Preview Newsletter
Ethicon Media Monitoring 12/8/2017
-
J&J Considers Sale of Anti-Dandruff Shampoo Nizoral
Dec 7, 2017 | Bloomberg
By Manuel Baigorri
... It’s also considering a divestiture of its vaginal-mesh surgical product, which could fetch from $500 million to $1 billion, people familiar with the matter have said. -
Most Transvaginal Mesh Devices Were Approved With Little Evidence
Dec 7, 2017 | MedPage Today
By Molly Walker
Most transvaginal mesh devices were allowed on the market without evidence from a clinical trial, with the first studies published years after initial clearance, an evidence review found. -
Lack of regulation led to harm for women with mesh implants, experts say
Dec 8, 2017 | Medical Plastics News
Women with transvaginal mesh implants have been exposed to harm because of failings in regulation, experts have said. -
Inadequate surgical mesh regulation put women at risk: experts
Dec 7, 2017 | CTV
By Angela Mulholland
A new report concludes that transvaginal mesh products used to help treat incontinence and organ prolapse were approved on the basis of weak evidence and “may have exposed women to avoidable harms.” -
Inadequate regulation for vaginal mesh products has exposed women to unnecessary harms, warn experts
Dec 7, 2017 | Medical Xpress
Inadequate regulatory processes for vaginal mesh products used to treat stress incontinence and pelvic organ prolapse have exposed women to unnecessary harms, warn experts in The BMJ today. -
Pathologist on Mesh Explant Findings
Dec 7, 2017 | Mesh Medical Device Newsdesk
Dr Vladimir Iakovlev is an Associate Professor of Laboratory Medicine and Pathobiology, University of Toronto; Director of Cytopathology, St. Michael’s Hospital, Toronto, Canada. He has examined over 50o specimens of mesh explants, taken from patients experiencing complications associated with both hernia and pelvic mesh. -
Pelvic mesh has caused nine years of pain, woman testifies against Johnson & Johnson
Dec 7, 2017 | northjersey.com
By Richard Cowen
The woman who is suing Johnson & Johnson and its subsidiary for what she says was a faulty pelvic mesh implant testified Thursday that the surgery has left her in chronic pain and with a harmful medical device in her body that will never be removed. -
Death of a Pelvic Mesh Fighter – “I Don’t Want This to Happen to Anybody”
Dec 7, 2017 | Mesh Medical Device Newsdesk
The last years of her life were spent educating and sharing on social media- talking about the life hers had become – one of pain and suffering after a TVT pelvic mesh implant to treat incontinence. -
Vaginal Mesh Campaigner Dies of Sepsis Following Controversial Implant
Dec 7, 2017 | Slater Gordon Lawyers
By Jack Bowman
A woman who campaigned for vaginal mesh to be banned as a treatment for prolapse has died – just a week after health watchdog NICE recommended the same. -
Australia Bans Vaginal Mesh for Safety Risks
Dec 7, 2017 | Daily Hornet
Australian safety regulators have banned the use of transvaginal mesh implants because the risks likely outweighs any benefits.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
-
J&J Considers Sale of Anti-Dandruff Shampoo Nizoral
Dec 7, 2017 | Bloomberg
By Manuel Baigorri
Nizoral sale could attract other health-care, consumer firms
U.S. health-care giant working with financial advisers on sale
Johnson & Johnson is considering a sale of its anti-dandruff shampoo Nizoral as the U.S. health-care giant continues to streamline its portfolio of products, according to people familiar with the matter.
A sale of Nizoral could be valued at a few hundred million dollars and attract other health-care and consumer companies with an interest in over-the-counter treatments, the people said, asking not to be identified because the deliberations are private. J&J is working with financial advisers on the sale, which is at a preliminary stage, the people said.
A spokesman for J&J declined to comment.
J&J has been reviewing products ranging from its over-the-counter business to medical devices. Earlier this year, it agreed to sell its blister and lip-care treatment Compeed to HRA Pharma. It’s also considering a divestiture of its vaginal-mesh surgical product, which could fetch from $500 million to $1 billion, people familiar with the matter have said. J&J is also evaluating options for the diabetes-care business, including a sale, partnership or joint venture.
While the health-care conglomerate has major medical-device and consumer divisions, drugs have been a recent standout. That’s helped J&J outpace many of its large pharmaceutical rivals this year. After buying Actelion Ltd. for $30 billion this year, Johnson & Johnson has signaled that a new generation of medicines holds the key to its future profits as some of its best-selling drugs begin to lose dominance.
— With assistance by Jared S Hopkins
https://www.bloomberg.com/news/articles/2017-12-07/j-j-is-said-to-consider-sale-of-antidandruff-shampoo-nizoral
-
Most Transvaginal Mesh Devices Were Approved With Little Evidence
Dec 7, 2017 | MedPage Today
By Molly Walker
Most transvaginal mesh devices were allowed on the market without evidence from a clinical trial, with the first studies published years after initial clearance, an evidence review found.
Sixty-one devices have been marketed based on the FDA's 510(k) clearance of two similar devices in 1985 and 1996, and no clinical trials for these devices were conducted at the time they were cleared, reported Carl J. Heneghan, DPhil, of Oxford University in the U.K., and colleagues.
