The Essure implant, used by the NHS to sterilise women, poses a serious safety concern, according to a new study in the British Medical Journal (BMJ).
Women who have had Essure fitted were shown to have ten times the risk of needing a repeat operation than women who had conventional sterilisations. Essure is a spring which is inserted into fallopian tubes to block eggs from reaching the womb.
The UK regulator, the Medicines and Healthcare products Regulatory Agency (MHRA) says that the device is safe, but is monitoring the situation following complaints from users about side-effects such as pain and misplacement. It has advised women who have experienced problems to see a doctor. The device is used by about 1,500 women a year.
The research in the BMJ tracked 8,000 women in the USA who had Essure fitted and 44,000 women who underwent conventional sterilisation to compare how well the procedures worked.
In rare cases, the device has punctured other organs, but more common are side-effects such as pain and allergies to the nickel which the implant contains.
In the study, Essure was linked to an extra 21 repeat operations per 1,000 patients undergoing surgery, which the authors say is significant and “a serious safety concern.” Study author Dr Art Sedrakyan said: “Our study is very helpful. It shows how Essure compares with the main alternative, which means women can weigh the benefits and harms and regulators can make better decisions.” Problems with the device can be reported to the MHRA by calling 020 3080 7080.
Inez Brown, Partner at Medical Accident Group, said: “There has been concern about Essure for some time and this study draws some useful conclusions which patients will want to discuss with their doctors. New techniques and devices can lead to advances in medical treatment but safety must be of paramount concern at all times.”
If you or a loved one have suffered as a result of the Essure implant, Medical Accident Group can help. Our experienced and sympathetic team, whose knowledge of clinical negligence and personal injury law is extensive, can support you through the process of making a claim and seeking justice. We can advise on issues from brain injury or birth injury to surgical and medical errors and accidents at work. Call us free on 0800 050 1668.