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Consumer Resources

The following information has been sourced from The Australian Government Department of Health and Aged Care (DoHAC), Australian Commission on Safety and Quality in Health Care (ACSQHC), Therapeutic Goods Administration (TGA), International Urogynaecological Association (IUGA),  Urogynaecological Society of Australasia (UGSA), Urological Society of Australia and New Zealand (USANZ), Royal Australian and New Zealand College of Obstetrics and Gynaecology (RANZCOG), Ministry of New Zealand, Continence Foundation of Australia, National Institute of Health and Care Excellence (NICE), and the British Society of Urogynaecology (BSUG).

Questions to ask your surgeon and credentialing

What is Credentialing?

Credentialing: A process used by health service organisations to verify the qualifications and experience of a medical practitioner or other clinician to determine their ability to provide safe, high quality health care services within a specific health care setting and role.

Credentialing has the potential to improve safety for patients by ensuring clinicians practice within the bounds of their training and competency, and within the capacity of the service in which they are working.

Credentialing is part of a wider organisational quality and risk-management system designed primarily to protect patients.

Each hospital is responsible for credentialing surgeons.
Reference: https://www.safetyandquality.gov.au/our-work/clinical-governance/credentialing-clinicians

The Australian Commission on Safety and Quality in Health Care (ACSQHC) has developed credentialing guidance for practitioners who perform procedures using pelvic mesh. This discusses the appropriate training and credentialing of clinicians who implant and remove mesh for treatment of SUI, POP. These are presented in the section ‘Resources for Clinicians’.


Questions to ask your surgeon

1. Questions sourced from Treatment Options for Stress Urinary Incontinence (SUI) | Australian Commission on Safety and Quality in Health Care (pg 8)

  • What are the chances that my incontinence will worsen if I don’t do anything?
  • What non-surgical options are there to treat my incontinence?
  • Will I be able to improve my incontinence by doing pelvic floor exercises and using a pessary?
  • What are the benefits and problems of using a pessary?
  • What are the surgical options for incontinence?
    What are the risks and benefits of these options for me?
  • Are you planning to use synthetic mesh in my surgery?
  • If you are considering a single incision mini-sling for my surgery, have you obtained the necessary approvals from the hospital where my surgery will be done and the TGA, and what are the risks?
  • Are you credentialed by the hospital where my surgery will be done to use mesh for treatment of SUI?
  • Do you receive payments or other benefits from the manufacture, distribution or implanting of synthetic mesh products?
  • If I develop a complication, will you be able to treat me, or will you refer me to another specialist?
  • What can I expect to feel after surgery? What specific symptoms should I report to you after the surgery?
  • Based on your experience, how long will I have pain after surgery?
  • Could I please have a copy of the synthetic mesh product information and the product number at the time of the surgery? (This will help in any future treatment of your incontinence.)
  • Who will perform all, or parts, of my surgery?
  • Will there be any people from the mesh company in the operating theatre during my procedure?
  • If I develop a complication a long time after the surgery, what should I do?

2. Questions sourced from Treatment Options for Pelvic Organ Prolapse (POP) | Australian Commission on Safety and Quality in Health Care (pg 6)

  • What are the chances that the prolapse will worsen if I don’t do anything?
  • What non-surgical options are there to treat my prolapse?
  • Will I be able to improve my prolapse by doing pelvic floor exercises and using a pessary?
  • What are the benefits and problems of using a pessary?
  • What are the surgical options for my prolapse? What are the risks and benefits of these options for me?
  • Are you planning to use synthetic mesh in my surgery?
  • If you are considering transvaginal mesh, have you obtained the necessary approvals from the hospital where my surgery will be done and the TGA, and what are the risks?
  • What are the potential risks of this treatment?
  • If transvaginal mesh is proposed, are you credentialed by the hospital where my surgery will be done to use transvaginal mesh to treat prolapse?
  • Do you receive payments or other benefits from the manufacture, distribution or implanting of synthetic mesh products?
  • If I develop a complication, will you be able to treat me, or will you refer me to another specialist?
  • What can I expect to feel after surgery? What specific symptoms should I report to you after the surgery?
  • Based on your experience, how long might I have pain after surgery?
  • Could I please have a copy of the synthetic mesh product information and the product number? (This may help in any future treatment of your prolapse.)
  • Who will perform all, or parts of my surgery?
  • Will there be any people from the mesh company in the operating theatre during my procedure?
  • If I develop a complication a long time after the surgery, what should I do?

3. Specialist’s advice on what questions you might ask before deciding if a surgeon you meet is right for you can be found in theconsumer webinar series presentation from December 2022 (p 40-41)- https://apfpr.org.au/wp-content/uploads/2023/05/APFPR-Consumer-Webinar-06122022-Final.pdf

A. General Questions

  • Do I really need this procedure?
  • What are the risks?
  • Are there any simpler, safer options?
  • What happens if I don’t do anything?
  • What are the costs?

How do I know if my surgeon is credentialed? This information can be found in the consumer webinar series presentation from December 2022 (link appended above).

