Connect with us

Anglais

‘We’re guinea pigs’: Canada’s oversight process for implanted medical devices stuns suffering patients

Published

on

[ad_1]

Millions of Canadians rely on surgically implanted medical devices in order to function — to do everything from walk without pain to pump blood through their veins. Yet many of those devices are approved for use in Canada with scant scientific evidence to show they are safe and effective, a new CBC/Radio-Canada/Toronto Star investigation has found.

An analysis of Health Canada data obtained through Access to Information also reveals that in the past 10 years, devices such as replacement hips, insulin pumps and pacemakers are suspected to have played a role in more than 14,000 reported injuries and 1,416 deaths.

Since Health Canada relies primarily on the companies that make the products to flag any safety issues, the agency itself acknowledges many cases likely go unreported.

Toronto-based surgeon Dr. David Urbach says patients — and even some doctors — may not realize the limitations of pre-market testing of medical devices in this country.

Testing high-risk devices that require surgery is more difficult than conducting drug trials, and often involves smaller groups and shorter time frames, he says. As a result, potential complications sometimes don’t reveal themselves until after a device hits the market.

Toronto-based surgeon Dr. David Urbach says implanted medical devices, such as replacement joints and bladder-support meshes, are somewhat ‘experimental’ even after Health Canada approves them. (Craig Chivers/CBC)

Essentially, devices are « somewhat experimental » even after they have been approved by Health Canada, Urbach says.

« Thinking of them as sort of like a large clinical trial, within which we’re all participants, is probably a very constructive way to think about how we use medical devices. »

But that’s not what 63-year-old Nonie Wideman signed up for.

A decade ago, she was busy caring for children and running her family farm just outside Fort St. John, B.C., when a persistent health problem became too uncomfortable to ignore.​

« I just wanted … to be able to lift something, or even cough, sneeze without wetting my pants, » said Wideman, who was diagnosed with stress urinary incontinence, a condition that affects thousands of Canadian women.

Wideman says she assumed medical devices undergo more rigorous testing before they are approved for surgery. (Craig Chivers/CBC)

Wideman’s doctor suggested a 15-minute surgical procedure to implant Ethicon’s Gynecare TVT Secur System — a plastic sling that would help support her bladder.

« The doctor said it was a new kind of mesh, smaller, and that it would change my life, » Wideman said.

She had the procedure in June 2008, and felt better for the next six months. Then she became chronically tired and felt intense pain in her pelvis.

« I walked like I had a stick stuck up my butt and a knife in my crotch. »

Investigating her own case

When she couldn’t convince her doctor the mesh was making her sick, she borrowed a microscope from the local elementary school to take a closer look at little blue fibres she kept finding in her underwear and urine.

« I couldn’t believe my eyes at first, but I looked it up, and this was blue polypropylene, » she said.

It was clear to Wideman that her mesh was breaking apart.

« I was just stunned, » she said.

Microscopic evidence from Wideman’s own investigation into her disintegrating bladder mesh device. (Nonie Wideman)

Wideman was far from the only woman hurting.

In October 2008, just a few months after Wideman’s surgery, the U.S. Food and Drug Administration warned surgeons about rare complications potentially linked to the use of meshes.

The FDA said nine different manufacturers had received more than 1,000 reports of serious reactions possibly associated with polypropylene, the plastic coating on the mesh.

Over the next three years, the FDA received another 2,800 adverse event reports. It strengthened its warning in 2011, telling doctors serious complications such as mesh erosion were « not rare. »

By comparison, Health Canada received 47 injury reports linked to the Gynecare TVT Secur System. The complications mentioned include erosion, painful intercourse and recurrent infections — all problems Wideman says she experienced. But Health Canada didn’t issue a warning to surgeons until 2010 — two years after the FDA sent out its first.

