THE state’s health watchdog has sharpened its focus on investigations relating to Australia’s unfolding women’s prolapse mesh disaster after serious complaints, including that a doctor allegedly falsely claimed he had ethics approval to conduct a mesh device study at a major public hospital.
NSW Health Care Complaints Commission executive officer Kathryn Borkovic confirmed on Thursday that the commission is investigating complaints made against a number of doctors following their use of transvaginal mesh devices during women’s prolapse surgery.
The complaints from patients and at least one doctor include that women did not give informed consent to have mesh devices implanted, were not warned of alternatives available, were not adequately warned of the risks involved, were not warned of the risks of different types of transvaginal mesh, and were left with serious and permanent injuries that often required multiple follow-up surgeries.
Ms Borkovic declined to respond to specific questions about the HCCC investigations.
“These investigations are ongoing and to protect the integrity of the investigations the commission is not proposing to provide more detailed information at this stage,” she said.
Medical Error Action Group founder Lorraine Long said it was appropriate to refer to the mesh device “disaster” because of the failure of regulators in Australia and overseas to adequately assess the devices, monitor problems and respond quickly.
The Therapeutic Goods Administration’s admission its assessment of the mesh devices from 2003 was not “mature” and lacked rigour was not a surprise, Ms Long said.
“That says everything, doesn’t it? It’s not good enough,” she said.
A federal Review of Medicines and Medical Devices Regulation in March 2015 found while the Therapeutic Goods Administration had an excellent reputation for ensuring high quality and safe medicines on the Australian market, its “performance in respect of devices is less notable”.