Moreover, any publication of clinical trials on the safety and efficacy of these devices was published a median of five years after device clearance (range 1 to 14 years), the authors wrote in the BMJ Open.
The 510(k) process does not require that devices undergo clinical testing prior to clearance -- they only have to demonstrate "substantial equivalence" to an already marketed device in terms of design, general function, and intended use. It's been criticized as being excessively lax, allowing products on the market with essentially no validated study.
Transvaginal mesh for pelvic organ prolapse in particular has been controversial, with the FDA issuing a high risk warning on transvaginal mesh products in January 2016, reclassifying them from class II to class III. The authors also cited a Cochrane review that said permanent transvaginal mesh may be associated with "higher rates of reoperation and bladder damage."
Heneghan and colleagues examined the FDA summary database, using the 501(k) clearance of Mersilene Mesh (Ethicon) in 1985 and ProteGen Sling (Boston Scientific) in 1996, and searching on related device clearances.
Overall, they found 61 devices claiming substantial equivalence to ProteGen Sling and Mersilene Mesh.
The authors characterize a "confusing picture," arguing that "newer devices are compared with various older devices, and devices with similar names are compared with each other," and even that some devices had "changes to their indications over time."
They were also unable to find clinical trial evidence for "any of the devices in the 510(k) submissions at the time of approval," they wrote. They traced relevant documentation and the year of clearance for 29 of 33 different mesh products and "in no case was the trial published before approval."
Heneghan and colleagues also retrieved 119 orders for postmarketing surveillance that the FDA ordered from these companies in 2012. These were from 126 different vaginal mesh devices, marketed by 34 different companies, with four companies covering 43% of the orders (American Medical Systems, Boston Scientific, Coloplast Corporation and Synovis Surgical Innovations/Baxter), the authors said.
In two-thirds of these orders, "the manufacturer ceased market distribution of the device subject to the postmarketing surveillance order," while in a quarter of cases, the order no longer applied because the indication had been revised, they said. In fact, less than 10% of orders reported they were doing postmarketing studies.
A separate analysis appearing in The BMJ, also written by Heneghan and colleagues, argued that the process is flawed, noting that "changes in design should have alerted regulators to important differences in the technological characteristics of the mesh that should have negated the use of equivalence" in the approval process.
Moreover, the analysis said, attempts to explore the long-term outcomes of these devices have been stymied by "methodological shortcomings, high drop-out rates, and sparse long-term data."
The authors further state some proposed changes to the regulatory process in their analysis, namely that "long-term implantable devices should have been evaluated in studies with follow-up of at least five years." They also suggested a patient registry "so that any shortcomings can be more readily tracked, patterns of use monitored, and patients later judged to be at risk more easily identified," they said.
Heneghan is an expert witness in a current medical device legal case and has received financial renumeration from an asbestos legal case. He has received support from the FDA and the National Institute of Health Research School of Primary Care, and was a recipient of a grant from the U.K. government.
https://www.medpagetoday.com/obgyn/generalobgyn/69741
-
Lack of regulation led to harm for women with mesh implants, experts say
Dec 8, 2017 | Medical Plastics News
Women with transvaginal mesh implants have been exposed to harm because of failings in regulation, experts have said.
Led by professor Carl Heneghan, a team from the University of Oxford examined the regulatory approval process in the US for the devices.
Transvaginal mesh implants were initially class II devices in the US, allowing new products to be approved on the basis of equivalence to existing products. The FDA changed the regulations in 2016, categorising mesh devices that treat transvaginal repair as class III medical devices and making it a requirement for manufacturers to submit a premarket approval (PMA) application.
The team looked at marketing clearance for 61 mesh devices and found that at the time of approval there was no evidence of clinical trial data. However, regulators should have been alerted to “important differences in the technological characteristics of the mesh that should have negated the use of equivalence” the team said.
The experts give the example of a mesh device that was still being used for the basis of equivalence despite it being removed from the market.
A high number of litigation cases have occurred across the world, with over 100,000 women suing device manufacturers such Johnson & Johnson. Heneghan’s team states that the number of litigation cases outweighs post-market reports of harm by the FDA by 25 times, suggesting a lack of reporting to regulatory bodies.
The lack of long-term clinical data has also impacted any assessment into the efficacy of mesh products. The team highlights that since 2005, the Medicines and Healthcare Products Regulatory Agency (MHRA) has received 110 reports of adverse events regarding vaginal mesh implants. However, the MHRA concluded that the benefits outweigh the risks and that “there appears to be no evidence that vaginal mesh implants are unsafe”.
The experts think that implantable devices should be evaluated in studies at least every five years if they are to be considered safe and effective. To ensure data is available before full marketing authorisation, Heneghan and his team believe that clinical trials should be offered temporary licences to mesh implants.
Finally, the team recommends that implantable devices should be put on a patient registry so that long-term follow-ups and surveillance can occur. The registry should include unique device identification so shortcomings can be tracked, the use of the devices monitored and patients at risk can be more easily identified.
