A NUMBER OF Irish women are pursuing legal action over complications they suffered after receiving vaginal mesh implants.
The cases have emerged following reports of thousands of patients in the US, UK and Australia enduring similar issues with the devices.
Transvaginal mesh implants are used to treat stress incontinence and more recently pelvic prolapse – when a pelvic organ such as the bladder drops. Both of these conditions are common in women after childbirth. The mesh, a net-like implant, which comes in a number of forms and sizes, is inserted in order to support the weakened organ. Tissue then grows into the pores of the mesh to fortify the walls of the affected organ.
These devices have been used across Europe, the United States and Australia since the early 2000s and while short-term trials have found low complication rates for implants that are used to treat stress incontinence, there is growing evidence that the efficacy is lower for devices used in women with pelvic prolapse – and complication rates are higher.
The US Food and Drug Administration reclassified the transvaginal mesh implant as a high-risk device in 2012 and some 100,000 women there have filed lawsuits, but it is only in recent months that the issue was highlighted in the UK.
Legal representatives for women in Ireland who have undergone the procedure have said it was on seeing reports in the UK that some of their clients made the connection between their health issues and the device.
Pain, which is now believed to be related to the implants, can begin at any time – even years – after the procedure. The devices are still in use in Ireland though guidelines have been issued to clinicians in recent years.
‘Like a razor blade inside you’
Issues reported by women include headaches, lack of energy, discharge, bleeding and pain – which some have said was so intense they were unable to walk. Many have also reported being unable to have sex long after having the procedure. In some cases, the device cut into their vaginas or damaged other organs.
NHS data provided to The Guardian recently suggests that one in 15 women in the UK who underwent this procedure later had to have the implant either partially or fully removed. More than 800 women are now suing the NHS and manufacturers of the mesh implants.
The Scottish government has asked health boards to suspend the use of mesh devices.
A survey by consumer advocacy group Health Issues Centre in Australia this year found 59% of women said the procedure did not resolve their original issue and 58% reported experiencing pain during sexual intercourse after having the mesh inserted. A Senate inquiry into the issue has been launched in Australia with a hearing due to take place today.
In a submission to this inquiry, one 72-year-old woman wrote that she suffered for 14 years after having the implant inserted to repair a tear in the wall of her vagina.
Pain is with you all the time, I have infections and discharge and I’ve had four erosions, which put me in the hospital where the surgeon removed pieces of the mesh each time. I can feel the mesh when it moves it feels like a razor blade inside you … the doctor said if I start haemorrhaging to go straight to a hospital. I hope I get rid of this mesh one day. I’d be a very happy, healthy 72-year-old and have a normal life, what’s left of it for me.
Now a number of Irish women affected by the issue are pursuing legal action – some against manufacturers and others against individual clinicians.
Solicitor Melanie Power is representing three of these women, though she told TheJournal.ieshe has been contacted by around 25 people in total who have had the implants and who suffered “unidentified pain”.
“It really is a case of people not knowing what is causing their problems and they are just putting up with it in a real Irish mammy way. They think this is what happens when you have a baby. And some people are just embarrassed to talk about it,” she said.
Power said she has heard some “harrowing accounts” from some women who have contacted her.
“Some of the women, the state they’ve been left in, they suffer terrible pain and some are getting addicted to painkillers that they’ve been prescribed.”
According to the solicitor, removal of the mesh is “fairly gruesome” as it is designed to become part of the walls of the person’s organs.
“It’s like chicken wire put in to hold up organs and the organs start coming through it.
“It’s like trying to remove chicken wire from the bladder or the bowel, all the really sensitive bits. You could end up with a colostomy bag for the rest of your life.”
Power said some of the women she has spoken to did not even know what kind of surgery they had or what kind of device they had put in.
‘Barrier to justice’
Liam Moloney also has a small number of clients affected by this issue, with one due before the courts over the next few months.
He stressed that any woman who is having this procedure is supposed to be told about all of the risks involved.
They should be told that it can migrate – in one in a thousand cases, it can cause perforation of the uterus. It doesn’t matter how remote the risk is, they have to advise the patient of any risks before they consent. If they haven’t the patient could take an action against the implanting doctor.
Complications from surgery to repair prolapse of the uterus are listed on the HSE’s website and include:
- The mesh wearing away – further surgery may be required to remove and replace the mesh
- Damage to the surrounding organs, such as your bladder
- Pain during sex
- Vaginal discharge
- Vaginal bleeding
- Experiencing more prolapse symptoms – which may require further surgery
- A blood clot forming in one of your veins (for example, in your leg).
“I’m surprised there hasn’t been more of these cases. I suspect there are quite a substantial number of cases in Ireland where people haven’t linked the problems with the device,” Moloney said.
He said it can be difficult to establish whether there is a defect with the device or whether it was inserted incorrectly by the surgeon without expert evidence. This is costly, according to Moloney, as it can only be sourced in the UK, “given the reluctance in Irish medical professionals to give evidence against one another”.
(TheJournal.ie contacted a number of Irish experts and clinicians in gynaecology for input into this article, but none responded to interview requests.)
Moloney said the lack of legal aid for people in these types of civil cases can also be a “significant barrier to justice”.
In response to a query from TheJournal.ie, the Health Products Regulatory Authority (HPRA) said it does not routinely collect or maintain information on the number of women in Ireland who have received transvaginal mesh devices or vaginal mesh implants as it does not have a direct role in licensing or certifying them.
Medical devices which have been appropriately CE marked and which meet all EU requirements can be freely placed on the European market. The authority did say it had identified “two unconfirmed reports of incidents” in respect of these devices.
“The HPRA is aware of reports of complications relating to the use of surgical meshes. At European level, the safety of surgical meshes used in urogynecological surgery was reviewed by the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR),” it said in a statement.
A number of women affected by this issue made submissions to the committee, including one Dutch woman who said that she had several operations over a six-year period after the implant procedure.
“I still have severe pain every day and even special medication and operations for pain blocking do not make any difference. When I was 51 I went for the mesh, after the operation I felt like an invalid woman of almost 100 years [of age],” she said.
The committee’s report said there was a need for further improvement in the composition and design of synthetic meshes, in particular for female pelvic organ prolapse surgery.
It also recommended that non-invasive solutions should be considered before resorting to surgery and the amount of mesh should be limited where possible.
The HPRA said that in January last year, it sent the SCENIHR opinion and the related fact sheet to The Royal College of Surgeons in Ireland and The Royal College of Physicians in Ireland for onward distribution to their members.
In 2009, 2011, and 2012, the HPRA also wrote to consultants in Ireland to inform them of notifications published by the Food and Drug Administration and the [UK’s] Medicines and Healthcare Regulatory Authority in relation to this topic.