tag:theconversation.com,2011:/nz/topics/vaginal-mesh-39303/articlesVaginal mesh – The Conversation2022-09-20T03:25:23Ztag:theconversation.com,2011:article/1905322022-09-20T03:25:23Z2022-09-20T03:25:23ZAction on faulty vaginal mesh took too long, now women struggle to access mesh surgery that works<figure><img src="https://images.theconversation.com/files/485259/original/file-20220919-27-xj3xmf.jpg?ixlib=rb-1.1.0&rect=395%2C1047%2C4586%2C2397&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">
</span> <span class="attribution"><a class="source" href="https://unsplash.com/photos/GcUe00s585w">Gwendal Cottin/Unsplash</a></span></figcaption></figure><p>Last week, Johnson & Johnson reached a <a href="https://www.theguardian.com/business/2022/sep/12/johnson-johnson-reaches-300m-settlement-over-pelvic-mesh-implants?CMP=share_btn_tw">A$300 million settlement</a> for two class actions brought by Australian women affected by complications from vaginal mesh products. </p>
<p>The products are surgically implanted to correct urinary incontinence or prolapse, where the vaginal tissues weaken and sag outside the vagina. </p>
<p>However, women involved in the class action experienced a <a href="https://www.theguardian.com/business/2022/sep/12/johnson-johnson-reaches-300m-settlement-over-pelvic-mesh-implants?CMP=share_btn_tw">range of issues</a> with vaginal mesh implants, including chronic pain, painful intercourse and incontinence.</p>
<p>The first of the Australian class actions against Johnson & Johnson was filed in <a href="https://www.lexology.com/library/detail.aspx?g=f0f3eaf1-8edb-4384-a0e2-c3ea7097eb61">2012</a>. Justice Katzmann <a href="https://jade.io/j/?a=outline&id=675422">ruled</a> the company hadn’t fully researched these products (which carried significant risks), was motivated by commercial factors, and failed to give doctors or patients adequate safety information.</p>
<p>The following ten years have seen a radical overhaul in the use of vaginal mesh implants in Australia and throughout the world. But we’ve also seen unintended consequences, with some women not accessing care. </p>
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<h2>What has changed?</h2>
<p>We now have strict <a href="https://www.safetyandquality.gov.au/sites/default/files/migrated/Credentialing-of-Senior-Medical-Practitioners-to-Undertake-Transvaginal-Mesh-Implant-Surgery-forStress-Urinary-Incontinence.pdf">training and credentialing guidelines</a> for surgeons using vaginal mesh, plus detailed management protocols for pelvic floor disorders. Only surgeons with advanced training in pelvic floor surgery following their specialty training are able to perform vaginal mesh surgery. </p>
<p>All patients are <a href="https://www.safetyandquality.gov.au/our-work/health-conditions-and-treatments/transvaginal-mesh/resources-consumers-clinicians-and-health-service-organisations-transvaginal-mesh-and-sacrocolpopexy#care-pathways">first referred</a> for extensive pelvic floor muscle training. Only those who don’t respond to conservative treatment and whose incontinence has a major impact on their quality of life are referred for a surgical review. </p>
<p>Mesh repair for prolapse is considered only in patients with severe or recurrent prolapse in whom basic surgery using the patient’s own tissues has failed. This tends to be patients with multiple health problems who are not fit enough for major abdominal surgery. </p>
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Read more:
<a href="https://theconversation.com/vaginal-mesh-controversy-shows-collective-failure-of-the-tga-and-australias-specialists-78605">Vaginal mesh controversy shows collective failure of the TGA and Australia's specialists</a>
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<p>Registration for mesh products has been rigorously upgraded and requires extensive pre- and post-marketing audit. This means implants are tested in lengthy clinicial trials before and after they’re implanted in patients. Trials also compare the outcomes and complications to women having surgery without mesh. </p>
<p>Formal <a href="https://www.monash.edu/medicine/sphpm/registries/apfpr">audit systems</a> monitor women’s long-term outcomes. And next year, all implants will have a <a href="https://www.tga.gov.au/sites/default/files/2022-07/presentation-arcs-annual-conference-establishing-the-australian-unique-device-identification-system.pdf">unique device identifier</a>. Similar systems are used for joint replacements and breast implants, allowing prompt review if there are concerns over a device.</p>
<p>All of these changes should have been standard practice a long time ago and will hopefully prevent similar mistakes in future. </p>
<h2>Some women not seeking treatment</h2>
<p>Through media coverage of the vaginal mesh issue, most of the population learned “mesh was bad”. They may not have known anything about prolapse or incontinence but they clearly got the message mesh was something to avoid. </p>
<p>Following the 2011 United States Food and Drug Administration (FDA) safety update citing possible complications associated with vaginal mesh, there was a <a href="https://journals.lww.com/fpmrs/Abstract/2013/07000/Impact_of_the_2011_FDA_Transvaginal_Mesh_Safety.2.aspx#:%7E:text=p%20191%2D198-,doi%3A%2010.1097/SPV.0b013e31829099c1,-Copy">marked reduction</a> in the use of vaginal mesh implants for prolapse surgery. </p>
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<img alt="Woman walks in the country with her dog" src="https://images.theconversation.com/files/485457/original/file-20220920-21052-deaukn.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/485457/original/file-20220920-21052-deaukn.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=477&fit=crop&dpr=1 600w, https://images.theconversation.com/files/485457/original/file-20220920-21052-deaukn.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=477&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/485457/original/file-20220920-21052-deaukn.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=477&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/485457/original/file-20220920-21052-deaukn.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=600&fit=crop&dpr=1 754w, https://images.theconversation.com/files/485457/original/file-20220920-21052-deaukn.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=600&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/485457/original/file-20220920-21052-deaukn.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=600&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
