Most pelvic mesh studies were written by authors who took money from industry, a damning new report has revealed.

Worse, more than 8 out of 10 of those authors kept the money a secret.

The latest findings add weight to our call for a UK Sunshine Payment Act amid concerns that industry money has influenced pelvic mesh scientific literature, resulting in overstated benefits, understated harms, and overuse of the plastic surgical implant.

The new report shows:

• Out of 56 pelvic mesh studies, 53 had at least one author who received industry funding (95%).
• For 47 the funding was not declared.
• Out of 247 mesh studies, 32 physician authors received payments ranging from $100K to $1million.
• Of those, 6 in 10 failed to declare the payments.
• Almost 6 in 10 studies concluded mesh was safe but only 4 in 10 outcomes supported this.

“Financial involvement of industry in mesh research is extensive, often undeclared, and may shape the quality and conclusions drawn,” warns authors of a new review into pelvic mesh scientific literature. “When medical research and vested interest collide, objectivity, research integrity, and best clinical practices are sometimes the victims.”

Extent, transparency and impact of industry funding for pelvic mesh research.

The ability to shine a light on industry funding was made possible thanks to searching for American pelvic mesh authors on the US open database – a system set up after the Sunshine Payment Act of 2013, requiring industry to log all money given to the American health sector.

It is impossible to similarly expose money exchanging hands in the UK because there’s no law forcing anyone to declare it. Instead, doctors voluntarily log payments – if they have time or inclination to do so.

This article from the BBC in 2019 shows the UK’s current voluntary system is failing. It reveals how a Scottish surgeon took £100,000 research funding from the makers of a mesh he was trialling. The money only came to light after a whistle-blower reported it, seven years after the research was published which supported mesh slings as a good treatment option.

Sling The Mesh has campaigned tirelessly for a UK Sunshine Payment Act to help patient safety campaigners and the media shine a light on the millions given each year from industry to doctors, surgeons, researchers, hospitals, charities, surgeon societies and Parliamentary lobby groups.

A Sunshine Act would shine a light on UK doctors’ secret money and give us vital transparency. Politicians at national and local level must declare conflicts of interest. The same should apply for the health sector.

And, while we have been successful in lobbying for the foundations of a Sunshine Act, nothing more has happened. A government consultation into transparency of payments from October 2023 is yet to publish its results (as of May 2024).

We await the results with interest.

By Kath Sansom and Ruth MacLeod

Pelvic mesh history

Mesh was first used in hernia surgery in the 1950s and has become the standard of care for hernia repairs, although controversy remains

By the late 1990s, surgical mesh was routinely inserted vaginally to treat pelvic organ prolapse and stress urinary incontinence. This repurposing of hernia mesh required no approval in the US because the Food and Drug Administration’s (FDA) 510k route allows for potentially catastrophic automatic approval for products deemed to be equivalent to devices already in use.

Prior to 1976 the FDA did not require testing of any biomedical devices, meaning surgical mesh had never undergone pre-market testing.

Women have a greater immune response to foreign materials

There’s an urgent need for studies into the autoimmune response to polypropylene plastic mesh. Also, into the difference response between men and women. This is discussed more in the paper Invisible Women Harmful Consequences  And also Sex Differences in Immune Responses

Hernia mesh studies have not reported on women specifically or considered that women’s greater immune response to foreign materials might predispose them to disproportionate harm.

This report Conflicts of Interest in Studies Related to Mesh Use in Vent… : Annals of Surgery (lww.com) determined that the majority of studies of mesh used for hernia repairs did not accurately report industry funding.

Industry funding compromises medical research in general and can affect research integrity Mapping conflict of interests: scoping review | The BMJ