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Ethicon Media Monitoring 2/23/2017
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Documentary: J&J Knew Risks of Prolift
Feb 22, 2017 | Mesh Medical Device Newsdesk
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. -
Canada: Beware Of Hernia Mesh Recalls: Physiomesh, Bard Ex Or Composix Kugel Mesh
Feb 23, 2017 | Mondaq
By Paul Miller
The next time you're reading a newspaper or surfing the Web, keep your eyes peeled for articles heralding "the next great medical breakthrough!" Researchers are making new discoveries at an astonishing rate, so it probably won't be long before you come across a report highlighting a new technique or medical device that will improve or save lives.
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Documentary: J&J Knew Risks of Prolift
Feb 22, 2017 | Mesh Medical Device Newsdesk
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. LUCENTE
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 2001 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 level of safety. 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##
http://www.meshmedicaldevicenewsdesk.com/documentary-jj-knew-risks-prolift/
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Canada: Beware Of Hernia Mesh Recalls: Physiomesh, Bard Ex Or Composix Kugel Mesh
Feb 23, 2017 | Mondaq
By Paul Miller
The next time you're reading a newspaper or surfing the Web, keep your eyes peeled for articles heralding "the next great medical breakthrough!" Researchers are making new discoveries at an astonishing rate, so it probably won't be long before you come across a report highlighting a new technique or medical device that will improve or save lives.
When you have a serious or debilitating condition, reading one of these types of stories relating to your particular illness can give you hope that you may not need to suffer much longer. Some years ago people with hernias who learned about promising new procedures using mesh-like materials to strengthen damaged tissue felt this hope. That hope was dashed for people who were given defective mesh products that ended up causing even more pain, complications and the need for additional surgeries.Hernia Symptoms
Hernias – the displacement of organs and tissues from their usual cavities due to torn or weakened muscle walls that usually kept them in place – are fairly common. They can also be quite serious.
There are a variety of types of hernias, including inguinal, hiatal, femoral, umbilical, and incisional, but most affect the abdomen or groin area. Symptoms vary, but can include weakness, a burning sensation, or feeling pressure in the abdomen, groin, or scrotum; soft bulge or lump that can be more visible when you cough and may disappear when you lie down; pain from actions such as coughing, sneezing or having a bowel movement that cause you to strain your muscles; and the feeling that something has ruptured.
Hernias do not heal on their own and can worsen over time. Early detection often helps to improve outcomes and more serious hernias, particularly those which are irreducible (bulging tissue remains in 'out' position and may cut off blood flow to the tissue) generally require corrective surgery.Hernia Mesh and Surgery
While surgeries are often successful, failures and reoccurrences are still fairly common and subsequent operations are even less likely to succeed. Operations also come with a general risk of infection, chronic pain, adhesion of skin and obstruction, so getting them right the first time is quite important.
When surgeons began using mesh – derived from either animal tissue or a variety of synthetic materials – it was considered a breakthrough because these patches acted as bridges over weakened tissue and generally improved the odds of a successful first surgery. However, in the rush to get these products to the market, some did not go through rigorous, long-term testing and many proved to be defective.
Side effects from hernia surgeries using these defective mesh products can worsen the usual complications that can occur from surgery and cause additional problems, such as: Mesh migration or shrinkage Perforation and fissures of the skin and organs (sometimes leading to blood poisoning and death) Chronic pain due to scarring and nerve damage
It was only after patients began reporting serious problems that some manufacturers issued recalls.Mesh Recalls and Lawsuits
There have been major recalls related to popular hernia mesh products that have been found to endanger the health of patients, including C.R. Bard's Composix Kugel patch and Johnson & Johnson's Ethicon Physiomesh.
In 2005, the maker of the Kugel patch began recalling some types of the device when medical reports and studies began revealing that a metal ring inside the mesh was failing and breaking, leading to side effects like bowel perforation and chronic enteric fistula. More recently, Physiomesh was pulled from the market in 2016 after studies found the product failed more often compared to similar products.What Can You Do?
If you have had a hernia operation where a mesh product was used, you should not worry unnecessarily; some patients with mesh products known to be defective will not experience side effects and complications.
However, if you have experienced symptoms such as pain, fever, nausea, vomiting, an inability to pass stools, a lump forming at the site of the surgery, you such seek medical attention immediately. Treatment options are often available and remedial surgeries may be necessary, though these are not always successful. Anyone who has been notified that a product implanted in them has been subject to a recall should be especially vigilant.
Hernias can be painful and serious. It's extremely frustrating to know that improper testing of some hernia mesh products has prolonged or increased this pain and created more anxiety for some patients.
If you or a loved one has been affected by symptoms you believe may be the result of a hernia mesh product, you may be able to obtain compensation and damages for your pain and suffering. As a medical product liability lawyer, I would like to hear your story and welcome your questions.
http://www.mondaq.com/canada/x/570414/Personal+Injury/Beware+of+Hernia+Mesh+Recalls+Physiomesh+Bard+Ex+or+Composix+Kugel+Mesh
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Client Attorney Privileged/Attorney Work Product/At Request of Counsel
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