Surgical interventions with vaginal mesh should be offered as a last resort, according to new UK draft guidelines, while the Australian government has, meanwhile, issued a national apology to women affected by a vaginal mesh scandal.
The Guardian reports health service officials that draft guidelines from the National Institute for Health and Care Excellence (Nice) say women who with stress urinary incontinence or pelvic organ prolapse, conditions that commonly occur after childbirth, should instead be offered a range of non-surgical treatments, such as lifestyle interventions, physical therapies and medications.
Surgical interventions using mesh should be considered when non-surgical options have failed or are not possible, Nice said.
The report says a recent scandal on vaginal mesh procedures revealed that thousands of women have complained of being left in constant pain after having the implants. An investigation found one in 15 women given a mesh implant later required surgery to have it removed, with some experiencing life-altering complications.
In July, the government paused the use of some vaginal mesh procedures in National Health Service (NHS) hospitals in England until certain conditions were met, including for all operations and any complications to be registered on a national database and for surgery to be performed by specialist surgeons based at specialist centres.
The report says Nice’s draft guidelines call for a national database to be set up to record all procedures involving the use of surgical mesh and tape in operations for stress urinary incontinence or pelvic organ prolapse. When surgical mesh is offered as a treatment, women must be fully informed of the risks, Nice has said.
Sir Andrew Dillon, the CEO of Nice, said: “Where surgical mesh/tape could be an option, there is almost always another intervention recommended in our guideline … If a surgeon cannot provide a full range of choices to the patient, then she should be referred to one who can.”
Commenting on the draft guidelines, Kath Sansom, the founder of the campaign group Sling the Mesh, said: “These draft guidelines are to be welcomed but they do not go far enough. Our ideal scenario is to see pelvic mesh stopped – full stop. The risks are too great. It is totally unacceptable that women come out of a ‘simple little operation’ with shattered lives.”
Carl Heneghan, a professor of evidence-based medicine at Oxford University who previously called for a public inquiry into the use of mesh, said: “We’ve been far too quick to resort to surgery as a first choice when it should have been a last chance and as a consequence many women have suffered harm.” Heneghan described the guidelines as “step in the right direction”.
The report says in a joint statement, the Royal College of Obstetricians and Gynaecologists and the British Society of Uro-gynaecology, said: “It is very important that women explore the range of non-surgical treatments, such as lifestyle interventions, physical therapies and medications, before considering surgical treatments. It is also crucial that women who need surgical procedures for these often distressing and debilitating conditions have access to these treatments.”
Owen Smith, who chairs the all-party parliamentary group on surgical mesh implants, said: “While I am pleased that Nice is now taking action to advise against mesh as a first-line treatment, this announcement is well overdue. I have called on them to get on and urgently publish these guidelines for the last two years and I’m glad they have finally listened.”
The Australian government has, meanwhile, issued a national apology to women affected by a vaginal mesh scandal, acknowledging decades of "agony and pain".
Mesh implants are at the centre of health scandal affecting women around the world, prompting lawsuits in the UK, US, Canada and Australia. And, the BBC News reports, in March, an Australian inquiry found that the devices had ruined many lives. More than 700 women in Australia have joined a class action against one manufacturer, Johnson & Johnson, but lawyers say up to 8,000 women may have been affected.
Health Minister Greg Hunt is quoted in the report as saying: "On behalf of the Australian government, I say sorry to all of those women with the historic agony and pain that has come from mesh implantation which have led to horrific outcomes. This has been an issue, over some decades in many cases, and on our time and our watch."
The Senate inquiry estimated that about 150,000 women in Australia were fitted with mesh implants in the past two decades, in many cases to help treat complications post-childbirth. Negative effects reported after surgery have included bleeding, nerve and tissue damage, perforated organs and mesh eroding into the vagina.
The inquiry found that many women had suffered chronic and debilitating pain, leaving a "devastating impact" on their lives, relationships and careers. The report says it also noted that those suffering had often struggled to have their condition identified or for their pain to be taken seriously by doctors – worsening distress.
Hunt said the government supported nearly all recommendations made by the inquiry, including improving regulation of medical devices. The report says the nation banned two mesh devices last year, after they were classified as "high risk", but still allows some mesh products to be used.
[link url="https://www.theguardian.com/society/2018/oct/09/vaginal-mesh-should-be-offered-last-resort-health-officials-say"]The Guardian report[/link]
[link url="https://www.nice.org.uk/guidance/GID-NG10035/documents/draft-guideline"]Nice guidelines[/link]
[link url="https://www.bbc.com/news/world-australia-45806324"]BBC News report[/link]