“If this hadn’t happened to me, and someone told me about it, I’m not sure I would have believed them. It’s like a bizarre horror story.” We’re 36 seconds into our conversation and Kath Sansom has already reached 200 words per minute. She has unwittingly become the face of the latest scandal in women’s health – and she is desperate to be heard. Kath is one of thousands of women in the UK – and all over the world – speaking up about transvaginal tapes, often made of mesh, being used in NHS surgical procedures. They are sold as the quick fix to end incontinence and pelvic organ prolapses, which has left thousands of women reeling in pain. The story hit national headlines all this week, and Kath, a local newspaper journalist and campaigner, has been at the heart of it. “I’ve seen some crap in my time,” she says. “But this has blown me away.”
Transvaginal tapes made of mesh have been used by the NHS since the mid-nineties, when it was introduced as time and cost effective way to treat women suffering from stress incontinence and pelvic organ prolapses (POP). The device is a polypropylene (plastic) mesh strip or panel, which is cut to size and then surgically placed through the vagina or abdomen. The 20-minute operation was seen as a “simple” way to alleviate taboo symptoms often suffered by women after childbirth – a fast alternative to the more invasive, lengthy procedures of the past. It proved popular. Between April 2007 and March 2015, some 92,000 women were treated with vaginal inserts.
Some women do have positive results from the surgery. And it feels like it should be a positive initiative for women. When it comes to talking honestly about the effects of childbirth – and incontinence, and the menopause, and pretty much any other topic surrounding the intricacies of women’s bodies – taboo still threatens to silence women’s voices, and often they are left to suffer alone. This should be a way for women to take back some control. For those who have positive experiences, it is.
Yet, even limited research shows that at least one in 11 women have experienced failed procedures, resulting in severe repercussions and chronic pain. Now, according to the BBC, at least 800 UK women are suing the NHS and manufacturers of the panels (Johnson & Johnson are one of the main producers), and the repercussions are wading into public life: Owen Smith MP announced he would hold a Parliamentary debate on the issue, and ordered an investigation. In Scotland, a 2014 inquiry following a petition prompted MPs to suspend NHS use of mesh implants pending safety investigations. The subsequent report published this year stated that mesh must not be routinely offered to women with POP and ordered mandatory reporting of all procedures and adverse effects.
Women have described intense pain on waking from the operation, struggling to urinate, the plastic cutting through the wall of their vagina, and even, in many cases, through the urethra. Many are left unable to have sex, due to pain or use tampons, or been left reliant on a wheelchair due to the pain. Some have said their partners have been cut by the tape during intercourse. The physical and emotional repercussions have left some women feeling suicidal. A woman speaking out on the Victoria Derbyshire show this week had lost the use of her bladder and bowel as a result of the procedure. When I mention the news to my friend, an NHS physiotherapist, over dinner last night, she says she can think of at least four patients she’s treated in just a few months who have all had the same failed surgery, and were suffering chronic pain.
I don’t know how I got through it. I had to keep getting up from my desk, hang my head over the sink and sob. I didn’t know what to do with myself
For Kath, it was intense pain, the inability to walk, and a feeling that her feet had been cut off at the ankle. She had the device taken out, but, despite leading an incredibly active life before her 20-minutes on the operating table – she was a keen highboard diver and cyclist – she is now unable to run, or even kneel down to garden for any period of time. Her experience led her to set up the Sling The Mesh campaign, and she's been campaigning tirelessly ever since.
“I started getting this cheese-wiring pain inside my vagina,” Kath explained. “And in my pelvic area. It felt like someone was cutting me, from the inside, with knives. I put it down to being post-op, but it didn’t end. I was freelancing, I had to get back to work as I’m a single parent. I don’t know how I got through it. I had to keep getting up from my desk, hang my head over the sink and sob. I didn’t know what to do with myself.”
But what makes this mesh so harmful? “The overriding problem with it is that it shrinks,” she says. It’s widely reported in medical journals that the material does shrink and can erode once inside the body, and that can lead to vaginal scarring as well as pain and other complications. She says that surgery guidelines state that materials which change over time should not be used as devices to be inserted in the body. “It should remain the same until the patient dies. But there are studies which show this fabric can shrink, and twist and the edges can fold, it can degrade and have fragments drop off, and it can go brittle or really hard.”
I'm still trying to verify the “surgical law” which Kath cites. But there are harrowing indictments that this device and procedure has long been considered unsafe which date back to the 1990s. Just three years after transvaginal tape made of mesh was introduced in 1996, one of the first products – ProteGen Sling, as it was known – was recalled due to safety concerns. In 2008, the first public health safety notification about the products was issued in the states, a measure which was “updated and strengthened” in 2011. By the same year, at least eight of 18 devices evaluated by the watchdog US Food & Drug Administration (FDA) had been removed from the market, and the FDA announced that transvaginal tape made of mesh was “high-risk” for women. That warning was reconfirmed by them as recently as 2015.
That’s not all. In Australia, a Senator compared the scandal to Thalidomide as one of Australia’s worst health scandals. In the US, a class action lawsuit over the devices – involving a reported 54,000 women – settled for $12.3m and new cases are still coming forward. There is little knowledge about long-term effects of the tape, though some women have had positive outcomes, only to experience debilitating symptoms when the material morphs up to a decade down the line.
The scale of the scandal is huge. Yet, it’s also sadly unsurprising. It’s indicative of the lack of respect we have for women’s health – and how little we care for women’s bodies. The frustrating thing, Kath says, is that women are often not well-enough informed of the risks before the procedure, nor are they being listened to when they speak up about the after-effects. “No one wants to take it seriously,” Kath explains. “Still surgeons are purporting that the surgery is more beneficial than risky. But what we should be doing, instead of rushing women into procedures like this, which are obviously not working well enough, is looking towards preventative measures.
“In France, women are given physiotherapy as standard to help repair their pelvic floor after giving birth. That works. This does not.”
Calls are now being made for the tape made of mesh to be banned, but Kath says her main objective is to tell as many women as possible of the real risks, and help them make an informed decision about their bodies. “I don’t want anyone to go through what I – and thousands of other women involved in my campaign have – been through,” she says. “This has to stop.”