A total of 32 women in Ireland reported falling pregnant while using a contraceptive implant device, the Irish Medicines Board has confirmed.
The licensing body was responding to reports in Britain that more than 500 women using the Implanon device reported they had become pregnant unintentionally. Channel 4 news revealed some 1,600 women complained about the device to the Medicines and Healthcare Regulatory Agency, the medicines watchdog in Britain, including 584 who said they had unwanted pregnancies.
In the most serious cases, National Health Service Trusts had offered settlements to seven women totalling nearly £200,000.
The device, inserted under the skin of the arm, releases the hormone progestogen to prevent pregnancy for up to three years.
Manufacturer MSD insisted it was extremely confident of the efficacy of the product once it was properly inserted, but said no contraceptive was 100 per cent effective. A spokesman said clinical data over a period of nine years had shown there would be about five pregnancies per 10,000 implants - a rate of 0.049 per 100.
In a statement the IMB said it had received reports of unintended pregnancies and implant-related reactions associated with use of Implanon, “consistent with those described in the product information for healthcare professionals and patients”.
A total of 32 reports have been received since Implanon was first authorised in Ireland in 1999.
That figure is likely to be a small percentage of the number using it here. Neither the IMB nor family planning clinics had figures for the number of women using the implants in Ireland, but the manufacturer says 1.3 million have been used in Britain.
The IMB said the risk of unintended pregnancy and effects associated with insertion/removal of Implanon were “well known and detailed in the product information”.
Specific requirements and recommendations about the timing and the procedure for inserting and removing the product are described in detail in the product information, it said.
It advised any woman with concerns about their contraception method to consult her doctor.
The Irish Family Planning Association says Implanon is and "extremely effective" method of contraception and that fewer than one in 1,000 women using it properly over three years will become pregnant.
With “perfect” use, less than one woman in 100 using the combined oral contraceptive pill will become pregnant in a year, the body says. For every 100 couples who use condoms “very carefully and consistently”, two women will get pregnant in a year, according to the IFPA.
MSD said the basis for successful use of Implanon was a correct and carefully performed insertion of the implant under the skin, in accordance with the product instructions. “If the implant is not inserted in accordance with the instructions and on the correct day, this may result in an unintended pregnancy. In addition, no contraceptive is 100 per cent effective.”
It said “post-marketing” events [with regard to drugs] were reported voluntarily from a population of uncertain size.
“It is generally not possible to reliably establish the frequency or establish a causal relationship to the use of Implanon.
“Therefore, accumulated reports cannot be used to calculate incidence or to estimate drug risk. For these reasons, it would be inappropriate to discuss numbers of reports.”
Implanon was replaced last October by the next-generation product Nexplanon, which has a new applicator and can be detected by X-ray or CT scan. Women who still use Implanon do not need to replace the device.
Additional reporting: PA