JOHNSON & Johnson has withdrawn two of its controversial pelvic mesh devices from the Australian market after the federal Department of Health required further evidence of device safety from mesh manufacturers.
But in a statement to a Senate pelvic mesh inquiry, before a public hearing in Sydney on Monday, Johnson & Johnson said it had “decommercialised” its Gynemesh Prolene and Gynemesh PSXL pelvic mesh devices because of the cost of mandatory changes to instructions for use.
“Johnson & Johnson Medical continues to have confidence in the safety and efficacy of these products,” the company said.
“Our decision to discontinue these products is based on their commercial viability following a recent direction from the Therapeutic Goods Administration to change the instructions for use for these products.
“The costs of making a change only for the Australian market would exceed the total value of the sales of the product for 2016.”
It denied the decision was a product recall, and said it was a “disappointing outcome”.
It comes as more than 800 Australian women launched a class action against Johnson & Johnson in the Federal Court in July that is expected to run for six months, and as more than 30,000 American women seek damages from the company because of injuries they allege were caused by the company’s pelvic mesh devices for incontinence and prolapse after childbirth.
Johnson & Johnson Medical continues to have confidence in the safety and efficacy of these products.
Johnson & Johnson and a second American mesh device manufacturer, Boston Scientific, will give evidence at a Senate pelvic mesh inquiry on Monday, along with the director of Australian company TFS Manufacturing, Paul Zadow. Mr Zadow is a former Australian champion basketballer and Newcastle Falcons player.
In its statement Johnson & Johnson said the two Gynemesh products were cancelled from the Australian therapeutic goods registry on August 22. Two of its Prolift mesh devices, and a Prosima device, were “decommercialised” in August, 2012.
“Like any company, the decision to introduce or discontinue a product is a matter we deal with regularly and this was a considered commercial decision,” Johnson & Johnson said.
In August there were just nine mesh device company entries on Australia’s therapeutic goods register, covering 22 individual mesh devices. In 2013, before the TGA requested evidence from manufacturers of mesh device safety and efficacy, there were 42 company entries on the register, covering 100 individual mesh devices.
In evidence at a Melbourne hearing of the Senate inquiry TGA deputy secretary Professor John Skerritt said a doctor’s evidence that the TGA had not cancelled any devices was “simply not true”.
He also rejected Dr Caroline Dowling’s evidence that companies made “commercial decisions” to withdraw devices “so there was no fault with those products, they were good products”.
Professor Skerritt told the inquiry: “Those cancellations were not for commercial reasons.”
Companies initiated cancellations because “they did not have the evidence to answer the questions we had asked”.
The public hearing on Monday will be held at Parliament House in Sydney, followed by a Canberra Parliament House public hearing on Tuesday.
The inquiry was launched after Victorian Senator Derryn Hinch described the marketing of pelvic mesh devices in Australia as “one of the greatest medical scandals and abuses of mothers in Australia's history”.