ONE of Australia's most senior health bureaucrats is under fire for repeatedly using his phone during an emotional presentation by pelvic and hernia mesh victims at a forum where the Morrison Government was slammed for its response to a series of medical device scandals.
Department of Health deputy secretary Professor John Skerritt used the touchscreen on his phone during a 30-minute film presentation that included a woman saying she was in constant pain and "totally incontinent, living in urine-soaked pads", and another saying "We've lost our mental health, our physical health and many of us contemplate suicide every day".
Professor Skerritt's phone use angered women who wept during the presentation, only minutes after Greens Senator Rachel Siewert cried during a Skyped speech while talking about the impact of devastating submissions by pelvic mesh victims to a Senate inquiry she chaired in 2018.
Nicolle Germano, whose pelvic mesh surgery in 2013 has left her with severe, permanent injuries requiring self-catheterisation every four hours, said she was gobsmacked to see Professor Skerritt beside her "with his head down and his phone in his lap" repeatedly through the film, or reading notes for a speech he delivered after the presentation.
"I was blown away. It was unbelievable he did not give the most important part of the day his full attention. I'm pretty hardened but hearing the stories of all those people so badly affected by mesh really hurt me, and he didn't even look up for a lot of it," Ms Germano said.
"I was in tears and he was doing things with his phone. I thought 'You didn't even hear that'. That's what it's been like for years - mesh victims trying to get people in the health system to listen."
In his speech Professor Skerritt said it was "very important for us to hear directly from individuals who have had adverse effects with medicines and devices and to hear their personal stories" to make sure products on the market "are as safe as possible".
In response to questions about the phone use a Department of Health spokesperson said Professor Skerritt had "special dispensation" to appear at the forum rather than Budget Estimates, but he was "required to provide support to those attending on his behalf".
"After international developments overnight on Thursday, urgent planning was required for a meeting of the TGA's breast implant expert reference group - being held (on Monday) - to discuss macro-textured breast implants," the spokesperson said.
"A number of other media enquiries and briefing requests also required Professor Skerritt's urgent attention. Professor Skerritt cleared his schedule as much as possible to attend the forum, where he recognised the serious impacts on the women who were affected and the need for the health system to work together to address the issue of mesh injuries.
"Professor Skerritt has reassured those who attended the forum and other affected women that the TGA is totally committed to ensuring that the regulation of medical devices protects the health and wellbeing of all Australian women."
The phone use on Friday was only hours after Professor Skerritt revealed a medical device national action plan, headed "The safety of Australian patients comes first", was developed in 2018 but not released until last Thursday, on the eve of a federal election where health is a key issue, because "politicians decide when things go out".
The plan aims to improve how devices get on the market, strengthen monitoring and "significantly improve" transparency about device approvals, after sustained criticism of device regulator, the Therapeutic Goods Administration, following a series of scandals, including pelvic mesh device approvals that have left some women with catastrophic injuries.
The action plan's release also follows a Department of Health report in the European Medical Journal in January showing only an estimated 0.5 per cent of adverse events involving implanted medical devices are reported to the TGA under a risk alert system that has operated for more than two decades.
The device action plan was announced on the first day of a forum in Melbourne organised by health consumer groups from across Australia aiming to make health system reforms a federal election issue.
Professor Skerritt told mesh-injured women that "much of the writing behind the action plan was done last year but we do not control when documents like that are released".
"I would have loved to have released that action plan ages ago but it's not my job and politicians decide when things go out," he said.
"It sounds like a cop-out but really, it's the same right across government."
Professor Skerritt said the TGA had discussed problems with the device adverse event reporting system "with all political parties", including making health care facilities and hospitals mandatory reporters of device adverse events.
"Governments have not had an appetite at any point in time, governments have not had an appetite to look at mandating the reporting by hospitals and health care facilities until the announcement this week and that's governments of both colour," Professor Skerritt said.
On Friday pelvic mesh and hernia mesh-injured people booed and jeered after a pre-taped film in which the Federal Government announced $2.3 million to fund a pelvic mesh registry for women implanted with devices in future.
A government spokesman told the forum he was "sorry for what has happened in the past" but was "delighted" to announce a $2.3 million registry "that we should always have had".
"So this is your moment, it's overdue recognition, but it's real action and it will protect women, it will protect their health and it will also protect their mental health. And it's an acknowledgement of that which has occurred in the past, on our watch, thanks to your work," the spokesman said.
"I want to thank you, I want to acknowledge the suffering of those who have suffered historic wrongs, but above all else it will give you a real note of hope that going forward this registry will help you and help us make a profound difference."
Forum participants booed, called the announcement "delusional", and strongly criticised the "This is your moment" comment.
"Our moment to be what, shat on again?" said Mesh Injured Australia Incorporated founder Justine Watson, who attempted suicide because of the severity of mesh device complications.
The government has not acted on a pelvic mesh Senate inquiry recommendation for a retrospective audit of an estimated 150,000 devices implanted in women since the late 1980s, after damning evidence that authorities have no firm data on how many women were implanted or have complications.
Injured women and health consumer groups say the audit is a "top priority" because stronger regulatory action can be delayed while accurate complication rates for different mesh devices remain unclear. Senator Siewert told the forum she was "disappointed" at the lack of action on a retrospective audit.
Two Newcastle women, who did not want to be named because of legal cases against a device manufacturer, said they were shocked and angered by Professor Skerritt's phone use during the film presentation, and despairing after the government spokesman's comments.
"The registry is for what happens in future, but what about financial assistance for everything we've already endured and have to endure in the future?" said one of the women.
"It's too late for so many of us. They're convinced there's just a few mesh-injured people because doctors have told them that, but they don't know and they don't want to know because then something would have to be done about it."
The TGA has not initiated criminal or civil penalty proceedings against any pelvic mesh manufacturers, despite manufacturers being the only mandatory reporters of device adverse events, and confirmation only a fraction of adverse events have been reported to the regulator over the past two decades. The TGA has only initiated criminal proceedings against four medical device manufacturers in the past decade.
Professor Skerritt told a forum event it was "very easy" to explain the lack of criminal proceedings against device manufacturers because "in order to prosecute a company in a criminal way you have to provide.. that there's been deliberate withholding of evidence by companies".
He said it was a failure of the legislation that more legal cases had not proceeded.
Professor Skerritt told the forum the TGA had only recently obtained powers to increase monitoring of drug manufacturers, but the increased powers did not extend to device companies.
Extending the powers to medical devices was "a decision of whoever our political masters will be", Professor Skerritt said.