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<span class="caption">Patients haven’t wanted procedures with mesh.</span>
<span class="attribution"><a class="source" href="https://unsplash.com/photos/Z3uWkv8Ovtc">Caspar Rae/Unsplash</a></span>
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<p>Over the past ten years, fewer women have had surgery for pelvic floor weakness. </p>
<p>This is most noticeable for a type of surgery for urinary incontinence, mid-urethral sling, which <a href="https://www.aihw.gov.au/reports/hospitals/procedures-data-cubes/contents/data-cubes">has dropped 64%</a> from its peak usage in 2010–2011. A mid-urethral sling uses a thin band of mesh under the urethra to manage incontinence. </p>
<p>Prolapse repair requires a larger patch of mesh to support the weakened vaginal walls. </p>
<p>Both these products are made from the same polypropylene mesh. This is the same material used in sutures (stitches) for many decades. </p>
<p>However, prolapse repair is more complex and has a higher risk of complications than mesh continence surgery, where short- and long term outcomes are <a href="https://pubmed.ncbi.nlm.nih.gov/30357298/#:%7E:text=PMID%3A%2030357298,10.1001/jama.2018.14997">very good</a>. </p>
<p>Yet we have <a href="https://www.aihw.gov.au/reports/hospitals/procedures-data-cubes/contents/data-cubes">not seen</a> any significant increase in other non-mesh continence surgery to compensate for this. </p>
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Read more:
<a href="https://theconversation.com/urinary-incontinence-can-be-a-problem-for-women-of-all-ages-but-there-is-a-cure-49365">Urinary incontinence can be a problem for women of all ages, but there is a cure</a>
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<p>It’s possible more women are turning to physiotherapy treatment which can improve incontinence symptoms and is recommended as first-line treatment. Physiotherapy can also <a href="https://www.cochrane.org/CD005654/INCONT_pelvic-floor-muscle-training-urinary-incontinence-women#:%7E:text=Cochrane%20Database%20of%20Systematic%20Reviews%202018%2C%20Issue%2010.%20Art.%20No.%3A%20CD005654.%20DOI%3A%2010.1002/14651858.CD005654.pub4">benefit</a> women with mild to moderate vaginal prolapse. </p>
<p>However private physiotherapy care can be costly and difficult to access. There has also been an ongoing <a href="https://treasury.gov.au/sites/default/files/2022-03/258735_continence_foundation_of_australia.pdf">decline</a> in physiotherapy and nurse continence services in public hospitals and community centres. </p>
<p>It is likely many women are not seeking help at all.</p>
<h2>Mesh still has a place</h2>
<p>The problem is, mesh is not inherently bad. Mesh has enabled surgeons to treat many women, including older or more frail patients, who aren’t suited to more major surgery. </p>
<p>Vaginal mesh surgery for prolapse is well tolerated in elderly and frail patients. Since its introduction, the <a href="https://obgyn.onlinelibrary.wiley.com/doi/full/10.1111/ajo.12445?saml_referrer#:%7E:text=https%3A//doi.org/10.1111/ajo.12445">greatest relative uptake in continence procedures</a> has been in women 75 years and older. </p>
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<img alt="Older woman sits near the beach" src="https://images.theconversation.com/files/485455/original/file-20220920-3237-c5izqq.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/485455/original/file-20220920-3237-c5izqq.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/485455/original/file-20220920-3237-c5izqq.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/485455/original/file-20220920-3237-c5izqq.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/485455/original/file-20220920-3237-c5izqq.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/485455/original/file-20220920-3237-c5izqq.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/485455/original/file-20220920-3237-c5izqq.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
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<span class="caption">Mesh is still a good option for many women.</span>
<span class="attribution"><a class="source" href="https://unsplash.com/photos/jeEedhJXoR0">sk/Unsplash</a></span>
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<p>For incontinence, a mid-urethral sling is <a href="https://pubmed.ncbi.nlm.nih.gov/20434257/#:%7E:text=PMID%3A%2020434257,j.eururo.2010.04.022">more effective</a> with fewer complications than other procedures for incontinence.<br>
The most effective surgical repair for severe and recurrent prolapse, particularly in younger women, is a sacrocolpopexy. Generally performed via keyhole surgery, this technique uses a mesh strip anchored to the triangular bone at the base of the spine to support weakened vaginal tissues. </p>
<p><a href="https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD012376/full">Sacrocolpopexy</a> has a good safety profile, is effective and durable – and wasn’t part of the recent class actions. </p>
<p>But this is no longer available, as the <a href="https://www.health.gov.au/news/phi-circulars/phi-8920-removal-of-urogynaecological-mesh-devices">manufacturers</a> of mesh for sacrocolpopexy in Australia <a href="https://usanz.org.au/publicassets/d5d87991-454e-ec11-9103-0050568796d8/ANZ-Mesh-Sales---Customer-Letter---FINAL-11-17-2021.pdf">recently removed</a> their products from the market. This was likely a commercial decision: the long-term studies required for registration of mesh products used in pelvic floor surgery are expensive and time consuming, and Australia is a relatively small market.</p>