In 2012, Ethicon, a Johnson & Johnson subsidiary, announced it would stop selling its Gynecare TVT Secur System and three other mesh products for commercial reasons. The company stressed that the decision was « not related to safety or efficacy. »

In a statement, Ethicon said it conducted « numerous cadaver labs and animal studies » prior to the device being approved for sale by Health Canada.

The company said those studies, « coupled with the decade-long clinical history » of two similar devices already on the market, « demonstrated the safety and efficacy of TVT Secur. »

There is no transparency. You have to dig for every bit of evidence if you want to expose a problem.– Nonie   Wideman

In an email to CBC, Health Canada said « in many cases, applications for new medical device licences are based on an earlier generation of a similar device previously licensed. » Additional information about the new product becomes available after it is approved for the market and used « under ‘real life’ conditions. »

A 2017 study from Oxford University’s Centre for Evidence-Based Medicine used the FDA’s databases to research the approval process for 61 pelvic meshes, including the TVT Secur. It found there was no evidence any of the meshes underwent clinical trials on women prior to their approval.

Wideman says she’s upset that she and many other women were left in the dark about how devices in Canada are approved and the lack of evidence available.

She says doctors « blindly trusted » that the mesh was tested thoroughly and that clinical studies proved it was a « gold standard of treatment. »

« They didn’t understand that we’re guinea pigs, » she said.

Problems likely underreported

The problem with Health Canada’s approach is when things do go wrong, only a fraction of cases are ever reported to the federal regulator, says Madris Tomes, a former analyst for the FDA who took a look at the data obtained by CBC.

Tomes was hired by the U.S. regulator in 2010 to create a new monitoring system for its medical device reports, known as the MAUDE database. She found there was a critical underreporting problem — as few as 14 per cent of adverse events were being flagged to the FDA.

Between 2008 and the first 9 1/2 months of 2018, a yearly average of just under 11,000 reports of technical problems and patient complications associated with medical products were submitted to Health Canada.

« These numbers, if I were to compare them with what the FDA has, seem very, very low, » Tomes said.

In Canada, only manufacturers and importers of medical devices are legally required to report possible safety issues and complaints to the government. Unlike in the U.S., any reporting by hospitals and health clinics is voluntary.

« If the manufacturer is the only one that’s going to be reporting, then you have only their viewpoint of what happened, » Tomes said.

And when a problem isn’t reported, she says, it means countries like Canada and the U.S. are missing crucial warnings that something might be wrong — and patients could be at risk.

« Maybe this [problem] happened 15 times, but if it had happened 1,500 times, maybe we’d stop blaming the user. And start looking more at that device. »

‘I was in pain’

Gloria McSherry knows all about the blame game.

In 2007, the woman from Creemore, Ont., woke up from hip replacement surgery with one leg longer than the other.

The pain persisted long after the procedure.

« I felt like I’d been hit by a truck, » she said.

McSherry says when she told her doctor about it, he said she was just taking a long time to recover from a difficult surgery. When she came back months later, still in pain, her doctor suggested she was probably depressed, she says.

« I said, ‘No, I’m not depressed. I’m in pain,' » she said. « I think the system failed me by not listening to me. »

Hip replacement surgery in 2007 left Gloria McSherry with one leg longer than the other — and in brutal pain. (Craig Chivers/CBC)

McSherry’s new hip was a product called the Durom Cup. Its manufacturer, Zimmer, issued a warning to U.S. surgeons in 2008, a year after McSherry’s surgery. The doctors were told to « stop implanting » the Durom Cup until they received additional training and also that the FDA had temporarily suspended the sale of the product.

But McSherry didn’t find out until 2009, when her case was referred to a specialist in Boston. Court documents later revealed that Zimmer knew it had sold exactly 4,941 devices in Canada, but kept no records of patients’ names or contact information and had no way of informing them about the recall.

In 2016, Zimmer settled three Canadian class action lawsuits involving hundreds of victims, including McSherry, who had to have a second hip surgery.

