Surgical Mesh

Surgical mesh is used to repair pelvic organ prolapse (the descent of the pelvic organs into or through the vagina) and to treat stress urinary incontinence (the leakage of urine during moments of physical activity) in women. Surgical mesh is also used for colorectal and hernia repairs,in breast reconstruction surgeries and to repair weakened or damaged tissue.

In Aotearoa New Zealand and internationally, significant numbers of women and men have experienced complications ranging from moderate discomfort to disabling pain and severe tissue damage as a result of surgical mesh implants.

Note: Click here  to read all the latest updates on surgical mesh in Aotearoa

What is surgical mesh?

Surgical mesh is a medical device made from porous absorbable or non-absorbable synthetic material or absorbable biologic material. It is designed to become incorporated with the body’s natural tissue. Surgical mesh was first developed in the 1950s for hernia repair, but in the 1990s it was adapted and promoted by many gynaecologists within Europe and later the USA to use in gynaecological procedures.

How is it used in gynaecological surgeries?

In urogynaecological procedures, surgical mesh is permanently implanted to reinforce the weakened vaginal wall, to repair pelvic organ prolapse or to support the urethra to treat urinary incontinence. Pelvic organ prolapse occurs when the pelvic muscles weaken, causing the uterus and/or bladder and/or rectum to bulge into the vagina or protrude out of the vagina. Urinary incontinence is the uncontrolled leaking of urine, usually due to issues with the muscles and nerves which regulate the flow of urine. Women of all ages may be affected by pelvic organ prolapse and urinary incontinence, however pregnancy, childbirth, and menopause can also contribute.[1]

Why is surgical mesh a cause for concern?

The adaptation of surgical mesh to gynaecological and colorectal surgeries is not well supported by research or clinical trials. There are ongoing reports of significant complications including buttock pain, vaginal erosion, bladder erosion and serious infection.

There has also been a marked increase in autoimmune issues and there are concerns within the medical community that this rise may potentially be attributable to mesh complications.

Worldwide lawsuits being brought against manufacturers relating to mesh related treatment injuries, including in the US, the UK and Australia now number in the thousands[2], prompting warnings by the US Food and Drug Administration (FDA).

 FDA warnings

By 2008, prompted by increasing numbers of reports of complications, the FDA began issuing safety warnings regarding the use of transvaginal surgical mesh. These warnings have continued and in 2011 the FDA stated it had serious concerns over the use of mesh for the treatment of vaginal prolapse and incontinence,[3] noting that existing studies supporting its use were poorly designed and documented, and research timeframes too short to establish clear proof of its effectiveness. Post-surgical mesh complications recorded include erosion, extrusion of mesh through tissue and organs, infections, severe pain, dyspareunia, urinary problems, recurrence and/or incontinence, bowel, bladder and blood vessel perforation during insertion and punendal neuralgia. The FDA has reported that neuromuscular problems, vaginal scarring, contraction of the mesh implant (shrinking), and deaths have been directly related to mesh replacement and now encourage health care providers to recognise “that in most cases, POP [pelvic organ prolapse] can be treated successfully without mesh, thus avoiding the risk of mesh-related complications.”[4] Worldwide cases related to treatment injuries from mesh, including in the US, the UK and Australia now number in the thousands[5].

In early May 2014, the U.S. Food and Drug Administration issued two proposed orders to address the “health risks associated with surgical mesh used for transvaginal repair of pelvic organ prolapse (POP). The orders would reclassify surgical mesh for transvaginal POP from a moderate-risk device (class II) to a high-risk device (class III) and require manufacturers to submit a pre-market approval (PMA) application for the agency to evaluate safety and effectiveness”[6].

 Investigations in the UK

As a result of consumer pressure both England and Scotland have launched investigations into the use of surgical mesh. As a result of the Scottish Surgical Mesh Interim Report the Cabinet Secretary and the Chief Health Officer made a public apology to all mesh victims. The findings of the report validate concerns about the use of these products. The Scottish Cabinet Secretary has stated that the suspension will stay in place until she is satisfied that all of the recommendations have been implemented or met.