The report follows news that the health watchdog NICE is to recommend a ban on vaginal mesh implants. Calls to ban the devices were rejected earlier this year by the Parliamentary Under-Secretary of State for Health, Jackie Doyle-Price, who said that issues were with clinical practice instead of being solely related to the devices.
https://www.medicalplasticsnews.com/news/lack-of-regulation-led-to-harm-for-women-with-mesh-implants/
-
Inadequate surgical mesh regulation put women at risk: experts
Dec 7, 2017 | CTV
By Angela Mulholland
A new report concludes that transvaginal mesh products used to help treat incontinence and organ prolapse were approved on the basis of weak evidence and “may have exposed women to avoidable harms.”
Researchers writing in the BMJ medical journal say regulatory “failings” enabled the devices to be brought to market without good evidence to show the products were safe.
Vaginal mesh has been used for close to 20 years to treat urinary incontinence as well as pelvic organ prolapse (POP), a condition in which the muscles that hold pelvic organs become weak from childbirth or age.
While thousands of women have had no problems with the mesh, thousands of others have complained about serious complications, including painful and seemingly never-ending bacterial infections.
More than 100,000 lawsuits have been launched over the meshes. CTV News has spoken with many of the women behind the Canadian lawsuits, including Chrissy Brajcic, of Windsor, Ont., who suffered numerous infections even after having her mesh implant removed.
Brajcic died last week after being treated for sepsis. A coroner has yet to determine whether her mesh implant played a role in her death.
In the new BMJ paper, a research team from Oxford University's Centre for Evidence Based Medicine looked at how 61 mesh devices received approval from the Food and Drug Administration.
They found that in the U.S., the FDA initially considered transvaginal meshes as equivalent to mesh products already on the market for other uses. That allowed them to be approved and classified as “Class II devices (lower risk).”
The British researchers say they could not find evidence that manufacturers submitted data from clinical trials that tested the meshes specifically for use in POP or incontinence.
“Clinical trials evidence did not form part of the approval process, and when trials were conducted, they occurred a considerable time later (up to 14 years),” the authors write.
The authors conclude that there was not enough evidence to approve the mesh products and “when evidence has been forthcoming, it has often emerged too late to inform clinical practice.”
Dr. Vladimir Iakovlev at Toronto’s St. Michael’s Hospital, who has researched some of the complications of transvaginal mesh, notes that the regulatory approval process in Canada is typically based on FDA analysis.
“We use the same meshes (in Canada) and the complications with patients are exactly the same,” he told CTV News.
The researchers who traced the FDA approvals of the 61 mesh products found the approvals were often based on “equivalence” to two existing products approved in 1985 and 1996.
One of those products was called the Protegen sling, which was made from polyester. But newer transvaginal mesh is typically made from polypropylene – a significant difference “that should have negated the use of equivalence," the authors say.
Polypropylene has a tendency to shrink significantly after implantation, they write, which can lead to serious complications, such as tissue erosion and organ perforation.
Removing the mesh once problems arise is not simple, the authors note, since the meshes are designed to integrate into the nerves and blood supply of nearby tissues.
Iakovlev says there need to be a better regulatory approval system for new medical devices such as transvaginal mesh.
“We have to develop a better approach for how to assess their safety… because these devices are implanted for life; they’re permanent,” he said.
The report authors say they would like to see national registries of “invasive devices,” that would detail the evidence behind the devices and keep track of any complications.
Iakovlev would like to see the same and says similar registries are needed for other devices such as hip replacements, implanted defibrillators.
“This study shows we need to monitor these devices. We need to slowly introduce them to the market. And that can only be achieved with nationwide registries.”
With a report from CTV medical specialist Avis Favaro and producer Elizabeth St. Philip
http://www.ctvnews.ca/health/inadequate-surgical-mesh-regulation-put-women-at-risk-experts-1.3711802
-
Inadequate regulation for vaginal mesh products has exposed women to unnecessary harms, warn experts
Dec 7, 2017 | Medical Xpress
Inadequate regulatory processes for vaginal mesh products used to treat stress incontinence and pelvic organ prolapse have exposed women to unnecessary harms, warn experts in The BMJ today.
Professor Carl Heneghan at Oxford University's Centre for Evidence Based Medicine and colleagues argue that regulatory failings have enabled new devices to be brought to market with inadequate evidence - and more than 100,000 women around the world are now suing manufacturers after developing serious complications.
What went wrong, they ask?
In the US, transvaginal meshes were initially class II devices (lower risk), allowing them to be marketed on the basis of equivalence to existing devices despite important changes, they explain.
So Professor Heneghan and his team traced marketing clearance for 61 mesh devices back through a chain of equivalence claims to only two unique originating devices approved in 1985 and 1996.
Their results, published in BMJ Open, show no evidence of any new clinical trial data at the time of device approval for all of these 61 devices, with empirical evidence of effectiveness from randomised trials emerging on average five years after approval (range 1 to 14 years).
They argue that changes in design "should have alerted regulators to important differences in the technological characteristics of the mesh that should have negated the use of equivalence."
They also show that evidence consistently pointed to a lack of long term data to inform use of vaginal mesh devices. And when longer term evidence did emerge, it identified serious concerns.
In recognition of the growing problems, many countries have already reclassified mesh as high risk, and NICE is recommending transvaginal mesh should not be used to treat vaginal prolapse because of safety concerns.
