Hernia Mesh Harm: Canada Health

Growing concerns in Canada over surgical mesh usage, recalls

Published Monday, April 17, 2017 10:00PM EDT CTV News.ca Staff  FiDA highlight

Warning: Some of the content may be disturbing to some viewers

There is growing concern over the number of recalls of hernia mesh in Canada, as patients speak out about complications they believe are linked to the surgical device.

Patients across the country contacted CTV News after a story on health problems linked to hernia mesh aired last month.

Patient Ivan Richardson said his hernia mesh has caused him ongoing, unexplained pain.

"You couldn't even touch me, I would cry, I mean literally cry and I went to the doctor and they kept saying they couldn't find nothing," Richardson said in an interview with CTV News.

That is until one doctor cut open his abdomen. There, what was supposed to be flat plastic mesh was rolled up inside Richardson's torso.

Even with part of it removed, Richardson said he still suffers.

"It will feel like a bunch of little needles," he said. "I assume that is the edge of the plastic mesh. I'm scared to do anything anymore, really."

Figures from Health Canada show that some 12 brands of hernia mesh have been recalled or removed from the Canadian market since 2000.

Some were linked to infections and perforations. There were 185 reports of serious injury and other complications, including three deaths.

Still, studies indicate the majority of hernia mesh patients have no problems, and its use is on the rise.

Data shows mesh helps improve recovery and lowers hernia recurrence.

But Dr. John Morrison, president of the Canadian Hernia Society, warns it may be used too often given the growing questions of the harm being done to some patients. In some cases, he said, mesh may not be required.

As part of his practice, Dr. Morrison often removes mesh that's shifted and punctured organs.

"I've seen pictures of it in the bladder, I've seen mesh in the stomach," Morrison told CTV News. "The mesh can erode into other organs over a period of time."

Morrison said studies show 10-20 per cent of people are left with chronic pain.

"It is a very serious phenomenon that's happened," Morrison said.

The physician said if the pain persists longer than three months, a hernia patient should find another physician or a hernia surgeon.

Morrison called the complications an "epidemic, and unfortunately, there's no end in sight, it's going to get worse because almost all hernias are now repaired with mesh."

Dr. Morrison advises patients who are scheduled for hernia surgery to "ask their surgeon if they're going to be using mesh, ask them exactly what type of hernia they have, why the mesh is being used.

He said prior to the operation, a patient should read on the internet the effects of the mesh being used on the hernia they're having repaired.

"An educated patient is the number one thing that will solve this problem," Morrison said.

There is research underway to try to better understand these emerging complications. The research will be of vital importance to the thousands of Canadians who have hernia surgery every year.

With a report by CTV medical specialist Avis Favaro and producer Elizabeth St. Philip

J&J Tylenol product: 38 years of harm-for-profit?

How Much Acetaminophen a Day is Safe? Canada May Decide It’s Less

After an investigation by the Toronto Star, Canada’s top health agency considers whether to lower the maximum recommended daily dose of the active ingredient in Tylenol and other painkillers.

by T. Christian Miller and Jeff Gerth

ProPublica, July 15, 2015, 12:08 p.m.

Canada’s top health agency is considering lowering the maximum recommended daily dose of acetaminophen, the active ingredient in Tylenol and other pain relievers.

Citing the risk of liver damage from overdosing on the popular pain medication, Health Canada announced it will review changes to labels, the creation of an educational awareness campaign and possible revisions to dosage recommendations.

Acetaminophen is considered safe when taken at recommended doses. Tens of millions of people use it weekly with no ill effect. But in larger amounts, especially in combination with alcohol, the drug can damage or even destroy the liver. In severe cases, acetaminophen overdose can cause death.

“Our goal is that we will have fewer effects on liver, less hospitalization, less instances of unintentional overdose, and we have more people that are informing themselves about all the products that they use, not just acetaminophen,” Supriya Sharma, senior medical adviser for Health Canada’s Health Product and Food Branch, told the Toronto Star, in an interview.

