Investigation exposes 'scandal' that has left thousands of women irreversibly harmed

October 11, 2018, British Medical Journal

An investigation by The BMJ reveals how vaginal mesh implant manufacturers "aggressively hustled" their products into widespread use, how regulators approved them "on the flimsiest of evidence" and how the medical profession failed to set up registries that might have picked up problems far sooner.

It also names prominent individuals—all on guidelines committees—who take money from mesh manufacturers for various activities including research grants, speaker honorarium and consultancy, as do the medical royal colleges, creating a potential for bias. And even where payments are declared, it is very hard to unpick their value, and there is no obligation on clinicians to declare their interests.

Altogether, this "hair raising" story offers lessons for the entire medical community, manufacturers and regulators, says author andinvestigative journalist, Jonathan Gornall.

Vaginal mesh implants were introduced in 1998 as a quick and easy way to treat stress urinary incontinence and in women. Twenty years on, their use in the NHS is suspended pending the findings of a major government review—and companies are facing tens of thousands of compensation claims.

In a series of special reports published today, Gornall charts the rapid rise of mesh in the UK and tracks down some of the doctors who warned of the consequences of mass launching a product on flimsy evidence.

He also tracks the failure of the surgical profession to register patients getting mesh implants, despite warnings from NICE and others dating back to 2003.

It wasn't until February 2018 that Jeremy Hunt, the former health secretary, announced that his department would be investing £1.1m "to develop a comprehensive database for vaginal mesh to improve clinical practice and identify issues." If all of [these warnings] had been heeded, "today's mesh crisis might have been largely averted," argues Gornall.

In a second report, Gornall goes in search of Ulf Ulmsten, the Swedish obstetrician who invented mesh, and uncovers how the original evidence was mired in a multimillion pound deal, industry funded research, and undisclosed conflicts of interest.

Gornall describes how, in March 1997, Ulmsten was paid $1m by global medical giant Johnson and Johnson ahead of a study to test the effectiveness and safety of his new tension-free vaginal tape (TVT) procedure.

While Johnson and Johnson deny allegations that the payment was conditional on the study proving successful, and rejected any suggestion that this had compromised the results of that trial, Gornall questions whether this was 'wallet driven' research.

Finally, Gornall reports on the NHS surgeons, professional bodies, royal colleges and medical conferences that benefit from corporate funding and how this financial involvement is hidden from patients. He describes how, despite government guidance on conflicts of interests, it remains difficult to unpick industry funding of clinicians in the UK—and specialists in vaginal mesh are no exception.

But it isn't only individual clinicians who have financial links with industry, says Gornall, who cites links between some of the leading mesh device companies and several royal colleges, including the Royal College of Surgeons and the Royal College of Obstetricians and Gynaecologists.

The UK Pelvic Floor Society, whose members use synthetic meshes for prolapse and incontinence surgery, is also supported by Shire, Cook Medical, Medtronic, THD, and BK Medical, he adds.

But regardless of the perceived or actual effect of such extensive industry influence within specialist branches of the , none of this information is freely or easily available to the public in the UK, argues Gornall.

The UK trails far behind the US in putting the relationship between doctors and industry in plain sight, he writes. Without legislation, he believes that "it is all too easy for patients to draw conclusions harmful to public confidence in the healthcare system."

In an editorial, Chris Allan and colleagues at Newcastle University warn that Europe's new device regulations "will fail to protect the public, unless they are reinforced."

They argue that the new rules, which come into force on 26 May 2020, "require further tightening to protect public safety." At the very least, for all high risk devices, national authorities such as Medicines and Healthcare products Regulatory Agency (MHRA) in the UK "should take over conformity assessments to reduce commercial conflicts of interest," they write.

And they say clinical studies of both efficacy and effectiveness "should be a condition of pre-market approval," and all data including clinical studies and investigations "should be available to everyone, ending differential rights of access for regulators and the public."

Dr. Fiona Godlee, The BMJ's Editor in Chief and Professor Carl Heneghan of Oxford University's Centre for Evidence Based Medicine, say the postmarketing assessment of vaginal mesh has been "a shameful episode in the history of implantable devices."

