The transvaginal mesh (also known as urogynaecological mesh) is a polypropylene mesh that is implanted to permanently fix pelvic organ prolapse and stress urinary incontinence. However, increasing numbers of lawsuits from women who have suffered lifelong complications such as infection, erosion of the vaginal tissues and organ perforation because of the design and implantation technique mean that new patients of the treatment are entirely put off.

To date, more than 100,000 women have sought compensation from maker, Johnson & Johnson, for their injuries and many have resulted in multimillion-dollar settlements. Fifty-one-year-old Ella Ebaugh, for example, was awarded USD57 million in damages – after the mother of five was left with a mangled urethra, bladder spasms and continual pelvic pain. Many others have been left with chronic pain, unable to walk or have sex.

Between April 2007 and March 2015, more than 92,000 women had vaginal mesh implants in the UK, 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. In addition, tshere are now fighting class actions in Australia and America – claiming the global healthcare giant did not investigate proper clinical trials on the possible complications of the mesh. Yet, president of the Australian Association Dr Michael Gannon says only “a minority of women having these kinds of operations have been damaged”.

Device feasibility is still being debated

Gannon, an obstetrician who has treated women harmed by the meshes shared, “we seem to have forgotten how many women have been helped by these operations over the journey in acknowledging that some may have been harmed by it.” The mesh, when used for hernia operations, is vastly more successful. Urogynaecology Society of Australia director, Jenny King echoes in agreement.

According to one expert, Prof 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 added.

Prof Carl Heneghan opines that manufacturers have to provide little evidence before their product is clinically approved and made available on the NHS. Photo credit: BBC News
Prof Carl Heneghan opines that manufacturers have to provide little evidence before their product is clinically approved and made available on the NHS. Photo credit: BBC News

Upon hearing that the device may be banned in Australia, King said it was “hysterical” because they had positive outcomes for women who were unable to undergo other major surgeries. Instead, she said, doctors should be more discriminatory in their use – avoiding operations on younger and healthy women. King herself said she was “timid” in her use, which she regretted sometimes as it meant some women had to undergo multiple surgeries.

Yet, a study published in the JAMA Surgery journal in 2015 discovered that one in 30 women, who have the mesh inserted, need surgery less than 10 years later to have it removed or replaced. This is compounded by the fact that since the mesh is designed to stay in the body forever, tissue and blood vessels grow around it, meaning multiple surgeries are required anyway to remove it, piece by piece.

Gannon believes that the media play a role in exaggerating the problem. Whilst acknowledging his sympathy for the women for whom the mesh has not worked, he iterated that “stories like theirs are highly charged, emotional stories that make for good copy and its inevitable the media would report them. It’s less interesting to talk to a woman who had an operation five years ago and their lives have been made a whole lot better.”

However, CEO of the Health Issues Centre in Australia, Danny Vadasz begs to differ, claiming this is “the wrong way to look at it”. Citing the example of thalidomide, which was prescribed to pregnant women to treat insomnia and morning sickness, but caused severe deformities in the babies born to these women remarked, “no one said, ‘Oh yes, but hundreds of thousands of women got a good night’s sleep on the drug – and that outweighs the harm’.”

Concern about the device continues to grow; device classified as “high-risk”

The US Food and Drug Administration (FDA) has reclassified the device as “high risk” – putting forward justification that it is not more effective than alternative treatments; and that complications from it are not rare. In fact, Johnson & Johnson’s parent company, Ethicon has altogether pulled the device from the market in America.

Although the manufacturer responded that they have acted “ethically and responsibly” in developing and selling the implant, internal company emails that were disclosed during Ebaugh’s trial show that this was not, in fact, the case. For example, when it became evident that the success rates for the device were “way below” those of its predecessors, senior executives suggested, “stop[ping] for a while such publications that could compromise the future”.

Additionally, many male executives allegedly exhibited blasé recklessness saying that sex with a patient with mesh complications must be “like screwing a wire brush”. They also launched an aggressive marketing campaign, downplayed the lack of controlled trials and tried to stop French health authorities publishing a report warning against the device.

During a trial for two Australian women who had suffered debilitating complications, the managing director of Johnson & Johnson Medical in Australia, Gavin Fox-Smith, was asked if he was personally affected by the women’s statements, Fox-Smith said, “our job is to make patients better. So, for me it’s really tough, it’s nowhere near as tough as what the patients have to deal with.”

Vadesz says, “to me, it’s a part of this larger, poor attitude towards women and not explaining the risks to them so they can give informed consent to procedures.” MIMS

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