The announcement comes after the Star published a lengthy investigation last year on the potential dangers of acetaminophen. The Star, which was assisted in its reporting by ProPublica, found that acetaminophen use in Canada had been responsible for hundreds of deaths, tens of thousands of hospitalizations and tens of millions of Canadian dollars in health-care system costs over the last decade.

An earlier ProPublica investigation done in collaboration with This American Life examined the toll of acetaminophen in the United States. The investigation found that 1,500 people in the U.S. had died and tens of thousands more had been hospitalized as a result of overdosing on acetaminophen over the past 10 years.

ProPublica and This American Life also found that the Food and Drug Administration had delayed implementing safety measures for decades. McNeil Consumer Healthcare, the Johnson and Johnson unit that makes Tylenol, had worked to repeatedly block tougher safety warnings on its billion-dollar product.

Both investigations found a common problem known as “double dipping.” Acetaminophen is present in hundreds of over-the-counter medicines. Thus, people may take several medicines containing acetaminophen — say Tylenol and Theraflu — and not realize that they have exceeded the maximum recommended daily dose of acetaminophen, which is four grams, or eight 500-mg pills.

Another problem with acetaminophen: While generally recognized as safe and effective, the drug has a narrow safety margin — the dosage that can help is relatively close to the dosage that can begin to affect liver function. Some studies have suggested that liver damage can result from taking a few additional pills over the recommended daily dose for several days.

Canada and the United States are among the few industrialized nations in the world to allow unlimited access to acetaminophen. Countries such as Britain, France and Germany restrict access to the amount of acetaminophen that can be purchased, as well as the amount of medicine in an individual pill.

In response to the ProPublica story, McNeil said the company has always put consumer health first and that Tylenol is safe as long as it is used as directed.

After a 2009 FDA hearing in which experts raised new concerns about acetaminophen safety, McNeil changed the label on its Tylenol product to recommend no more than 3 grams, or six extra-strength tablets, per day.

The company maintains that acetaminophen’s safety compares favorably with other over-the-counter pain medications. (The FDA recently announced additional warnings about the risk of heart attacks of taking non-steroidal anti-inflammatory drugs, or NSAIDs, found in popular brands such as Advil.)

“McNeil takes acetaminophen overdose very seriously, which is why we have taken significant steps over the years to mitigate the risk,” the company wrote in an emailed statement.

“We will continue to work hard to educate and warn consumers of the dangers of acetaminophen overdose, reminding them to read the labels on all medicines before taking them, to take medicines only as directed and to be aware that any medicine they take has risks.”

The FDA did not respond to a request for comment on Friday. The agency has previously acknowledged that its procedure for regulating over-the-counter drugs, known as the monograph process, is cumbersome and slow. More than 38 years have passed since the FDA first began hearings on acetaminophen, and the FDA has yet to issue final guidelines on the safe use of the drug.

Last year, the agency announced that it would begin to review the monograph process in order to improve it.

It has yet to take any action.

http://www.propublica.org/article/how-much-acetaminophen-a-day-is-safe-canada-may-decide-its-less?utm_source=et&utm_medium=email&utm_campaign=dailynewsletter&utm_content=&utm_name=

FDA Approval Is Faster!

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FORBES   BUSINESS | 6/19/2012 @ 10:15AM

More Proof FDA Is Faster Than Other Drug Regulators

This guest post was written by Joseph Ross, an assistant professor of medicine at the Yale University School of Medicine and Nicholas Downing, a third year medical student, also of Yale University School of Medicine. Ross has done extensive study of how new drugs are approved. In this article, they provide more evidence that the FDA’s review process is not longer than that in other countries.  (FiDA blog bold added.)

Last month, we published with our colleagues a study in the New England Journal of Medicine examining the time required by three prominent pharmaceutical regulators to review applications for new drugs that have never before had medical uses.

Our main finding: the FDA was nearly two months faster than the European Medicines Agency and Health Canada, the primary regulators for the European Union and Canada. This is true both for the time it takes for the FDA to do the first regulatory review and for total regulatory review time of these applications.

