Preview Newsletter
Ethicon Media Monitoring 2/13/2019
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FDA Panel Assesses Risks of Women’s Surgical Mesh
Feb 12, 2019 | The Wall Street Journal
By Thomas M. Burton
Officials should consider women’s reports of pain, sexual dysfunction and other maladies as they re-evaluate a medical device used in women’s pelvic surgery that has triggered thousands of lawsuits, an advisory panel said. -
FDA Assessing Risks of Vaginal Mesh Amid Thousands of Lawsuits
Feb 12, 2019 | WTTW News
By Alexandra Silets
The Food and Drug Administration met again Tuesday over the safety and effectiveness of using vaginal mesh. The FDA has already reclassified the mesh as a Class III high-risk surgical device. -
Surgical mesh: Defenders shine a light on yet another dangerous device
Feb 12, 2019 | KVUE
By Terri Gruca
Nearly one in every five women suffer from prolapse, a condition where pelvic muscles no longer support pelvic organs. -
Debate will hear how more than 1,000 patients have died and 20,000 suffer serious consequences from medical implants
Feb 12, 2019 | Cambs Times
By Kath Sansom
Scandals involving surgical mesh, defective pacemakers, faulty artificial hips and harmful breast implants, have shone a spotlight on failings in device licensing, says MP Owen Smith. -
MP to call for medical device regulation reforms
Feb 12, 2019 | Medical Plastics News
This comes after scandals involving surgical mesh, defective pacemakers, faulty artificial hips and harmful breast implants. -
“I’m a broken soul”
Feb 12, 2019 | Bonnyville Nouvelle
By Meagan Maceachern
All he wants is help. For years, Bryan Wayne Kopala has been suffering. But the pain isn’t only being caused by the mesh that was used to treat a severe hernia in 1997.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
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FDA Panel Assesses Risks of Women’s Surgical Mesh
Feb 12, 2019 | The Wall Street Journal
By Thomas M. Burton
Officials should consider women’s reports of pain, sexual dysfunction and other maladies as they re-evaluate a medical device used in women’s pelvic surgery that has triggered thousands of lawsuits, an advisory panel said.
The panel of outside doctors, convened to advise the Food and Drug Administration, recommended that the agency evaluate women’s medical self-reports as it decides whether synthetic mesh products should stay on the market. Such recommendations are generally, but not always, followed by the federal agency.
The mesh product—used to treat a condition called pelvic organ prolapse, in which organs like the bladder, uterus and others sag into the vaginal area—was first cleared by the FDA for U.S. marketing in 1996.
The condition can be treated with conventional surgery using the patient’s own tissue, but the synthetic mesh product is considered more permanent by many surgeons, at least in proper surgical hands. The product is also used in some other conditions such as hernia repair and urinary incontinence, which some doctors say present lower risk.
But since vaginal mesh was introduced, complications such as vaginal pain, bleeding and scarring have been extensive. Billions of dollars in damages have been awarded after findings of crippling conditions and multiple reoperations in many patients.
Vaginal mesh entered the U.S. market through a quick approval process that required fewer safety studies. Now, the FDA is insisting that the two remaining companies on the market prove the benefits of their products through clinical studies. The panel suggested that questionnaires filled out by women be part of that process.
The FDA issued a public-health notice in 2008 advising of serious complications associated with the mesh in some cases. By 2011, it updated that advisory to let the public know that these complications aren’t rare.
The agency said it did a search of its database of device injuries through October 2018 to help determine the seriousness of the issue. It identified 10,391 reports of serious injury and 77 deaths potentially related to the products.
“Women’s lives have been changed, and in some cases ruined,” Diana Zuckerman, president of the National Center for Health Research, a consumer group in Washington, D.C., said at the hearing.
Many women have filed lawsuits in federal and state courts against manufacturers.
Boston Scientific, one of two companies with mesh products on the market, said in an FDA filing for the Tuesday hearing that it “firmly believes that the totality of clinical evidence supports the positive benefit/risk profile of transvaginal mesh devices to treat pelvic organ prolapse.”
The other such company, Coloplast Corp., said that patients and surgeons need options and that surgical mesh “is a safe, effective and important treatment option.”
