More than 800 UK women are taking legal action against the National Health Service (NHS) and Johnson & Johnson, over 'barbaric' vaginal mesh implants, BBC News reports the Victoria Derbyshire programme has learned. The implants are used to treat pelvic organ prolapse and incontinence after childbirth, but some can cut into the vagina – causing severe discomfort. Some women have been left in permanent pain, unable to walk, work or have sex. One called the implants "barbaric". The UK's medicines regulator said it "sympathises" with the women affected.
The report says Kate Langley had to give up her business as a childminder because the pain was so intense she could not look after the children. The surgeon who first examined her, she explained, "could see the [mesh] tape had come through my vagina – protruding through. Other women, reporting similar symptoms, have said the perforation was so severe their partners had been injured by the mesh during sex.
Langley, who described the meshes as "barbaric", said she has had 53 hospital admissions to try to end the pain, but the mesh was so near the nerve it could not be fully removed. She has been left in permanent pain by the implants and has nerve damage.
The report says the plastic meshes are made of polypropylene – the same material used to make certain drinks bottles – and manufactured by many different companies. They are used to ease incontinence and to support organs such as the vagina, uterus, bowel, bladder or urethra which have prolapsed after childbirth.
Claire Cooper began to experience pain three years after her operation. Doctors wrongly believed the source of discomfort was her womb, which she had had removed at the age of 39. When the pain continued, she said a GP told her she was imagining it. The news made her want to take her own life. She said she "mapped out" her suicide, but wanted to live on for her children. She still lives in pain and said her husband has "turned into my carer". "We haven't had sex for four-and-a-half years. This stuff breaks up marriages. I wouldn't at all be surprised if there are mesh-injured women that have taken their own lives and didn't know what the problem was," she said. "I want the procedure banned, I want the material banned."
Between April 2007 and March 2015, more than 92,000 women had vaginal mesh implants in England, according to NHS data from the Hospital Episodes Statistics, obtained by the Victoria Derbyshire programme. About one in 11 women has experienced problems, the data suggests.
Now, the report says, more than 800 women in the UK are taking legal action against the NHS and manufacturers, including US pharmaceutical giant Johnson & Johnson – the biggest makers of mesh implants. Its subsidiary, Ethicon, said it was "vigorously defending litigation".
The report says many of the women said they had never been told by their surgeons about the potential risks associated with the implants.
The Medicines and Healthcare products Regulatory Agency (MHRA) says for the majority of women, the use of vaginal mesh implants is safe and effective. The report says the meshes are still prescribed on the NHS across the UK, although a recent review in Scotland said they should not be routinely used for pelvic organ prolapse.
In the US, thousands of women have sued manufacturers, receiving payouts that total several billion dollars.
Currently in the UK, there are around 100 types of vaginal mesh implants.
So far, not one model has been recalled in the UK. The report says according to one expert, Professor Carl Heneghan, manufacturers have to provide little evidence before their product is clinically approved and made available on the NHS. "The regulatory body… doesn't even look at the device," he said. Heneghan also said manufacturers just have to provide documents that show their vaginal mesh implant is similar to one already on the market and it is highly likely to be approved.
The report says one leaked email from Johnson & Johnson suggested it had known problems existed with one of its products since 2004. The email said the company needed to start a "major damage control offensive" because "the competition will have a field day". The manufacturers said highlighting this email in isolation was "extremely misleading".
An MHRA spokesperson said in the report it was "committed to help address the serious concerns raised by some patients". It added: "The greater proportion of the clinical community and patients support the use of these devices in the UK."
Ethicon is quoted in the report as saying that "these devices have helped millions of women". It said it had "acted appropriately and responsibly in the research, development and marketing of its pelvic mesh products".
[link url="http://www.bbc.com/news/health-39567240"]BBC News report[/link]