Lawyers have begun legal action on behalf of 200 UK women against the makers of the Essure sterilisation device, after claims of illness and pain, reports the BBC.
Manufacturer Bayer has already set aside more than $1.6bn (£1.2bn) to settle claims from almost 40,000 women in the US. It has withdrawn the device from the market for commercial reasons but says it stands by its safety and efficacy.
The metal coil, introduced in 2002, was inserted into the fallopian tube to cause scarring, blocking the tube and preventing pregnancy. It was promoted as an easy, non-surgical procedure – a new era in sterilisation.
But many women who had the device fitted have now either had hysterectomies or are waiting for procedures to remove the device.
Solicitor Lisa Lunt, head of medical product liability at the law firm PGMBM, who is leading the group action in England, says: "The reports that have come out from the American proceedings are that [developer] Conceptus and Bayer were failing to report adverse events.
"That's when they become aware that there are problems with the device. And that's something that we're going to look at very, very, carefully indeed."
Bayer strongly denies the allegations, saying it has never violated regulations around complaints. "Patient safety is Bayer's highest priority," it said.
"We take all adverse events seriously, continually collect and analyse the data we receive, and work with the [US Food and Drug Administration] to monitor Essure's safety profile. The company stands behind the safety and efficacy of Essure, which are demonstrated by an extensive body of research, undertaken by Bayer and independent medical researchers, involving more than 270,000 women over the past two decades."
But some doctors who have fitted Essure devices remain sceptical. Gynaecology professor Bas Veersema, an expert in Essure removal, at UMC Utrecht hospital, in Holland, says the monitoring of new medical devices is inadequate.
"We learned from the mesh problems, we have learned from the breast implants, we have learned from the Essure device, that if you put materials in the body for a long time, we need more information, with long follow-ups, what it does to the body," he says. "And, to be honest, we don't know."
The UK Medicines and Healthcare Products Regulatory Agency said: "Patient safety is our highest priority And there is currently no evidence to suggest any increased risk to patient safety. Any women with questions should speak to their GP or healthcare professional."
[link url="https://www.bbc.com/news/health-54420174"]Full BBC report[/link]
See also:
[link url="https://www.medicalbrief.co.za/archives/bayer-discontinues-essure-us-denies-safety-concerns/"]MedicalBrief archives: Bayer discontinues Essure; denies safety concerns[/link]
[link url="https://www.medicalbrief.co.za/archives/fast-tracked-contraceptive-device-under-renewed-fda-scrutiny/"]MedicalBrief archives: Fast-tracked contraceptive device under renewed FDA scrutiny[/link]