JAN Wise is a woman “rotting from the inside” – implanted with a high risk pig intestine pelvic mesh device in 2012 by a doctor with a history of botched surgery involving women in America.
The doctor – former Newcastle University Associate Professor Richard Reid – is the subject of complaints being prosecuted by the NSW Health Care Complaints Commission after a number of women alleged serious injuries following pelvic mesh surgery by him over nearly a decade.
The pelvic mesh implanted in Mrs Wise – Cook Medical Surgisis for women’s prolapse repair after childbirth complications – is still classified high risk nine years after it was cleared for use in Australia in 2008, and later promoted by Dr Reid as having “no mesh complication risk”.
Mrs Wise, 52, of northern Victoria, cannot speak of the devastating impacts of the mesh surgery on her life without sobbing.
“I try to wake up hoping the thoughts of the nightmare won’t take up too much of that day. I allow myself only one period of sadness and crying per day,” she said.
In an adverse event report in 2016 to Australia’s drug and medical device regulator, the Therapeutic Goods Administration (TGA), Mrs Wise said she can no longer have sex. She has back and leg pain and “shooting electrical shock pain from my lower body up through to my head”.
She advised the TGA she had suffered “permanent incontinence” since the surgery, her vaginal vault had collapsed and she had been diagnosed with a “putrid seroma”, or build-up of fluid in her pelvis, which caused “continuous pelvic discharge with a foul smell”. She lives with “the threat of timebombs” of further complications, she said.
“It’s a dreadful mess down there but I have to accept it’s now part of me. I’m no longer embarrassed by my health issues. I’ve accepted things that I can’t go back and change, but I can’t let the hurt just be buried and forgotten.”
Speaking in public about her pelvic mesh surgery, supporting the Australian Pelvic Mesh Support Group which demanded the TGA list 30 known mesh complications on its website in 2016, and making a submission to an upcoming Senate inquiry on transvaginal (surgery via the vagina rather than the abdomen) mesh devices and procedures, helped keep her going, Mrs Wise said.
Several specialists have told her they cannot provide further surgical options to alleviate the symptoms. One offered pain management. A major legal firm declined to take legal action on Mrs Wise’s behalf because the number of women implanted with Surgisis for prolapse in Australia was relatively small, the risks involved with legal action were high, and her case would not be “commercially viable”.
She no longer teaches people to drive, or rides a motorbike, or enjoys social events with her husband at a motorcycle club that was a significant part of their lives.
“I did not have any of these issues before being implanted with this product. Before the surgery I’d lost a lot of weight and I felt so fit and healthy. I had the surgery because of incontinence and I went to a doctor who was promoted as a women’s health expert. He told me he had done the repair procedure many hundreds of times and to him it was a simple fix,” Mrs Wise said.
“People were waiting to see me get well, but I didn’t get well. No one knew what was going on, and you can’t talk about what’s happened because it’s so awful and so private. I thought I was the only one.”
Asked about Mrs Wise’s surgery, Dr Reid said he had “no recollection of that and I don’t want to comment”.
No one knew what was going on, and you can’t talk about what’s happened because it’s so awful and so private. I thought I was the only one.Pelvic mesh victim Jan Wise
Dr Reid disclosed to a urogynaecological conference in April, 2011 that he had “received financial support from the manufacturer, developer, distributor of the Surgisis device”. He told the Newcastle Herald the support related to speaker’s fees at conferences.
In 2006 Cook Medical released a public statement in America claiming a “94 per cent success rate” for a version of Surgisis pig intestine prolapse mesh, based on “research conducted by Dr Richard Reid” in Australia.
Dr Reid said he had "no idea what they're relying on" to make the statement. He said he completed "audits" of his surgery and presented them at a conference, but only held "discussions" with Cook about his results. He said he was unaware of the 2006 Cook Medical statement.
In 2015 Cook Medical cited research by Dr Reid and other doctors, in an unsuccessful attempt to stop America’s medical device watchdog, the Food and Drug Administration (FDA), from reclassifying its transvaginal pig intestine meshes to high risk. The FDA found there was “no data” from randomised controlled trials with long-term follow-up to demonstrate clinical effectiveness, compared with conventional prolapse repair.
In September, 2011 Dr Reid had conditions placed over his practice that included the need to obtain valid informed consent for the surgery he performed, after a complaint to the NSW Medical Council from a woman who had Surgisis transvaginal mesh implanted by him.
In 2014 the NSW Medical Council suspended Dr Reid after further complaints from women, including at least two who were implanted with Surgisis mesh. The suspension was overturned after a NSW Civil and Administrative Tribunal appeal.
The NSW Health Care Complaints Commission is prosecuting fresh complaints against Dr Reid in the NSW Civil and Administrative Tribunal. The matter is listed for a directions hearing in April.
Dr Reid was suspended for three months by the Michigan Board of Medicine in 1998 and fined $10,000 after findings of ‘‘incompetence’’ following surgery on three women, leading to at least one substantial financial settlement.
The disciplinary actions were not carried out because Dr Reid returned to Australia in November, 1996 to resume work after more than a decade as a gynaecologist and obstetrician in America. Dr Reid told the Newcastle Herald he advised the then NSW Medical Board of the Michigan suspension when he returned to Australia.
The NSW Medical Board (which became the NSW Medical Council) did not become aware of the American board’s action against Dr Reid until 2006 after a complaint from an Australian patient, the Medical Council advised the Herald in a statement.
Under disclosure rules applying to doctors in 1996 Dr Reid was only required to complete a non-identifying questionnaire when he returned to Australia, that was filed with the Department of Health for statistical purposes. It was not until an amendment to the Medical Practice Act in 2000 that doctors were required to record if they had been suspended in Australia or elsewhere in the previous year, the Medical Council said.
It wouldn’t be appropriate for us to comment without all of the information about this specific case.Cook Medical
One of the American women in the Michigan Board case, who was 23 when she first saw Dr Reid in 1989, was awarded $7.6 million in a civil case after she was left with serious complications following eight surgical procedures. Dr Reid told the Board the surgical procedures were carried out as part of approved research.
The Herald understands the conduct of the US proceedings and decisions on settlements were made by Dr Reid's insurers.
A Cook Medical spokesperson said every patient’s case was unique and “It wouldn’t be appropriate for us to comment without all of the information about this specific case.”
In a submission to the FDA in 2015 Cook Medical said it sold 57 per cent of its devices outside America. A list of class actions underway in America showed 612 women had initiated legal action against Cook Medical for pelvic mesh devices, and 497 were on-going by February.
More than 100,000 American women have initiated legal cases against transvaginal mesh manufacturers, with 61,000 cases on-going. Many thousands of cases have settled with damages payments to women.
In Australia 450 women are registered in a class action against Johnson & Johnson over transvaginal mesh devices, that is listed to start in July and run for six months, with another 300 registered for a class action against American Medical Systems for its range of mesh devices.
The global legal bill for transvaginal mesh cases is predicted to be more than $20 billion.