A world leading, UK based uro-gynaecologist has said Australia is leading the way in independently determining the efficacy (or not) of transvaginal mesh.
Dr Wael Agur presented a paper about transvaginal mesh implants at the 30th Action against Medical Accidents (AvMA) clinical negligence conference in Brighton, UK that we attended in July 2018.
He argued that there is world-wide recognition that there are negligible benefits, but significant risks and complications, associated with the use of transvaginal mesh for certain gynaecological problems.
Dr Agur referred to the Australian Senate Inquiry into the use of transvaginal mesh implants as being the most independent study for determining the efficacy (or not) of transvaginal mesh.
This got us thinking about the outcome of the Australian Senate Inquiry into transvaginal mesh and what needs to be done to support women who have suffered from having implants as well as other women into the future.
Action from regulators and Government
On 28 March 2018 the Senate Community Affairs References Committee (‘the Committee’) for inquiry and report into the number of women in Australia who have had transvaginal mesh implants and related matters issued its report.
The Therapeutic Goods Administration (TGA) had already taken urgent action. In November removed transvaginal mesh devices solely used for the treatment of pelvic organ prolapse from the Australian Register of Therapeutic Goods. The TGA advised that the benefits of using transvaginal mesh products in the treatment of pelvic organ prolapse did not outweigh the risks the devices pose to patients.
The Australian Commission on Safety and Quality in Health Care (ACSQHC) had reached a similar conclusion in September 2017. It formed the view that transvaginal mesh implants for the treatment of pelvic organ prolapse should only be used in the context of research, due to the uncertainly surrounding long term effects and risks of complications.
What is transvaginal mesh?
Transvaginal mesh is a net-like implant used to treat pelvic organ prolapse and stress urinary incontinence in women. According to the Committee’s report, the number of women who have received transvaginal mesh implants is unknown though it was estimated that around 120,000 women in Australia have undergone a mesh sling procedure since the introduction of sling and tape devices in 1998. The release of the results of randomised controlled trials in 2002 and 2004 confirmed the benefits of this procedure over traditional surgical procedures and as a result, procedures using these devices quickly became the standard (some would say the ‘gold standard’) for treating stress urinary incontinence. It was the early success in the use of transvaginal mesh devices in the treatment of stress urinary incontinence that lead to their adoption in the treatment of pelvic organ prolapse.
What are the reported risks and complications?
The Committee found that while many women who have had a procedure using transvaginal mesh experienced no difficulties, some women do and for some of those women, “the complications following their surgery have had a devastating impact on their lives.” Read more.
The Committee recognised that the prevalence and severity of problems associated with transvaginal mesh implants has risen since the first Australian adverse event was reported in 2006.
Some of the symptoms reported by women include: severe pelvic, vaginal, rectal and anal pain; pain at the base of the spine; neurological deficit and impaired sensation of the leg; obstructed defecation; faecal and/or urinary incontinence; urinary retention requiring self-catheterisation; pain during sexual intercourse; recurrent urinary tract infections; recurrent pelvic infections; restricted movement; impaired ability to sit or stand for extended periods of time; disturbed sleep due to pain and discomfort; constant malaise or feeling unwell.
Some women report that their symptoms following surgery were worse than the initial symptoms they presented with.
Other serious complications of mesh implants include erosion of the mesh, migration of the anchors used to implant the mesh to other areas of the pelvis, bladder and other organs; and piercing of/ injury to those organs.
In addition to the physical symptoms, the emotional injuries reported by women include anxiety, depression, stress, difficulty maintaining relationships, reduced social contact and therefore social isolation.
The Committee found that the true incidence of women experiencing complications following transvaginal mesh procedures remains unclear and that adverse events relating to the insertion of uro-gynaecological mesh have most likely been under reported.
One of the key concerns raised by women during the Senate Inquiry was the lack of information provided at the time the mesh implants were recommended and the fact the complications associated with such devices were not communicated to them. Many women recalled being told simply that the procedure was safe, minimally invasive and uncomplicated.
