Mesh News Desk, February 22, 2017 ~ A news magazine in The Netherlands has just aired a documentary that says Ethicon/ Johnson & Johnson was well aware problems would happen with the Prolift transvaginal mesh and marketed it anyway.
The documentary shown on the show RADAR in mid-February. #radartv
Prolift was the most used pelvic mesh in that country, according to government officials.
Prolift is a larger mesh used to cradle falling pelvic organs. It is implanted through the vagina, hence the name transvaginal mesh. Prolift is no longer on the market in the U.S.
See the Radar program here.
New Jersey trial attorney Adam Slater is featured, in the program as well as two women implanted with Ethicon’s mesh – Maria and Dora.
In the 35 minute program, Ethicon’s Worldwide Medical Director, Piet Hinoul told Slater in a videotaped deposition, he knew mesh retraction, dyspareunia and pain would occur.
“Those bastards,” says Maria.
Offering commentary is gynecologist, Dr. Heinrik Cammu who comments, “At some point you have to say ‘We’re not doing it'”.
But Ethicon never reached that point.
Dr. Vince Lucente in the U.S. helped bring Prolift to market as a consultant and teacher to other doctors on its use. TVM mesh was the prototype of Prolift.
While it was launched on the market in March of 2015, the FDA was never alerted and there was no clearance obtained for Prolift. In fact, the FDA was not even aware it was being sold until Ethicon applied for the next generation of POP mesh, Prolift M+ and cited Prolift as its predicate device.
Slater requested raw data from Dr. Lucente in preparation for his trials in the U.S.
“The reported data has under 20% complications but our expert found there were failures that hadn’t been counted. More erosions, more recurrences, these were the key points for safety and efficacy and the reports were worse than what Ethicon was telling people. This great doctor had a 49.7% failure with Prolift,” said Slater referring to Lucente.
Dr. Lucente admits in his videotaped interview that he collected $1,709,291 in compensation from Ethicon over ten years.
“Ethicon knew he wasn’t telling the truth,” says Slater.
INSTRUCTIONS FOR USE
Two months before the launch of Prolift, Ethicon employees in medical affairs said doctors should be told Prolift may present significant risks for sexually active women. That warning was not in the IFU (instructions for use). Instead of revising the IFU, the concerned doctors were told that the instructions had already been printed.
They would get to the revision next time. That never happened.
Dr. Axel Arnaud, a French consultant to Ethicon, explains that any competent gynecologist would understand the risk, attempting to explain away the omission. Slater says they didn’t want to scare doctors away from using Prolift.
If that warning had been in the IFU, along with the true erosion rate, the risk of dyspareunia, a return of prolapse and a risk of another surgery, no doctor would be interested in the product.
Professor Bernt Klosterhafen, who collects explanted hernia mesh, is a leading expert on removed mesh. Over time, he says, mesh becomes tough and has no function. He has a database of 600 meshes and they all have the potential to produce complications. He believes we are at the beginning of a process and will see an increasing number of complications.
In 2008 and again in 2011, the Food and Drug Administration (FDA) issued Safety advisories about transvaginal mesh. Those warnings never made it to The Netherlands until 2013.
In January 2012, the FDA alerted Ethicon it would have to provide a higher assurance of safety for Prolift. That day Ethicon employees talked among themselves – “if we pull the product off the market, we may avoid having to do those studies.”
Ultimately a deal was made with the FDA, Prolift was pulled off the market in June 2012. Ethicon didn’t have to do its safety study.
Ethicon said it discontinued marketing Prolift (and three other meshes) for commercial reasons.
A European study, published in December 2015, concluded that meshes are not effective or safe in the long term. See See Scientific Committee on Emerging and Newly Identified Health Risks (here).
There’s only one person to protect you and that’s you, concludes the presenter. ##