And new EU regulations, published in May 2017, mean that clinical investigations for class III and implantable medical devices will be required to provide evidence of safety and performance, explain the authors.
However, they point out that there is a three year transition period before these rules fully come into force, in May 2020. "We think these changes are insufficient, and the long delay in implementation does not represent a timely response to patients' needs," they write.
In the case of vaginal mesh devices, they argue that evidence from large pragmatic trials did not emerge until 20 years after the first products were introduced and 12 years after the call for longer term studies. "In our view, to be considered safe and approved for widespread use, long term implantable devices should have been evaluated in studies with follow-up of at least five years."
They suggest that limited access could be provided through temporary licences that restrict use to within clinical trials with long follow-up. "This would ensure that safety and effectiveness data were available before full marketing authorisation," they say.
They also recommend that a patient registry should be established for all implantable devices to enable long term follow-up and surveillance. "Such registries should include unique device identification so that any shortcomings can be more readily tracked, patterns of use monitored, and patients later judged to be at risk more easily identified." they conclude.
https://medicalxpress.com/news/2017-12-inadequate-vaginal-mesh-products-exposed.html
-
Pathologist on Mesh Explant Findings
Dec 7, 2017 | Mesh Medical Device Newsdesk
Mesh Medical Device News Desk, November 7, 2017 ~ Dr Vladimir Iakovlev is an Associate Professor of Laboratory Medicine and Pathobiology, University of Toronto; Director of Cytopathology, St. Michael’s Hospital, Toronto, Canada.
He has examined over 50o specimens of mesh explants, taken from patients experiencing complications associated with both hernia and pelvic mesh.
Pathologists examine the tissue around the device and play the role of detective to determine a cause of death. He is being called into advise the coroner in the recent death of a 42-year-old Windsor, Ontario woman, who suffered complications from a TVT Exact mesh implant. Dr. Iakovlev will advise which tissues will need to be sampled.
At this time, there is no official cause of death specifically related to mesh infections. Often sepsis is listed as a cause of death, or an uncontrollable blood bacterial infection, but the cause of sepsis is not identified.
Mesh News Desk interviewed Dr. Iakovlev about the steps he takes in his detective work.
Q: What do you find in the body near a mesh implant?
A: “There is a degree of complexity. Based on the pathologists’ knowledge we’ve accumulated over 200 years about changes involving any foreign body. There is an inflammatory reaction as the body recognizes the foreign body is harmful. It wants to get rid of it, digest or expel it. The first reaction is an inflammatory reaction.
“Since any surgery makes a surgical pocket, the space is filled with fluid. The same thing happens around implants. This clotted fluid forms the mold for future tissue to form granulation tissue, which matures to scar tissue. If a foreign body cannot be destroyed, the body tries to isolate it. It makes a fibrous capsule which is the same as scarring.
“Mesh is porous and scar forms inside and outside the mesh.
“We need to remember that our soft tissues heal by laying scar tissue. Mesh cannot be integrated by normal tissue in humans. There is also foreign body inflammation which damages tissue and is a stimulus for further fibrosis or scarring.
“The problem with meshes is that the porous ones have scar tissue inside the pores. As granulation tissue matures into scar it can pull the mesh fibers together and the entire mesh shrinks. The main problem with scarring and inflammation is mesh shrinkage.
“Nerves can grow into and around the mesh. This tells us that the tissue can sense what is going on. As any innervated tissue it can feel pain too. Also, those nerves that grow into the mesh can get trapped and deformed there. Nerves can be effected by migration as well when the mesh moves.
“We know mesh doesn’t stay stationary, it can migrate, fold or bunch up. The tissues around mesh are not strong enough to hold it. In some people it is just millimeters, in some centimeters. We know that even implants and nails in the bones can still slowly migrate.
“Some mesh migrates through the spermatic cord inside the groin. In the pelvis, meshes can migrate or erode internally into the bladder or rectal wall.
“It can deform, fold and bunch up. It can happen during, right after, or many months and years after surgery. Tissues in the vaginal wall have elastic and muscle fibers so they can contract and expand. In mesh, once it’s folded it’s folded and stays folded. There is no mechanism to stretch it back.”
Q: What about the role of biofilms in harboring infection?
A: “Biofilm is a loose term. People can mean different things using it. They may mean coat of bacteria or proteins. Generally, we don’t have to reinvent the bicycle. Foreign bodies have been known forever as a potential source or reservoir for infection. The surface and some small spaces in the implants can harbor bacteria. That is why we try to remove all bullets, splinters and dead tissues.
“As I mentioned foreign body type inflammation and other standard pathological processes related to foreign bodies have been known for a long time, some over 100 years. For example, foreign body reaction studies are from the late 1800s. Look at Russian scientist Eli Metchnikoff in Paris, who gave the first description of these immune responses.
“Any foreign object can provide shelter for bacteria. For bacteria, it’s difficult to survive on native tissues because they are protected by the immune system. But a foreign object provides shelter for bacteria. That’s been known for a long, long time.
“We get the bullet out because it may get infected. We get rid of all dead tissue and the foreign object to clear up an infection.
“Even if bone fragments go necrotic, due to insufficient blood supply, it can become infected.”
Q: Does it depend on the mesh?