The Committee heard that some women were not informed that a medical device was being implanted as part of their surgery, that many women were not told that they had a mesh implant until they began to experience complications and that other women were not advised that the ‘sling’ or ‘tape’ being used in their surgery was in fact polypropylene mesh. A number of women were not informed that the implant is intended to be permanent and that in the event of complications, removal could be difficult and in some cases, impossible.
The law requires medical practitioners, as part of their duty of care, to provide patients with information necessary to give consent to treatment, including information on all material risks of the proposed treatment.
In the case of transvaginal mesh, the Committee determined that a treating surgeon should explain the treatment options, both non-surgical and surgical, the permanent nature of synthetic mesh and the likely success rates considering the individual woman’s clinical factors. Possible risks should be explained including general surgical risks and the risks specific to mesh implants.
Recognition of complications
Evidence provided during the Senate Inquiry suggested that in many cases women reporting complications following transvaginal mesh surgery experienced poor responses from medical practitioners. The committee received many accounts describing the challenges and frustration that patients faced in having their symptoms addressed or taken seriously.
Women reported being told that they were the only woman the surgeon had treated who had experienced such complications, that theirs was an unusual case or that they were simply unlucky. Other women reported been told that their symptoms were ‘imagined’.
Unsurprisingly, women told the committee that they suffered frustration and stress associated with the delays in medical practitioners identifying and treating the symptoms they described.
A catastrophic failure of the health system
In its report, the Committee states:
[W]e believe this is a catastrophic failure of the health system to protect women and ensure they have access to safe health care. We feel that women have been let down by their doctors, by the manufacturers of mesh and by the TGA as the regulator.
At the same time, the committee is acutely aware that for many of the women suffering as a result of transvaginal mesh implants, the responses to date have been slow in addressing the concerns they have raised and, for some, will make little difference to their circumstances.
Senate Committee recommendations
The Committee made 13 recommendations to ensure the protection of women seeking treatment for symptoms of stress urinary incontinence, pelvic organ prolapse and other gynaecological procedures. These recommendations include:
- regulation of the introduction and use of transvaginal mesh implants, including pre-market assessment and clinical trials
- re-classification of surgical mesh devices aligned with the European Union regulatory framework
- patient implant cards
- an information sheet for implantable devices
- mandatory reporting by medical practitioners of adverse events associated with the use of mesh procedures
- the ACSQHC prepare guidance material on effective informed consent processes as well as treatment guidelines by ACSQHC which clearly indicate that transvaginal mesh implantation should only be undertaken with fully informed consent and as a last resort
- the implementation of governance arrangements by medical professional colleges and specialist societies for transvaginal mesh procedures covering training, monitoring, recording and reporting outcomes and complications
- an audit by ACSQHC of all transvaginal mesh procedures undertaken and their outcomes since the introduction of transvaginal mesh devices in Australia.
- a review by the Department of Health in conjunction with the Medical Technology Association of Australia and the Medical Board of Australia into the systems in place within the device manufacturing industry and the medical professions particularly to prevent the payment of inducements to medical professionals and teaching hospitals
- further guidance for medical professionals on recording the use of implantable devices on medical records and reporting adverse events to the Therapeutic Goods Administration
- consideration be given to the establishment of support mechanisms for women who have received transvaginal mesh implants including information and helplines, specialist counselling programs, specialist multidisciplinary units for the assessment and management of complications associated with transvaginal mesh procedures, specialist pain management expertise, advice and practical assistance for women seeking to access their medical records.
We sincerely hope that the recommendations made by the Committee are followed and that Australia continues to work towards banning the use of transvaginal mesh products in gynaecological procedures, so that women in this country and around the world no longer suffer in silence.
Support for women who have had a transvaginal mesh implant
If you or someone you know has had a transvaginal mesh implant and would like to discuss your legal options or support in accessing your medical records please give one of our expert, female, health law team members a call to make an appointment to discuss your needs.