Vaginal mesh is a prime example of what critics say has been the FDA’s lenient approval process for many medical devices. It was originally cleared through a pathway known as 510K, in which a device is allowed onto the U.S. market based on being substantially equivalent to an existing product already being sold. That process doesn’t require a gold-standard safety-and-effectiveness study.
“Surgical mesh for repair of pelvic organ prolapse is a quintessential example of the fundamental deficiencies in the FDA’s oversight of medical devices, particularly those that are permanently implanted,” said Michael Carome, director of the Public Citizen Health Research Group, in a statement before the hearing.
The FDA and the device industry have said that the 510K pathway is necessary to get innovative products to market more quickly.
In a statement in preparation for Tuesday’s hearing, the FDA said the “risk profile of surgical mesh” is “greater than that of native tissue repair.…Management of mesh erosion may not be uncomplicated, may require multiple additional surgeries to address and may remain unresolved despite treatment.”
https://www.wsj.com/articles/fda-panel-to-assess-risks-of-womens-surgical-mesh-11549976401
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FDA Assessing Risks of Vaginal Mesh Amid Thousands of Lawsuits
Feb 12, 2019 | WTTW News
By Alexandra Silets
The Food and Drug Administration met again Tuesday over the safety and effectiveness of using vaginal mesh. The FDA has already reclassified the mesh as a Class III high-risk surgical device.
There are more than 100,000 women suing manufacturers over painful complications from vaginal mesh. That makes it one of the largest product lawsuits in history – bigger than the class-action suits over asbestos. Legal verdicts have reached in the hundreds of millions of dollars.
But some doctors stand behind the product, saying it helps women who need it to repair weakened pelvic tissue, urinary incontinence and prolapse.
Weighing on the latest FDA hearing on the controversial product is journalist Susan Berger, who wrote a story about the issue in the Washington Post.
Below, find an edited Q&A with Berger.
Chicago Tonight: First of all, tell us what vaginal mesh is made of. Is it just a piece of plastic?
Susan Berger: Yes, it's made of a synthetic plastic material that's called polypropylene.
CT: So why are women having this surgery, and what does the mesh do?
Berger: It was introduced in about 1998, and it's implanted in the vaginal wall. It's for women who have stress urinary incontinence. Like when you laugh, you sneeze, you cough, you kind of pee a little bit.
Women who have had babies have this problem. Women just get it as they get older. It could be related to estrogen levels and menopause. There are all kinds of problems. So the mesh is done for stress urinary incontinence is one thing, and the other thing is prolapse. And prolapse is when the bladder is basically getting weak and falling. It needs to be lifted with a sling. The mesh acts as a sling and holds up the bladder, basically.
CT: You've interviewed a number of women. What went wrong when after they had this surgery?
Berger: The stories are pretty horrendous. One woman after the mesh surgery, for two years she had constant pain. She had trouble walking. So I've had women tell me that walking felt like a cheese grater was inside of them. Or like sandpaper scratching them. And some of the women had blood in their urine and had pain when they urinated. There were a whole myriad of problems.
But it's not even just the women. There are people who in my research would say that polypropylene should never be implanted in a human body because it gets hard, it changes to the point where for some women it would come through the vagina where husbands were getting scratched during sex. So it's affecting their partners, too.
I had one woman that I interviewed tell me that she took her husband to her OB-GYN who didn't believe her and her husband showed him where he got scratched. So it's a big problem that it's hard plastic coming through the vaginal wall.
And I had one woman tell me that her gynecologist – and they're in a small town – wasn't really aware of what this was all about – his exam glove was cut during the exam from the mesh.
CT: It's one of the largest lawsuits in history. One of the settlements in in 2015 was for $457 million dollars. This is just one settlement?
Berger: There've been many settlements. That's right. Just last week after my article came out, on Jan. 31, there was a settlement of $41 million to one woman against Johnson & Johnson, the maker of Ethicon, who makes the mesh.
CT: Let's talk about the FDA. They're having a meeting today. Do they think it's safe?
Berger: Well the FDA over a period of time from 2008 to 2010, got 2,800 reports of complications about mesh and that's when they started looking into it. And they actually reclassified this as high risk.