<p>Mesh for vaginal prolapse had already been removed from the <a href="https://www.tga.gov.au/news/safety-alerts/tga-actions-after-review-urogynaecological-surgical-mesh-implants#:%7E:text=The%20TGA%20decided%20on%2028,of%20Therapeutic%20Goods%20(ARTG).">Australian Register of Therapeutic Goods</a> in 2018, meaning it can’t be supplied in Australia, after Australia’s regulator classified it as high risk. </p>
<p>Progress has been made to protect patients from the harms of faulty mesh implants but we need to ensure women have access to safe, effective surgical procedures to treat incontinence and prolapse – and for some women, this will include mesh. </p>
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Read more:
<a href="https://theconversation.com/not-all-vaginal-implants-are-a-problem-and-treating-them-the-same-puts-many-women-at-risk-94403">Not all vaginal implants are a problem and treating them the same puts many women at risk</a>
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<img src="https://counter.theconversation.com/content/190532/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Jennifer King is affiliated with International Urogynaecological Association, Continence Foundation of Australia NSW Branch </span></em></p>We need to ensure women have access to safe, effective procedures to treat incontinence and prolapse – including those using mesh.Jennifer King, Senior Clinical Lecturer, University of SydneyLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/944032018-04-04T08:10:29Z2018-04-04T08:10:29ZNot all vaginal implants are a problem and treating them the same puts many women at risk<figure><img src="https://images.theconversation.com/files/213103/original/file-20180404-189830-7ufdlf.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Around on in five women might need surgical treatment for prolapse or urinary incontinence.</span> <span class="attribution"><span class="source">from shutterstock.com</span></span></figcaption></figure><p>Last week, a <a href="https://www.aph.gov.au/Parliamentary_Business/Committees/Senate/Community_Affairs/MeshImplants">Senate Committee</a> investigating the impacts of “transvaginal mesh implants” on women in Australia handed down its report, with 13 recommendations. The implants are medical devices surgically inserted to prevent prolapse and urinary incontinence - conditions that affect many women over their lifetime, with around 20% <a href="https://www.ncbi.nlm.nih.gov/pubmed/24807341">requiring surgical</a> treatment.</p>
<p>The inquiry was the result of many <a href="http://www.abc.net.au/news/2017-05-31/more-women-mesh-implant-side-effects-than-thought-experts-say/8572840">women coming forward</a> reporting <a href="http://www.abc.net.au/news/2017-05-31/how-a-vaginal-mesh-implant-destroyed-maessens-life/8573878">serious side effects</a>, such as chronic pain and trouble walking, after vaginal mesh surgery. Recommendations included that these medical devices are to be used only “as a last resort”, that each mesh implant be registered, patient counselling and decision-making, surgeon training and better reporting of adverse events. </p>
<p>Proposals to improve outcomes for patients by implementing stricter standards in training, audit, research and monitoring of medical implants are welcome. However, the Senate has lumped together incontinence and prolapse devices, considering them all to be “transvaginal meshes”. </p>
<p>Only the prolapse devices are problematic, while those used for incontinence are safe and evidence-based procedures. Conflating the two confuses women and may lead them to seek snake-oil type treatments that have no evidence base, and can be risky.</p>
<h2>Different devices</h2>
<p>Prolapse is when pelvic organs – such as the bladder, bowel or uterus (womb) – fall through the vagina. Stress urinary incontinence is involuntary urine leakage with activity such as sport, coughing or even walking. Both conditions are types of pelvic floor dysfunction, but the surgery and medical devices used to treat them are different.</p>
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Read more:
<a href="https://theconversation.com/urinary-incontinence-can-be-a-problem-for-women-of-all-ages-but-there-is-a-cure-49365">Urinary incontinence can be a problem for women of all ages, but there is a cure</a>
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<p>Despite many <a href="https://www.aph.gov.au/Parliamentary_Business/Committees/Senate/Community_Affairs/MeshImplants/Submissions">submissions to the inquiry</a> from clinical bodies, the Senate committee has been unable to distinguish between midurethral mesh slings (used for urinary incontinence) and transvaginal mesh (used for prolapse). The first is a mesh tape placed under the urethra like a sling for support. The second are sheets of mesh placed under the bladder, or in front of the bowel, to stop prolapse and prevent recurrence.</p>
<p>Midurethral slings in Australia have been associated with complaints in around equal numbers to mesh used for prolapse, but proportionately most problems have been seen with prolapse. This is because an estimated 120,000 sling operations have <a href="https://www.aph.gov.au/Parliamentary_Business/Committees/Senate/Community_Affairs/MeshImplants">been performed</a>, compared to only around 30,000 prolapse mesh procedures.</p>
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<a href="https://images.theconversation.com/files/213106/original/file-20180404-189798-kzkowr.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/213106/original/file-20180404-189798-kzkowr.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/213106/original/file-20180404-189798-kzkowr.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/213106/original/file-20180404-189798-kzkowr.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/213106/original/file-20180404-189798-kzkowr.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/213106/original/file-20180404-189798-kzkowr.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/213106/original/file-20180404-189798-kzkowr.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/213106/original/file-20180404-189798-kzkowr.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
