Medical Devices

Revised: 7 August 2018

Surgical Mesh Implants

Information for Healthcare Professionals


The relevant professional colleges provide general guidance and specific guidelines on their websites, links to some of which are provided further down this page.

Guidance from Medsafe


On 11 May 2018, the Director-General of Health wrote to all Chief Executive Officers of District Health Boards and private surgical hospitals to remind them that surgical mesh remains an important clinical issue, to update them on recent developments and to describe actions to be taken in response to the information provided in the letter. Medsafe advice to professional colleges (PDF 754 KB, 2 pages)

On 11 December 2017 Medsafe provided the professional colleges with information about our regulatory request for safety information. Surgeons planning surgery using urogynaecological mesh implants should contact the company supplying the specific implant required to determine availability.
Medsafe advice to professional colleges (PDF 2 MB, 4 pages)

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)

While some of the links provided in this letter are no longer available or have been updated, the general advice provided remains current.

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/

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)

TGA actions after review into urogynaecological surgical mesh implants https://www.tga.gov.au/alert/tga-actions-after-review-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

Other Published Information on surgical mesh

Pause on the use of vaginally inserted surgical mesh for stress urinary incontinence https://www.gov.uk/government/news/pause-on-the-use-of-vaginally-inserted-surgical-mesh-for-stress-urinary-incontinence

Vaginal mesh for pelvic organ prolapse (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