Apology for Mesh?
The latest news in the surgical mesh saga is that there may be an official apology to those New Zealanders whose lives have been damaged – in many cases devastated and ruined – by surgical mesh.
On the 10th of October, the Australian Health Minister, Greg Hunt, issued a national apology to the many Australian women whose lives have been ruined by the debilitating effects of pelvic mesh implants. Only days later on the 15th of October, it was reported here in New Zealand that James Shaw, Acting Associate Health Minister had said that "I expect to get advice back about what would be the most meaningful and sincere way for the [NZ] Government to apologise."
The moves to apologise in each country came on the heels of a series of scathing reports on surgical mesh published in the British Medical Journal, saying that mesh manufacturers "aggressively hustled" the products into circulation and that regulators approved them on "the flimsiest of evidence, and that conflicts of interest have been ubiquitous since the product's inception in 1998."
While an apology would be great - especially if the New Zealanders damaged by mesh don't have to wait 30 years to get it – what we really need is change.
Mesh procedures need to be halted!
We also need a registry of all those affected by mesh. And, as much as we need those things, we need for our system to change: for there to be better licensing and approval procedures in New Zealand for devices and medicines – to not just rely on approvals in the UK or the US; for there to be better oversight of the safety of new medical treatments; for our agencies to be more responsive to the harms caused; for GPs, physicians and surgeons to be more open to reports of harm, to listen to what patients have to say. What we really, really need is for this to not happen again with the next "big thing" that comes along.
The Ministry of Health commissioned a cost:benefit analysis of a clinical quality register (CQR) designed to continually monitor and improve surgical outcomes, resulting in lower treatment cost, mortality and morbidity. The report was released on the 24th of September 2018 and “provides an analysis of the number and cost of mesh surgery, the cost of the burden of disease, the costs and benefits of clinical registries generally, and an estimated benefit-cost ratio for a surgical mesh registry in New Zealand. It responds to the Health Committee’s report, presented to Parliament in June 2016, which recommended that the Government investigate options for establishing and maintaining a centralised surgical mesh registry.”
“The cost of establishing and maintaining a full registry is estimated at $15 million over 10 years. With a potential return of $45 million in benefits from improvements in surgical quality estimated over the same time period, this gives a benefit-cost ratio of approximately 3:1.”*
However, the MoH goes on to say that “the 3:1 figure takes into account all surgical mesh usage. Around 80 percent of the information gathered and held in a full registry would relate to hernia repair procedures which are considered lower-risk compared to certain urogynaecological procedures (namely, pelvic organ prolapse [POP] and stress urinary incontinence [SUI]).”
The report also estimates a register to take two years to design and implement and up to five years to return usable and actionable data.
Of course, just like requests for a full suspension of mesh procedures, a mesh registry is not being rushed into by the MoH. They say that it is still under consideration, but in the meantime they have asked DHBs to hold and maintain local registers to collect information on surgeries involving surgical mesh. They say this will “support the ability to identify those most at-risk, follow up with patients as needed and ensure robust informed consent processes are being followed.”
The problem with this is that, as we go to press, the quality of the materials and information provided to patients about surgical mesh procedures, especially the risks and potential for serious injury as a result, remain poor, and improved patient materials are still under development. This also doesn’t impact upon the procedures that are carried out in private practice, which are estimated to be 60% of all mesh procedures in New Zealand.
After canvasing the people in their support group regarding what would help to make an apology meaningful, Mesh Down Under (MDU) have formally written to Prime Minister Jacinda Ardern to ask her personally to make the apology. MDU says that people affected by mesh are upset that Ms Ardern has not commented publicly on this issue since becoming the Prime Minister. The majority saw the apology being made by the Prime Minister as extremely important, particularly given the severity and significant impact mesh complications have had. Charlotte Korte says that MDU are hoping that along with an apology, the Government articulates precisely what they will do to address the many issues relating to the mesh debacle.
In addition, MDU have asked to meet with James Shaw to discuss this and other concerns regarding the mesh issue. They met with the MOH regarding the review that the MOH is going to undertake of mesh injured new Zealanders and have requested that both men and women be included in the apology and the review.
Sophie Scott and Alison Branley, 10 October 2018: Mesh implants: Government issues national apology over 'agony and pain' caused by device, ABC Australia, accessed at https://mobile.abc.net.au/news/2018-10-10/mesh-implants-government-issues-apology-to-women/10355546?pfmredir=sm
Aine Kelly-Costello, 15 October 2018: Advocates thankful apology for surgical mesh victims coming, Newshub, accessed at https://www.newshub.co.nz/home/new-zealand/2018/10/advocates-thankful-apology-for-surgical-mesh-victims-coming.html
Gornall J. (2018): How mesh became a four letter word, BMJ; 2018 Oct 10; 363:k4137.
Gornall J. (2018): The trial that launched millions of mesh implant procedures: did money compromise the outcome? BMJ; 2018 Oct 10;363:k4155.
Gornall J. (2018): Vaginal mesh implants: putting the relations between UK doctors and industry in plain sight, BMJ; 2018 Oct 10;363:k4164.
Heneghan C, Godlee F. (2018): Surgical mesh and patient safety, BMJ; 2018 Oct 10;363:k4231.
Mesh Down Under, 21 August 2018, Shaw considering a surgical mesh suspension in NZ, Press Release, accessed at http://www.scoop.co.nz/stories/PO1808/S00293/shaw-considering-a-surgical-mesh-suspension-in-nz.htm
Deloitte Access Economics (2018): Surgical Mesh Registry: Cost Benefit Analysis, Ministry of Health, July 2018.