CT: But some doctors are disputing the safety concerns. What did you find out?
Berger: Well, when I did my reporting, I did find doctors who used the mesh and like the mesh and they think it's really good. It solves the problem of stress incontinence for women and their prolapse. And most of the doctors that I spoke to who like the product say the most important thing is to go to a doctor who does many surgeries and who does it often and who knows what they're doing. It's the doctors who don't know how to put it in properly, they contend, that's the problem.
Other experts say, no – it's the polypropylene that changes in the human body and becomes hard and it shrinks and it protrudes through your vagina and all that. So, it's a matter of dispute.
Medicine is supposed to be about risk/benefit. And the numbers here are important because the doctors told me that there have been estimated 4 million women worldwide have had mesh implanted. About 5 percent of them have complications. Well, that equals 200,000 people. And from reading about the complications, half of those people with complications require surgery. And the complications are very hard to get rid of.
The one thing I was told: removing mesh from the human body is like getting bubblegum out of hair. Another analogy I heard was getting rebar out of concrete. So it's a lifelong problem.
CT: It's been banned in some countries, right.
Berger: It is. Australia, Ireland, Scotland and the U.K. have banned it. I believe the UK and Australia, I think they had a rate of 10 percent complication rate even higher than what we're reporting here. But they've also issued public apologies about it. They've banned the product from the market.
CT: So is there a non-surgical way to help with prolapse or incontinence?
Berger: Yes. The doctors who do a lot of the removals who I interviewed, they say there are non-surgical options, including exercise. There are swings that are made from organic and biologic material or come from your own tissues in your own body. That's another way to go. And there's something else called a Burch procedure, which is a surgical procedure.
CT: Are there more lawsuits in the pipeline?
Berger: Yes. There are lawsuits filed by Washington, California, Kentucky and Mississippi against Johnson & Johnson, the parent company of Ethicon. The basis of the lawsuit says that the marketing was deceptive. They accused the company of destroying lives. I mean, it’s pretty strong language, as lawsuits usually are.
https://news.wttw.com/2019/02/12/fda-assessing-risks-vaginal-mesh-amid-thousands-lawsuits
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Surgical mesh: Defenders shine a light on yet another dangerous device
Feb 12, 2019 | KVUE
By Terri Gruca
Nearly one in every five women suffer from prolapse, a condition where pelvic muscles no longer support pelvic organs.
For years, surgeons made repairs using tissue from women's bodies. But, in recent years, a surgical mesh has been used to treat prolapse.
Tuesday, following thousands of complaints and years of warnings from the FDA itself, a public hearing shed light on what is growing evidence of medical device dangers.
“This is affecting lives and it’s major, and no one is really listening to us,” said Barbara Melling, a patient who is suffering from complications of surgical mesh.Women from across the country gathered in Maryland to share their stories about how mesh products changed their lives.
“If there are 100,000 women injured by mesh for any reason, it should not be on the market. If tomatoes are killing people, they take them off the market,” said Lana Keeton, who had a sling implanted in her.
Jodie Callahan is a mother who had surgery in 2010 at the age of 45.
“I am one of over 100,000 women who have been severely and permanently harmed by the devastating complications from the interior transvaginal mesh,” she said. “This changed my life and made me limit a lot of activities with my family. I went to nine different specialists all trying to help me deal with this.”
Three years later, after years of pain, a surgeon removed the mesh.
“During the procedure, I experienced life-threatening complications due to the extensive lengths to remove the mesh," she said. "The doctor reported the mesh had eroded into my bladder, attached to my bowels, my nerves and my muscles and the incontinence sling had twisted my urethra, so voiding [emptying her bladder] was nearly impossible. They also removed a large gelatinous cyst that was in my cervix that was engulfed in mesh."
Last month, she learned she has to undergo another surgery. She said her doctor found more plastic mesh inside her body.
“I am scared, frustrated and devastated that I will have to do this again,” she cried.
“On behalf of Boston Scientific and myself as a physician, I want to express my deepest sympathy and my sincere empathy for those women who have been harmed by surgical mesh therapies,” said Dr. Ronald Morton Jr., a medical doctor with the urology division at Boston Scientific.
