Stephanie Smail reported this story on Tuesday, November 18, 2014 18:38:00 on ABC Radio National.
MARK COLVIN: More evidence has emerged about the potentially devastating side effects from products used to support weak pelvic floor muscles.
Last year, PM reported that hundreds of women had joined a class action against the medical giant Johnson and Johnson after they suffered painful complications from tape or mesh implants.
Now, Shine Lawyers are pursuing a class action against another manufacturer, American Medical Systems.
Stephanie Smail reports.
STEPHANIE SMAIL: Kirsty Ann Datar had issues with incontinence after the birth of her fourth child.
In 2005, a doctor recommended she have a surgical sling – or transvaginal mesh – implanted in her pelvis.
She started experiencing chronic pain about 12 months later.
KIRSTY ANN DATAR: And not really knowing why, finding I’m having post-menopausal bleeding. We were checking for things like ovarian cancer and things like that because some of the symptoms are very similar to ovarian cancer symptoms.
For me, a lot of the problem was just the absolute pain that I was in all the time, the exhaustion that was coming from, I’m assuming now from the toxicity and the autoimmune response and the foreign body reaction that my body was having to the mesh.
STEPHANIE SMAIL: After years of pain, a visit to a gynaecologist revealed the transvaginal mesh had eroded through the wall of her vagina. She says she had to fly to the United States to get it removed.
Shine Lawyers is investigating six pelvic mesh or tape products made by American Medical Systems, including Mrs Datar’s surgical sling.
Rebecca Jancauskas is a partner with the firm.
REBECCA JANCAUSKUS: These products are made of polypropylene. They’re implanted inside the pelvis, and these products have not performed as they should have performed, and they’ve caused an array of complications that have had devastating effects on women’s lives.
STEPHANIE SMAIL: She says Shine Lawyers is pursuing a class action on behalf of women who have received American Medical Systems products and suffered painful side effects.
REBECCA JANCAUSKUS: We’ve received inquiry from around 120 women that we have confirmed have received the implants that we’re currently investigating. We’ve received an additional amount of inquiry from probably 400 women, and we’re in the process of investigating what implants they have and discerning whether they have the implants that are the subject of this claim.
STEPHANIE SMAIL: In 2011, serious complications prompted the United States Food and Drug Administration to issue warnings about pelvic mesh.
But Kirsty Ann Datar says she wasn’t warned about the potential side-effects.
KIRSTY ANN DATAR: I certainly was not made aware of the fact that it was made out of polypropylene and that there were already, even back in 2005, from all the research I’ve done, already studies showing the complication rates. I had no idea about any of that.
Obviously I would never have gone through with it if I had have known.
STEPHANIE SMAIL: She says she hopes the class action will help other women who are suffering.
KIRSTY ANN DATAR: For me, it’s about helping the other women that are out there, who, like me, didn’t know or aren’t sure that the mesh is causing the problems that they are having in their life.
I gave up work a few years ago because I just could not keep it up and I didn’t know at the time it was because of all of this that I could no longer teach high school, I just wasn’t physically capable of getting through a day properly.
STEPHANIE SMAIL: The American Medical Systems case isn’t the first of its kind. Last year, hundreds of women joined a class action against Johnson and Johnson over its pelvic mesh and tape implants.
At the time the medical giant had pulled its mesh products off the market, but some tape products were still available.
Rebecca Jancauskus says the six American Medical Systems products her firm is investigating are still available in Australia.
REBECCA JANCAUSKUS: There’s great concern expressed by the women who contact us. They question why these products were approved and why variants of them continue to be used and sold. But that’s not the subject of this action; we’re focused here on the harm that’s been suffered by women historically.
STEPHANIE SMAIL: PM contacted American Medical Systems for comment about its products and information about how many women suffer side effects, with no response.
Kirsty Ann Datar is calling for all transvaginal mesh products to be suspended in Australia until it’s clear how many women suffer side effects.
The products have already been banned in Scotland after patients complained of painful complications.
Mrs Datar says it’s time to review the use of the products in Australia too.
KIRSTY ANN DATAR: Let’s do a retrospective study of all the women who have had all the different types of mesh kits in, whether they be a sling or a POP — the pelvic organ prolapsed kits — and ask them are they having any of these symptoms?
A lot of them wouldn’t know, like I didn’t know, that they would be from the mesh.
MARK COLVIN: Kirsty Ann Datar ending Stephanie Smail’s report.