Thousands of women in the United Kingdom have had to have surgery to remove vaginal mesh implants over the course of the last ten years, National Health Service records have revealed. The Guardian obtained figures that suggest that nearly one in fifteen women who were fitted with the common mesh support eventually had to have surgery to extract it, because of later complications. The rate of removal has been called a “scandal” by University College Hospital’s consultant urogynaecological surgeon Sohier Elneil, who has been responsible for carrying out hundreds of such removal procedures, and notes that those who had to have it removed were likely to be those with the most serious complications.
The failure rate
The implants have been in use as a less invasive, and much simpler alternative to the more traditional approaches for the treatment of common post-childbirth conditions, such as urinary incontinence and prolapse, which generally requires surgery. The operation has been a success for most women, but concerns have been growing over the serious complications that have manifested in a wide array of patients, such as chronic pain and the mesh cutting through vaginal tissue, resulting in women being unable to have sex, or in some cases, even walk. The producer of one of the most commonly used meshes, Johnson & Johnson (via their Ethicon subsidiary), is already involved in a class action lawsuit within Australia and could face similar legal battles in the United Kingdom.
According to NHS digital records, around 75,000 trans-vaginal implants were fitted between 2006 and 2016, with over 4900 removal procedures also carried out in the same period, around 6.5 percent of those fitted. Over a thousand removals were also performed for another kind of mesh, known as transobturator tape, which was fitted in as many 44,000 women during this decade.
The figures suggest a much higher complication rate than has been claimed, in both a 2014 government report that assessed the benefits and risks of vaginal mesh, and in short term clinical trials. The removal rate of TVT was estimated at just 0.9 percent with a complications rate of less than 1.5 percent in the former. The University of Oxford’s professor of evidence-based medicine, Carl Heneghan, who wants a public inquiry into mesh use, says that the figures are only likely to worsen, potentially resulting in as many as one in fifteen women requiring their mesh to be removed in the future.
TVT implants have been in favour in the United States and Europe since the beginning of the 2000s, coming to be used more commonly ahead of traditional open surgery procedures. These also came with complications, involved much longer patient recovery times, and took more time to carry out. TVT procedures usually take just half an hour with the use of keyhole surgery, and patients can usually be sent home on the same day.
The trials also showed an impressive success rate for the resolution of incontinence problems. Elneil notes that many patients think the procedure fixes a distressing condition simply and easily, but removing the mesh can be a very different story. The plastic mesh is intended to be permanent once placed inside the body, with full removal often necessitating hours of surgery that carry the risk of damaging nerves, and organs such as the bowel and bladder. 1769 full removal procedures have been performed since 2006, NHS figures state. No device is without risk, according to the Medicines and Healthcare products Regulatory Agency, and Johnson & Johnson maintain that most women have had their lives improved via the mesh.
There are a number of possible alternatives to the use of vaginal mesh. Corrective surgery can help in serious cases of prolapsed organs, using tissue grafts or even the tissue of women’s own bodies. Although such surgeries are invasive and complex, they leave almost no foreign material within the human body following completion.
Other options include bulking agents such as Botox, synthetic sugars, specialised gels, and collagen, which can be injected into tissues surrounding the bladder. This treatment only applies to SUI. Pessaries are devices inserted into the vagina which can give support to the vagina, uterus, rectum and bladder for weeks at a time, and can relieve the symptoms of prolapse, though they’re not a cure. Hormone replacement therapy may help some POP cases, and the pelvic floor may also be assisted by Kegel exercises in minor SUI or POP cases.