Medical device makers apologized to the women on Tuesday.
“Boston scientific is purposeful and committed to provide medical devices that are safe and effective and supported by clinical evidence supported by physician training and the best possible outcomes,” he said, citing studies that show the mesh devices continue to improve.
The Defenders have learned the FDA warned about serious complications involving mesh implants in 2008. In 2011, the FDA mandated companies produce studies to show the safety of the devices.
“In 2011, Public Citizen and I petitioned the FDA to ban and label all mesh products for vaginal repair of POP [pelvic organ prolapse] because these devices offer no clinically proven benefits in comparison with non-mesh repair of POP and have high rates of serious complications," said Dr. Michael Carome, M.D., of Public Citizen. "The FDA denied our petition in 2014. Surgical mesh for trans-vaginal POP repair is a quintessential example of the deficiencies of the FDA’s oversight of medical devices, particularly those that are permanently implanted.”
The FDA will continue to look at the evidence presented to determine if more action should be taken for surgical mesh.
“I truly hope the FDA is serious about addressing the research, development, training as well as adequate oversight for future medical devices,” said Callahan.
U.S. Congressman Lloyd Doggett is sponsoring the Medical Device Safety Act as a result of our original investigation into implanted medical devices and sent us this statement:
“The danger is not limited to one medical device, one manufacturer or one lawsuit. The KVUE Defenders has done a really good job reporting this and the urgent need to get some action, transparency and accountability, and empower patients and help them not to have to endure the same needless suffering. Mindful of that is what I'm doing is supporting an improved medical device registry and legislation to help patients harmed by medical devices seek damages from the device manufacturer.”
https://www.kvue.com/article/news/investigations/defenders/surgical-mesh-defenders-shine-a-light-on-yet-another-dangerous-device/269-ceeef975-edc7-427b-9f5d-e431b08e7d59
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Feb 12, 2019 | Cambs Times
By Kath Sansom
Scandals involving surgical mesh, defective pacemakers, faulty artificial hips and harmful breast implants, have shone a spotlight on failings in device licensing, says MP Owen Smith.
Worse, patients may not even be`protected after Brexit, he said.
Tonight, he leads a debate in the House of Commons for radical reform of the rules regulating licensing and marketing of implants.
Owen Smith, MP for Pontypridd, and chairman of the All Party Parliamentary Group on Mesh, said: “More and more patients are undergoing surgery involving innovative, implantable devices, the vast majority of which can transform and save lives.
“However, a number of recent problems involving medical devices have called into serious question the way in which they have historically been tested, approved and marketed to patients and doctors.
“Medical devices cannot, of course, be tested against placebo in randomised control trials, as is the case with medicines, but current checks on the safety and efficacy of these devices are far too weak, with many simply having to prove on paper that their effect and design is equivalent to earlier and similar devices.
“This has led, for example in the case of surgical mesh, to such follow-on devices being made of completely different, inappropriate and even toxic materials, compared to the original licensed device.
“The weaknesses in the current testing regime has led to changes at the European level, but even prior to their introduction the new rules have been subject to significant criticism as being insufficiently robust and too favourable to the companies involved.
“Here in the UK, we face the prospect of not even being protected by the new regulations after Brexit and this poses real questions as to how our regulators are going to respond.
“The MHRA must now set out robust regulations, starting with tougher device licensing and the introduction of a national registry to monitor all devices through a publicly available national database.”
A Guardian investigation in November 2018 revealed that in the UK, the Medicines and Healthcare Products Regulatory Agency (MHRA) received 62,000 “adverse incident” reports linked to medical devices between 2015 and 2018.
A third of the incidents had serious repercussions for patients and 1,004 resulted in death.
The investigation showed examples of failure in the devices market including replacement hips and vaginal mesh products sold to hospitals without any clinical trials.
It also highlighted patients relying on faulty pacemakers when manufacturers were aware of problems, and regulators approving spinal disc replacements that later disintegrated and migrated in patients.
These scandals have led to calls for tightening of the regulations globally. The EU has responded by introducing a new Directive for Medical Devices which is due to come in to effect next year.