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<span class="caption">Many women who had mesh surgery for pelvic prolapse have experienced significant pain, bladder injury and incontinence.</span>
<span class="attribution"><span class="source">from shutterstock.com</span></span>
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<p>There is <a href="https://theconversation.com/common-surgery-for-vaginal-prolapse-can-lead-to-complications-review-shows-54559">still clinical uncertainty</a> and insufficient data on indications for use and best practice when it comes to the mesh used to treat vaginal prolapse. A <a href="http://cochranelibrary-wiley.com/doi/10.1002/14651858.CD012079/abstract">review of several studies</a> found that the artificially grafted mesh had more problems than benefits, and the women who underwent the operation had high rates of needing repeat surgery due to mesh exposure, bladder injury and urinary incontinence.</p>
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Read more:
<a href="https://theconversation.com/common-surgery-for-vaginal-prolapse-can-lead-to-complications-review-shows-54559">Common surgery for vaginal prolapse can lead to complications, review shows</a>
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<p>Midurethral slings, however, have an <a href="https://www.ncbi.nlm.nih.gov/pubmed/26130017">excellent track record</a> and are the <a href="https://www.ncbi.nlm.nih.gov/pubmed/23563892">most researched incontinence procedure</a> in history. Midurethral slings have been recognised by every national and international medical or regulatory organisation as the treatment of choice for stress urinary incontinence in patients who have failed conservative management, such as pelvic floor exercises.</p>
<h2>There are riskier procedures</h2>
<p>The Senate also tasked the Australian Commission on Quality and Safety in Health Care with carrying out many of its recommendations. The commission recently <a href="https://www.safetyandquality.gov.au/our-work/transvaginal-mesh/status-of-commission-guidance-february-2018/">published guidelines</a> for hospital credentialing of surgeons to perform transvaginal mesh procedures for urinary incontinence and prolapse. </p>
<p>Along with many sensible recommendations on training and audit, the commission determined that surgeons needed to perform:</p>
<blockquote>
<p>a minimum of ten surgeries for stress urinary incontinence (either mesh or non-mesh) each year. </p>
</blockquote>
<p>This is not ten midurethral slings – the procedure for which the whole guideline was designed – but any surgery for stress incontinence.</p>
<p>There is no requirement from the commission that such procedures have proven efficacy and safety. This means that, in theory, a completely non evidence-based treatment such as vaginal laser could be claimed as a continence procedure. Vaginal laser is essentially a cosmetic laser treatment, for which there is absolutely no scientific data for any effect in patients with urinary incontinence.</p>
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<strong>
Read more:
<a href="https://theconversation.com/vaginal-mesh-controversy-shows-collective-failure-of-the-tga-and-australias-specialists-78605">Vaginal mesh controversy shows collective failure of the TGA and Australia's specialists</a>
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<p>Along with the Senate’s recommendation that mesh be used as a “last resort”, this suggests patients should be offered less effective procedures, such as an <a href="http://cochranelibrary-wiley.com/doi/10.1002/14651858.CD003881.pub4/abstract">injection therapy</a>, or <a href="http://cochranelibrary-wiley.com/doi/10.1002/14651858.CD001755.pub2/abstract">big abdominal operations</a>, with <a href="https://www.ncbi.nlm.nih.gov/pubmed/28479203">more complications</a> and no better efficacy, simply because they don’t involve mesh.</p>
<p>We have already seen a <a href="https://obgyn.onlinelibrary.wiley.com/doi/10.1111/ajo.12445">reduction in continence surgery</a> over the last several years, which could be related to adverse mesh publicity. This has not been replaced by an increase in conservative management. Rather Australian women are now continuing to suffer with their incontinence. And there is a risk they will turn to expensive “snake oil” treatments, such as <a href="https://splinternews.com/vaginal-rejuvenation-stem-cell-therapy-is-probably-bogu-1793859971">vaginal rejuvenation therapy</a>.</p>
<p>We anticipate further patient anxiety and poor outcomes if the system doesn’t guarantee patients receive evidence-based care. We have the data on midurethral slings so we can’t compromise access to the safest and most effective surgical treatment for their stress incontinence.</p><img src="https://counter.theconversation.com/content/94403/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Jennifer King is the Chair of the UroGynaecological Society of Australasia.</span></em></p>Mesh surgery for urinary incontinence is effective and extensively studied, while the mesh used in pelvic prolapse is problematic. But the Senate has conflated the two, which will confuse women.Jennifer King, Honorary Clinical Lecturer, University of SydneyLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/833572017-09-07T03:54:07Z2017-09-07T03:54:07ZAssassination by pacemaker: Australia needs to do more to regulate internet-connected medical devices<figure><img src="https://images.theconversation.com/files/184831/original/file-20170906-9830-1sg515t.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Australia's medical regulator needs to do more about cybersecurity.</span> <span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/dddr-pacemaker-xray-image-cardiac-catheterization-441650620?src=blj2MLS4Anocx1W3Ze3OnQ-1-20">Korawig Boonsua/Shutterstock</a></span></figcaption></figure><p>In the future, people are going to be just a little bit cyborg. We’ve accepted hearing aids, nicotine patches and spectacles, <a href="https://www.embs.org/about-biomedical-engineering/our-areas-of-research/wearable-implantable-technologies/">but implanted</a> medical devices that are internet-connected present new safety challenges. Are Australian regulators keeping up?</p>