Video link to the live stream broadcast of the Scottish Health Select Committee meeting that was held on the 6th of October. http://www.scottishparliament.tv/search.aspx?keywordSearch=Public+Petitions+Committee+-+Scottish+Parliament%3A+6th+October+2015&initialLoad=1&x=-1190&y=-233

 Mesh Injuries in Aotearoa New Zealand

In Aotearoa New Zealand hundreds of individuals have had their injury claims accepted by ACC. One of the most concerning issues is that these devices are a permanent implant, designed to become incorporated within the body’s natural tissue. Therefore, when the surgery is not successful or complications result, it may not always be possible to remove the mesh, or removal may require multiple surgeries.[7].

Currently there are very few surgeons in Aotearoa New Zealand who have the surgical skills to be able to complete complicated removal procedures and in many cases it is impossible to fully excise all the mesh.

In a 2014 petition to the Health Select Committee, campaigners for an independent inquiry into the use of mesh Carmel Berry and Charlotte Korte asked for surgeons to be upskilled to ensure any future patients and patients with existing complications. Berry and Korte have also highlighted the need for true informed consent procedures to be established so that patients truly understand the permanent nature of these devices and of the difficulties they may face if complications arise.

 Medical device approval process

Medsafe, who are responsible for the regulation of medical devices in New Zealand, are limited in their regulatory ability which means they are only able to monitor what comes on to the market in New Zealand. This means they are reliant on overseas regulators such as the FDA or European Union. Unfortunately, this enables the release of some categories of devices onto the market such as surgical mesh, that have been approved for use by the FDA, the European Union or a similar body and marketed without having to undergo clinical trials.[8] In Aotearoa New Zealand, surgical mesh kits are currently registered as a Class II B devices, which means there is no requirement for this type of medical device to be approved by any overseas medical device regulator before they can be supplied in New Zealand[9].

Medsafe has maintained mesh is safe and the problems experienced were not with the product, and that issues only occurred when mesh was incorrectly used.Medsafe has noted that that, “Surgical mesh products available in New Zealand are manufactured overseas and have met requirements set by reputable regulators in countries with pre-market assessment systems” [10].

It is important that information about the effectiveness of medical devices is based on robust clinical trials or approval processes to ensure the safety of health care consumers. The flaws in relying on overseas approval are highlighted by the investigation by Oxford University academics into the medical device approval process of the European Union. This investigation resulted in the mesh from a supermarket grocery bag gaining approval as a medical device: http://www.womens-health.org.nz/fruit-netting-approved-as-surgical-implant/

 The current use of surgical mesh and consumer rights issues

While the extent of harms and complications from the use of mesh, particularly in gynaecological surgery, continue to be debated, there are significant consumer protection issues that need to be addressed including ensuring robust and specific informed consent processes about the risks involved and the alternatives available in mesh surgeries. Medical device approval, product monitoring and information about treatment injuries and outcomes are also important. Other jurisdictions such as Scotland and England have set up consumer hotlines and support groups: http://www.scottishmeshsurvivors.com/

Informed Consent

Informed consent is a process involving good communication, the exchange of relevant information between the health consumer or patient and the health professional, which enables the consumer to make an informed and unpressured decision about their health care.

In the case of surgical mesh, it should involve a discussion of the medical condition, an explanation of the proposed procedure and its risks, who will carry out the procedure, an assessment as to how effective the product will be, what could happen if the procedure is not carried out, and other options available. Meshdownunder, the New Zealand consumer support organisation, has reported recent and frequent cases of patients who were not informed about the complications of mesh prior to surgery. Patients have also reported that they are often not given alternative, non-mesh surgical options.

Training and monitoring of standards and informed consent

The Royal College of Obstetricians and Gynaecologists UK argues stricter governance needs to be employed for anyone who undertakes mesh repairs. They argue that mesh surgery should only be carried out under carefully controlled circumstances, ideally under trial conditions. They state that these procedures should only be carried out by gynaecologists with special expertise in the surgical management of pelvic organ prolapse[11].