Owen said: “Brexit will, of course, place the UK outside the scope of this new Directive and it remains how the UK Government and Regulators intends to ensure our patients are similarly safeguarded with a tougher licensing and monitoring regime.”
https://www.cambstimes.co.uk/news/owen-smith-mesh-hips-pacemakers-implants-1-5888951
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MP to call for medical device regulation reforms
Feb 12, 2019 | Medical Plastics News
This comes after scandals involving surgical mesh, defective pacemakers, faulty artificial hips and harmful breast implants.
Mr Smith, who is also chair of the All Party Parliamentary Group on Surgical Mesh Implants said: “More and more patients are undergoing surgery involving innovative, implantable devices, the vast majority of which can transform and save lives. However, a number of recent problems involving medical devices have called into serious question the way in which they have historically been tested, approved and marketed to patients and doctors.
“Medical devices cannot, of course, be tested against placebo in randomised control trials, as is the case with medicines, but current checks on the safety and efficacy of these devices are far too weak, with many simply having to prove on paper that their effect and design is equivalent to earlier and similar devices. This has led, for example in the case of surgical mesh, to such follow-on devices being made of completely different, inappropriate and even toxic materials, compared to the original licensed device.”
An Implant Files investigation last November revealed that in the UK alone, the Medicines and Healthcare Products Regulatory Agency (MHRA) received 62,000 “adverse incident” reports linked to medical devices between 2015 and 2018. A third of the incidents had serious repercussions for patients and 1,004 resulted in death.
The investigation showed examples of failure in the devices market including replacement hips and vaginal mesh products sold to hospitals without any clinical trials, patients relying on faulty pacemakers when manufacturers were aware of problems, and regulators approving spinal disc replacements that later disintegrated and migrated in patients.
These scandals have led to calls for tightening of the regulations right across the World and the EU has responded by introducing a new Directive for Medical Devices which is due to come in to effect next year. Brexit will place the UK outside the scope of this new Directive and it remains to be seen how the UK Government and Regulators intend to ensure patients are similarly safeguarded with a tougher licensing and monitoring regime.
The MP for Pontypridd added: “The weaknesses in the current testing regime has led to changes at the European level, but even prior to their introduction the new rules have been subject to significant criticism as being insufficiently robust and too favourable to the companies involved. Here in the UK, we face the prospect of not even being protected by the new regulations after Brexit and this poses real questions as to how our regulators are going to respond.
“The MHRA must now set out robust regulations, starting with tougher device licensing and the introduction of a national registry to monitor all devices through a publicly available national database.”
https://www.medicalplasticsnews.com/news/mp-to-call-for-medical-device-regulation-reforms/
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Feb 12, 2019 | Bonnyville Nouvelle
By Meagan Maceachern
All he wants is help.
For years, Bryan Wayne Kopala has been suffering. But the pain isn’t only being caused by the mesh that was used to treat a severe hernia in 1997.
“I had a dream… and I lost it all,” Kopala said, wiping tears from his eyes.
Scattered before him are dozens of documents, outlining a journey that started after an inguinal hernia repair in 1997. Since then, Kopala has been misdiagnosed, denied funding from AISH, the province, and federal disability programs, and living in pain.
Once a man that was active and community-oriented, Kopala now spends up to 20 hours per day in bed, and is required to use a cane to walk.
“I’m a broken soul.”
Kopala was born and raised in Bonnyville when “the roads were still gravel and eating dirt was like eating food.”
His parents and grandparents lived in the area, and owned businesses in the community.
“I went to Duclos School until Grade 9. I got pulled out of class lots because the principal thought I was more active running the school than in class,” reflected Kopala. “I had individual teachers teach me one-on-one because I was excelling quicker than the average student.”
Kopala later attended NAIT for business administration, but dropped out halfway through.
That was when he created a stay in school program, where he would travel the province giving presentations to kids about the dangers of drugs, alcohol, and opioids.
It was shut down by the federal government in 1999, but Kopala always had the intention of continuing his dream and starting it back up again.
Over the years, Kopala managed football players like Willie Pless from the Edmonton Eskimos.
They were at a gym in Slave Lake in 1996/97 when “my guts fell out of my ball sac area.”
