Nearly 600 women who used a popular contraceptive implant have had unwanted pregnancies despite believing it would stop them conceiving for up to three years.
Complaints about scarring, incorrect fitting, device failure and other problems were also made to medical regulators about the matchstick-sized tubes filled with synthetic hormone that are fitted into women's upper arms by health professionals.
Channel 4 News said that NHS trusts have offered settlements totalling nearly £200,000 in seven of the most serious cases, arising from more than 1,600 reports citing 2,888 suspected adverse reactions. These included 584 unwanted pregnancies. The implant's makers said no contraceptive was 100% effective.
The implant, called Implanon, the only such subdermal contraceptive available in the UK, has been used by thousands of women over the past 11 years. It was replaced by a newer version, Nexplanon, by manufacturers MSD in October 2010 under pressure from the Medicines and Healthcare products Regulatory Agency (MHRA), although suppliers were allowed to use up stocks. Nexplanon includes a new applicator designed to reduce insertion errors, and is made so it can be located easily by an x-ray or CT scan.
June Raine, a director at the MHRA, told Channel 4: "We worked closely with the company to enable the new version to be developed. They are fully aware of all the concerns that we have."
Lara, from south London, told Channel 4 how she had felt on discovering four years ago that she was pregnant because her implant was incorrectly fitted. "I feel very, very disturbed – hitting the head on the table. Crying, weeping again … I wasn't happy, not feeling well. Your mind is disturbed … my mind was so disturbed – thinking, why is this happening to me?"
Lara said her marriage collapsed and she had nightmares for months after having an abortion. "This is not what I want. I put this thing in to protect myself so I can continue with my studies. I don't want kids at this time. It really disturbed me."
Stephanie Prior, a partner of Anthony Gold Solicitors, said: "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."
MSD said it was "confident in the efficacy and safety" of Implanon, which was first approved in September 1999.
"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% effective.
"Post-marketing events are 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.
"MSD encourages consumers to speak with their healthcare providers if they have any questions about contraceptive options and to report any adverse experience associated with any MSD medication."