But our original measure of regulatory review time only included the time an application actually spends being reviewed by the FDA and its peers. For some drugs, the total time can be longer, as a company may need to conduct additional research before resubmitting a drug to regulators. Investors and industry are focused on the total time it takes to go from submission to approval.

So we re-crunched the numbers. Our analysis is limited because it included only applications that were eventually approved, since only this information is made publicly available by all three regulators.

But we found more proof that the FDA is faster than its peers. 

As can be seen in the accompanying figure(on website), the FDA was the fastest of the three agencies, even when we look at the total time from submission to approval, including time when both the agency and the industry applicant were “on the clock”. The median time to approval was 322 days at the FDA, compared to 366 days at the EMA and 409 days at Health Canada.

Our comparison is complicated by the fact that all three regulators do not behave in the same way, but we would expect that to make the FDA look slower – and it doesn’t. Among these applications that were eventually approved, the EMA approved almost every one in a single review cycle, 96%, whereas 3% required two cycles and 1% required three cycles. In contrast, 62% and 69% of applications were approved by the FDA and Health Canada in a single review cycle, respectively. More than 30% of applications required multiple reviews before approval. For the FDA, 36% required two cycles and 1% required three cycles; for Health Canada, 24% required two cycles, 4% required three cycles and 3% required four or more cycles.

You might think that extra requests for statistical analysis, data collection, or even new clinical trials would make the FDA process more time-consuming than that in other countries, but it doesn’t.

Nevertheless, there are more nuances to this story. You can see in the Figure that there was much more variation in time to approval among applications to the FDA. More than half of approvals were complete within one year, but there were many examples of the FDA requiring 800, 1000, even 1200 total days before approval. For instance, the well-known anti-cancer drugs Sanofi‘s Eloxatin and Novartis‘ Gleevec were both approved in less than 80 days, however it took more than 10 years from initial submission to approval for Sabril, and anti-seizure medication, and Asclera, a sclerosing agent to treat varicose veins.

A lot of the variation in FDA time to approval can be attributed to whether one or more cycles of review were required. Among the 62% of applications the FDA approved after a single review, the median time to approval was 278 days. In contrast, the median time to approval was 765 days among the 38% of applications that required multiple cycles of review.

Interestingly, applications within the hematology, oncology, and immune-modulating and anti-infective therapeutic classes were most likely to receive FDA approval after a single review. Applications within the musculoskeletal and pain and psychiatry and central nervous system therapeutic classes were most likely to require multiple cycles of review.

It is important to point out that there is no right review speed or right number of cycles of review. The FDA may have been acting appropriately in these slower reviews that required additional cycles. These applications could have raised important safety concerns or included poorly designed trials that could not support approval. Perhaps the FDA was right to request more statistical analysis, additional data collection, or even new trials, from the applicants.

One can argue that FDA has been cautious in ways that benefit the public. There are certainly cases where the FDA did not approve a drug, and other countries did only to have to withdraw it for safety reasons. Examples would include Acomplia for obesity and Thelin for pulmonary arterial hypertension. On the other hand, some medicines, like AstraZeneca‘s Iressa for lung cancer or perfenidone for idiopathic pulmonary fibrosis, are being used in other countries but are restricted or not approved by the FDA. But either way, a tortoise-like pace is not one of the FDA’s problems.

Comment:  Joleen Chambers

Thank you for your research!  After a family member experienced a serious adverse event from a failed implanted medical device designed by the Mayo surgeon and approved by FDA without clinical testing, I began advocating for safer implanted medical devices.  Legislation to renew MDUFA must be complete by September 2012, yet the medical device industry is balking at contributing financially to oversight that would protect patients from harm.  The 'talking points' are focused on speeding 'innovations' to a (unconfirmed & DTC marketed) demanding and growing pool of desperate patients and the need to maintain jobs-at-all-cost for workers in the profitable medical device industry.  Bill Walton has been hired to lobby Congress. The industry threatens that if it is not placated they will go to other countries.  Let them go so there are fewer American victims in medical and legal purgatory!