Kopala was rushed to the hospital where a doctor did an emergency repair.
“They put a tennis ball there actually,” he laughed.
From there, Kopala was taken to the Grey Nuns Hospital where he said they opened him up and sewed him back together again.
After notifying Grey Nuns he was still in a lot of pain, they made a recommendation.
“They told me they were going to have to bring me in again and put mesh in me. When I asked why, they told me it would make me feel like Superman, that I would be able to play sports again,” Kopala said. “At the time, I had to sign a waiver, and I asked them why. They said that way they wouldn’t be liable for something. I haven’t been able to find that waiver.”
According to Karen Diaper, communications manager for Covenant Health, the managing body for Grey Nuns Hospital, “all patients, following discussion with their surgeon, would sign a consent form prior to their surgery, not a waiver.”
She also said in an email to the Nouvelle that the decision to use mesh for a hernia repair is “determined by the surgeon, not the hospital,” and that risks for any surgery are discussed prior to a consent form being signed.
Up until 2017, Kopala lived a normal life. He started two businesses, remained active, and dreamed of moving to the Caribbean.
His first endeavour was opening King Kans in Bonnyville. He worked hard and watched it grow, and eventually created a second company.
All of that came crashing down in November 2017.
“The doctors thought that maybe I had cancer. They took blood work on Dec. 21, 2017,” Kopala described.
The blood work confirmed Kopala was cancer-free, but that left unanswered questions.
He wanted to know why he was in constant pain.
Little did he know, that stabbing pain he was feeling was the mesh that had been implanted years before.
Kopala had to shut down his King Kans business, and gave his newly created company away.
He described having to let go of his dream.
“I’m at the doctor’s office once or twice a week (now) because I have infections around my abdomen area,” he said. “The breakdown is all of the time. I try to beat the infection, take probiotics, and get myself back to normal, but in the meantime, finding out that I worked so hard for everything I have ever done, created all of these things… I’m in my life right now where I’m fighting to get help because of this.”
It has taken over a year for a doctor to confirm that it’s the mesh causing the pain and his condition constitutes him as disabled.
While pain medication is an option, Kopala wants more than just a bandaid fix.
“I would really rather live than not know if I’m going to wake up dead, with an overdose, in a coma, or totally blackout with no one around to help me.”
Over the years, Kopala has applied for disability funding through AISH, the province, and the federal government, but has constantly been denied.
“I didn’t wake up in the morning wanting to fight this s**t,” he stressed. “This isn’t me, but I can’t do anything more. They’ve taken everything away from me and they still haven’t helped me.”
A report from AISH claims Kopala isn’t eligible for funding through their program because he doesn’t fall under their definition of disabled.
When the Nouvelle contacted AISH for a comment, they provided a copy of their policy, which outlines the eligibility for the program.
In order to qualify for funding, your disability “must be permanent and substantially limit the person’s ability to earn a living.”
“It’s quite amazing how I have been able to find a way to afford to keep going,” Kopala said.
The federal government denied him the disability tax credit, stating in their letter his impairment in walking and managing bladder and/or bowel functions isn’t severe, and they will only consider an impairment acute if it markedly restricts a basic activity of daily living at least 90 per cent of the time even with the use of appropriate therapy, medication, and devices.
Kopala applied for the province’s Alberta Health Benefit program, but much like the rest of his applications, was denied.
However, it wasn’t the fact that he was ineligible for the funding that surprised Kopala, it was their claims that he wasn’t a Canadian citizen.
He said if it weren’t for the Canadian Pension Plan (CPP), he wouldn’t have any help financially.
“They took the time. They called me, they asked questions, called my doctors, and did so much follow up,” he explained. “If they hadn’t stepped in and said, ‘Bryan, you paid into it, we can help you,’ I’d be dead.”
When the provincial government refused to help, Kopala wasn’t sure where to go, so he turned to Bonnyville-Cold Lake MLA Scott Cyr.
“When it comes to Albertans that are vulnerable, we need to be cautious. We need to make sure the system is fair, appropriate, and gives everyone the opportunity to get the help that they need,” Cyr stated. “If we hear the health system is failing them, instead of just throwing them into a limbo where they just can’t seem to move beyond, there needs to be a mechanism.”