Similarly, the Royal Australian and New Zealand College of Obstetricians and Gynaecologists acknowledge FDA warnings about mesh, while continuing to support its use, suggesting post-operative care, rather than the mesh itself, may be the cause of complications[12]. Information published by the College emphasises the importance of specialist training for operating surgeons, informed consent including discussion of alternatives, and for surgeons to be up-to-date on the latest practice literature and potential complications.

Currently, surgeons’ experience and qualifications in regards to mesh are not publicly available to health consumers in Aotearoa New Zealand.

 Interagency co-operation

The use of these types of medical devices in Aotearoa New Zealand is not specifically monitored and neither the number of successful procedures nor the number of adverse outcomes is known. Mesh is used in a variety of surgeries for variable complaints by an unknown number of health care providers. Consumers who have suffered treatment injuries include men and women and a range of age groups, in one case as young as 18[13]. There is currently a lack of information about whether the location of the surgery, the severity of the complaint, the type of procedure used to insert the mesh, the type of mesh or mesh kit used, the brand of mesh used or the clinicians involved contributed to treatment injuries in Aotearoa New Zealand.

In addition, there is no central or consistent monitoring of the use of surgical mesh, communication between Medsafe, ACC, the Health and Disability Commission, and the College of Obstetricians and Gynaecologists regarding adverse events is not mandatory, and the definitions of what is an adverse event is, is not consistent across the organisations.

Mesh petition and the Health Select Committee

In 2014 Carmel Berry and Charlotte Korte petitioned the NZ Health about the use of mesh. The petition can be read here

The Health Select Committee responded with their recommendations in June 2016. The report can be read here

 Women’s Health Action recommendations:

Women’s Health Action appeared before the Health Select Committee on Wednesday the 3rd of July 2014.

Our recommendations were:

  • Medsafe must provide evidence of testing and evidence based peer-reviewed research that establishes these products’ safety, particularly in urogynaecological and colorectal surgery, or should consider withdrawing mesh products from the market until better evidence about their safety is provided and monitoring systems are in place.
  • A register of all Aotearoa New Zealand mesh surgeries must be established to monitor the short and long term outcomes of each use of surgical mesh.
  • ACC must conduct an independent audit of all mesh related claims and the way in which ACC has defined “treatment injury” in this context, and to report all existing and future claims to Medsafe as adverse events.
  • The Medical Council and the Royal College of Obstetricians and Gynaecologists must ensure the qualifications and experience required of surgeons using mesh are made clear to the public via a specialist registry. In addition, surgeons should be required to use a specific informed consent process and assessment procedures.
  • The Health Quality and Safety Commission must ensure all relevant agencies (ACC, the office of the Health and Disability Commissioner, Health Quality and Safety Commission and Medsafe) share information about treatment injuries and adverse events.
  • An independent examination of Medsafe’s process for approving and classifying medical devices should be undertaken. In particular, whether Medsafe’s approval procedures for medical devices in Aotearoa New Zealand should ever rely solely on overseas evidence.
  • Read Women’s Health Actions report to the Health Select Committee: http://www.womens-health.org.nz/wp-content/uploads/2016/04/20140514-Surgical-Mesh-submission-final-V2-.pdf

 Before Undergoing Mesh Surgery

While there are many instances where surgical mesh is used successfully in gynaecological and colorectal surgeries, Women’s Health Action have become increasingly concerned about problems with its use and control. For this reason, we suggest anyone considering mesh surgery seek more information and ensure that your health professionals have discussed both the benefits and risks of mesh, have undertaken a proper process of informed consent with you, and that your surgeon is suitable qualified and trained in mesh surgery.

Support and more information

Meshdownunder

A support, information and consumer lobby group which raises awareness amongst New Zealanders about complications with the use of surgical mesh and provides information to enable anyone considering having surgical mesh surgery, particularly women having pelvic floor or bladder sling repairs, to be fully informed before consenting to this surgery: http://meshdownunder.co.nz/

FDA Safety Communication about mesh

Latest Cochrane reviews

http://www.cochranelibrary.com/editorial/10.1002/14651858.ED000108 [1]

http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD012079/abstract [2]

Boston Scientific case USA

Boston Scientific Corporation in the USA has been accused of purchasing Chinese resin (which was not fit for human implantation) to use in their surgical mesh devices. The FDA is currently investigating these allegations. They FDA have requested that Boston Scientific test the resin themselves to see if the resin they obtained from China is substandard. The descision to not provide independent testing has drawn criticism.