<p>A global recall <a href="https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm573669.htm">of pacemakers</a> has sparked new fears and splashy headlines about hacked medical devices. But the next 20 years of medicine will normalise the use of intelligent implants to control pain, provide data for diagnostic purposes and supplement ailing organs, which means we need proper security as well as access in case of emergency. </p>
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Read more:
<a href="https://theconversation.com/three-reasons-why-pacemakers-are-vulnerable-to-hacking-83362">Three reasons why pacemakers are vulnerable to hacking</a>
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<p>Pharmaceuticals and medical devices in Australia are regulated by the <a href="https://www.tga.gov.au/tga-basics">Therapeutic Goods Administration</a> (TGA), an arm of the national Health Department. </p>
<p>Can we rely on Australia’s medical devices regime? Recurrent criticisms by parliamentary committees and government inquiries suggest the regulator may be struggling.</p>
<h2>The job of the TGA</h2>
<p>The TGA regulates medical devices such as stents, pacemakers, joint implants, <a href="https://theconversation.com/victims-of-faulty-breast-implants-were-let-down-by-the-tga-13074">breast implants</a>, and the controversial <a href="https://theconversation.com/vaginal-mesh-controversy-shows-collective-failure-of-the-tga-and-australias-specialists-78605">vaginal mesh</a> that has featured recently in the media (and a <a href="http://www.smh.com.au/national/pelvic-mesh-victims-blamed-by-asleep-at-wheel-health-system-inquiry-to-hear-20170719-gxehqv.html">Senate inquiry</a>) over claims it seriously injured patients.</p>
<p>The role of the TGA is vital, because defective devices can result in injury or death. They have a major cost for the public health system and affect patient quality of life. They often result in litigation, sometimes with <a href="http://www.reuters.com/article/us-johnson-johnson-verdict-hipimplants-idUSKBN13Q5XF">billion-dollar</a> <a href="http://www.abc.net.au/news/2016-03-31/class-action-over-defective-hip-replacements-settles-for-$250m/7288350">settlements</a>.</p>
<p>In undertaking its mission, the TGA looks to information from <a href="https://www.theguardian.com/australia-news/2017/jul/10/johnson-johnson-tried-to-prevent-report-about-pelvic-mesh-devices-court-hears">manufacturers</a> and distributors, from overseas regulators and its <a href="https://www.tga.gov.au/publication/therapeutic-product-vigilance">own staff</a>. </p>
<p>Like counterparts such as the US <a href="https://www.youtube.com/watch?v=UVUHEtrbL7A">Food and Drug Administration</a>, TGA staff are under pressure to get products into the marketplace and reduce “<a href="https://www.tga.gov.au/sites/default/files/tga-business-plan-2016-17.pdf">red tape</a>”.</p>
<h2>The TGA and cybersecurity</h2>
<p>Wireless medical devices need greater security than, say, an internet-connected fridge. It is axiomatic that they must work. </p>
<p>We need to ensure that information <a href="https://www.wired.com/2017/03/medical-devices-next-security-nightmare/">provided</a> by the devices is safeguarded and that control of the devices – <a href="https://spqr.eecs.umich.edu/papers/b1kohFINAL2.pdf">implantable</a> or otherwise – is not compromised. </p>
<p>To do that, we can use existing tools such as robust passwords, encryption and systems design. It also requires product vendors and practitioners to avoid negligence. Regulators must proactively foster and enforce standards. </p>
<p>Put simply, bodies like the TGA need to deal with software rather than simply bits of metal and plastic. It is unclear whether the TGA has the expertise or means to do so. </p>
<h2>Solutions, not panic</h2>
<p>The past decade has seen a succession of inquiries into the TGA, including the 2015 <a href="https://www.tga.gov.au/mmdr">Sansom Review</a> and 2012 Senate <a href="http://www.aph.gov.au/Parliamentary_Business/Committees/Senate/Community_Affairs/Completed_inquiries/2010-13/implants2012/report/index">PIP Inquiry</a>. Each has demonstrated that the TGA is not always <a href="https://theconversation.com/consumers-lose-out-as-tga-reform-turns-into-a-hot-potato-13383">keeping up</a> with its task. </p>
<p>Problems are ongoing: think defective joint implants, <a href="https://theconversation.com/victims-of-faulty-breast-implants-were-let-down-by-the-tga-13074">breast implants</a> and <a href="http://www.aph.gov.au/Parliamentary_Business/Committees/Senate/Community_Affairs/MeshImplants">vaginal mesh</a>. But there are some potential paths towards improvement.</p>
<p><strong>Accountability</strong></p>
<p>One solution is to ensure the TGA is more accountable. </p>
<p>Currently, if someone wishes to bring a claim alleging a device was improperly permitted, the TGA has <a href="https://www.legislation.gov.au/Series/C2004A03952">immunity</a> from civil litigation about regulatory failure. </p>
<p>Removal of immunity will force it to focus on outcomes. That can be reinforced by giving it independence from the Department of Health, making it report direct to Parliament and ensuring the openness emphasised by the <a href="http://pandora.nla.gov.au/pan/141595/20130902-0954/www.health.gov.au/internet/ministers/publishing.nsf/Content/mr-yr10-ck-ck005d526.htm?OpenDocument&yr=2010&mth=11">Pearce Inquiry</a>. </p>