A: “Yes. Some mesh types can harbor more infections and limit ability of immune system to kill the bacteria. The microporous meshes have small pores where the bacteria can get stuck.
“Neutrophils, a type of immune cell, cannot move well and kill bacteria. Multifilament or braided meshes are in that category. However, generally all meshes can contain infection, it is just some have higher risk and some lower.”
Q: What do tissues tell you about mesh-related cause of death?
A: “When doing an autopsy, and I’ve done a number of them, we can answer several questions. One is immediate cause of death. Also we can collect information which can be used to answer other questions.
“Doing an autopsy one needs to be thorough and approach with open mind. Examine entire body and all organs, heart, brain, lungs, kidneys. Collect all information and tissue samples for later microscopy. Look for changes and sample more tissue in areas that are affected by a disease, previous surgery etc. Then all information comes together from history, gross findings, microscopy and toxicology.
“One would need to look at the chart information, check previous blood tests. Autopsy may or may not show answers for all questions. Generally, if we focus on chronic infection, whether it is related or not to the immediate cause of death, it can be of different sources including urosepsis. A cause of it can be recurrent UTI spikes, or something in the kidney, bladder or elsewhere in the genitourinary system that leads to recurrent infection.
“In any death there is the immediate cause of death then there are the background conditions. Sometimes it is more complicated than seems.
“For example, if during an argument a person punched in face and falls from stairs, sustains trauma but also is found to have a heart disease at autopsy. The injury itself was substantial but not likely not lethal on its own. Also without the incident he likely would not have a heart attack at the time. So, did he die from the punch and fall or natural causes such as a heart condition? It’s not black and white sometimes.
“I know little more about meshes, where they are placed and changes that can be there. In this case I’m not the official person doing the autopsy, I was only asked to share my knowledge in this specific field, what tissue can be preserved. Autopsy is done by the coroner’s office and they will do their assessment.”
Q: In your experience what have you seen at mesh sites?
A: “Pathology has drifted from autopsies to now surgical specimens. Every lump is being biopsied. Biopsies and excisions are overwhelmingly higher in volume than autopsies. Regular pathologists mainly look at biopsies and excised tissues.
“Similarly, all removed implants come to pathologists. Then it depends on a pathologists’ knowledge and experience how much they can describe. We see scarring or fibrosis, we see foreign body type inflammation, we see nerves and sometimes small parts of other organs. If mesh is infected we see neutrophils. It is hard to see bacteria if they are in small numbers, but neutrophils that come to kill the bacteria are easier to see.
(More on neutrophils here, which help fight infection by ingesting microorganisms. Microphage/ Macrophage – present in the blood that migrates to tissue in the inflammatory immune response. See the human immune system here. )
“All of these changes are well known. There are only few issues that need to be studied. For example, leachables from plastics can have some effect. That has to be studies. As far as I know we do not know exactly what can leach from plastics and what are the effects of these substances on our tissues.
“I read articles that some plasticizers and other chemicals leaching from the labware can have effect on cell cultures in laboratory experiments. See more here and here.
“The substances also appear to leach from plastic syringes into the fluid that contain, if they are stored for a long time. Some patients feel a stale, metallic or plastic taste in the mouth after injections, when compared to a freshly filled syringe.”
LEARN MORE:
MND, What’s Added to Plastic Mesh, March 7, 2017
https://www.meshmedicaldevicenewsdesk.com/whats-added-plastic-mesh/CTV, Mesh Misery
https://www.youtube.com/watch?v=rCFu5NIo0bIhttps://www.meshmedicaldevicenewsdesk.com/pathologist-mesh-explant-findings/
-
Pelvic mesh has caused nine years of pain, woman testifies against Johnson & Johnson
Dec 7, 2017 | northjersey.com
By Richard Cowen
HACKENSACK — The woman who is suing Johnson & Johnson and its subsidiary for what she says was a faulty pelvic mesh implant testified Thursday that the surgery has left her in chronic pain and with a harmful medical device in her body that will never be removed.
"It scares me, because I don't know what's going to happen," Elizabeth Hrymoc said of the nine-year ordeal she's been living since doctors inserted two polypropylene mesh devices in her vagina in 2008. The mesh "can shrink. It can get hard. And it can hurt me more."
Hrymoc, 71, came to Superior Court in Bergen County on Thursday with her husband of 50 years, Tad, and told the jury how three subsequent surgeries to correct or remove the Prolift mesh device have all failed, and that sexual relations are now too painful.
"We love each other," Hrymoc said of her husband. "Intimacy was a very important part of our life."
Hrymoc says Johnson & Johnson knew the mesh device developed by its subsidiary, Ethicon, known as a Prolift, was faulty when it went on the market in March 2005. Once implanted, the polypropylene mesh tended to harden and twist, causing discomfort, and in more serious cases eroding the vaginal walls.
Hrymoc claims that Ethicon concealed some of the potential dangers in its first run of patient brochures and also failed to adequately inform doctors of the health risks due to complications. Johnson & Johnson didn't take the product off the market until August 2012, after thousands of women who had received the mesh implants filed lawsuits.
The Hrymoc case is one of the first to go to trial. Previous jury awards ranged from $10 to $20 million.
