AT least 40 Hunter women suffering serious and chronic conditions after genital implant surgery could join a legal class action against pharmaceutical giant Johnson & Johnson.
The Hunter women are among 400 Australian women seeking damages after Australian and US regulators this year severely restricted the use of 60 or more mesh genital implant devices after years of controversy.
‘‘The mesh is an absolute disaster, there’s no doubt about it,’’ said Buttaba woman Janet Scaysbrook, who had mesh surgery in 2011 but had the mesh removed this year after serious complications.
‘‘I could feel my life shutting down, and now we find out all these women are suffering because of it.’’
Mesh devices in the form of tapes or slings are used to repair prolapses, where organs including the bowel or bladder protrude into a woman’s vagina. Prolapses affect about 20per cent of women, most commonly after childbirth, and can lead to devastating symptoms including urinary and faecal incontinence.
But increasing alarm about high rates of serious complications including haemorrhaging, infection, severe pain, mesh rejection and erosion prompted the US government’s Food and Drug Administration and the Australian government’s Therapeutic Goods Administration to act this year.
Both have called for mesh manufacturers to provide clinical studies showing mesh products are safe and beneficial for women.
The Food and Drug Administration is considering upgrading mesh devices from medium to high risk, and in August the Therapeutic Goods Administration found that though mesh devices might be of benefit to a restricted group of patients, ‘‘there is little evidence to support the overall effectiveness of these surgical meshes as a class of products’’.
The Johnson & Johnson class action launched by Shine Lawyers involves just one group of mesh devices. So far, 25 Hunter women have joined the class action, and 15 more are considering it.
They include Wallsend woman Trish Sara, who had part of her bowel removed following prolapse surgery in 2008.
Shine Lawyers solicitor Rebecca Jancauskas said the number of Hunter and Central Coast women who would join the action would probably increase, in a class action the firm believed could become one of the biggest in Australia.
At least 40,000 women have had mesh implant surgery for prolapses and urinary incontinence.
‘‘There’s an unacceptably high rate of complications, and an unacceptably high number of women need to have surgery to correct or remove damage the implants have caused,’’ Ms Jancauskas said.
Legal firm Maurice Blackburn has a separate case against US manufacturers of another group of mesh devices, and Australian women are increasingly seeking damages from doctors after failed mesh surgery.
Four women are taking legal action against suspended former University of Newcastle associate professor and gynaecologist Dr Richard Reid after mesh surgery, and at least one woman has completed a mesh case against him.
His suspension followed promotion on his website of a ‘‘type of implant’’ to treat prolapses that carried ‘‘no risk of morbidity nor complication’’. His suspension prompted a wave of anger from women in support of Dr Reid, who had helped them by removing mesh implants that had failed after surgery by other specialists.
In an email in response to questions this week, Dr Reid wrote: ‘‘Am not a god and certainly not a monster. Have tried my best with difficult cases all of my career. In particular, I have spoken against the often poorly thought out use of mesh in the repair of prolapse.’’
Sydney University gynaecology and obstetrics professor Peter Dietz said the controversy about mesh implant devices failed to acknowledge the need for better treatments for the large number of women who experienced prolapse in their lives.
JANET Scaysbrook was one of the last women operated on by Dr Richard Reid before the NSW Medical Council suspended him in July, and one of the first to rush to his defence.
‘‘I don’t have the words to truly express my gratitude to him for giving my life back to me,’’ said Mrs Scaysbrook, who was treated by Dr Reid at the Sydney Private Hospital in April after the failure of previous prolapse mesh surgery by another gynaecologist.
‘‘In suspending Dr Reid the medical council has denied numerous women in Australia the opportunity to be rescued from disastrous life-destroying medical situations,’’ she said.
But while many women responded angrily to Dr Reid’s suspension, others contacted the Newcastle Herald to say they were relieved the NSW Medical Council had acted.
‘‘There was no informed consent for what he did to me,’’ said a Sydney woman who received mesh implants during surgery by Dr Reid in 2010 and 2011.
‘‘I’ve had severe adverse reactions. I’ve been advised I’m not going to be able to give birth naturally because of the surgery, and I still have mesh in me.’’
Dr Reid has denied the allegations.
The lead plaintiff in the Australian case against Johnson & Johnson, Julie Davis, alleged the mesh devices came on the market without proper clinical trials. The issue was a ‘‘real can of worms’’.
Ms Davis had her original surgery in 2008, and experienced severe complications.
‘‘I can fly the flag with the class action, on behalf of so many other women out there, but I have my moments when I get very, very angry about it all,’’ she said.
A NEWCASTLE specialist has complained about the lack of ‘‘rigorous constraints’’ controlling new medical devices, when compared to drugs, after a woman nearly died of excessive blood loss linked to mesh implant surgery.
The specialist warned the Therapeutic Goods Administration an approved suture device used in prolapse surgery was unsafe after a woman suffered a severe haemorrhage last October.
The woman, 66, who was to undergo mesh implant surgery after two previous prolapse repairs, has complained to the Health Care Complaints Commission, after her family was told she might have died when her organs started shutting down because of the blood loss.
‘‘I do not want this to happen to any other person and this is the one and only reason I have in making this complaint,’’ the woman wrote in a complaint to the commission.
‘‘The operation went dramatically wrong as I was on the operating table for about nine hours due to severe bleeding.’’
The woman spent nine days in intensive care after the failed attempt at mesh implant surgery, before she required further emergency surgery on her bladder and uterus.
In a letter to another doctor on October 24 last year the specialist wrote of ‘‘trialling a new suture driver’’ during the woman’s surgery.