Mesh Down Under

2012 –

Mesh Down Under

2012 –

Theme: Health

This essay written by Carmel Berry was published online in Women Together: a History of Women's Organisations in New Zealand in 2019.

The problem with mesh

The female pelvic floor is a group of muscles supporting the uterus, bladder, vagina and rectum. Around half of women who have had children will experience some kind of pelvic floor dysfunction, including pelvic organ prolapse (POP) or stress urinary incontinence (SUI).

Historically, surgery for POP involved repairing the weakened connective tissue with sutures. To achieve lower rates of recurrence, surgeons and manufacturers decided that the surgical mesh already routinely used to treat abdominal hernias could be placed through the vagina to treat POP.  Such implants were intended to be permanent.

Despite no clinical trials on living humans, the first mesh for this purpose, ProteGen, was approved by the US Food and Drug Administration (FDA) in 1996. It was recalled by the manufacturer in 1999 after too many women experienced serious complications. [1] By then the market was flooded with surgical mesh devices approved as ‘substantially equivalent’ to ProteGen. These were not recalled, and were aggressively marketed to surgeons and hospitals around the world.

By 2002 they were freely available in New Zealand, which had no requirements for pre-market testing or proof of safety or efficacy for medical devices. Surgeons recommended the procedure to patients, who received very little information about what the surgery involved. Research showed that very few, if any, were warned about the potential risks of lifelong complications. [2]

In 2008 a statement was released by the FDA, warning of risks from pelvic mesh such as erosion of vaginal tissues, pain, infection, recurrence of POP, and new onset of SUI.  At that time New Zealand’s Medsafe had received only 14 reports of adverse events (such reports are not mandatory, and the Accident Compensation Corporation (ACC) did not share treatment injury information with Medsafe until 2017.) [3] After a review, Medsafe concluded that the benefits outweighed the risks.

In 2011 the FDA, after evaluating adverse event reports and assessing the scientific literature, stated that it had not seen conclusive evidence that transvaginally placed mesh improved clinical outcomes any more than traditional POP repair, and ‘may expose patients to greater risk’. [4] However, New Zealand surgeons continued to offer mesh as a first choice option, and were very slow to recognise that transvaginal mesh implants were causing such severe complications. Patients reported that their debilitating pain was dismissed and they received responses such as ‘it’s in your head’, ‘mesh can’t cause pain’, and, most frequently, ‘you are the only one that has this problem’. They were referred to pain clinics and psychiatrists.

This all changed in 2012, when the first court case against a mesh manufacturer concluded in favour of the woman. The gag order came off and media coverage began. [5] Affected women made the link between their pain and suffering and the mesh implant, and realised they were not alone.  As Carmel Berry recalled: ‘The feeling of finally being believed was overwhelming. I wanted to talk to other women, share my story publicly and warn others to avoid mesh.’

The formation of Mesh Down Under

Mesh Down Under was initially conceived as an online support group for people to share their lived mesh experiences. From the initial group of six members, numbers grew to over 50 within a few months. Co-founders Carmel Berry, Patricia Sullivan and Charlotte Korte realised that the number of mesh-injured New Zealanders was increasing and that the issue needed to be highlighted to the health sector and lawmakers.

Over the following two years, calling themselves ‘The Three Meshketeers’, they undertook to fully research the scale and scope of the issue, and endeavor to highlight to health authorities the difficulties faced by these patients, as they searched for the recognition of their symptoms and the help they needed. They doggedly sought help from many organisations and people in the health sector, including Medsafe, Women’s Health Action, representatives of various medical colleges, the Health Quality and Safety Council, Health and Disability Commissioner (HDC), and ACC.  Almost every meeting concluded with a recommendation that they pursue another agency or organisation that ‘may be able to help’.

They also regularly wrote to politicians and ministers asking them to investigate the growing number of mesh-related treatment Injury claims. They established relationships with media contacts and got regular coverage by investigative journalists, who were also seeing the global scandal unraveling. [6]

Taking action

The team requested and collated various government documents through the Official Information Act, and conducted their own research within the growing Mesh Down Under community. By March 2014 they believed they had enough evidence to convince the government to launch a full inquiry into the problem. They launched a petition calling for the Health Select Committee to recommend an independent and transparent inquiry into the use of surgical mesh in New Zealand. This was followed by their supporting submission, providing ‘overwhelming evidence about the use and issues of surgical mesh and … concrete ways to improve outcomes for patients’. [7]

After numerous gruelling sessions where the women were challenged by top health officials, the Health Select Committee’s report was presented to Parliament on 1 June 2016. [8] It included seven recommendations, in three areas: the investigation of options for a surgical registry, improvement in medical practice, and the role of the regulator in pre-market medical device approval. In a report tabled on 24 August 2016, the government carefully considered the Committee’s report and supported all of its recommendations. [9].

