Mesh Medical Device News Desk, August 14, 2017 ~ Wealth and Status, Reputation/Ego listed as Key Values for doctors using an Ethicon/ Gynecare TVT polypropylene pelvic mesh.
“Surgery is the Cha-ching thing”
ABC News Australia (Australia Broadcast Company) reports (here) that the pelvic mesh scandal in that country was incentivized by mesh makers who offered surgeons a jet-set lifestyle if they used the medical devices.
The information is revealed in internal Johnson & Johnson documents, part of a federal court class action trial underway in Sydney, Australia, that pits 700 Australian (AU) women against the healthcare giant, maker of pelvic mesh implants used to treat incontinence and prolapse. The plaintiffs claim life-altering injury from the permanent polypropylene implants.
There is no subtle suggestion from J&J in the marketing script that adopting mesh implants into your medical practice can make you wealthy. In fact, it is probably the most blatant indictment of medical devices marketed for money revealed so far in pelvic mesh litigation.
WHO WAS THIS MESSAGE FOR?
A document from Johnson & Johnson entitled “The Practice Driven Physician,” describes him as a highly motivated doctor, looking to make his practice more efficient and profitable, and to enhance his reputation and revenue. Surgeons could insert four devices “before lunch” and make $10,000.
As a result he would enjoy Wealth and Status, Reputation/Ego as one of the “Key Values.”
He is “less inclined to attend multiple conferences.”
A cover of Fortune Magazine was included with the words “Retire Rich.”
The script shows the typical conversation J&J hears from doctors using its products. Just back from a week in St. Moritz skiing, picking up the Lamborghini on Friday “An amazing machine.”
One unnamed doctor allegedly writes in the talking points, “I use your products because I can do more procedures in less time with better reimbursement.”
The memo says a TVT-O can be implanted in eight minutes.
In the U.S. courts, the TVT-O has been found defectively designed by at least three different juries.
Barrister Tony Bannon (senior counsel of New South Wales) has said there was a “tidal wave” of aggressive marketing to surgeons and patients suggesting mesh was a “quick and easy” operation. None of the plaintiffs would have consented to the operation had they had true informed consent outlining the “true risks” of the mesh, he told the court in the first week of this trial that began July 4.
The Shine Law firm is representing the women in this class action, the largest in AU history.
See the document here The Practice Driven Physician.
As early as 2009, documents just released in this class action, show concerns were raised inside the company about the Prosima.
Following a Prosima “summit” some said “rushing to market” was a “huge mistake” and opening up the use of the product to “unqualified surgeons.”
Insiders to J&J admit that Prosima has a 30% failure rate. The push to Prosima occurred after surgeons were losing faith in the Prolift procedure, another mesh designed to treat pelvic organ prolapse. It was launched to compete with Boston Scientific’s Pinnacle and AMS’s Elevate.
See MND story here.
Prolift, Interceed and Versapoint were listed with the word “NOT” before them.
The brands pushed in this document include Gynecare Thermachoice, TVT Morceluex, (for hernia) and Prosima.
Prolift and Prosima were two of four meshes voluntarily removed from the market by J&J in June 2012. See MND story here.
Johnson & Johnson would not comment on the documents presented in this class action.
At least 3,000 Australian women have been left with injuries from serious to catastrophic, according to a Senate inquiry in Melbourne, AU last month.
See Prosima document here, AU Class Action on Prosima.
TRAVEL TO ST. LOUIS
With an estimated 100,000 mesh implants used in Australia, ABC News reports Sydney gynecologist Professor Theirry Vancaillie has just returned from St. Louis where he studied with Dr. Dionysios Veronikis on how to do full mesh removals, a difficult task most doctors will not attempt.
“I believe that Dr. Veronikis has shown that by removing mesh in a number of, several hundreds of cases, that he achieves better results in pain management, “ Dr. Vancaillie is quoted as saying by ABC.
Australian women find themselves travelling to the U.S. to have a full mesh removal.
Caz Chisholm, founder of the Australian Pelvic Mesh Support Group found in her poll that “70 percent of women who’ve had a partial removal are worse off after their partial removal.”
Members of the Australian Pelvic Mesh Support Group, who want a ban on the devices, called a nationwide inquiry and the Senate responded.
Victorian Senator Derryn Hinch campaigned for the inquiry, calling mesh “one of the greatest scandals against women in Australian history.”
During the first day of the two-day hearings earlier this month, two doctors testified who are also set to be expert witnesses for Johnson & Johnson in an ongoing class action trial in Sydney.
Joanne McCarthy reports for The Herald (here) that Dr. Anna Rosamilia admits she “should have disclosed” she would be giving evidence for the company.
“I wasn’t aware that I needed to,” she told the paper.
Dr. Peter Dwyer, also an expert witness for J&J, told the inquiry that patients have died from these devices, mesh used to treat prolapse and incontinence, when surgeons put them in the wrong place. Training on mesh surgery was “falling between the gaps a bit.”
Mesh manufacturers should not be doing the training of doctors he said. Dr. Dwyer said “on occasion the rep does come into the operating theatre.”
There will be another public hearing August 25th in Perth, AU. ###
ABC News, July 4, 2017, Class Action begins against J&J in Sydney Courtroom Includes 700 Plaintiffs
www.Pelvichealthsolutions.com was established by J&J for women to find out more about the procedures. no longer opens except with dot.ca
Mesh News Desk, September 23, 2015, Plaintiff’s Expert Outlines J&J’s Push to Market Prosima Pelvic Mesh
Mesh News Desk, July 24, 2017, Australian Health Advocates Articulate Goals for Mesh-Injured
Newcastle Herald, August 4, 2017, A Melbourne Senate inquiry hearing was told up to 3000 women left with serious mesh injuries, Joanne McCarthy
Mesh News Desk, March 16, 2017, Australian Investigation into Transvaginal Mesh Leads to Trials and Senate Inquiry
The Age, March 14, 2017, Pelvic Mesh Devices Hit by Allegations of Research Fraud, Experimental Surgery on Thousands of Women, Joanne McCarthy
Mesh News Desk, June 2012, Four J&J Vaginal Meshes to be Removed from Market