HEALTH experts have expressed “serious concerns” over the safety of a sterilisation implant used by women on the NHS.
Those implanted with the Essure device, an approved method of sterilisation in the UK, have a 10 times higher risk of needing another operation, a team of researchers has found.
The Food and Drug Administration (FDA) in the US is reviewing its benefits after it received thousands of reports about the device with some women claiming it has perforated their womb, colon or other tissues.
The latest study was published in the British Medical Journal (BMJ) after experts decided to investigate Essure, made by pharmaceutical giant Bayer, following the safety concerns reported to the FDA.
They compared results for 8,048 patients undergoing sterilisation with Essure and 44,278 undergoing usual laparoscopic sterilisation who were treated between 2005 and 2013 in New York State.
Researchers looked at safety outcomes within 30 days of the first operation, unintended pregnancies and re-operations.
They said there was a “significant” rise in the use of Essure over the period.
They wrote: “At one year after surgery, hysteroscopic sterilisation (Essure) was not associated with a higher risk of unintended pregnancy but was associated with a substantially increased risk of re-operation compared with laparoscopic sterilisation.”
Essure was linked to an extra 21 re-operations per 1,000 patients undergoing surgery according to the study with the authors warning that this increased rate was a “serious safety concern”.
Patients most frequently reported pain or abdominal pain (3,353 reports), heavier or irregular periods (1,408), headache (1,383), fatigue (966), and fluctuations in weight (936).
Most patients reported multiple problems.
A statement from Bayer said: “Essure is a highly effective birth control option with a positive benefit-risk profile for women who have completed their families and want permanent contraception with a non-surgical procedure.
“Over a decade of research and development and a decade of real world experience supports the safety and efficacy of Essure.”