Surgical Mesh

Surgical Mesh

Is this the most serious health crisis of our generation?

By Charlotte Korte, Carmel Berry and Patricia Sullivan

First published in the January 2018 edition of the Auckland Women’s Health Council Newsletter

The significant increase in the number of patients suffering from surgical mesh complications globally is alarming, with many patients left disabled and living in extreme, chronic and debilitating pain. This has led many in the medical community to shy away from using these medical device implants.

The establishment of overseas governmental mesh inquiries and the reclassification of some surgical mesh devices to a “high risk” category by the FDA, EU and, more recently, authorities in Australia, has substantiated many of the concerns raised regarding the use of surgical mesh.

Surgical mesh has been in the news a lot recently and some doctors have said that the media reports are scaring people away from agreeing to have a surgical mesh procedure; they have accused the media of scare mongering. Up until now, it has mainly been health advocates shining the light on mesh complications, yet professionals within the medical field are now starting to speak out.

In a submission to the Australian Senate mesh inquiry,1 Danny Vadasz (CEO of the Health Issues Centre in Australia) pointed out that there had been attempts to deflect attention away from the medical profession, for example statements that ‘the majority of women who undergo mesh procedures had not been harmed’.  Vadasz stated:

“My frustration is that I’m on various reference groups and government committees dealing with the mesh issue and this narrative of ‘we made mistakes in the past and it’s fine now’ keeps emerging. But it’s not fine”.

“To me it’s a part of this larger, poor attitude towards women and not listening to women when they say something is wrong, and not explaining the risks to them so they can give informed consent to procedures.”

Mesh Down Under members Charlotte Korte and Patricia Sullivan, presented evidence to the Australian Senate inquiry drawing attention to the New Zealand situation, which parallels that in Australia. Korte said “Patients are still not being informed accurately about the true risk of undergoing a surgical mesh procedure, the severity of the potential complications, nor the permanent nature of these devices.”

Scottish urogynaecologist, Dr Wael Agur, said on Newshub’s The Nation2,  “The most serious complications that could happen are disability, inability to walk, having to use crutches and wheelchair. Chronic pain is the second most serious complication. It’s vital that patients should be told that the risks of mesh could be irreversible. In the majority of patients the mesh device cannot be taken out completely safely.”

Mesh Related Treatment Injury Claims

In October 2017, ACC released a report detailing a more in-depth analysis of the 810 ‘treatment injury’ claims relating to surgical mesh that have had a decision for cover made in the past 12 years.3

The report showed that claim numbers each year have continued to increase, despite a private petition to the New Zealand Health Select Committee in 2014 asking for an urgent inquiry into the use of surgical mesh. ACC are unable to provide more detail on the numbers of surgical mesh claims that are currently in the ACC system or under review.

Petitioners Carmel Berry and Charlotte Korte, who worked with ACC on the retrospective data analysis, together with their colleague Patricia Sullivan, have established a support group for patients:

“Mesh Down Under is all inclusive for men and women and includes many patients injured by mesh used to treat hernias as well as POP [Pelvic Organ Prolapse] and SUI [Stress Urinary Incontinence]. It has grown at a significant rate from only 90 members in 2014 to over 500 today,” says Carmel Berry, “but this group is only a small percentage of the number of people we are in contact with, as we are also in touch with others by post, email and telephone on a daily basis. The number of people contacting us asking for help is getting too many for us to manage and so we have asked the Ministry for help.”

“Most of our members believe that they had insufficient information from their doctors to provide informed consent for the procedure; in other words, they were not warned what their life might be after a mesh implant. Chronic pain, infections, nerve damage, mesh migration, degradation, mesh cutting them internally, painful intercourse, systemic and autoimmune issues, an inability to walk and function normally is the norm for many of these women,” she added.

In terms of quantifying the risk of a patient having a bad outcome, Charlotte Korte says, “We do not know in New Zealand because medical devices are not monitored through a registry and because of the legislative restrictions of Medsafe, many of these devices did not undergo clinical trials before being allowed to be sold in New Zealand. In essence, the clinical trials have been on the patients themselves.”

“What we do know is the rate of ‘revision surgery’ in the UK4 for mesh used to treat SUI is around 10% and in Australia the re-operation rate is just over 7%5. Taking into consideration the severity of mesh injuries these statistics are extremely concerning”.

