Vaginal mesh risks downplayed by Johnson & Johnson, court told

Device was aggressively marketed as a way to treat pelvic floor damage but left thousands of woman in debilitating and lifelong pain

A pharmaceutical giant allegedly played down the risks of a vaginal medical device that has caused debilitating and irreparable pain to thousands of women after giving birth.

Instead it was aggressively marketing the products to surgeons as a cheap and easy way to boost their profits.

Up to 8,000 women in Australia and 100,000 worldwide are thought to have used the vaginal mesh and tape implants, which were produced by the Johnson & Johnson group as a low-cost way to treat prolapsed pelvic floors and urinary incontinence usually caused by complications after giving birth.

On Tuesday, a trial involving 700 Australian patients against three Johnson & Johnson companies began in the federal court. Many of the women allege the devices ruined their lives.

They suffered irreparable, debilitating pain after the devices began to erode into surrounding tissue and organs, causing infections and complications. The mesh is unable to be removed. Even after further surgery, women continue to suffer chronic pain.

Johnson & Johnson allegedly failed to properly warn patients and surgeons of the risk, or test the devices adequately.

Transvaginal
Transvaginal mesh implants were designed to treat prolapsed pelvic floors and urinary incontinence.

The trial has been described as one of the countrys largest product liability class actions, and Shine Lawyers, representing the applicants, described its commencement as an important step on the road to justice, accountability and recompense.

One woman involved in the case, Joanne Maninon, spoke outside of court on Tuesday. She said she wants to make sure no woman is ever subjected to the trauma inflicted by the devices again.

It cant go on, Maninon said. Theres too many women who have gone through the pain, the complications … its lifelong, she said.

You cant just have the mesh removed. Youre damaged for life.

The case is expected to run for six months, and Tony Bannon SC began a four-day opening submission on Tuesday. He said Johnson & Johnson had aggressively marketed the lucrative benefits of the products to surgeons.

The risks of the surgery, Bannon alleged, were either minimised or not communicated to either surgeon or patient.

[They were] overwhelmed by a tidal wave of aggressive promotion, designed to persuade both surgeons and patients of the quick, easy one operation able to resolve the particular difficulties, Bannon told the court.

He said the company saw a valuable market to be gained through emphasising the speed and ease with which the devices could be installed.

Its alleged the consultants engaged to trial the devices knew the risks.

Bannon cited an email exchange, involving French doctors enlisted for the trial, which appeared to show awareness of the dangers associated with surgery. One doctor wrote that he would not like my wife to undergo this procedure, and did not think he would be alone in that view.

The doctor is now earning royalties from their use, the court heard.

That is one of the transvaginal mesh team members, one of the consultants. His view is that I wouldnt like my wife to undergo that, and I dont think Im alone, Bannon said.

He said the comment was known to Johnson and Johnson, but was not followed up.

The mesh is designed to cause inflammation upon its surgical insertion, to help fix it in place. But the inflammation did not subside as intended. The continuing inflammation allegedly caused the mesh to stiffen, meaning it did not have the flexibility the body requires.

Johnson & Johnson, which has also faced action in the United States, stopped selling the product. It claimed this was a commercial decision.

Bannon characterised it as an act designed to limit the number of women given the device, and therefore reduce its exposure to damages.

At the end of the day, apart from being an ethical decision, I suppose thats a commercial decision as well, he said.

The tape product is still being sold by Johnson & Johnson. The trial continues on Tuesday.

Read more: https://www.theguardian.com/australia-news/2017/jul/04/vaginal-mesh-risks-downplayed-by-johnson-johnson-court-told