B. Mesh Revision questions to ask your surgeon:

  • Is the surgeon credentialed to treat mesh complications?
  • How likely are my problems to be fixed by surgical revision of the mesh?
  • What kind of mesh do I have and where it is located?
  • Which of my problems are likely to be related to the mesh?
  • Is the aim to cut, partially or completely remove the mesh?
  • What are the potential complications and side effects of mesh revision?
  • Chance that pelvic floor problems (SUI/POP) will return?
  • What are the non-surgical alternatives and how likely are these to work? Who else will be involved in my care?
  • How many mesh revision procedures like mine have you performed?
  • How do you monitor and audit your outcomes e.g. APFPR
  • What are the outcomes – success, persistent and new problems
    • Pain, Bladder, Bowel, Prolapse and sexual function

4. The Australian Government Department of Health and Aged Care has a website, Health Direct that helps patients prepare for your medical appointment by creating a list of questions to ask your doctor. This can be accessed by clicking here.

Regulation on use of implants/devices in pelvic floor procedures

The Therapeutic Goods Administration (TGA) is Australia’s regulatory authority of therapeutic goods.  The Urogynaecological (transvaginal) surgical mesh hub provides information and support related to Urogynaecological (transvaginal) surgical mesh devices.

The following information is included in the Urogynaecological (transvaginal) mesh hub:

  • The Australian Government actions related to Urogynaecological mesh
  • List of approved Class III urogynaecological mesh devices currently listed on the ARTG
  • Final Report on the Australian Government response to the recommendations of the Senate Community Affairs References Committee Report

Special Access Scheme (SAS)
Unapproved products for individual patients (Special Access Scheme) | Therapeutic Goods Administration (TGA)

“OFF Label use”- Currently there are no Urogynaecological mesh devices that remain listed on the ARTG for the treatment of POP.
Understanding regulation of off-label use of medical devices

A list of adverse events can be found in the following link:
Urogynaecological surgical mesh complications | Therapeutic Goods Administration (TGA)

Implantable devices: Patient Information Leaflets and Patient Implant Cards
Medical device patient information leaflets and implant cards | Therapeutic Goods Administration (TGA)

Pelvic Floor disorders and treatment options

Pelvic floor disorders, such as stress urinary incontinence (SUI) and pelvic organ prolapse (POP), are common disorders with prevalence increasing with number of births and age. In Australia up to 50% of women are affected by SUI and 9% are symptomatic for POP with a 20% lifetime risk of receiving a pelvic floor reconstructive procedure.

For more information, see the below links-
Stress Urinary Incontinence – Your Pelvic Floor
Pelvic Organ Prolapse – Your Pelvic Floor

Consumer Resources for treatment options for SUI including a list of questions to ask your doctor (ACSQHC).
Treatment Options for Stress Urinary Incontinence (SUI) | Australian Commission on Safety and Quality in Health Care

Consumer Resources for treatment for POP including a list of questions to ask your doctor (ACSQHC).
Treatment Options for Pelvic Organ Prolapse (POP) | Australian Commission on Safety and Quality in Health Care

Consumer Resources for treatment options for complications of transvaginal mesh
https://www.safetyandquality.gov.au/publications-and-resources/resource-library/treatment-options-complications-transvaginal-mesh-including-options-mesh-removal

Resources for clinicians

1. Guidance for hospital credentialing of senior medical practitioners to implant and remove transvaginal mesh

Guidance for Hospital Credentialing of Senior Medical Practitioners to Undertake Transvaginal Mesh Surgery for Stress Urinary Incontinence | Australian Commission on Safety and Quality in Health Care
Guidance for Hospital Credentialing for Transvaginal TV Mesh surgery for Pelvic Organ Prolapse (POP) | Australian Commission on Safety and Quality in Health Care
Guidance for Hospital Credentialing for the Removal of Transvaginal TV Mesh | Australian Commission on Safety and Quality in Health Care

2. Care pathways for management of SUI, POP and transvaginal mesh complications for healthcare professionals

Care Pathway for the Management and Referral of Urinary Incontinence in Women- https://www.safetyandquality.gov.au/publications-and-resources/resource-library/care-pathway-management-and-referral-urinary-incontinence-women

Care Pathway for Management and Referral of Pelvic Organ Prolapse (POP)- https://www.safetyandquality.gov.au/sites/default/files/migrated/TV-mesh-care-pathway-for-GPs-pelvic-organ-prolapse.pdf

3. Professional College Position Statements

A. Urogynaecological Society of Australasia (UGSA)

B. Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG)

  • Position statement on mid urethral slings – click here
  • Position statement on sacrocolpopexy – click here
  • Guidance statement on use of mesh for vaginal prolapse – click here

4. Agency for Clinical Innovation has developed a SUI decision aid for women
Stress urinary incontinence: decision aid for women | Agency for Clinical Innovation (nsw.gov.au)

5. Ministry of New Zealand patient guide
All women considering surgical mesh for SUI should discuss and be provided with this patient guide 2024- click here

Reporting your mesh complications

The Therapeutic Goods Administration (TGA) encourages consumers and health professionals to report any problem with medical devices.

https://www.tga.gov.au/safety/reporting-problems

For more information, see  the TGA Incident Reporting and Investigation Scheme (IRIS)

Pelvic Floor Procedures-Services in Australia

Service Model Framework – provides state by state information on mesh surgery services available in Australia

The Australian Commission on Safety and Quality in Health Care (ACSQHC) has developed this service model framework to support the states, territories and the private sector in developing services for transvaginal mesh complications and mesh removal services. Clinical care pathways, models of care, and workforce considerations also inform the development of service models and service delivery.

Service model framework for transvaginal mesh complications and removal | Australian Commission on Safety and Quality in Health Care

Information about Pelvic Floor Procedures

Non-surgical alternatives for SUI and POP
IUGA resources
Non-surgical approaches to managing bladder problems
Vaginal pessary for POP
UGSA resource- Vaginal pessaries