ALMOST 600 women have become pregnant despite using a popular contraceptive implant, the MHRA has confirmed.
The health watchdog also said more than 1,600 complaints have been made of adverse reactions to the Implanon device, which is designed to prevent pregnancy for three years. The NHS has paid compensation totalling nearly £200,000 in seven of the most serious cases because of the failures, Channel 4 News reported.
A total of 584 unwanted pregnancies have been reported by Implanon users since the device was launched in the UK 11 years ago. The implant’s makers, MSD, said no contraceptive is 100 per cent effective. It added that unwanted pregnancies may occur if the implant is not correctly inserted, and said the failure rate is only one per cent if fitted correctly.
Implanon is a small plastic rod fitted under the skin which contains etonogestrel, a synthetic version of the hormone progesterone. There have been reports of problems inserting and removing the device and, in some women who had unplanned pregnancies, Implanon was found not to have been inserted at all. The MHRA said complaints had been received from doctors and nurses as well as from Implanon users. A new, easier-to-insert version of Implanon, Nexplanon, was introduced late last year.
A lawyer for some of the 14 women claiming for personal loss and damage said many had not realised the pre-loaded applicator had not released the implant. Stephanie Prior, partner of Anthony Gold Solicitors, told Channel 4 News: "I have clients who fell pregnant as they were unaware that the Implanon device had not been inserted into their arm and they suffered psychological difficulties as a consequence of falling pregnant and later miscarrying or having to make the difficult decision to terminate the pregnancy."
In a statement, manufacturers MSD said: "The basis for successful use of Implanon is a correct and carefully performed subdermal insertion of the implant 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." The MHRA said that although the implant has been replaced, “the safety of Implanon remains under close review.”
For more information, read the MHRA safety warning here