News

Johnson & Johnson to pay millions to pelvic mesh patients


Evelyn Lewin


4/03/2020 3:28:59 PM

But one expert laments the difficulty in fixing issues for women who have experienced complications from the implants.

Women embrace
Women embrace outside Federal Court in Sydney after the vaginal mesh class action judgement was handed down in November 2019. (Image: AAP)

The Federal Court has ordered pharmaceutical company Johnson & Johnson, and related companies, to pay $2.6 million in damages to three women at the centre of a class action on pelvic mesh implants.
 
Ann Sanders, Kathryn Gill and Diane Dawson have been awarded individual figures ranging from $555,555 to $1,276,113.
 
This follows a landmark judgement by Justice Anna Katzmann in November last year.
 
At that time, Justice Katzmann found Johnson & Johnson and affiliated companies in Switzerland and the US, Ethicon Sarl and Ethicon Inc, engaged in negligent conduct, misleading patients and doctors about the safety and efficacy of nine mesh products.
 
‘The risks were known, not insignificant, and on Ethicon’s own admission, serious harm could ensue if they eventuated. A far more cautious approach was warranted than the respondents took,’ Justice Katzmann said.
 
Obstetrician and gynaecologist Dr Alex Polyakov agrees a more cautious approach regarding pelvic mesh implants would have been sensible.
 
He told newsGP a number of issues led to poor outcomes for women who were treated with the implants.
 
Initially, Dr Polyakov explains, such implants were only used to treat urinary stress incontinence via a mid-urethral sling. Such procedures only require ‘very small’ pieces of mesh, which are then fixated at two points.
 
That technique was found to be superior for the treatment of urinary stress incontinence, and the complication rate was low, around 2–3%.
 
From there, companies expanded the use of mesh products by broadening them for use for pelvic organ prolapse, which required much larger pieces of mesh.
 
‘And if you use a large foreign body, the risk of complication of course rises,’ Dr Polyakov said.
 
Furthermore, instead of only having two points of fixation, mesh used for pelvic organ prolapse has many points of fixation.
 
‘So the chance of inadvertently damaging something – it could be nerve damage, bladder, bowel – is much higher,’ Dr Polyakov said.
 
‘But also the risk of infection is much higher because the mesh itself is so much larger.
 
‘There is also a much higher risk of erosion – the raw surface of the mesh becomes exposed in the vagina, not covered by the vaginal epithelium – and that causes bleeding, pain, infection.’
 
Dr Polyakov said a further problem with using mesh is that, once implanted, it becomes embedded in tissue.
 
‘And it’s impossible to take out intact,’ he said.
 
‘The only way to take it out is to pull it out bit by bit, and because the mesh implants for the prolapse were so large … it is horrendously difficult to remove without damaging the vagina or bladder or the bowel.
 
‘So people who ended up with complications like erosion or chronic pain, there is no easy way to actually fix it.’
 
It is therefore vital to differentiate between the use of mesh for urinary stress incontinence, which Dr Polyakov says works very well, has a low complication rate and is still in use today, and its use for prolapse surgery, where the chances of complications could be as high as 15%.
 
He is also concerned that patients were not told of the significantly greater risks of pelvic mesh implants used for pelvic organ prolapse, as opposed to for urinary stress incontinence.
 
‘The patients were not told that the risk was so high because the clinicians themselves didn’t realise initially that it would be so high,’ he said.
 
‘So there is this issue of informed consent, which wasn’t adequate at the time.’
 
That lack of informed consent also related to inadequate collection of data.
 
‘One of the issues was that for years nobody recognised how big the problem was because there was no proper way to collect data from these implants,’ Dr Polyakov said.
 
‘We still don’t know exactly how many of them were implanted.’

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Obstetrician and gynaecologist Dr Alex Polyakov says the exact number of women who have been treated with pelvic mesh implants remains unknown.

Centralised databases are used to collate information and complication rates of procedures involving foreign bodies, as is the case for hip replacements.
 
‘And if there are problems with particular implants it becomes obvious in a short period of time,’ Dr Polyakov said.
 
‘However, with mesh, that wasn’t the case. There was no systematic data collection, there was no database that accounted for all the patients who had these implants.
 
‘And for that reason it took quite a long time for consumers, patients and doctors to recognise that the complication rate was so high.
 
‘I think the judgement alludes to the fact that the companies that manufactured these implants knew much earlier about these complications, yet did not react to the high complication rate.’
 
Dr Polyakov is appalled by that notion.
 
‘It is pretty awful,’ he said.
 
‘So there are a number of aspects to this and now we have the result. There are lots of women where they have complications, but their treatment options are not really clear because removing the implant is not easy and in some cases is not possible without inflicting further damage.’
 
Dr Polyakov believes better systems may have helped prevent this situation.
 
‘Where foreign bodies are implanted or used there must be a system, some sort of database, to monitor the possible side effects, and if something is flagged it should be acted upon straight away with further research and further evaluation, rather than to release a product onto the market with minimal surveillance of its use and complications,’ he said.
 
More than 1350 women signed on as part of the class action, and the parties are expected to develop a framework for assessing individual group member claims by 30 June.
 
Justice Katzmann is expected to make a ruling on injunctions sought by the firm acting for the women, Shine Lawyers, at a later date. Those injunctions relate to potential labelling and warnings relating to the products.
 
‘We’re pleased with the result and encouraged by the compensation for the three lead applicants ordered today,’ Shine Lawyers’ Head of Class Actions, Jan Saddler, said.
 
‘Today is a significant step forward, but there is still a way to go until all Australian women affected by these products receive compensation.’
 
The Therapeutic Goods Administration previously approved more than 100 transvaginal mesh products for use in Australia. However, by January 2018, it had banned most of them from being sold in the country.
 
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