The Australian Commission on Safety and Quality in Health Care (the Commission) organised a series of consumer consultation forums with the assistance of state health consumer councils in Brisbane, Melbourne, Perth and Sydney from January to March 2017. The intent was to provide consumers with the opportunity to provide information about their experience of transvaginal mesh treatment to inform the development of patient decision support resources.
Thirty-one women participated in the forums, either in person or by telephone. All but one of the women who participated in the forums had experienced complications following transvaginal mesh treatment, and the majority of participants had been treated for stress urinary incontinence.
Since this time, the Commission has embarked on the development of patient information resources, which have been informed by the forums. As part of this process a working group has been formed to guide development and two further meetings in Sydney and Perth were held with women who have had mesh implanted to comment on the draft resources. The resources will be finalised in conjunction with the working group and the women we have met during the consultation process
The common themes and issues raised by women who attended the forums are summarised below.
Treatment options for stress urinary incontinence and pelvic organ prolapse
- Women told the Commission that general practitioners, medical specialists, other healthcare providers and patients need to be better informed about surgical and non-surgical treatment options for stress urinary incontinence and pelvic organ prolapse, and the potential complications of transvaginal mesh treatments
The impact of complications
- The majority of women who attended the forums reported experiencing chronic pain, ongoing incontinence, loss of sexual function, various forms of emotional and psychological distress, broken relationships and unemployment following treatment with transvaginal mesh
- Many women reported that their general practitioner and/or medical specialist either did not recognise signs and symptoms of complications following transvaginal mesh treatment or did not associate those signs and symptoms with transvaginal mesh treatment
Informed consent processes
- Many women felt that easily accessible information was needed about surgical and non-surgical treatment options for stress urinary incontinence and pelvic organ prolapse, the potential short and long term complications of transvaginal mesh treatments and the difficulty of removing mesh as it was intended to be permanent
Services for assessment and treatment of complications associated with transvaginal mesh
- Easily accessible information is needed for patients, general practitioners and medical specialists about the location of, and referral pathways for, Australian services for assessment and treatment of complications and removal of mesh
- Women attending the forums said consideration should be given to development of specialist services for assessment and treatment of mesh complications; they said a range of skilled health care providers should be part of those services including surgeons, physiotherapists and pain management specialists
- Women said general practitioners and other healthcare providers needed to be better informed about the diagnosis and management of transvaginal mesh complications and services to which patients could be referred for specialised assessment and treatment of complications
- Women said a consistent approach and more evidence was needed to improve assessment and treatment of transvaginal mesh complications
Reporting of complications
- A number of women said processes for consumers to report problems and complications to the Therapeutic Goods Administration (TGA) should be made easier, and information should be provided about action in response to those reports
- Several women said action was needed to require surgeons and general practitioners to report complications following transvaginal mesh surgery, and to make the information about complications and actions taken in response to reports easily available
- Women felt much better information was needed about the number of women who are treated with transvaginal mesh, and the number who experience complications following that treatment
Skills levels of surgeons who implant and remove mesh
- A number of women called for information about the skill level of surgeons who implanted and removed mesh, and the outcomes for their patients, to be easy to access
- Women felt there should be standards which surgeons have to meet if they were permitted to implant and remove transvaginal mesh
Some women who attended the forums thought that transvaginal mesh should be banned because of the serious complications it could cause. Others acknowledged that, as there are women who have benefited from treatment with mesh, informed consent, ensuring that surgeons have the right skills, better reporting of complications and better information on the number of women who have had transvaginal mesh procedures should be a priority.
The Royal Australian and New Zealand College of Obstetricians and Gynaecologists has information on use of mesh for treatment of pelvic organ prolapse available on its website. The College is currently reviewing its information on use of mesh for treatment of stress urinary incontinence.
The Urogynaecological Society of Australasia also has a range of information available for patients on pelvic organ prolapse and stress urinary incontinence and treatment options.
The Commission has developed Top Tips for Safe Health Care to help consumers, their families, carers and other support people get the most out of their health care. The booklet includes information on providing feedback to healthcare providers and organisations and making and resolving complaints.
The Therapeutic Goods Administration has information on its web site about mesh complications, reporting of complications and action it has taken in relation to mesh.
The Australian Senate Community Affairs References Committee led an inquiry into the number of women in Australia who have had transvaginal mesh implants and related matters. More information is available here.
There is more information on the Commission’s work on Transvaginal mesh here.