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Safety Information

Revised: 7 February 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/or hernia repair. Some medical device regulators have raised concerns about such mesh implanted transvaginally to treat certain conditions. Medsafe has investigated surgical mesh and concluded that it 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 2008
Information from the College of Obstetricians & Gynaecologists
Information from overseas medical device regulators
Medsafe surgical mesh implant events report
Reporting adverse events to Medsafe

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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 uro-gynaecological surgery including repair of pelvic organ prolapse and stress urinary incontinence. 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 amounting to 800,000 cases out of a total of one million annually. By 2000, more than 90% of all groin hernia repairs in the US utilised surgical mesh.

  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 Australia and New Zealand College of Obstetricians and Gynaecologists (RANZCOG) and the Urological Society of Australia and New Zealand (USANZ)

The key issues were clinicians should:

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

Medsafe Investigation 2008

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 Australia and New Zealand College of Obstetricians and Gynaecologists trains and accredits obstetricians and gynaecologists in Australia and New Zealand. RANZCOG has published the following regarding the use of urogynaecological surgical mesh implants.

Use of Mesh in Gynaecological Surgery (PDF 116 KB, 4 pages)

Media statement - More research needed into effectiveness of pelvic prolapse treatments

Use of mid-urethral slings in the surgical management of female stress urinary incontinence

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

Scientific Impact Paper on the Use of Mesh in Gynaecological Surgery

RCOG Statement on report commissioned by MHRA on vaginal tape and mesh implants

Information from other Medical Device Regulators

Several medical device regulators have published information about urogynaecological surgical mesh implants on their websites. No recall actions have been undertaken and 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)

Results of review into urogynaecological surgical mesh implants

US Food and Drug Administration (FDA)

Urogynaecological surgical mesh implants

FDA Safety Communication: Update on Serious complications associated with transvaginal placement of surgical mesh for pelvic organ prolapse

Update on the Safety and Effectiveness of transvaginal placement for pelvic organ prolapse
(PDF 244 KB, 15 pages)

UK Medicines and Healthcare products Regulatory Agency (MHRA)

Summary of the evidence on the benefits and risks of vaginal mesh implants
(PDF 1158 KB, 92 pages)

Vaginal mesh for pelvic organ prolapse

York Health Economics Consortium summaries of the safety/adverse effects of vaginal tapes/slings/meshes for Stress Urinary Incontinence and Prolapse
(PDF 545 KB, 72 pages)

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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, reviewed and included in ongoing 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 - December 2016
(PDF 391 KB, 25 pages)

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Reporting Adverse Events to Medsafe

Healthcare professionals, patients, and carers lodging adverse event reports with Medsafe should use the joint Medsafe-TGA \ adverse event reporting form.

Medsafe-TGA medical device adverse event reporting form
(Word 106 KB, 2 pages)

Completed adverse event report forms may be submitted to Medsafe by any of the following ways:

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