Mesh Medical Device News Desk, July 10, 2017 ~ In a class action trial of 700 Australian women who claim injuries from pelvic mesh, Johnson & Johnson documents reveal the sales pitch used to urge physicians to readily adopt the pelvic mesh implants.
It’s estimated 8,000 Australian women were implanted with pelvic mesh beginning in 2005.
Here is a review of the recent coverage of this precedent setting trial.
In an Opinion piece in The Herald, Saturday, July 8, reporter Joanne McCarthy writes about a revealing document introduced in the first day of this class action trial, expected to last six months.
Entitled, “The Practice-Driven Physician,” it was an aggressive marketing campaign authored by Ethicon in 2010, that was intended for physicians who would be the ready and willing market for upcoming pelvic mesh devices to treat incontinence and prolapse.
The J&J target doctor was highly motivated to succeed and to grow a positive reputation as well as revenue by adopting the eight-minute procedure to treat incontinence or pelvic organ prolapse.
Ideally, the doctor could charge more and perform four procedures before lunch. There is no mention of the patient in this sales pitch.
As an example, the ideal doctor is quoted as saying he, “just got back from a week in St. Moritz- fabulous ski conditions. I picked up the Lamborghini on Friday. An amazing machine.”
That kind of doctor.
Two women, who have had to stand during much of the trial due to their pelvic injuries, were met by McCarthy outside the courtroom, visibly shocked and horrified by the description.
McCarthy equates mesh injuries to child abuse carried on by institutions she reported on in Australia. Both involve abuse of power and a lack of consent.
She writes, “Doctors do not want to hear this, and some will no doubt be angered by the comparison. But the medical industry – for that is what the mesh device scandal exposes – has to face what that Johnson & Johnson document says. Women patients have been reduced to things.”
ABC.net.au reports a lawyer for Johnson & Johnson, Steven Finch SC told the court that transvaginal mesh has been used to treat a wide variety of pelvic-floor problems, including urinary incontinence and organ prolapse.
“All devices have pros and all have cons. It’s not defective if a device has a con,” he said.
“The fact the device is associated with a rate of failure is simply one of its features.”
J&J TRIES TO SPIKE REPORT
Reporter Christopher Knaus, reports that the case of 700 women is being heard before Justice Anna Katzmann in federal court in Sydney, Australia.
In week one, The Guardian reports the plaintiffs’ lawyers told jurors women were used as guinea pigs after J&J tried to stop French health authorities from publishing warnings about the use of untested pelvic mesh.
Just as occurred in the states, the Australian version of the Food and Drug Administration, the Therapeutic Goods Administration (TGA), did no testing and required no clinical trials before the mesh devices were placed on the market.
Ethicon, the medical device division of Johnson & Johnson, told doctors the devices were inexpensive and simple to implant in women.
There would be many women in need, especially as the baby boomer generation aged. More devices would mean more income to a medical office. But there was a problem – without randomized controller clinical trials the scant testing on dogs, sheep and cadavers was insufficient or too short-term.
Barrister Duncan Graham SC said “It was sell first, test later. The women who had them implanted were part of an experiment, they were guinea pigs.”
THE FRENCH REPORT
In 2007, Ethicon was concerned about a French report.
It concluded clinical research was needed on Ethicon’s pelvic organ prolapse (POP) mesh Prolift, before the pelvic mesh could be approved or cleared for market.
At that time, Prolift was already being sold in Australia and had been for two years, reports The Guardian.
Minutes from an Ethicon meeting said the company feared the report “Could have a major impact on our business if made public.”
SAFE AND EFFECTIVE
A New England Journal of Medicine article published in 2011, Anterior Colporrhaphy versus Transvaginal Mesh for Pelvic-Organ Prolapse, was supportive of the mesh devices.
Two years later, JAMA revised the report, admitting the study was edited by Ethicon.
The authors, Daniel Altman among them, had been paid consulting fees. Ethicon reviewed and edited the pre-submission draft of the manuscript. The conflict of interest disclosure did not contain that information.
There were significant differences to the articles.
The article said the mesh could be implanted in a standardized technique, negating the complexity of the surgery beyond the skills of a lesser-trained inexperienced surgeon.
Instead, according to an article in The Lancet in December, women with pelvic mesh implant were roughly three times more likely to suffer a complications and twice as likely to require revision surgery compared to women who had surgery using sutures alone. ###