Australian Investigation into Transvaginal Mesh Leads to Trials and Senate Inquiry
Mesh Medical Device News Desk, March 16, 2017 ~ Unlike the U.S. media, Australian media is reporting on its transvaginal mesh debacle with citizens leading the charge.
Transvaginal mesh devices seem to be front page news overseas.
Joanne McCarthy writes for the Newcastle Herald, located about 100 miles north of Sydney, Australia. The paper is in the midst of a series of aggressive investigative reports on the gaps in Australia’s health regulatory systems.
That has helped galvanize the efforts of the Australian Pelvic Mesh Support Group and bring forward the voice of the injured. The reports have also highlighted the huge gaps in any safety net to assure patient safety.
An estimated 100,000 women in Australia have been implanted with transvaginal mesh. More than 40 mesh devices for prolapse surgery were eventually cleared for use in Australia.
The Australian process for medical device approval mirrors that established by the U.S. Food and Drug Administration (FDA), that is cleared for marketing with no clinical evidence supporting safety and efficacy.
As a result of the publicity and patient activism, Australia is taking some action.
The Australian Pelvic Mesh Support Group initiated a Senate inquiry into the mesh scandal in Australia. It is taking submissions until May 31 and a public hearing will take place mid-year with a report expected in November.
On July 4, 2017, Shine Law in Australia is representing about 450 women in a class action against Johnson & Johnson which could run up to six months.
It will be one of the largest medical civil actions in Australia.
A second class action involving 300 Australian women will be launched against American Medical Systems, maker of the Perigee and Apogee.
McCarthy’s Reports Include:
“Transvaginal mesh devices have left many women with permanent injuries.”3/14/17
A 2013 paper titled “The Transvaginal Mesh Decade” was written by Associate Professor Chris Maher. He blames the U.S. Food and Drug Administration and regulators in Australia for clearing transvaginal mesh devices without evidence of safety and efficacy.
“Pelvic mesh victim in the dark about mesh implant for nearly a decade” (here) 3/15/17
Lynda Garling didn’t even know she had been implanted with transvaginal mesh in 2004. She lost her business after being treated for a cluster of symptoms and pain. Here is a video that accompanies the story. Lynn Garling said “I feel like I’d been raped.”
“Dr. Peter Petros said he warned women about the ‘very frightening’ symptoms of his procedure” 3/15/17
In a 2004 court action in Western Australia Dr. Peter Petros, who brought one mesh to Australia, testified that women could experience a disgusting yellow discharge following an implant. That was “how the operation works” was offered as an explanation. The 45-year-old woman, who sued him, was awarded more than $136,000 as compensation.
Dr. Petros performed the first prototype IVS operation in Perth and in 1990 he filed for the IVS-Tunneller patent. Dr. Petros collaborated with the late Dr. Ulf Ulmsten to develop the midline IVS operation. He was compensate $15 per instrument of the IVS Tunneller he performed at about 400 per year, according to the inquiry. The story outlines his attitude toward the pelvic surgery and its associated complications.
In Australia just one company, the Adelaide firm TFS Manufacturing sold more than 15,700 devices from 2006. In November, 2014 TFS became one of the first mesh devices in the world to be deregistered after failing to provide evidence of its safety.
“Newcastle doctor and Queensland colleague sounded alarm on mesh in 2003” 3/14/17
Two doctors who wrote a paper in 2003 sounding the alarm about pelvic mesh procedures after treating women injured by the products seen in Germany and Switzerland as well as Australia.
The publicity is not limited to print. Radio show 2HD Radio Newcastle has broadcast two high profile interviews.
- A radio host calls the mesh debacle, “The biggest medical scandal since Thalidomide.” 2HD Radio Newcastle interviewed the founder of the Australian Mesh Support Group founder Caz Chisholm. Chisholm had her mesh removal in St. Louis by Dr. Veronikis.
- Senator Derryn Hinch is interviewed (here) by 2 HDRadio says because the word “transvaginal”, the media won’t touch it. Here is his testimony to the Senate, The Age newspaper, Women are, “kept in the dark like mushrooms, fed bullshit.”
The Newcastle Herald Inquiry
The newspaper finds the IVS Tunneller was tested on 13 large dogs in Western Australia in 1987. It became the first transvaginal mesh used in Australia beginning in 2001.
Associate Professor Chris Maher blames regulators in the U.S. as well as his country. The IVS Tunneller was cleared by the FDA in 2001 to treat prolapse in women. Using the 510(k) substantially equivalent standard it served as a predicate for a proliferation of prolapse mesh devices for the next decade.
Referring to the period from the 1980s to the 1990s, any safety measures suffered a system failure he says in his 2013 report, The Transvaginal Mesh Decade.
While regulators were asleep, doctors provided an even bigger gap in the safety net.
Instead of protecting patients, doctors were ready and willing to hear the “aggressive marketing” messages from manufacturers and were largely silent. Surgical techniques were taught and developed by the manufacturers of the products and the lessons disseminated by key opinion leaders.
The ever-widening hole in any safety net is blamed on Australia’s version of the FDA, the Therapeutic Goods Administration (TGA). It was not able to share the percentage of women suffering adverse events after their mesh surgery.
The second mesh device used in Australia was the Tension-free Vaginal Tape or TVT, which resulted from a collaboration between Dr. Peter Petros and the late Dr. Ulf Ulmsten of Sweden, who developed TVT and sold it to Johnson & Johnson.
The TGA estimates it only receives 10% to 20% of all complication reports associated with mesh, largely because surgeons are not aware of that country’s adverse event reporting systems. ###
Here is the 510(k) FDA Summary of the Covidien IVS Tunneller
IVS Tunneller trademark details
History of IVS Tunneller
Korean J of Urology Mar 2006 IVS for patients
Maher writes about this in his 2013 paper titled “The Transvaginal Mesh Decade.”
Mesh News Desk, August 2016 ~ TGA Urges women to report Mesh Adverse Events,
Mesh News Desk, October 15, 2012 ~ Australia’s Vaginal Mesh- Largest Class Action in History?
Mesh News Desk, March 6, 2012 ~ Australia’s Version of FDA Lax on Medical Device Safety
Mesh News Desk, July 12, 2016 ~ Mesh Mess- Banner Pelvic Mesh receives New Life as a Breast Lift
TFS tissue fixation system made by TFS Surgical of Adelaide Australia, created by Dr. Petros in collaboration with the late Dr. Ulf IUlmsten, MD.