In court on Thursday, Hrymoc remained stoic and composed as she told the jury of her ordeal. A native of Poland, Hrymoc told of how she met her future husband in their homeland, then followed him to America. The couple married in 1967 and raised three children, and eventually settled in South River in Middlesex County.
She worked as a research technician for Mobil in Edison and he was an engineer. Hrymoc said she was suffering from vaginal discomfort and urinary stress incontinence in 2008 when her gynecologist recommended the Prolift implant and another mesh device, known as a transvaginal tape, or TVT.
Her attorney, Adam Slater, showed the jury the brochure that was given by her doctor that explained the surgery, known as pelvic floor repair. The brochure said there was a "small risk" of mesh material being exposed to the vaginal canal.
But Slater showed the jury numerous other reports and correspondences by Ethicon researchers that suggest the risk was felt to be much greater. One document said early clinical experience showed there was an "unacceptably high mesh complication rate."
Slater also showed the jury documents indicating that scientists knew beforehand of one of the most painful complications, that of scar tissue causing tension on mesh and shrinking the device, which can lead to pain during sexual intercourse.
Johnson & Johnson's attorney William Gage countered on cross-examination by replaying a portion of the deposition given by the plaintiff. Asked whether she read the brochure before agreeing to have the implant surgery, Hrymoc answered in a single word: "Thoroughly," she replied.
Gage also tried to pin the blame on Hrymoc's gynecologist, Dr. Mark Mokrzycki, suggesting that it was his responsibility to inform her of the risks. He ticked off a long list of potential complications: internal discomfort caused by scar tissue, erosion of the vaginal walls, painful sex and failure to relieve incontinence. He asked Hrymoc if she would have had the surgery had she known about them.
"I would not," Hrymoc said repeatedly. After Hrymoc's testimony, the plaintiff's side rested its case late Thursday. On Friday, it will be Johnson & Johnson's turn to mount its defense. The company contends that the Prolift device wasn't necessarily faulty, but Hrymoc experienced complications and was aware of the risks before agreeing to have the implant.
The trial is expected to last through next week and is being held before Judge Rachelle Harz. In the lone New Jersey case heard so far, a jury in 2013 awarded plaintiff Linda Gross $11.1 million in damages.
Civil juries in Pennsylvania have subsequently awarded plaintiffs damages of $12 million, $20 million, $12.5 million and $13.5 million, according to published reports.
Johnson & Johnson developed its mesh products as an alternative to traditional methods to combat pelvic organ prolapse, which is a common problem for women. The muscles in the pelvic region tend to weaken with age, which can cause the organs to bulge or slip down into the vagina. Pressure on the bladder can cause incontinence.
Commonly known as a sling, the pelvic mesh is made of polypropylene, a porous plastic. The Food and Drug Administration approved pelvic mesh in 2002, but after receiving thousands of complaints, it now considers the device to be a "high-risk" procedure.
http://www.northjersey.com/story/news/bergen/2017/12/07/woman-seeking-damages-johnson-johnson-over-pelvic-mesh-implant-testifies/930386001/
-
Death of a Pelvic Mesh Fighter – “I Don’t Want This to Happen to Anybody”
Dec 7, 2017 | Mesh Medical Device Newsdesk
Mesh Medical Device News Desk, December 6, 2017 ~ The last years of her life were spent educating and sharing on social media- talking about the life hers had become – one of pain and suffering after a TVT pelvic mesh implant to treat incontinence.
Christina Lynn Brajcic of Windsor, Ontario had emerged as a leader of Canadian women suffering pelvic mesh complications. Her message was heard internationally and when Canadian television was looking for a representative, Chrissy was chosen.
Always looking well put together and glamorous, she was interviewed and videotaped for a September CTVspecial on Mesh Misery. (Here). It reported a 2-15% complication rate following permanent mesh implants, much lower for hernia repair, using the same mesh.
She launched a Facebook Live with interactive questions to raise awareness, not unlike a Mesh TV show, she said. She wanted to make sure polypropylene (PP) pelvic mesh or hernia mesh also made of PP, was not implanted in anybody else.
Among the last posts of Chrissy the Fab, as she was known, talked about the relentless infections that would return despite treatment with antibiotics.
“Literally couldn’t move talk I was dying, I couldn’t breathe….How did this happen how do I go from infection to heart failure?”
“I’m fighting hard”
“I can’t wait to get back to my old self and get back to being an advocate. I don’t want this to happen to anybody.”
Her last picture appeared on Facebook November 27. She looked pale and weak but held her fist up. She expected two more weeks of antibiotics, “the really strong stuff.”
“But finally beat sepsis again and I’m ready to kick some butt again. This mesh madness has to stop. Thanks for all the love….”
Chrissy lost her fight on November 30th. Her husband Tony says she was a strong fighter right up to the very end.
Ultimately her heart couldn’t continue the fight.
Now her family is planning her memorial. It is scheduled for Friday, Dec. 8th at 2 PM at the Kingdom Hall, 6870 Hawthorne Dr., Windsor, Ontario, N8T 1J9.
Tony asks for privacy during this time and, “Thank you all her friends and family who had given her all the much needed support over the past few year!”
For those who cannot attend, a candlelight memorial is being planned.