More information:

http://www.massdevice.com/boston-scientific-smuggled-counterfeit-resin-for-pelvic-mesh-racketeering-lawsuit-alleges/

http://meshmedicaldevicenewsdesk.com/judges-order-to-boston-sci-do-not-destroy-chinese-pelvic-mesh-docs

http://www.plasticstoday.com/articles/boston-scientific-used-counterfeit-resin-chinese-supplier-make-vaginal-meshes-alleges-lawsuit-160115

Essure case USA

http://essureprocedure.net/

For information and support contact: Angie Firmalino at the Australian and New Zealand support group or Amanda Dykeman

Newspaper reports:

http://www.cambstimes.co.uk/news/mesh_slings_used_in_hospitals_across_the_region_are_a_bigger_health_scandal_than_thalidomide_says_leading_politician_1_4788167

http://www.smh.com.au/federal-politics/political-news/weve-lost-so-much-senate-urged-to-act-on-failures-over-mesh-device-implants-20160413-go5obe.html

http://www.theherald.com.au/story/3778936/women-pay-the-price-for-a-most-private-medical-disaster/

ACC Case study

European Association of Urogynaecology speaking about the problem with meshes

References

1. Mayo Clinic. 2014. ‘Uterine Prolapse’ http://www.mayoclinic.org/diseases-conditions/uterine-prolapse/basics/definition/con-20027708

Mayo Clinic. 2014. ‘Posterior prolapse (rectocele)’ http://www.mayoclinic.org/diseases-conditions/rectocele/basics/definition/con-20027826

Mayo Clinic. 2014. ‘Anterior prolapse (cystocele)’ http://www.mayoclinic.org/diseases-conditions/cystocele/basics/definition/con-20026175

Mayo Clinic. 2014. ‘Urinary Incontinence’ http://www.mayoclinic.org/diseases-conditions/urinary-incontinence/basics/definition/con-20037883

Office on Women’s Health. 2012. ‘Urinary Incontinence Fact Sheet’. https://www.womenshealth.gov/publications/our-publications/fact-sheet/urinary-incontinence.html

2. For example: About 20,000 lawsuits filed against mesh manufacturer American Medical Systems Inc. settled for about $830 million, according to a news release from Endo Health Solutions, which bought AMS in 2011. http://www.wvgazette.com/article/20140501/GZ01/140509972#sthash.le3JokzO.dpuf

3. FDA 2011 Urogynecologic Surgical Mesh: Update on the Safety and Effectiveness of Transvaginal Placement for Pelvic Organ Prolapse.

4. FDA 2011 Urogynecologic Surgical Mesh: Update on the Safety and Effectiveness of Transvaginal Placement for Pelvic Organ Prolapse.

5. For example: About 20,000 lawsuits filed against mesh manufacturer American Medical Systems Inc. settled for about $830 million, according to a news release from Endo Health Solutions, which bought AMS in 2011. http://www.wvgazette.com/article/20140501/GZ01/140509972#sthash.le3JokzO.dpuf

6. See appendix 3 for full text

7. Nygaard I, Brubaker L, Zyczynski HM, et al. Long-term Outcomes Following Abdominal Sacrocolpopexy for Pelvic Organ Prolapse. JAMA. 2013;309(19):2016-2024.

8. http://nationalwomenshealth.adhb.govt.nz/language/en-nz/health-professionals/general.

9. NZ Medicines Act 1981

10. Letter to Women’s Health Action from Minister Tony Ryall.

 11. RANZCOG College Statement: C-Gyn 20

12. http://www.nzherald.co.nz/nz/news/article.cfm?c_id=1&objectid=10841865

13. http://www.nzherald.co.nz/nz/news/article.cfm?c_id=1&objectid=10843419