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The Globe and Mail

Mesh implants: A common procedure with serious risks

On Wednesday, British parliamentarians will debate if a public inquiry into a common surgical procedure called TVT (transvaginal mesh implant) is needed – the latest victory of an increasingly vocal campaign called "Sling the Mesh."

Roughly 75,000 British women underwent the surgery – which is common after childbirth – between 2006 and 2016, and more than 800 are suing. Activists want TVT outlawed and compensation for those harmed.

There are similar moves afoot in Scotland, Australia, New Zealand, the United States and Canada – although in North America, most of the action is in the courts, not in the political sphere.

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In September, a Pennsylvania woman, Ella Ebaugh, was awarded $57-million (U.S.) in a lawsuit against Ethicon (a subsidiary of Johnson & Johnson). The jury ruled that the mesh maker marketed a product that was defectively designed, inadequately tested and which caused grave harm. Ms. Ebaugh's urethra was shredded by the mesh and she lives with debilitating pain.

Ethicon is appealing the award, but the case has shone a spotlight on an issue that has been long-simmering but has received little media attention.

The exception is CTV medical reporter Avis Favaro, who has followed the story doggedly since the first warnings were issued in 2010, and recently broadcast a hard-hitting W5 documentary entitled Mesh Misery.

TVT is a non-invasive operation used to treat stress urinary incontinence (SUI) and pelvic organ prolapse (POP). The mesh procedure has been done since the 1960s, but numbers exploded after 2010, when manufacturers began aggressively marketing their products.

SUI is a condition in which urine leaks when coughing, sneezing, laughing or with exertion. The bladder and urethra are supported by pelvic-floor muscles and these can be weakened by childbirth.

POP is a condition where pelvic organs (uterus, bladder, rectum) bulge from their natural position into the vagina.

In both cases, a mesh can be implanted in the form of a sling to provide extra support.

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(Mesh surgery is also done commonly for hernias and there are complications and lawsuits in some of those cases too, but they have not led to the same public outcry.)

The surgeries are often effective, but, for some women, there are dire consequences, such as chronic pain, infections and an inability to have sex or even walk.

Blue-ribbon panels who studied the issue in both Britain and Scotland concluded that TVT can be a legitimate treatment of SUI, but not for POP, except in rare instances.

The experts also highlighted four problems: The procedure has been overused; surgery is often performed by doctors who are inadequately trained; many women were given inadequate information about the benefits and risks; and most of the products were approved without adequate testing or study of long-term impacts.

To make matters worse, the women who were in pain were rarely taken seriously – an all-too-common reality for those with "invisible" chronic pain.

In the CTV documentary, Ms. Favaro featured patients who went from being healthy young moms to being so disabled that they require a wheelchair. One woman likened her pain to being constantly pierced by barbed wire, but couldn't find a surgeon who would remove the mesh. (The mesh, made of pliable plastic, is designed to provide permanent support, but it can sometimes become rigid and pierce the vaginal wall or bladder, or cause chronic inflammation.)

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Conditions such as incontinence and prolapse can be anything from embarrassing to painful, so they can't be ignored. There are non-surgical treatments, but for serious cases, surgery is required. That can be done using a mesh device, or with a more invasive technique that can also lead to complications.

In the British press, TVT has been likened to thalidomide, but that is a poor comparison. Many women benefit from mesh surgery after childbirth. If it is done appropriately and properly, complications can be minimized.

In both Britain and Scotland, the formal examinations came up with some practical solutions, notably ensuring patients know the risks, that surgeons be qualified and that better tracking be done to understand the long-term impacts and why some patients suffer so severely.

Canadian women would benefit from a similar exercise in this country.

Whether a broader public inquiry is required for cathartic and compensatory reasons is another matter – a political, not a medical decision.

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