The failure to properly assess vaginal mesh device outcomes has been described a “shameful episode in the history of implantable devices".
Wallet-driven research, an absence of post-marketing research and the cosy relationship between manufacturers and medical professionals and bodies are to blame for the vaginal mesh scandal, according to a new investigation published in the BMJ.
The series of articles by British investigative journalist Jonathan Gornall plots a timeline of the missteps and failures that resulted in hundreds of thousands of women being exposed to a potentially risky and unproven treatment.
“Twenty years [after its introduction], amid claims that it left many thousands of women around the world irreversibly harmed, mesh is at the centre of a storm of protest that has launched tens of thousands of compensation claims, divided the medical profession, exposed major flaws in regulatory procedures, and raised serious questions about the financial relations between clinicians and researchers and the manufacturers of devices that outraged campaigners say are not fit for purpose,” he wrote.
One of the most blatant failures was the lack of effective post-marketing tracking of complications once mesh had been introduced, according to Mr Gornall. Regulatory bodies such as NICE had called for a national registry as early as 2003, and yet progress was “glacial”, he said.
It took until 2017 for NICE to finally declare that the evidence base for the use of mesh for pelvic organ prolapse was “inadequate in quality and quantity”, and it was only February of this year that the UK health secretary finally allocated the money for a comprehensive database.
This delay resulted in thousands of women agreeing to treatment unaware of what the true extent of adverse outcomes might have been.
Back in 1999, just over 200 English women were surgically treated for urinary incontinence. But this drastically changed with the introduction of tension-free vaginal tape (TVT) over the next few years and had ballooned to more than 11,000 by 2009.
Where a major surgery, such as colposuspension, would have been considered too extreme for many women’s symptoms, this simpler and easier treatment led to an explosion in the number of women offered the treatment.
By 2014, 29 different products, including mesh tape for stress urinary incontinence and mesh sheets for pelvic organ prolapse, had hit the market and between 2005 and 2013 more than 3.6 million devices had been sold worldwide, Mr Gornall said.
In an accompanying editorial, Professor Carl Heneghan, GP and director of the Centre for Evidence Based Medicine, and Dr Fiona Godlee, editor in chief at the BMJ, called the failure to properly assess mesh device outcomes a “shameful episode in the history of implantable devices”.
“Mandated national registries are needed for all implantable devices to protect patients, improve outcomes, reduce costs and identify best practice,” they wrote. “Another mesh tragedy is otherwise inevitable.”
Mr Gornall also pointed the finger at regulators for allowing inadequately tested devices onto the market as manufacturers “aggressively hustled” them.
In one instance NICE’s predecessor decided to promote TVT devices from a “C” rating to an “A” rating, which told clinicians that safety and efficacy had been established and that the devices could be used outside the research setting. Separate trial investigators expressed concern, with one saying the rating was given “on the basis of no evidence at all” other than information provided by the manufacturers.
“Nobody involved with the mesh revolution emerges covered in glory,” Mr Gornall wrote.
Two decades since the introduction of these devices, governments are acting.
In Australia, the government has promised to address the scandal by reclassifying all surgical mesh as high risk from medium to high risk, requiring device manufacturers to supply information leaflets with every device implanted, introducing new Medicare item numbers for surgical repair of pelvic organ prolapse and mesh removal and improving the TGA’s reporting process for adverse events.