Cyr said they’re doing what they can to help, but there’s no one-size-fits-all solution.
“In this case, we potentially have a constituent that has had some health issues and hasn’t got access to the appropriate records,” expressed Cyr. “In this case, I would suggest the Ministry of Health has failed this particular constituent.”
Like many living in pain as a result of a mesh implant, Kopala has considered suing the company that made the material, but when he went to locate the paperwork in his archived file at the hospital, it was gone.
“I went there, I went to my files, paid for them in the archives… the mesh information was out of my file,” he said. “Now, lawyers say they can’t help me because we can’t identify who manufactured the product… They can’t help me without the evidence, but the evidence is in me.”
Diaper said Covenant Health’s policy is to keep patient records for 11 years from their date of discharge.
Lawyer Jill McCartney, partner assistant for Siskends LLP in Ontario, is working with hundreds of Canadians suffering from hernia mesh implant complications.
Some are part of ongoing litigations, while others are just looking for answers.
“Generally speaking, people can have issues relating to mesh migration, various issues relating to pain, which is a big category. It can have a lot of different causes depending on movement, with some of the materials for mesh you can have hardening and stiffening of the product that can cause pain, so there’s a lot of pain symptomatology,” she detailed, adding infection is another common concern.
McCartney said while some have their mesh implant identification number in their hospital records, like Kopala, that’s not always the case.
“What we find is people will contact us about hernia mesh, but usually it takes us a little bit of effort to jump through hoops to see if we can help people get the specific product identified, because that’s important for this litigation,” McCartney detailed.
Their first step in identifying the product is checking the client’s records, if the information isn’t there, they reach out to the surgeon who made the implant.
Unfortunately for Kopala, his surgeon has since passed away.
McCartney said there is a window of opportunity when it comes to filing a class-action lawsuit in relation to products and health complications, and some of that has to do with how long a hospital will retain your records.
“There are time limits on how long you have access to your medical records, bringing action, whether it’s against a product manufacturer, a physician, or a hospital. If that’s a concern and that’s coming to the forefront for you when you’re having these health problems, it’s important to do your best to take some steps,” she added.
McCartney said more and more people are coming forward and sharing their stories when it comes to hernia mesh complications, for one reason or another.
“I think it’s a combination of things. We see more products being used and we sometimes see changes being made to products, and sometimes those changes can be for the better and sometimes they may not be,” expressed McCartney.
In relation to Kopala’s case, she said he could have the material removed and preserved.
“There can be steps taken to try to preserve the mesh, so that’s another option if he is having a revision or removal surgery… it’s another place where we can sometimes look for clues.”
In a letter from his doctor provided to the Nouvelle by Kopala, the physician claims that “given the location of the mesh device, the removal of the mesh device is not suggested by the specialist due to complications of the surgery. These complications include loss of testicles, disfigurement, loss of feeling in the legs, and possible death.”
“My family, they don’t know how to handle it. I don’t blame them, there’s a displacement that happens,” Kopala noted. “I don’t blame people for not wanting to be around me because I’m sore all of the time. I get it.”
Last Thursday, Kopala visited a specialist who within minutes confirmed it was more than just the mesh causing Kopala’s pain.
“There’s a hernia within the mesh,” Kopala explained.
For Kopala, this news was a weight off of his shoulders.
“After a year, you almost think you’re crazy inside because you keep telling doctors this is what’s wrong,” he exclaimed. “This is very refreshing, it’s mentally refreshing. It’s a bad feeling when no one wants to listen to you. I get it now. I get why a lot of people just give up on life. This is such an emotional thing for me.”
Regardless of the most recent diagnosis, Kopala said it’s still inoperable.
“They can’t do anything. It’s just acknowledging the truth.”
Now, he will continue the fight for his health and his dream.
“I’m not going to give up,” he stressed. “I won’t quit fighting.”
He added, “I don’t know where I’m going to go from here. People keep telling me to reapply for things, to do this again, redo that. Mentally, it’s exhausting.”
https://www.bonnyvillenouvelle.ca/article/im-a-broken-soul-20190212
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