AUSTRALIA’S medical device gatekeeper and peak health regulator only listed 30 serious complications linked to women’s pelvic mesh surgery for the first time in 2016, more than two years after requiring manufacturers to provide evidence to back mesh devices, and after a meeting with women suffering mesh complications.
The Therapeutic Goods Administration (TGA) website carried the list in a public statement in August that acknowledged complications involving mesh devices are “most likely under-reported” and “some patients may not realise their symptoms are associated with an adverse event”.
The acknowledgement appeared eight years after an expert committee advised the TGA that mesh erosion into women’s vaginas and rectums were “common adverse events with these types of devices”, and 13 years after Newcastle Dr Alan Hewson and Brisbane Dr Chris Maher warned that a mesh device procedure “cannot be recommended” because of complications and lack of supporting evidence of safety and efficacy.
It also came as estimates of the global cost of mesh legal cases could reach $20 billion.
The TGA’s response has been slammed by Australian Pelvic Mesh Support Group founder Caz Chisholm as “too little, too late”, after telling the Newcastle Herald that women were treated as “guinea pigs, we just didn’t know until it was too late”.
“The women who went to that meeting used their own money to get to Canberra. Women in the group donated money to pay for my flight and the women's accommodation,” Ms Chisholm said.
“If it were not for the women contributing financially and being there for each and every one of us, we would not have had that meeting.
“The TGA have ignored women's phone calls about their complications, they have not responded in a timely manner. They told us they would put out a media campaign to let women know that their complications may be mesh related, and yet all they did was put the complications list on their website where no woman can find it and no general practitioners know about it.
“The complications list has not been broadcast Australia-wide at all and women are still being treated like hypochondriacs at the appointments because this TGA alert is not known to the medical community.”
The TGA have ignored women's phone calls about their complications, they have not responded in a timely manner.
The TGA warned that transvaginal mesh – implanted via the vagina to treat incontinence or prolapse problems after childbirth – could cause punctures of vessels, nerves, structures or organs, including the bladder, urethra or bowel and requiring surgical repair; serious infection; mesh tape rejection; erosion into the vagina or rectum; chronic pain; painful sexual intercourse for women and their partners; permanent lower urinary tract obstruction; acute and chronic pain in the groin in the legs, pelvis and abdomen; vaginal discharges; bleeding and defecation dysfunction.
In the public statement the TGA urged patients and health professionals to report complications with the devices to the TGA’s incident reporting and investigation scheme, despite mesh device manufacturers having a mandatory requirement to report complications.
Between July, 2012 and June, 2016 the TGA received 99 adverse event reports involving transvaginal mesh devices, with pain and mesh erosion into organs including the vagina and rectum as the most frequent complaint.
During the same period 450 women registered as part of a class action run by Shine Lawyers against Johnson and Johnson over incontinence and prolapse devices sold on the Australian market, another 300 women have registered for a class action against American Medical Systems, and many more have taken, or are taking, action against other manufacturers because of mesh complications.
In August, 2013 an expert panel advising the TGA on pelvic mesh devices after tens of thousands of women around the world initiated legal cases alleging complications, said there was “recognition of significant under-reporting” of complications in Australia, in a system that relied on manufacturers to make mandatory reports.
The TGA estimated it only received 10-20 per cent of all adverse events following transvaginal mesh surgery and expert panel members were aware “that company representatives aren’t reporting all complications to the TGA”.
The expert panel advised that “surgeons do not have a strong awareness of Australia’s adverse event reporting systems”. The TGA “only has the legislative power” to require manufacturers, but not doctors, to report complications and adverse events.
“It was noted that with mandatory reporting by (manufacturers) and spontaneous reporting from other sources, it is not possible to determine an incidence rate from adverse event reports,” minutes of an expert panel meeting advising the TGA on transvaginal mesh devices said.
The Herald has put a list of questions to the TGA about its adverse events reporting system and what action, if any, it took against manufacturers where there was evidence they had not reported complications involving their products.