The Royal Australasian College of Obstetricians and Gynaecologists have said that “very little robust information is available on the efficacy and long-term safety of polypropylene mesh kits marketed for use in the management of pelvic organ prolapse”. They recently updated their guidelines and no longer recommend mesh to treat POP except in very rare circumstances.6 This updated guideline is in line with recommendations made by the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) in their “Opinion on the safety of surgical meshes used in urogynecological surgery” (2015), which stated “due to increased risks associated with the use of synthetic mesh for POP repair via a trans-vaginal route, this option should only be used when other surgical procedures have already failed or are expected to fail.”7

Although the New Zealand Health Select Committee declined to call for an official inquiry, they did publish a set of recommendations on 1 June 2016.8 The previous National Government accepted all recommendations in August 20169 but Mesh Down Under claims that very little has been done to address many of the recommendations until recently.

When asked about what steps he would take to expedite the Health Select Committee recommendations, current Health Minister, the Hon. David Clark said, “I have previously met with members of Mesh Down Under and have listened to them describe the horrific impact on their lives from suffering debilitating surgical mesh injuries.

Now that I’ve become Health Minister, I look forward to being briefed more fully by health officials about this issue and ways to better respond to it, alongside my colleague, ACC Minister Iain Lees-Galloway.

Also, I have asked the Ministry of Health for a report on impediments to progressing the Health Select Committee recommendations.

I’m pleased that the Ministry held a positive meeting last month [November 2017] with people injured by surgical mesh. As an initial response, it has committed to looking at a cost-benefit analysis for a pelvic surgical mesh registry.

I expect the Ministry will continue to build their relationship with people with surgical mesh injuries.”

Acknowledgment of the harm resulting from surgical mesh procedures has finally been made by the Ministry of Health, the Health and Disability Commission, ACC, Medsafe and the medical community.

In October 2017, at a cross sector meeting in Wellington to discuss the complex issues surrounding surgical mesh use, some progress was made.

“The lack of progress by the previous Government in implementing the Health Select Committee recommendations was outlined at the meeting,” Korte said. “There was a willingness to work in a collaborative manner to implement short term immediate changes and also in the longer term, which we feel is a positive step forward”.

The Ministry of Health has agreed to develop an ongoing working group to address the many concerns raised regarding mesh use, including the need for a registry, updated patient literature and in-depth retrospective research. Korte agreed that “this will hopefully enable the medical community to be able to provide accurate information about the risks and benefits of mesh surgery.”

In the meantime the group actively encourage patients suffering complications following a mesh implant to report it to Medsafe. An updated complaint form can be found on the Medsafe website.

GLOBAL Scandal

Problems with surgical mesh are headline news around the globe and litigation in several countries is ongoing.

Thousands of lawsuits have been filed against various mesh manufacturers in the US and Canada alone. Owing to the total number of mesh injured patients being so large, the court combined all the cases in a West Virginian Court. This is known as multidistrict litigation (MDL).

Judge Joseph Goodwin was chosen to be the head of the MDL, whose job it was to move the cases through the court as quickly as possible. Amassing cases in one court meant there would be no conflicting lower court rulings that would have to be sorted out later.

But no one had any idea the mesh MDL would grow this large. To date, there are nearly 104,000 product liability claims in that court, more than any other mass tort ever amassed in a single court. Millions of dollars have been awarded to victims as compensatory damages and punitive damages.

Across the ditch, a class action trial against Johnson & Johnson Medical for its vaginal mesh implants, began in Sydney on 4 July 2017, and is one of the largest of its kind in Australian history. Shine Lawyers10 has brought the action on behalf of nearly 8,000 women across Australia that have received the implants and suffered devastating, irreparable complications. The trial is ongoing.

A campaign in the UK known as ‘Sling the Mesh’ recently met Government officials at the House of Commons. Labour and Conservative MPs have called for tighter restrictions on the use of vaginal mesh implants, in a Parliamentary debate that heard how the lives of women had been avoidably blighted by complications linked to the surgery.

Figures released by the UK’s National Health Service suggest one in 15 women who underwent a mesh procedure later had to have the implant either partially or fully removed.

The mesh saga mirrors many of the ethical issues raised during the inquiry into the treatment of cervical cancer at National Women’s Hospital in 1987-88, and then in the recommendations contained in the Cartwright Report. In the words of the late Lynda Williams, “Sometimes we have to fight for the same things again and again and again”.

Carmel Berry concluded, “As various countries wake up to the scope and scale of the mesh problems we, the patient advocates who have formed local support groups, all communicate amongst ourselves. We share research and information and ultimately, maybe thirty years down the track the next generation will look back on the mesh disaster and ask ‘what were they thinking – putting plastic in vaginas?”