The founders of Mesh Down Under finally felt that progress was being made, yet ACC claim numbers continued to rise. This was made public with a full review published in 2015 and updated in 2018; the data showed that over a thousand New Zealanders had suffered mesh related adverse events. [10]

A literature review published in 2016 concluded that mesh placed in the vagina for treatment of prolapse was not recommended. Results of a Scottish clinical trial which Mesh Down Under had discussed at length with the Select Committee, published in January 2017, also led to the finding that mesh implants for pelvic organ prolapse were not proven to be effective or safe.  [11]  

After much pressure from Mesh Down Under, on 11 December 2017 Medsafe used the provisions available under section 38 of the Medicines Act to contact four suppliers of surgical mesh implants used in urogynecological surgery, requesting information relating to the safety in use of products currently notified as being available in New Zealand. On 31 January 2018 Medsafe announced that all four companies had confirmed that all transvaginal surgical mesh products for pelvic organ prolapse were no longer supplied in New Zealand. [12]

The Mesh Roundtable

While Mesh Down Under’s 800 members welcomed this outcome, the battle to address the continued use of surgical mesh for other health conditions, including stress urinary incontinence resulting in ongoing ACC claims, remained to be fought. By 2018 the organisation was part of a government working group known as the ‘Mesh Roundtable’, chaired by the Ministry of Health, with representatives from three medical colleges, ACC, HDC, the Private Health Association, and Medsafe.

The first completed project was the creation of a patient information document specific to female stress urinary incontinence procedures which use surgical mesh.  This was designed to be provided to potential patients, to ensure that all the potential risks and complications of the procedure would be disclosed, so that the patient could feel they had made an informed decision before proceeding with this treatment option.  It was due to be launched in mid-2019. The Mesh Roundtable was working on several other projects, all with the common objective of creating better patient outcomes – exactly what Mesh Down Under had aimed for with its 2014 petition.

Mesh Down Under co-founders

Mesh Down Under

Mesh Down Under co-founders Charlotte Korte, Carmel Berry and Patricia Sullivan (left to right), accepting the Women of Influence Public Policy Award award on behalf of the hundreds of New Zealanders injured by surgical mesh implants, 18 September 2018.

In 2018 Mesh Down Under was recognised by receiving the Women of Influence Public Policy Award. It also received a Certificate of Achievement at the 2019 New Zealander of the Year Awards.

Carmel Berry

Notes

[1] Mostyn Perspectives, ‘ProteGen: The Grandmother Mesh’, 26 July 2016. Available from: https://mostynperspectives.com/2016/07/26/protegen-grandmother-mesh/

[2] See http://www.meshdownunder.co.nz/survey/

[3] Medsafe, ‘Surgical Mesh for Uro-Genital Report Adverse Event Reports’, November 2008. Available from:

https://www.medsafe.govt.nz/Consumers/devices/UrogynaecologicalSurgicalMeshMedsafeReport2008.pdf

[4] FDA, ‘Urogynecologic Surgical Mesh: Update on the Safety and Effectiveness of Transvaginal Placement for Pelvic Organ Prolapse’, July 2011. Available from: https://www.fda.gov/media/81123/download

[5] For example, Drugwatch picked up news items about this first case, which resulted in US$5.5 million being awarded to the couple concerned. See: https://www.drugwatch.com/news/2012/07/25/california-couple-gets-5-5-million-in-transvaginal-mesh-case/

[6] For example, NZ Herald, One News, and RNZ. See: https://www.nzherald.co.nz/chloe-johnson/news/article.cfm?a_id=721&objectid=10838873

https://www.tvnz.co.nz/one-news/new-zealand/use-of-surgical-mesh-dubbed-an-emerging-health-scandal-6017508

https://www.radionz.co.nz/national/programmes/ninetonoon/audio/201814284/medsafe-responds-to-concerns-over-surgical-mesh

[7] Petition 2011/102 of Carmel Berry and Charlotte Korte: ‘Surgical Mesh in New Zealand: Submission prepared for The New Zealand Health Select Committee by Carmel Berry and Charlotte Korte’, 14 May 2014. Available from:

https://www.parliament.nz/resource/en-NZ/50SCHE_EVI_50DBHOH_PET3197_1_A394422/861343a36cc964e44c2af9f61401375a13b9a2d5

[8] Petition 2011/102 of Carmel Berry and Charlotte Korte: Report of the Health Committee (1 June 2016). Available from:

https://www.parliament.nz/en/pb/sc/reports/document/51DBSCH_SCR69220_1/petition-20110102-of-carmel-berry-and-charlotte-korte

[9] Government Response to Report of the Health Committee on Petition 2011/102 of Carmel Berry and Charlotte Korte, 24 August 2016. Available from: https://www.parliament.nz/en/pb/papers-presented/current-papers/document/51DBHOH_PAP69804_1/government-response-to-report-of-the-health-committee-on

[10] The majority of these claims related to POP and/or SUI repair. See ACC treatment injury claims: Surgical mesh-related claim data from 1 July 2005 to 30 June 2018, 18 October 2018. Available from:

https://www.acc.co.nz/about-us/news-media/latest-news/surgical-mesh-claim-data/

[11] See https://www.cochrane.org/CD012079/MENSTR_transvaginal-mesh-or-grafts-compared-native-tissue-repair-vaginal-prolapse; https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(16)31596-3/fulltext

[12] Medsafe, ‘Surgical Mesh Implants: Regulatory action on surgical mesh products’, 31 January 2018. Available from: https://www.medsafe.govt.nz/hot/alerts/UrogynaecologicaSurgicalMeshImplants.asp

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Posted: 08 Jul 2019

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