CHRISSY’S PASSING
Her attorney Paul Miller tells MND, he is, “Shocked and saddened to hear of her passing. I got the news from a CTV producer… it’s a complete shock”
He will consider amending her complaint filed against Ethicon (Johnson & Johnson), maker of the TVT Exact she received four years ago, but is awaiting the result of an autopsy to determine the cause of death.
Dr. Vladimir Iakovlev, a pathologist from Toronto who has an extensive experience with mesh explants, will share with the Windsor, Ontario coroner his knowledge of which tissues should be preserved to answer any mesh-related questions, now and in the future.
He is not involved directly in this case. See more on the pathologist here.
The coroner’s office will make its assessment as it routinely does, to determine the immediate cause of death.
Chrissy had recently been hospitalized for a return of sepsis, a bacterial infection which antibiotics could no longer address.
Dr. Iakovlev tells MND, “Information from autopsy alone may determine the immediate cause of death but may not answer all questions. The previous lab tests and history have additional information. For example, if the focus is on chronic infection, it could be urosepsis which can come from recurrent UTI spikes or the cause can be in the kidneys, bladder or other site.
“It has to be put all together, autopsy findings and previous labs.”
Any background conditions, a history of the development of her sepsis and how it’s related to the cause of death will require a thorough analysis of the medical history.
At the time of her death, Chrissy said she was on 15 different drugs and was getting weaker and she experienced right-sided heart weakness. She spent most of her time in bed with her two sons by her side.
Quite a departure from the woman of years earlier. Prior to June 2013, Chrissy was athletic and, according to her videos, she had a six-pack and enjoyed boxing. She was an interior designer and sold Argonne cosmetics on the side. But she lost the ability to work and was unable to participate in athletic, social and household activities with her family.
Chrissy had been undergoing Phage treatment. Phages are bacterial agents in humans treated with phage therapy. It involves using bacteriophages to target pathogenic bacteria and kill them. Phages are an antibacterial agent that increase in numbers in the presence of bacterial targets.
Phage targeting was largely replaced by the use of antibiotics after World War II but was rediscovered in the 1980s. Phage treatment is an alternative approach when bacterial contamination is increasingly resistant to treatment such as methicillin-resistant staphylococcus aureus (MRSA).
THE LAWSUIT
Christina Brajcic filed her lawsuit against Johnson & Johnson Inc, Ethicon Inc and Gynecare Worldwide in Ontario Superior Court of Justice on April 29, 2015. Case No. CV-15-22181.
The complaint seeks general damages in the amount of $346,154 and punitive damages in the amount of $5 million. Special damages in an amount to be determined.
“The particulars of which will be provided prior to trial.”
She received no informed consent, even after the Health Canada warning? Doc said there was nothing to worry about the bad mesh was off the market.
Attorney Paul Miller, then at Will Davidson, filed the action. It says:
Brajcic lives in Windsor, in the Province of Ontario. She received a Gynecare Tension Free Vaginal Tape “Exact”, also known as TVT on or about June 25, 2013. It was used to treat her stress urinary incontinence. Almost immediately she suffered pelvic pain, infections and dyspareunia. She had trouble urinating and suffered ongoing infections. She continued to take pain medication on an ongoing basis.
“As a result of having the mesh implanted, Christina has experienced significant physical psychological and emotional pain and suffering, and has sustained permanent and debilitating injuries. Furthermore, despite having the procedure, Christina continues to experience problems with incontinence.”
Attempts to remove the mesh have failed. Christina continues to lose income as she is unable to work.
The complaint outlines what Gynecare/Ethicon knew or should have known:
· Whether mesh would withstand movement within the pelvis
· Whether mesh would erode within the body causing pain, suffering and infections
· Whether mesh erosion could cause nerve and vascular damage
· Who would have adverse reactions to a foreign body implanted
· How to completely remove the mesh
· It was impossible to implant mesh through the vagina without an infection
· The mesh could cause sexual relations to become extremely painful or impossible
· How to train specialized surgeons to implant mesh properly
· There was insufficient scientific information with no studies longer than six months
· That a study on mesh had to be discontinued because of the rate of complications
· Post market studies were essential
· That risks to women were extremely high and the extent of damage mesh could cause
· That blind insertion of mesh could damage the Plaintiff
· They knew it was their duty to conduct appropriate testing of the mesh before introducing it for use to the public
· That their representatives had an obligation to make accurate statements about safety and efficacy but failed to do so
· That abdominal muscles are stronger and thicker than the tissue of the anterior and posterior vagina
· That the mesh used on the plaintiff was too inelastic and infeasible for tissue and motion of the pelvis
· Unpublished studies were proof the mesh should not be implanted in women
· And that they had an obligation to adequately warn doctors of mesh’s known dangers
· That they had a continuing obligation to conduct testing and studies and update the medical community
“As a result of the negligence of the Defendants, Christina has suffered and will continue to suffer a loss of enjoyment of life as a result of her injuries.”
And as to punitive damages:
“The Plaintiff, Christina, pleads that the Defendants have conducted themselves in a highhanded, wanton and reprehensible manner which warrants the awarding of punitive and/or exemplary damages.”