Surgeons, manufacturers, regulators, and governments have all played their part in this failing, they write in an editorial. "Mandated national registries are needed for all implantable devices, to protect patients, improve outcomes, reduce costs, and identify best practice. Another mesh tragedy is otherwise inevitable."

Explore further: Inadequate regulation for vaginal mesh products has exposed women to unnecessary harms, warn experts

More information: Jonathan Gornall. The trial that launched millions of mesh implant procedures: did money compromise the outcome?, BMJ (2018). DOI: 10.1136/bmj.k4155

Jonathan Gornall. Vaginal mesh implants: putting the relations between UK doctors and industry in plain sight, BMJ (2018). DOI: 10.1136/bmj.k4164

Chris Allan et al. Europe's new device regulations fail to protect the public, BMJ (2018). DOI: 10.1136/bmj.k4205

Carl Heneghan et al. Surgical mesh and patient safety, BMJ (2018). DOI: 10.1136/bmj.k4231

Jonathan Gornall. How mesh became a four letter word, BMJ (2018). DOI: 10.1136/bmj.k4137

Related Stories

Inadequate regulation for vaginal mesh products has exposed women to unnecessary harms, warn experts

December 7, 2017
Inadequate regulatory processes for vaginal mesh products used to treat stress incontinence and pelvic organ prolapse have exposed women to unnecessary harms, warn experts in The BMJ today.

Surgical mesh itself not tied to increased complications

September 28, 2018
(HealthDay)—Use of mesh is not independently associated with an increase in the rate of complications of pelvic organ prolapse repair, according to a study published in the August issue of The Journal of Urology.

Careful patient selection is the key to achieving the best results for vaginal mesh surgery

July 19, 2018
The high number of reported complications from transvaginal repairs for pelvic organ prolapse (POP) using vaginal mesh have led to a significant decline in its use, despite its initial promise. Following a six-year analysis ...

Failure rate in some surgical mesh treatments unacceptably high

September 18, 2018
Failure rates in some treatments using surgical mesh are unacceptably high according to a newly published comprehensive biomedical review that considers the findings from peer-reviewed scientific articles assessing its use. ...

Not all vaginal implants are a problem and treating them the same puts many women at risk

April 4, 2018
Last week, a Senate Committee investigating the impacts of "transvaginal mesh implants" on women in Australia handed down its report, with 13 recommendations. The implants are medical devices surgically inserted to prevent ...

Pelvic Floor Society statement—use of mesh surgeries for constipation and rectal prolapse

September 21, 2017
In light of ongoing concerns by the media and the public surrounding the use of mesh in women with pelvic organ prolapse and urinary incontinence, the Pelvic Floor Society has issued a consensus statement addressing the use ...

Recommended for you

Early postpartum opioids linked with persistent usage

December 14, 2018
Vanderbilt researchers have published findings indicating that regardless of whether a woman delivers a child by cesarean section or by vaginal birth, if they fill prescriptions for opioid pain medications early in the postpartum ...

Hysterectomy linked to memory deficit in an animal model

December 6, 2018
By age 60, one in three American women have had a hysterectomy. Though hysterectomy is a prevalent and routine surgery, the removal of the uterus before natural menopause might actually be problematic for cognitive processes ...

Obesity intervention needed before pregnancy

December 6, 2018
New research from the University of Adelaide's Robinson Research Institute supports the need for dietary and lifestyle interventions before overweight and obese women become pregnant.

First baby born via uterus transplanted from dead donor

December 5, 2018
In a medical first, a mother who received a uterus transplant from a dead donor gave birth to a healthy baby, researchers reported Wednesday.

Researchers find evidence of prenatal environment tuning genomic imprinting

December 5, 2018
A team of researchers from the U.S., Australia and Denmark has found evidence of the prenatal environment tuning genomic imprinting. In their paper published in Proceedings of the National Academy of Sciences, the group describes ...

RSV study reveals age when infants are most vulnerable to asthma

December 5, 2018
New research suggests a maternal vaccination against RSV should be augmented with active immunisation in a child's first two years to reduce the onset of asthma.

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.