New Zealand & Mesh Implant Changes

This morning I received wonderful news from two women who have worked very hard to change things in their country’s Government for a few years. We all know that nothing changes overnight and not always the way we want it to, so these two badly injured women kept on trying. They used their voices and their faces to put this in the forefront of women’s health issues in New Zealand. This is what she said in her email.

“It’s a long time since I have been able to stay up late at night (my time) and say hello and thank you to you for all your hard work, published literature and also the support you have given us in New Zealand.

Our government have just announced a probable law change!!!   So exciting, but of course it will require much debate and consultation.  They hope to have the whole Medicines Act ( 1981) re-written, repealed, updated and include regulation for therapeutic products including tissue replacement therapies.

Without your help and input our petition would have never made it past the first step.  This has ended up being a much bigger systemic problem that is now (hopefully) being addressed in entirety, not just about surgical mesh – but our entire regulatory system!!  That is hopeful news.

The decisions in the papers on the link above set the direction for the new regulatory regime and form the basis of drafting instructions for the new legislation, which will replace the Medicines Act 1981 and its Regulations.”

Thank YOU!!

I clicked on the link and began reading it. They are doing amazing work and seem to be getting through to their government and making changes, far beyond just mesh implants. Now read the first part from that link.

Therapeutic products regulatory regime Published April 2016

The New Zealand Government is working on a new and comprehensive regulatory regime to regulate therapeutic products in New Zealand, which will replace the Medicines Act 1981 and its Regulations.

Therapeutic product is an umbrella term for products that are intended to be used in or on human beings for a therapeutic purpose. Examples of therapeutic purposes include bringing about a physiological response to prevent, diagnose, monitor, alleviate, treat, or cure a disease, ailment, defect, or injury.

Therapeutic products can present serious risks of harm, especially if used inappropriately. Assuring that the benefits of therapeutic products outweigh possible risks of harm to consumers is fundamental to the delivery of high quality health and disability support services.

The Government is currently developing a new therapeutic products regulatory regime. This follows the cessation of the Australia New Zealand Therapeutic Products Agency (ANZTPA) project. The intention is for a Bill to be introduced to Parliament in 2016.

As well as replacing and odernizing the regulatory arrangements for medicines, the regime will provide regulation of all therapeutic products. This includes medical devices and cell and tissue therapies which are currently not fully regulated in New Zealand. Here is the link to read it all. http://www.health.govt.nz/our-work/regulation-health-and-disability-system/therapeutic-products-regulatory-regime

These two women have been working for a few years and now you can read articles and watch them tell their stories to the media, by video.

This is a petition from 2011. http://www.parliament.nz/en-nz/pb/presented/petitions/50DBHOH_PET3197_1/petition-of-carmel-berry-and-charlotte-korte-that-the

This is a story about the government backing of implants, published in October 2012 http://www.nzherald.co.nz/nz/news/article.cfm?c_id=1&objectid=10838873

This is another Story about what these women were trying to do, published in July 2014 http://papertrail.co.nz/surgical-mesh-taken-to-parliament/

This is a video of these women about what had happened to them and why they wanted change. It was published in March 2014 http://www.newshub.co.nz/nznews/mesh-sufferers-petition-govt-for-inquiry-2014032416#axzz47bKF8nJP

Another story published in May 2014 http://accfocus.org/health/item/3916-mesh-blamed-for-agony-still-used-in-ops.html

Another article published in July 2014 http://www.odt.co.nz/news/dunedin/307848/group-push-surgical-mesh-inquiry

This is all about the recommendations for change, published in October 2014 http://www.womens-health.org.nz/surgical-mesh-update/

This is a story about their hard work, published in 2015 http://www.stuff.co.nz/national/politics/68907049/Calls-for-parliamentary-inquiry-into-use-of-surgical-mesh

This video you can see how both women tell their story of suffering, just before going before their parliament http://tvnz.co.nz/breakfast-news/hundreds-affected-improper-removal-surgical-mesh-video-6016826

I also searched and found a submission to the following surgical organization.

