New Rules for Mesh as Report Examines 'Shameful' Marketing

Peter Russell

October 11, 2018

The National Institute for Health and Care Excellence (NICE) is to impose tighter restrictions on the use of surgical mesh and surgical tape to treat urinary stress incontinence and pelvic organ prolapse in women.

The announcement was made 2 days before an investigation published in The BMJ revealed how vaginal mesh implant manufacturers "aggressively hustled" their products into widespread use, while an editorial in the same journal described the era of mesh implants as "shameful" and said a mandatory device registry was long overdue.

In July this year, the Department for Health and Social Care announced a national 'pause' in England on the use of vaginal mesh implants following preliminary recommendations from an independent review. It heard that the procedure, which involves inserting a net-like fabric into the vagina to support the bladder, womb, or bowel, had led to disabling complications in thousands of women.

Former Health Minister Baroness Julia Cumberlege, who chaired the review, said she was "appalled at the seriousness and scale" of what had happened to the women affected.

The new draft guidance says women should be offered a full range of non-surgical treatment before the use of surgical procedures including mesh or tape.

Use of Mesh or Tape 'When Other Options Exhausted'

It will recommend that surgical mesh or tape should only be considered when non-surgical options have failed or are not possible.

In the cases where it is agreed to use surgical mesh or tape, women must be fully informed of the risks, NICE decided.

In cases where surgery is offered, women should be referred to an alternative surgeon if her chosen intervention is not available from her first consultant.

Also, a national database should be set up to record all procedures involving the use of surgical mesh or tape procedures to help with future decision making.

The new guidelines also detail procedures that should be followed in cases where women report complications from mesh or tape procedures. These include referring them to a urogynaecologist or colorectal surgeon, or a consultant at a regional centre, for assessment.

It also recommends individualised investigation plans for each woman who has experienced complications as a result of mesh or tape surgery.

Non-Surgical Options 'Should be a Priority'

The guidance details the non-surgical procedures that should be considered before surgery.

Non-surgical options for urinary incontinence include:

  • Lifestyle interventions

  • Physical therapies

  • Behavioural therapies

  • Medicines

Non-surgical options for pelvic organ prolapse include:

  • Lifestyle modification

  • Topical oestrogen

  • Pelvic floor muscle training

  • Pessary management

The current 'pause' in procedures will continue until a number of conditions are met, including registering all operations and any complications on a national database, and until surgery is performed by specialist surgeons at specialist centres.

Sir Andrew Dillon, chief executive of NICE, said: "Our independent advisory committee looked at a range of evidence for interventions for urinary incontinence and pelvic organ prolapse in women and made a series of detailed recommendations, using the best evidence currently available.

"It is important that every woman is supported to make decisions that are right for her, consents to a procedure, and fully understands the benefits and risks of the procedure being offered before consenting to it.

"Where surgical mesh/tape could be an option, there is almost always another intervention recommended in our guideline, which does not involve surgical mesh/tape. If a surgeon cannot provide a full range of choices to the patient, then she should be referred to one who can.

"Surgeons must also record any intervention using surgical mesh/tape in a national database."

Consultation on the draft guidance is open until November 19th 2018.

Reaction to the Guidance

Dr Duncan McPherson, clinical director, medical devices at the Medicines and Healthcare products Regulatory Agency (MHRA), said: "The safety of patients is our highest priority and while we recognise some women do develop serious complications, we also know many women gain benefit from these surgical procedures for what can be extremely debilitating conditions.

"We echo NICE’s view that the decision to use mesh surgery for urinary incontinence and pelvic organ prolapse should be made between the patient and clinician, after discussing all the options and recognising the benefits and risks in the context of the distressing conditions being treated.

“Working with other organisations including NHS England, NICE and professional bodies, we are committed to helping address the serious concerns raised by women who have experienced complications.

"We encourage anyone; patient, carer or healthcare professional, who is aware of a complication after a medical device is implanted, to report to us via the Yellow Card scheme, regardless of how long ago the implant was inserted."

The Royal College of Obstetricians and Gynaecologists (RCOG) and The British Society of Urogynaecology (BSUG) have welcomed the draft guidelines. A joint statement said: "We particularly welcome the emphasis on providing women with the support and information they need about all treatment options. This is to ensure they can make informed decisions about the best treatment for their individual circumstances.

"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."

Linda Millband, national head of medical negligence at Thompsons Solicitors, which has represented a number of men and women injured as a result of vaginal and rectal mesh surgery, commented: "This is a step in the right direction. However, our concerns remain that private hospitals will ignore these guidelines in the same way they have failed to implement the pause on mesh surgery that the government has imposed on the NHS.

"The real answer here is for the government and NICE to stop making small amends to guidance and to issue an absolute ban on mesh use until its risks are fully investigated and patients can be confident about its safety."

Investigating the Marketing of Mesh Implants

An investigative report in The BMJ by journalist Jonathan Gornall charted the way that mesh implant manufacturers managed to sell their products since they were first introduced in 1998.

He also examined how regulators approved their use "on the flimsiest of evidence" and how problems were allowed to accumulate because of the medical profession's failure to introduce registries, despite warnings from NICE and other bodies.

In one of a series of reports in the journal, Mr Gornall named prominent individuals who he said took money from mesh manufacturers for various activities including research grants, speaker honorarium and consultancy work.

In an editorial, Prof Carl Heneghan director of the Centre for Evidence Based Medicine, Oxford, and Fiona Godlee the BMJ's editor in chief, described the post-marketing assessment of vaginal mesh as "a shameful episode in the history of implantable devices".

They wrote that surgeons, manufacturers, regulators, and governments must all shoulder part of the blame for what went wrong. "Mandated national registries are needed for all implantable devices, to protect patients, improve outcomes, reduce costs, and identify best practice," they said.

Editor's Note: This article was updated after publication to include BMJ material that was embargoed until after the NICE guidance was released.

Vaginal mesh implants: putting the relations between UK doctors and industry in plain sight, Gornall, The BMJ. Article.

Surgical mesh and patient safety, Heneghan; Godlee, The BMJ. Article.


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