<p><strong>Regulatory capture</strong></p>
<p>Medical products regulation in Australia has been a matter of penny wise, pound poor. The TGA is <a href="https://www.tga.gov.au/cost-recovery-implementation-statement-2016-17">funded</a> by fees from the manufacturers and distributors that it regulates, in addition to some government funding. </p>
<p>It needs a discrete budget that recoups costs but is not dependent on companies that complain regulation is expensive. It needs enough resources to do its job well in the emerging age of the internet of things, including access to independent expertise regarding cybersecurity and devices. </p>
<p><strong>A device register</strong></p>
<p>How many devices have been implanted and how many removed? The lack of data about medical devices is a problem.</p>
<p>The government has so far not embraced recommendations for a comprehensive device register, one allowing timely identification of what was implanted and by whom. </p>
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Read more:
<a href="https://theconversation.com/vaginal-mesh-controversy-shows-collective-failure-of-the-tga-and-australias-specialists-78605">Vaginal mesh controversy shows collective failure of the TGA and Australia's specialists</a>
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<p>Such a register would provide a means for determining problems with devices or medical practice. We need timely, consistent reporting of problems on a mandatory basis, as well as recall and <a href="http://pandora.nla.gov.au/pan/141595/20130902-0954/www.health.gov.au/internet/ministers/publishing.nsf/Content/mr-yr10-ck-ck005d526.htm?OpenDocument&yr=2010&mth=11">transparent</a> investigation of what went wrong.</p>
<p><strong>Disclosure of interests</strong></p>
<p>The inquiry into vaginal mesh revealed the WA Branch of Australian Medical Association had a <a href="http://www.watoday.com.au/wa-news/australian-medical-association-president-confirms-ama-was-role-in-pelvic-mesh-scandal-20170822-gy1hzj.html">financial interest</a> in a device that may have seriously affected numerous women. </p>
<p>There must be full disclosure of such interests, with meaningful sanctions where disclosure has not been made. This requires action by the TGA, professional bodies and the government.</p>
<h2>So, what about assassination by wireless pacemaker?</h2>
<p>The cybersecurity of medical devices is a matter for everyone. </p>
<p>We need the TGA to work with manufacturers, distributors and health professionals to mandate best practice. Should, for example, manufacturers and practitioners ensure that implants do not rely on default passwords that are easily <a href="https://www.fastcompany.com/3061323/brainjacking-or-how-hackers-can-remote-control-your-medical-implants">crackable</a>? What about access by emergency services?</p>
<p>There is a fundamental need to develop and enforce a national safety standard regarding all wireless implants. For that we need thoughtful policy, not just headlines.</p><img src="https://counter.theconversation.com/content/83357/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Bruce Baer Arnold does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>Australia’s Therapeutic Goods Administration must learn to deal with software rather than simply bits of metal and plastic.Bruce Baer Arnold, Assistant Professor, School of Law, University of CanberraLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/786052017-06-06T19:21:24Z2017-06-06T19:21:24ZVaginal mesh controversy shows collective failure of the TGA and Australia’s specialists<figure><img src="https://images.theconversation.com/files/172197/original/file-20170605-20608-1x1wfgp.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Hundreds of women have complained of adverse reactions from transvaginal mesh implants.</span> <span class="attribution"><a class="source" href="https://unsplash.com/search/older-women?photo=_EKlFRXUuvg">Anna Noack/Unsplash</a></span></figcaption></figure><p>Australian women are coming forward with <a href="http://www.abc.net.au/news/2017-05-31/how-a-vaginal-mesh-implant-destroyed-maessens-life/8573878">stories of the negative impacts on their lives of transvaginal mesh implants</a>, medical devices surgically inserted to prevent pelvic organ prolapse. </p>
<p>A recent <a href="http://www.abc.net.au/news/2017-05-31/more-women-mesh-implant-side-effects-than-thought-experts-say/8572840">Australian consumer group</a> survey reported more than 700 women said they had a mesh implant that had caused adverse effects. These included incontinence, severe chronic pain, problems walking, painful intercourse and even marriage breakdown. In the United Kingdom, hundreds of women are <a href="http://www.bbc.com/news/health-39567240">taking legal action</a> against the National Health Service and the makers of mesh implants. </p>
<p>The <a href="http://www.aph.gov.au/Parliamentary_Business/Committees/Senate/Community_Affairs/MeshImplants">Senate is conducting an inquiry</a> into transvaginal mesh implants in Australia. The questions the inquiry aims to answer include why there is no accurate record of how many meshes have been inserted in Australia, and how we can guarantee safer introduction of new products in future.</p>
<p>So, how did we get to a place where hundreds of Australian women have allegedly had this surgery leading to lifelong complications? </p>
<h2>A history of transvaginal mesh</h2>
<p>The pelvic floor is a group of muscles in the pelvic area that support the bladder, vagina and rectum. About 50% of women who have had children <a href="http://www.ajog.org/article/S0002-9378(00)53840-X/abstract">experience pelvic floor dysfunction</a>. As many as 20% <a href="https://www.ncbi.nlm.nih.gov/pubmed/24807341">will require surgery</a> for these conditions.</p>
<p>Pelvic floor dysfunction includes prolapse (falling through) of pelvic organs, such as the bladder, bowel or uterus (womb), through the vagina. It also includes stress urinary incontinence, which is involuntary urine leakage with activity such as sport, coughing or even walking.</p>
