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PELVIC MESH SENATE INQUIRY REPORT RELEASED

The Senate Committee inquiry into pelvic mesh has released its report following its year-long deliberations. The Committee made 13 recommendations including mandatory reporting of adverse effects on women, more information about the risks of implants, and better training for doctors and surgeons.

Since February 2017, the Senate Community Affairs References Committee has considered more than 550 submissions from patients, surgeons, medical device companies, regulators and other stakeholders. The Committee also held five public hearings across Australia, hearing testimony from a number of stakeholders, including from women who bravely shared their stories of experiencing complications from their treatments.

The Committee recognised both the complexity of the conditions – stress urinary incontinence and pelvic organ prolapse – and treatment options available to clinicians and acknowledging the many Australian women whom have benefited from procedures involving transvaginal mesh products.

The Medical Technology Association of Australia (MTAA) and some of its member companies also testified before the committee, acknowledging the pain and suffering experienced by the women who had testified before the Committee, but also reiterated its agreement with groups representing medical professionals, that the products remain important treatment options.

Urogynaecological Society of Australasia (UGSA) Chair, Dr Jenny King, said the Committee’s recommendation that all mesh devices should be used as a last resort would affects women’s options for care by limiting access to the safest and most effective surgical treatment for urinary incontinence, the mid-urethral slings.

“This decision is one of the most retrograde steps in the history of modern surgery. It simply disregards sound scientific data,” Dr King said.

Australian Medical Association President, Dr Michael Gannon, added that not all women had problems with the devices.

“It [the report] fails to recognise the massive number of women who have benefited from mid-urethral sling operations,” he said.

The MTAA’s CEO, Ian Burgess, said the industry body is committed to working with the Government as it considers its response to the Committee’s report.

“Registries can be invaluable but they are complex and expensive. We need to ensure that when we set up a registry we’re very clear around what data is being collected and the extent of that data,” Mr Burgess said.

“Further, in terms of the cost of registries, we need to ensure all those that benefit pay for it – including regulators, healthcare professionals, insurers, hospitals and policy makers.

“The Committee also recommends the Department of Health work with MTAA and the Medical Board to review systems in place to support consistent, high ethical standards. The report notes the evidence of MTAA and member companies that no financial or other incentives have been provided to medical practitioners to use or promote transvaginal mesh implants, and that members of MTAA are bound by a Code of Practice that sets high standards for ethical interactions with healthcare providers.

“Should the Government accept this recommendation, we look forward to working with the Department. A key reform would be the implementation of a harmonised industry code of practice which all device manufacturers and suppliers are required to adhere to by law or regulation. The MTAA Code of Practice would be an appropriate basis for such a harmonised code.”

PulseLine understands the Government will be looking to complete its response by the end of November.

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