ROYAL AUSTRALASIAN COLLEGE OF SURGEONS SUBMISSION TO THE HEALTH SELECT COMMITTEE ON THE PETITION 2011 / 102 CARMEL BERRY AND CHARLOTTE KORTE REGARDING SURGICAL MESH

MAY 2015

Introduction

The Royal Australasian College of Surgeons (the College) is the leading advocate for surgical standards, professionalism and surgical education in New Zealand and Australia.

Surgical mesh is a broad term encompassing a variety of surgical implants used in the repair of structural defects, usually occurring as a consequence of defective supporting fascial or fibrous tissue. While the mesh may be constructed from a range of absorbable or non-absorbable materials, either harvested from biological materials or by synthetic manufacture, most concern appears to be related to the use of synthetic non-absorbable meshes constructed of polypropylene, polyester or polytetrafluoroethylene (PTFE).

Biological meshes have been produced as an alternative to synthetic mesh. Biological absorbable meshes have limited data available, have durability issues, significant complication rates and are very expensive. Even when used in the presence of a contaminated field their efficacy is questionable. The use of biological meshes for abdominal wall hernia repair was the subject of an evidence-based report produced by ACC in July 2013. Biologic mesh consists of an extracellular collagen matrix and the commercially available ones are derived from human and porcine dermis, small intestinal mucosa and bovine pericardium. The rate of hernia recurrence after the use of biological mesh appears to be similar to that of synthetic mesh but the research evidence for the use of biological mesh is sparse.1 Biological mesh is more expensive than synthetic mesh and there are concerns relating to disease transmission by biological materials.

Further comment on surgical mesh in this submission is limited to the synthetic non-absorbable meshes.

Synthetic non-absorbable surgical meshes have been widely used by General Surgeons, Pediatric Surgeons, Urologists, and Plastic and Reconstructive Surgeons for more than thirty years in the repair of hernias (cavity wall defects) involving the abdomen and chest. When mesh reinforcement is required to repair a hernia of the groin or abdominal wall, a synthetic nonabsorbable mesh is the standard of care. The use of surgical mesh in these situations has been associated with a lower risk of hernia recurrence than where techniques without mesh have been employed. There has been no increase in other symptoms such as local discomfort by the use of these meshes. Meshes have also been used (but less commonly) in complex breast reconstruction surgery. While the use of any artificial or synthetic implant is associated with a slightly greater risk of infection, the overall benefits arising through the use of mesh in these clinical situations have been confirmed through its extensive use over many years.

Given the successful use of surgical mesh in the repair of cavity wall defects the indications for its use have been extended into other areas of surgery. Its use in surgery for female urinary stress incontinence has been associated with a number of complications and concerns in respect to this specific use have triggered the Health Select Committee investigation. It is also used in procedures such as abdominosacrocolpopexy and rectopexy to correct vaginal or rectal prolapse. While these procedures have permitted sometimes difficult conditions to be better managed, resulting in improved comfort for most patients, there has been a higher incidence of local complications including discomfort and implant extrusion.

Informed Consent and the Use of Surgical Mesh

Patients should be well informed of the risks outlined above (along with other significant risks attributable to the planned surgery and anaesthetic) as part of the consent process as they consider whether surgery is the best option in their situation.

There is an expectation that patients will be provided with a general overview of the benefits and the risks of the potential care options available to them. Surgeons should assist patients in their selection of the form of treatment most appropriate to their particular situation. Where any form of surgery is planned information should be provided to the patient in respect to the anticipated benefits of the intervention along with the potential risks associated with the procedure. The need to substitute foreign materials to replace or augment a patient’s natural tissues during any operation should be discussed in general terms (and there might, in some situations, be the need to discuss the specific structure or technology of the proposed implant). Discussion is expected to be more specific where the proposed procedure is more controversial or of higher risk.

When consenting a patient for hernia repair the risk/benefit of non-operative management must be also discussed. The consequences of non-operative management may be ongoing pain, bowel obstruction, intestinal strangulation and even death.

To read more you can find this on the following site.

https://www.surgeons.org/.

If you are living in New Zealand and want to learn about what mesh does in a woman’s body, you can learn more by visiting their website. http://www.meshdownunder.co.nz/

This is their Facebook page https://www.facebook.com/MeshDownUnder/

Congratulations ladies and I am happy you are now reaping the rewards of all your hard work.

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