AUSTRALIA’S peak health regulator has not pursued the prosecution of a single pelvic mesh manufacturer for failing to report serious injuries to women despite at least 1000 known serious injury cases linked to mesh, criminal sanctions if a manufacturer fails to report, and a 2013 report acknowledging the regulator “only receives 10-20 per cent” of all adverse events.
The Therapeutic Goods Administration (TGA) has outraged Australian Pelvic Mesh Support Group founder Caz Chisholm and mesh victim Gai Thompson after urging women and doctors to report serious injuries, and advising the Newcastle Herald it “did not receive any material evidence to enable investigation of a manufacturer”.
This is despite advice from a specialists’ working group to the TGA in 2013 that while “the reporting of adverse events is mandated for manufacturers”, there was “awareness that company representatives aren’t reporting all complications to the TGA”.
Under the Therapeutic Goods Act it is a criminal offence for a manufacturer not to report to the TGA within 30 working days of becoming aware of an adverse event, with penalties of up to 12 months’ jail and fines of up to $180,000. Manufacturers are the only mandatory reporters of medical device adverse events under current legislation.
“Women have reported their injuries and the TGA has done nothing, and now they’re putting responsibility for their failure to act back onto the injured patients,” Ms Chisholm said.
“I think it’s disgusting what they’ve said because they’re responsible for allowing these devices to be used, they’re responsible for not acting when women reported their injuries, and they’re responsible for not prosecuting these manufacturers who are the only ones with a mandatory responsibility to report adverse events.
“They’re leaving it up to women to sue the manufacturers directly, and they’ve done nothing.”
I think it’s disgusting what they’ve said because they’re responsible for allowing these devices to be used, they’re responsible for not acting when women reported their injuries, and they’re responsible for not prosecuting these manufacturers who are the only ones with a mandatory responsibility to report adverse events.Australian Pelvic Mesh Support Group founder Caz Chisholm
The TGA confirmed “there have been no criminal or civil penalty proceedings against any transvaginal mesh manufacturers for failing to report an adverse event” in response to Herald questions about what action the TGA took after a 2013 report raised serious questions about the failure of the medical device complaints process to respond quickly, despite warnings about transvaginal mesh devices from as early as 2003.
The devices are used to treat prolapse complications after pregnancy and birth with surgery through the vagina rather than the abdomen.
The August, 2013 urogynaecological devices working group report, released after a freedom of information application, noted that by 2008 the TGA knew that symptoms linked to transvaginal mesh surgery, including erosion of mesh into the vagina or rectum, were “common adverse events with these types of devices”.
The TGA acknowledged the number of device incident reports on transvaginal mesh was “small, considering the number of mesh devices supplied to the Australian market”, while the “potential adverse effects of surgery and mesh exposure on the bowel, bladder and sexual function are considerable and serious”.
“It was noted that there was recognition of significant under-reporting (of adverse events) for all products, with the TGA estimating it only receives 10-20 per cent of all events,” the working group noted.
The working group of specialists advised the TGA that “surgeons do not have a strong awareness of Australia’s adverse event reporting systems”.
In response to questions from the Herald the TGA said it was the Office of the Commonwealth Director of Public Prosecutions’ responsibility to prosecute alleged criminal offences against Commonwealth law.
“In the case of transvaginal meshes, the TGA did not receive any material evidence to enable investigation of a manufacturer for not providing the TGA with the required adverse events data. The TGA needs to have in its possession sufficient facts and evidence behind an allegation to enable an investigation to commence,” the TGA said.
The response outraged Gai Thompson, whose complaint in writing to the TGA in October, 2011 about serious and permanent complications following mesh surgery in 2008 that made her life “a living nightmare”, was not responded to until October, 2014, when the TGA advised “an investigation into the incident you reported… is now complete”.
The TGA thanked Mrs Thompson for her “support of the Medical Device Incident Report Investigation Scheme”, and noted her incident summary would be included on the TGA’s database.
“I wrote to them. I made so many phone calls to them and they were so rude and so dismissive of what I was saying. They don’t care,” Mrs Thompson said.
“They’re supposed to be the regulator. They’re supposed to be the ones protecting the public but they’ve done nothing, and now they’re trying to say we should have reported. We did report, but it’s not up to us. Why is it up to the women who are the victims of this whole thing to be the watchdog as well?”
Mrs Thompson said she was aware of the TGA and the adverse event reporting system because of a previous medical incident involving her mother.
“How on earth are average members of the public supposed to know about a system that relies on the victims to report when things go wrong?” she said.
Ms Chisholm said she hoped a Senate inquiry on transvaginal mesh that is taking submissions until May 31, and expected to hold public hearings across the country by mid-year, includes questions about the adverse report system that leads to change.
“The manufacturers and the doctors have vested interests in mesh surgery so they’re not going to report adverse events, and so it’s left up to the women,” Ms Chisholm said.