‘A tragedy created by greed’. Mounting pressure for a women’s mesh sling operation to be withdrawn
PUBLISHED: 20:27 29 August 2016 | UPDATED: 11:57 31 August 2016
A third American state is suing the makers of a pelvic mesh sling which is the most commonly used brand in UK hospitals
The news comes amid changes at Addenbrooke’s in Cambridge, which until recently, marketed mesh as the gold standard treatment
In a quiet change to its website, however, it now says that the traditional hitch and stitch bladder support surgery is the gold standard.
Mark Slack, head of gynaecology at Addenbrooke’s said during a lecture that the American litigation made him feel that: “The TVT will go after all.
“We really should have been saying to these companies take your tape and go away because you have no evidence, but we didn’t,” he told members of the British Association of Urological Surgeons (BAUS) conference.
“It was a tragedy created by greed, history is going to judge us quite badly.
“We may now lose an outstanding operation because we failed to police the situation.”
The TVTO, introduced in 2004, should be avoided, he said, because it is an: “awful, awful operation that we knew was going to misbehave by the construct and design of it.”
He added he was not convinced that the mini slings, about to be trialled in England after trials stopped in Scotland, were a good idea.
He said: “Patients and their advocacy groups are very concerned and very vociferous and very active.
“There’s mounting pressure for the tapes to be withdrawn.”
Addenbrooke’s website says that “Although mid-urethral slings offer an average success rate of 85%, there are potential complications of which the patient needs to be aware of.
The traditional hitch and stitch - known as a Burch colposuspension - “is still considered the gold standard for stress incontinence surgery because of the impressive long-term data.” the web site says.
Lawyers in the states of Kentucky, Washington and California have all filed lawsuits against Johnson & Johnson, whose medical unit Ethicon make the most popular slings used to treat incontinence and prolapse in British women,
They are suing because they say J&J has deceptively marketed the product as safe.
The permanent implant has caused devastating injuries to victims, according to all three Attorney Generals, and they seek millions of dollars in penalties from the health care giant.
In the latest law suit Kentucky alleges J&J introduced products into the marketplace using false, misleading, deceptive or unfair acts.
“The way this company clearly chose profits over people is outrageous,” Kentucky Attorney General Andy Beshear said.
“My office has talked to victims whose lives have been devastated by this company’s deceitful practices.
“We may not be able to give them back the lives they once had, but my office will do everything we can to hold this company accountable.”
According to an Ethicon spokeswoman the lawsuit is, “unjustified, and the company plans to vigorously defend itself against the allegations.
Johnson & Johnson/Ethicon has the greatest number of product liability lawsuits filed in the US - around 50,000 women.
The legal cost of mesh litigation in the US currently stands at around $9 billion, according to Mr Slack.
• Listen to Mark Slack, head of gynaecology at Addenbrooke’s, give his talk at the BAUS 2016 annual meeting in Liverpool