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A group of 63 women who became pregnant despite using a controversial hi-tech contraceptive aid are suing the makers for millons of pounds. The women all used the Persona device following its launch in the UK in 1996.
Persona is a computerised kit which analyses a woman's hormones to calculate when during her menstrual cycle she is able to have unprotected sex with a minimal risk of getting pregnant.
When the device flashes up a red light, unprotected sex is not safe, when it flashes up a green light, it is indicating that the risk of becoming pregnant is minimal.
Not perfect
However, there is no time during the menstrual cycle when conception is impossible, particularly as sperm can remain viable in the female sexual tract for several days.
As a result, many women who used the kit to try to predict when they should avoid sex have become pregnant.
Among them is Eloise King, 42, who became pregnant with her fourth child 12 years after she had decided her family was complete.
Mrs King said she had contacted Unipath to voice concerns about the accuracy of the machine before she became pregnant, but was told not to worry.
She said: "I do not want this to happen to any other woman and that is the only reason I am taking this action.
"It is not for the money. We already had three children and we did not plan to have any more.
"Right from the beginning I had doubts about the accuracy of the Persona machine.
"The readings did not seem right to me. I queried them with the company numerous times, but I was assured over and over again that it was reliable and I was worrying unnecessarily.
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"I do not want this to happen to any other woman and that is the only reason I am taking this action" |
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Eloise King |
"When I found out that I was pregnant just a few months later, it was a shock."
Critical review
Persona was approved by the Vatican on its launch.
However, a 1998 review by the Medical Devices Agency (MDA) found one in 17 women using the device would become pregnant every year.
This compares with one in 100 women on the pill, and one in 50 couples using condoms.
In a statement, the MDA said: "While a useful addition to the range of contraceptive choice, Persona is basically a test-based form of the rhythm method of contraception.
"However, due to its technological basis, expectations of Persona may be higher than for other forms of contraception."
The government subsequent issued a warning that women should only use the device if they did not mind getting pregnant.
A spokeswoman for Unipath said the device carried a warning that it was not suitable for women who have abnormal cycle lengths, or who have been using hormonal contraceptions in the past three months.
She said: "While we are sympathetic to any woman experiencing problems with our equipment, we shall definitely be defending this action."
[Lancet]
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Last Revised at December 10, 2007 by Lusine Kazoyan, M.D.
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