<p>The surgery and the medical devices used differ between these two conditions.</p>
<p><strong>Stress incontinence</strong></p>
<p>In the late 1990s, <a href="https://www.ncbi.nlm.nih.gov/pubmed/7618052">an innovative treatment</a> for stress incontinence was introduced. This involved a <a href="https://www.thewomens.org.au/health-information/continence-information/urinary-incontinence/">permanent synthetic sling, called a mid-urethral sling</a>, placed under the urethra (the tube through which urine travels from the bladder) to give it support. </p>
<figure class="align-right zoomable">
<a href="https://images.theconversation.com/files/172196/original/file-20170605-20575-160pays.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/172196/original/file-20170605-20575-160pays.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/172196/original/file-20170605-20575-160pays.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=600&fit=crop&dpr=1 600w, https://images.theconversation.com/files/172196/original/file-20170605-20575-160pays.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=600&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/172196/original/file-20170605-20575-160pays.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=600&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/172196/original/file-20170605-20575-160pays.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=754&fit=crop&dpr=1 754w, https://images.theconversation.com/files/172196/original/file-20170605-20575-160pays.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=754&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/172196/original/file-20170605-20575-160pays.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=754&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
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<span class="caption">The mid-urethral sling is placed under the urethra for support.</span>
<span class="attribution"><span class="source">from shutterstock.com</span></span>
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</figure>
<p>By 2002, the mid-urethral sling became the most frequently performed incontinence surgery in Australia. This was <a href="https://www.ncbi.nlm.nih.gov/pubmed/12114234">because doctors saw</a> the procedure was equivalent to, or better than, alternative procedures. The blood loss and operating time were less and recovery times were shorter than older procedures. </p>
<p>This clinical experience was later <a href="https://www.ncbi.nlm.nih.gov/pubmed/14981369">confirmed in large trials</a>. But while we waited for the results of these, which were published from 2004 onward, many women gained from a highly effective and safe operation, demonstrating the benefits of the innovation.</p>
<p><strong>Pelvic organ prolapse</strong></p>
<p>Traditional surgery for pelvic organ prolapse involved repairing the torn connective tissue with sutures. This was called vaginal repair. Unfortunately, this <a href="https://www.ncbi.nlm.nih.gov/pubmed/9083302">surgery was associated</a> with a <a href="http://www.ajog.org/article/S0002-9378(01)99389-5/abstract">high rate of the prolapse</a> recurring.</p>
<p>Following the success of the sling tape in stress incontinence, and of mesh use for hernias, doctors and manufactures looked to <a href="http://www.ejog.org/article/S0301-2115(00)00341-9/abstract">introduce a mesh</a> product to treat vaginal prolapse. This involved sheets of mesh being placed under the bladder, or in front of the bowel, to stop prolapse and prevent recurrence.</p>
<p>The <a href="https://www.ebs.tga.gov.au/servlet/xmlmillr6?dbid=ebs/PublicHTML/pdfStore.nsf&docid=2349C2AAB6E8898ECA2577DD0001C16B&agid=(PrintDetailsPublic)&actionid=1">Therapeutic Goods Association (TGA)</a> approved a variety of transvaginal mesh kits for pelvic organ prolapse from 2003. As with the mid-urethral sling four years earlier, little supporting data on the safety and efficacy of these kits was initially available. </p>
<p>Due to a lack of detail in the Medicare codes used to record the surgeries, we are unable to accurately determine how many women underwent surgery. I estimate that around 150,000 tapes for stress urinary incontinence and between 30,000 and 40,000 transvaginal meshes for pelvic organ prolapse have been performed to date.</p>
<h2>Problems with vaginal mesh</h2>
<p>Since the introduction of transvaginal mesh, long-term trials and <a href="http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD012079/abstract">reviews have demonstrated</a> it has some advantages over traditional vaginal repair. These include reduced symptoms of prolapse and need to operate again. But the mesh kits also have disadvantages. </p>
<p>The mesh rubs or <a href="http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD012079/abstrac">becomes exposed in the vagina</a> in as many as 14% of cases. For some women, the exposure has no symptoms, but others experience bleeding, discomfort and painful intercourse. </p>
<p>At least half of the women in the studies reviewed needed surgery to treat the exposed mesh and sew over the vaginal tissue. The surgical correction is relatively straightforward and is generally successful. </p>
<p>Another problem is <a href="http://www.ajog.org/article/S0002-9378(10)02270-2/abstract">vaginal and groin pain</a>, which affects 3-4% of women. Sometimes multiple surgeries are required to remove large portions of the mesh. The pain <a href="https://www.ncbi.nlm.nih.gov/pubmed/26506159">persists in as many as 25% of women</a>, even after mesh excision, and may become chronic and disabling. Some find it difficult to maintain employment and intimate relationships. </p>
<h2>What regulatory bodies did</h2>
