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Safety Information

Revised: 7 September 2017

Surgical Mesh Implants

Medsafe continues to monitor adverse event reports relating to the use of surgical mesh implants for the treatment of pelvic organ prolapse, stress incontinence and hernia repair. Concerns have been raised by some regulators about such mesh implanted transvaginally to treat certain conditions. Links to information from other medical device regulators, the Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG) and the UK Royal College of Obstetricians and Gynaecologists (RCOG) are also provided below.

Medsafe continues to review published information on the use of surgical mesh and, to date, the evidence supports the position that surgical mesh is safe when used in accordance with the manufacturers’ instructions by an appropriately trained surgeon. This conclusion is in line with that of other device regulators and professional bodies. Medsafe notes that surgical mesh remains approved for use by medical device regulators globally.

What is surgical mesh?
Medsafe advice to clinicians
Medsafe investigation
Information from College of Obstetricians and Gynaecologists
Information from other medical device regulators
Medsafe surgical mesh implant events report
Reporting adverse events

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What is surgical mesh?

Surgical mesh is a medical device that is used when repairing weakened structures with the aim of providing additional support. It can be absorbable or non-absorbable. Non-absorbable mesh will remain in the body indefinitely so should be considered a permanent implant.

Surgical mesh is in use for urogynaecological surgery including repair of pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Surgery is used to treat pelvic organ prolapse when other non-invasive treatments have been found to be not suitable or have failed. The use of mesh in surgery was introduced in response to the high failure rate of both initial surgery and revision surgery estimated at about 30%1, with the aim of augmenting the surgery and reducing the failure rate.

Surgical mesh is also widely used for hernia repair. The most common hernia corrective procedure in the US relates to inguinal (inner groin) repair.

  1. www.nice.org.uk/guidance/ipg267/documents/surgical-repair-of-vaginal-wall-prolapse-using-mesh-interventional-procedures-consultation

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Medsafe advice to clinicians

In September 2015, Medsafe wrote to all Chief Executive Officers of District Health Boards and private surgical hospitals to advise them of the latest information available at that time about the use of surgical mesh, particularly for urogynaecological applications. A copy of this letter was also sent to the Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG) and the Urological Society of Australia and New Zealand (USANZ).

The key issues were that clinicians should:

A copy of this letter is available for download below:
Medsafe advice to clinicians (PDF 1.4MB, 2 pages)

This advice remains current.

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Medsafe Investigations

In 2008 a review of reports of adverse events relating to urogynaecological surgical mesh implants was conducted by Medsafe. This investigation included a literature review of papers published on this subject.

The report was submitted to the Medical Device Incident Review Committee, an Australian advisory committee with representatives from several Professional Colleges, for review along with a report on the same subject from the Therapeutic Goods Administration Medical Device Incident Review and Investigation System. The committee concluded that the return of symptoms and erosion (into the vagina or rectum) were the most common problems associated with these devices and that there was a need to explain this to the patient in terms of the success rate they could expect. It also noted that training of surgeons was important to the success of this new type of surgery.

A copy of the Medsafe report is available for download from the link below. Note that some information has been removed from the report as permitted by the Official Information Act 1982 in order to protect the privacy of individuals.

Medsafe Surgical Mesh Report - 2008
(PDF 773 KB, 4 pages)

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Information from College of Obstetricians and Gynaecologists

The Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG) trains and accredits obstetricians and gynaecologists in Australia and New Zealand. It has published information on its website regarding the use of urogynaecological surgical mesh implants.

Pelvic Mesh Information
https://www.ranzcog.edu.au/Mesh-Resources

Response to the Health Committee of New Zealand House of Representatives Report on Surgical Mesh
https://www.ranzcog.edu.au/news/Response-to-the-Health-Committee-of-New-Zealand-Ho

Use of mesh for the surgical treatment of vaginal prolapse and urinary
incontinence
https://www.ranzcog.edu.au/news/Use-of-mesh-for-the-surgical-treatment-of-vaginal

Polypropylene vaginal mesh implants for vaginal prolapse
https://www.ranzcog.edu.au/RANZCOG_SITE/media/RANZCOG-MEDIA/Women%27s%20Health/Statement%20and%20guidelines/Clinical-Obstetrics/Polypropylene-vaginal-mesh-implants-for-vaginal-prolapse-(C-Gyn-20)-Review-November-2016.pdf?ext=.pdf