MEANING IN DEATH
It will be up to Chrissy’s followers to turn grief into meaningful long-term action. See Monday Mindfulness – in memory of Chrissy. A petition is underway in her honor to reach the inner chambers of Canadian Parliament.
Her story is being echoed across the internet and there will be wreaths of flowers from her followers at her Friday memorial service.
“I don’t want this to happen to anybody” was Chrissy’s true wish. Knowledge, information, education were her goals, and by all accounts, she did it brilliantly, as her many followers attested.
“Chrissy, your passing has given the world greater awareness of mesh destruction. You didn’t die in vain. We will keep fighting. “
A request for comment from Ethicon, (J&J), the maker of her pelvic mesh, had gone unanswered by publishing time.
In the September CTV story on mesh injuries, the company responded:
“We empathize with all women suffering from stress urinary incontinence, a condition that can be serious and debilitating. Pelvic mesh devices have helped millions of women suffering from stress urinary incontinence. There are limited treatment choices for women with stress urinary incontinence seeking to improve their quality of life, including surgical treatment with implantable mesh, which is backed by years of clinical research and is considered by most doctors to be the gold standard treatment. Ethicon is confident in the positive impact our pelvic mesh products have had on the vast majority of women who have chosen this treatment option. In addition, the evidence shows that Ethicon acted appropriately and responsibly in the research, development and marketing of its TVT device for the treatment of stress urinary incontinence.” ###
https://www.meshmedicaldevicenewsdesk.com/death-pelvic-mesh-fighter-dont-want-happen-anybody/
-
Vaginal Mesh Campaigner Dies of Sepsis Following Controversial Implant
Dec 7, 2017 | Slater Gordon Lawyers
By Jack Bowman
A woman who campaigned for vaginal mesh to be banned as a treatment for prolapse has died – just a week after health watchdog NICE recommended the same.
Mum-of-two Christina Brajcic passed away as a result of sepsis following a four-year struggle caused by a TVT vaginal mesh implant.
It is believed that Ms Brajcic, 42, of Ontario, Canada, is the first woman to die in the vaginal mesh scandal after developing a resistance to antibiotics, having taken so many during her ongoing battle.
Conservative MP, Alec Shelbrooke, had previously called the implant “the new thalidomide”.
On November 15, Ms Brajcic, who detailed her health battle on social media in recent months, posted on Facebook: “Funny how after going septic and almost dying now I’m getting respect and being treated well by doctors. All it took was dying to get better care and better pain management. I will take it...it’s better than fighting for my care.”
Ms Brajcic's death follows new guidance from the UK-based National Institute for Health and Care Excellence to recommend the controversial implants should no longer be used as a routine treatment for prolapse.
The mesh scandal was brought to the nation’s attention in April when hundreds of women who had received the implant complained of severe pain.
Australian watchdogs also banned the use of vaginal mesh implants for prolapse last week after a review found “the benefits do not outweigh the risks”.
Julia Reynolds, a medical negligence lawyer at Slater and Gordon Lawyers, said: “The women affected by these products underwent what should have been relatively straightforward procedures which would have resolved troublesome symptoms, usually after childbirth, but some have been left in chronic pain and had their lives altered forever.
“Sepsis is becoming so much more common and is a condition the NHS will have to get to grips with.
“We are likely to see huge numbers of patients affected in the future by this condition which develops rapidly, and if not recognised and treated quickly, is life threatening, and can lead to long term organ damage for those who do survive.”
https://www.slatergordon.co.uk/media-centre/industry-news/2017/12/vaginal-mesh-campaigner-dies-of-sepsis-following-controversial-implant-36508/
-
Australia Bans Vaginal Mesh for Safety Risks
Dec 7, 2017 | Daily Hornet
Australian safety regulators have banned the use of transvaginal mesh implants because the risks likely outweighs any benefits.
On November 28, the Australian Therapeutic Goods Administration (TGA) decided to ban the use of surgical mesh implants for the treatment of women with Pelvic Organ Prolapse (POP), including products known as “mini-slings” that treat urinary incontinence.
The TGA noted that 45 transvaginal mesh products have been removed from the market in Australia. The only remaining manufacturers of transvaginal mesh were Boston Scientific and Coloplast, and those products will be banned by January 4, 2018.
In the United States, Boston Scientific and 7 other manufacturers were hit with over 100,000 lawsuits from women who were injured by transvaginal mesh side effects over the last few years.
Those side effects commonly include erosion of the mesh through the vaginal wall, infections, organ perforation, chronic pain, inability to have sexual intercourse, vaginal disfigurement, and incontinence.
Most manufacturers in the U.S. have paid settlements to resolve the litigation, but more than 30,000 lawsuits remain pending against Johnson & Johnson’s Ethicon subsidiary. Ethicon pulled its products off the market in the U.S. shortly after the FDA ordered manufacturers to conduct more rigorous safety tests on transvaginal mesh products.
The safety data on transvaginal mesh is still minimal, according to Australian health officials.
The number of lawsuits grew rapidly after July 2011, when the FDA warned that over 5,000 women had reported severe side effects from transvaginal mesh between January 2008 and December 2010.
https://dailyhornet.com/2017/australia-bans-vaginal-mesh-for-safety-risks/
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
Add recipients
Suggested