STATE and federal health bodies were urged to audit a NSW private hospital, and find injured women, one year before primary school teacher Alison Blake took her own life after devastating complications following pelvic mesh surgery at the hospital.
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Between June and September 2014 a pelvic mesh patient advocate urged NSW Health, the NSW Medical Council, the NSW Health Care Complaints Commission and the federal medical device regulator, the Therapeutic Goods Administration, to urgently investigate the hospital where a doctor with an “extensive” complaint history was implanting a device that was cancelled by the end of 2014 because of lack of evidence it was safe to use.
The state and federal bodies were told possibly 100 or more women were implanted with modified versions of the device; injuries to patients were not being reported to authorities; women were undergoing multiple surgeries after complications and “the full extent of patient injury and device failure will not be known without proper investigation”.
“A full clinical audit of (pelvic mesh) surgeries at the hospital needs to be conducted by the Department of Health, as there are likely many more patients out there,” a complaint to the regulators in 2014 said.
Mrs Blake died in June, 2015 only two weeks after a specialist confirmed she would have to self-catheterise for the rest of her life and there was little that could be done to address her severe, permanent and disabling pain.
Mrs Blake’s daughter, Leesa Tolhurst, wept on Thursday after learning authorities were made aware of the need to find injured women like her mother, one year before Mrs Blake took her own life after she was implanted with the problem mesh device at the hospital in October, 2013, by the doctor with the “extensive” complaint history. The device was cancelled in November, 2014.
Do they even recognise they have a duty of care to the women? If you’re cancelling a device that’s already been put in people you should find out what’s happened to them.
- Leesa Tolhurst
In a final letter to her daughter Mrs Blake, 64, said she could not bear the thought of leaving Ms Tolhurst but “the emotional torment and physical pain I’m going through are just too much”.
“I simply cannot bear to be lying on a couch for months on end and to have to rely on catheters, enemas, Temazepam, pain killers and be a burden to my family and friends,” she wrote.
Ms Tolhurst said her mother went from doctor to doctor in the final 16 months of her life, unsuccessfully seeking help for her mesh injuries. She was unaware of the more than 100,000 women worldwide who were taking legal action after mesh surgery, including many in Australia.
“I’m sitting down because I’m in shock,” Ms Tolhurst said.
“People in positions where they could and should have done something to find and help women like my mother just didn’t. They didn’t respond to that appeal for a full audit to find out how many women were left with terrible injuries. I just think that’s the cruellest thing of all.
“Do they even recognise they have a duty of care to the women? If you’re cancelling a device that’s already been put in people you should find out what’s happened to them.
“She would have wanted so much to hear from someone in authority to acknowledge that what happened to her was wrong.
“They shouldn’t just have cancelled the device and then nothing else. It’s just like trying to sweep it under the rug really quickly and not draw attention to the damage that’s been done.”
A NSW Health spokesperson said the department “deeply regrets” the pain and suffering Mrs Blake experienced from pelvic mesh complications.
A NSW Health taskforce established in July 2017, and chaired by NSW chief health officer, Dr Kerry Chant, is “coordinating a state-wide response to issues arising from the use of transvaginal (surgery through the vagina rather than the abdomen) mesh for pelvic organ prolapse”, the spokesperson said.
The statement did not refer to a state response to issues for women who received the “gold standard” incontinence mesh slings, who have also experienced severe and disabling complications.
A Therapeutic Goods Administration spokesperson said the regulator “does not have the powers to undertake audits of clinician or health facilities” and the Australian Health Practitioners Regulatory Agency was responsible for investigating complaints about health practitioners and health service providers.
Lifeline: 13 11 14.