Position statement on midurethral slings
https://www.ranzcog.edu.au/RANZCOG_SITE/media/RANZCOG-MEDIA/Women%27s%20Health/Statement%20and%20guidelines/Clinical%20-%20Gynaecology/Position-statement-on-midurethral-slings-(C-Gyn-32)_1.pdf?ext=.pdf

Mid-urethral tapes for genuine stress incontinence
https://www.ranzcog.edu.au/news/Mid-urethral-tapes-for-genuine-stress-incontinence

The Royal College of Obstetricians and Gynaecologists (RCOG) trains and accredits in the UK. RCOG has published the following regarding the use of vaginal tape and mesh implants:

Mesh resources to assist decision making
https://www.rcog.org.uk/en/guidelines-research-services/patient-safety/mesh/

RCOG and BSUG response to NHS England report
https://www.rcog.org.uk/en/news/rcog-and-bsug-response-to-nhs-england-mesh-report/

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Information from other Medical Device Regulators

Several medical device regulators have published information about urogynaecological surgical mesh implants on their websites. The regulators conclude that the risks of complications are minimised when the product is used by surgeons who have had suitable training. Below are links to this information.

Australian Therapeutic Goods Administration (TGA)

Concerns with urogynaecological surgical mesh implants
https://www.tga.gov.au/behind-news/concerns-urogynaecological-surgical-mesh-implants

Results of review into urogynaecological mesh implants
https://www.tga.gov.au/behind-news/results-review-urogynaecological-surgical-mesh-implants

US Food and Drug Administration (FDA)

Urogynaecological surgical mesh implants https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/UroGynSurgicalMesh/default.htm

Update on the Safety and Effectiveness of transvaginal placement for pelvic organ prolapse (PDF, 244kb) https://www.fda.gov/downloads/MedicalDevices/Safety/AlertsandNotices/UCM262760.pdf

UK Medicines and Healthcare products Regulatory Agency (MHRA)

Final report: Use, safety and efficacy of transvaginal mesh implants in the treatment of stress urinary incontinence and pelvic organ prolapse in women (The final report from the Scottish independent review of the use, safety and efficacy of transvaginal mesh implants) https://www.gov.uk/government/publications/final-report-use-safety-and-efficacy-of-transvaginal-mesh-implants-in-the-treatment-of-stress-urinary-incontinence-and-pelvic-organ-prolapse-in-women

MHRA response to the final report of the Mesh Oversight Group https://www.gov.uk/government/news/mhra-response-to-the-final-report-of-the-mesh-oversight-group

Summary of the evidence on the benefits and risks of vaginal mesh implants (PDF 1158KB, 92 pages)
https://www.gov.uk/government/publications/vaginal-mesh-implants-summary-of-benefits-and-risks

York Health Economics Consortium summaries of the safety/adverse effects of vaginal tapes/slings/meshes for Stress Urinary Incontinence and Prolapse http://www.mhra.gov.uk/home/groups/comms-ic/documents/websiteresources/con205383.pdf

Other Published Information on surgical mesh

Vaginal mesh for pelvic organ prolaps (NHS)
http://www.nhs.uk/conditions/Prolapse-of-the-uterus/Pages/Introduction.aspx

UK NICE guidance on use of mesh to repair uterine prolapse https://www.nice.org.uk/guidance/ipg577/ifp/chapter/What-has-NICE-said

PROSPECT study clinical trial results
http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(16)31596-3/fulltext

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Medsafe surgical mesh implant events report

All adverse event reports relating to the use of surgical mesh implants received by Medsafe are recorded in the Medsafe post-market investigations database and reviewed and included in the on-going monitoring.

A summary table of events reported to Medsafe is available for download below. This information will be updated on a quarterly basis.

Note: This table includes only adverse events reported following the implantation of the mesh device in patients.

Adverse Event Reports Relating to Surgical Mesh Implants - August 2017
(PDF 408 KB, 26 pages)

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Reporting Adverse Events to Medsafe

Information on reporting adverse events to Medsafe is available at http://www.medsafe.govt.nz/regulatory/DevicesNew/9AdverseEvent.asp

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