women with one fitted.
In trials, the Ballerine significantly reduced bleeding and pain for 366 women aged 25 to 42 who replaced their regular IUD.
‘ This technology succeeded in improving user quality of life,’ said Dr Baram. ‘There are more than 50,000 cases of IUD perforating the uterus annually, with 20 per cent of women opting for removal.’
Clinical trials of the Ballerine in Eastern Europe saw j ust one woman opt for removal after six months. The secret to its success is the size ( half that of traditional IUDs) and circular shape, which ensures the device moulds to each woman’s shape. This is achieved through the use in the Ballerine of Nitinol, a metal with elastic properties already used in implants such as coronary stents.
Nitinol is able to retain a certain shape, making it easy to manoeuvre through the cervix canal, and much less likely to move once in position. Fitting takes 15 minutes and women can choose from two fits according to their uterus size.
The metal sphere is mounted with copper pearls, coated with protective plastic and works like other IUDs – via a chemical reaction – preventing fertilisation.
The device has been tested for four years, with more than 14,000 fitted in Europe, Israel and Africa.
Developers Ocon Medical plan to offer it to private UK clinics in April, before NHS distribution.
Nick Morris, consultant gynaecologist at London’s Wellington Hospital, welcomed the Ballerine.
‘It’s a clever design that should reduce pain and bleeding,’ he said,
‘IUDs are popular, but for a significant number of women there are complications. This new device appears to get round those.’
Andrea Grgic, 25, from Austria, had a Ballerine fitted three years ago. She said: ‘I wanted to try something non-hormonal and the shape appealed to me. I see my gynaecologist twice a year and she is happy the device is still in place and doing its job.’