<p>Following reports of these complications, the <a href="https://www.fda.gov/downloads/medicaldevices/safety/alertsandnotices/ucm262760.pdf">US Food and Drug Administration</a> (FDA) <a href="http://www.mdedge.com/obgmanagement/article/63461/fda-alert-transvaginal-placement-surgical-mesh-carries-serious-risks">issued alerts</a> in 2008 and 2011 that the mesh carried serious risks. Many transvaginal mesh kits were voluntarily removed from the market. Most doctors in Australia stopped using the mesh for prolapse from 2012.</p>
<p>While the evidence of the benefits of the mid-urethral sling for urinary incontinence is overwhelming, <a href="http://journals.lww.com/co-urology/Abstract/2004/11000/Trans_obturator_tape_procedure____inside_out_or.3.aspx">some changes to the tapes</a> were introduced from 2005 to decrease adverse events. The TGA approved these new mini-slings (or obturator slings) and specialists used these without evidence confirming whether they were safer or more effective than the traditional mid-urethral sling.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/172354/original/file-20170606-16849-6hfs7h.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/172354/original/file-20170606-16849-6hfs7h.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/172354/original/file-20170606-16849-6hfs7h.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/172354/original/file-20170606-16849-6hfs7h.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/172354/original/file-20170606-16849-6hfs7h.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/172354/original/file-20170606-16849-6hfs7h.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/172354/original/file-20170606-16849-6hfs7h.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/172354/original/file-20170606-16849-6hfs7h.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
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<span class="caption">Disabling vaginal and groin pain can be a complication of vaginal mesh implants.</span>
<span class="attribution"><span class="source">from shutterstock.com</span></span>
</figcaption>
</figure>
<p>In 2015, an <a href="http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD006375.pub3/abstract">extensive Cochrane review</a> showed 2-3% of women developed significant groin pain after surgery with the obturator slings. It also showed the obturator slings were not as effective as the traditional slings at the five-year mark. But the obturator slings were quicker to perform and had less bladder injury than the traditional mid-urethtral slings. </p>
<p>In 2016, specialist groups such as the Urogynaecology Society of Australia and the Australian College of Obstetricians and Gynaecologists undertook <a href="http://www.ugsa.org.au/data/MUS_Presentations/3.UGSA_MUS_SUI_treatment_Read-Only.pdf?COLLCC=3602805463&">educational courses and later issued statements</a> cautioning doctors about using the new slings.</p>
<p>Many of the affected women have asked how procedures could be performed on them when the full benefit-to-risk profile of the intervention was not yet known. It can be argued doctors wanted to provide new and better options. But, in hindsight, innovation and patient safety could have been far more closely aligned. </p>
<p>This could have been achieved if both the TGA and the specialists themselves had more thoroughly evaluated transvaginal meshes by ensuring these were used under the oversight of medical ethics committees. The well-established practice of performing large trials under the guidance of an ethics committee encourages innovation while ensuring patients are properly informed of the possible benefits and risks of the innovation. </p>
<p>While some Australian hospitals took this precautionary step, the fact it did not happen uniformly is a collective failure of both the TGA and specialists. </p>
<h2>Next steps</h2>
<p>The Senate review will evaluate how sponsoring manufacturers interact with doctors performing surgical interventions, and how the broader medical community and public are educated about new interventions. </p>
<p>It is hoped the inquiry will inform the general community, doctors and industry of a clear and transparent pathway that balances the need for innovation and the responsibility for protecting patients.</p>
<p>Finally, while waiting on the inquiry’s deliberations, women should remain confident mid-urethral slings used for stress incontinence are an excellent intervention. Those undergoing prolapse surgery should also be reassured that highly trained specialists will carefully evaluate and perform surgery without the need for transvaginal mesh. </p>
<p>Those affected by ongoing complications associated with transvaginal mesh can be reassured Australian specialists are leaders in the management of these problems. Not only were we among the first in the world to report large trials that evaluated transvaginal mesh, we’ve also reported on the safety, technique and efficacy of mesh-removal procedures for vaginal pain in peer-reviewed publications.</p>
<p>We are fully supportive of the women who have experienced complications of transvaginal mesh. We look forward to working collaboratively at a national and local level, under the auspices of the Senate enquiry, to ensure we learn from the mistakes made when introducing transvaginal mesh into clinical practice. </p>
<hr>
<p><em>Further information is available on the websites of the <a href="https://www.ranzcog.edu.au/Womens-Health/Patient-Information-Guides">College of Obstetricians and Gynaecology</a> (RANZCOG) and the <a href="http://www.ugsa.org.au/pages/patient-information.html">Urogynaecology Society of Australia</a> (UGSA).</em></p><img src="https://counter.theconversation.com/content/78605/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Christopher Maher does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>Regulatory bodies approved some medical devices to treat pelvic organ prolapse and urinary incontinence before having data to prove their safety and efficacy.Christopher Maher, Associate Professor, Urogynaecology Royal Brisbane and Women's and Wesley Hospitals Brisbane, The University of QueenslandLicensed as Creative Commons – attribution, no derivatives.