Published: 31 January 2018
Revised: 28 June 2018
Safety Information
Surgical Mesh Implants
Regulatory action on surgical mesh products
31 January 2018
Medsafe has today announced the outcomes of recent regulatory action on surgical mesh products in New Zealand.
In December 2017, Medsafe used the provisions in the Medicines Act 1981 to request safety information from four suppliers of surgical mesh products in New Zealand.
Section 38 of the Medicines Act 1981 permits the Director-General of Health to request safety information from a supplier should there be reason to believe a medical device is unsafe.
This action followed the Australian TGA (Therapeutic Goods Administration) review of surgical mesh for urogynaecological use, and subsequent regulatory action.
"All four companies contacted have responded and have confirmed that all products removed from the Australian register are no longer supplied in New Zealand,” says Chris James, Group Manager, Medsafe.
This means:
- All surgical mesh products whose sole use is the treatment of pelvic organ prolapse via transvaginal implantation will no longer be supplied
- One product, a single incision mini-sling for the treatment of stress urinary incontinence, is also now no longer supplied in New Zealand.
This action only relates to use of surgical mesh in pelvic organ prolapse via transvaginal implantation and one single type of mesh for stress urinary incontinence. This action does not affect the ongoing supply of surgical mesh products for other uses such as hernia repair or stress urinary incontinence.
For those products where changes to warnings in the Instructions for Use were required to be made by the TGA, companies have advised Medsafe these changes have either been implemented or will be implemented once the wording has been agreed.
Medsafe will be continuing to work with these companies to ensure changes are implemented in New Zealand as soon as possible.
“The section 38 review and restrictions are the strongest action possible under current legislation,” says Mr James.
“As with all medical devices, Medsafe continues to monitor the use of surgical mesh products. Information for surgeons and patients is published on the Medsafe website.
Patients who are considered for surgery, where there is potential for the implantation of surgical mesh products, should be fully informed about the benefits and risks of treatment and informed consent obtained.”
FURTHER INFORMATION:
Medsafe has been informed that the following products are no longer supplied in New Zealand:
Boston Scientific NZ Ltd
Solyx
Uphold Life
(The other products are available with amended Instructions for Use)
Culpan Medical
Restorelle DirectFix Anterior mesh
Restorelle DirectFix Posterior mesh
ALTIS single incision sling
(The other products are available with amended Instructions for Use)
Endotherapeutics NZ Ltd
TOA Sling
TVA Sling
Multi Purpose Sling
BSC Mesh
EndoGYNious
Ophira Minisling
Update on Surgical Mesh Implants used in Urogynaecological surgery
On 28 November 2017 the Therapeutic Goods Administration (TGA) in Australia, published information following its review of surgical mesh implants used in urogynaecological surgery. https://www.tga.gov.au/alert/tga-actions-after-review-urogynaecological-surgical-mesh-implants
Medsafe reviewed the information available relating to the Australian decision and determined there were sufficient grounds to request evidence to support the safety in use of these implants. On 11 December Medsafe used the provisions available under section 38 of the Medicines Act 1981 (the ‘Act’) http://www.legislation.govt.nz/act/public/1981/0118/latest/DLM55446.html and contacted four suppliers of surgical mesh implants used in urogynaecological surgery requesting information relating to the safety in use of products currently notified as being available for use in New Zealand. Under the provisions of the Act the suppliers have 45 days to supply the requested safety information to Medsafe for review.
Preliminary advice from the suppliers contacted is that the any changes to availability of the affected medical device implants required by the TGA (cancellation from the register, limitation of indications for use or route of administration) will also apply to products supplied in New Zealand.
Medsafe advice to clinicians
The relevant professional colleges provide general guidance and specific guidelines on their relevant websites, links to some of which are provided further down this page.
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:
- Consider research material and include it into their assessment and decision-making process with respect to examining and determining treatment options for patients under their care
- Communicate the treatment options with patients and discuss with them the evidence supporting the risks and benefits of the treatment option being proposed, in clear and simple terms to allow the patient to make an informed decision on their treatment.
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.
Ongoing Monitoring
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
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.
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:
- Consider research material and include it into their assessment and decision-making process with respect to examining and determining treatment options for patients under their care
- Communicate the treatment options with patients and discuss with them the evidence supporting the risks and benefits of the treatment option being proposed, in clear and simple terms to allow the patient to make an informed decision on their treatment.
A copy of this letter is available for download below:
Medsafe advice to clinicians
(PDF 1.4MB, 2 pages)
This advice remains current.
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)
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)
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
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)
Reporting Adverse Events to Medsafe
Information on reporting adverse events to Medsafe is available at http://www.medsafe.govt.nz/regulatory/DevicesNew/9AdverseEvent.asp