In a statement sent to the the Washington-based International Consortium of Investigative Journalists, Zimmer Biomet says the safety of its patients has always been its top priority and that it « adheres to strict regulatory standards. »

CBC’s analysis of Health Canada’s database shows that, in the past decade, 15 per cent of industry reports were submitted after the 10- or 30-day deadline for reporting. In at least 21 cases involving a death, manufacturers notified Health Canada more than a year after learning about the fatality.

Bioethicist Bryn Williams-Jones of the University of Montreal says it’s the government’s responsibility to monitor the safety of medical devices used to treat Canadians.

« At the end of the day, we’re in a commercial environment, and companies’ bottom line is to generate revenue and boost sales, » he said. « In a context like that, of course there’s going to be pressure to not do this level of evaluation and of course pressure to hide information. »

In a statement, MEDEC, the organization that represents Canada’s medical technology industry, said its products have a « strong track record of safety when you consider the millions of medical devices implanted in Canadians and the devices Canadians use every day. »

Health Canada’s plan

Health Canada acknowledges underreporting is a problem. The agency is amending regulations to make it mandatory for hospitals to report suspected problems with medical devices. It says the new rules could be in effect as early as next year.

« Mandatory reporting by Canadian hospitals is expected to increase the volume of incident reports, which would address, in part, issues with underreporting, » spokesperson Eric Morrissette said in an email.

But Nonie Wideman says that’s not enough. Last year, she petitioned the House of Commons to make clinical trial data for medical devices publicly available.

« There is no transparency. You have to dig for every bit of evidence if you want to expose a problem. »

The federal government denied her request, assuring her that « Canada’s medical devices regulatory system is one of the most rigorous in the world. »

[ad_2]

Source link

قالب وردپرس

Anglais

12 strategies to manage credit card payments and debt

Published

on

By

Today, almost everyone carries a credit card in their wallets. It is used to pay for almost everything from groceries to flight tickets to gas.

If managed properly, credit cards can be an essential financial tool that allows users to build credible credit, earn money back and gain great perks, like purchase protection and insurance. However, carrying a poor credit balance can plunge you into massive debt.

“Credit card debt is very high-interest debt, typically in the neighbourhood of 20% or more,” said Scott Hannah, president and CEO of Credit Counselling Society in a report.

If you have a balance payment on your credit card, clearing it off can be a difficult task if you’re a low-income earner—or you’ve already incurred too much debt that after using a credit card payment calculator you know you’ll be unable to pay back.

However, no matter how terrible you think your current situation is, there’s always a way out that works best for you. With interest on loans compounding everyday, there’s little wonder why clearing a credit card debt is so difficult. In fact, according to MNP, an accounting firm, nearly half of all Canadians are less than $200 per month away from becoming financially insolvent.

Tackling credit card debt can seem quite tedious, especially with many people choosing to ignore the problem and just keep making the minimum payment. Here are some practical strategies you can take advantage of to effectively tackle credit card debt.

1. Gain a complete understanding of your debt problem

This starting point for anyone trying to get out of debt is to understand why you’re in debt, in the first place.

Critically examine all areas of your finances to determine if your expenses don’t match your finances or if it was due to an unforeseen circumstance such as a medical emergency. Whatever the case may be, it is very important to know the reason why you are in so much debt so you can effectively tackle the root cause.

2. Look into your spending habits

Typically, one quick way to stop yourself from running into credit card debt is to examine your spending habits. What are the things you spend your credit card on? Are they essentials or things that can be easily done away with?

According to Hannah, most people can only account for about 75 to 80 per cent of their monthly expenditures and the remaining gets blurry. It is important to track your expenditure—whether it’s an extra shot of drinks at the bar or a box of cereal from the supermarket. Knowing what you spend money on allows you to build a better financial strategy against debt.

3. Build a budget

Once you have a clear picture of what your monthly expenses are, building a budget becomes the most important step towards managing your income better. Having one central location for tracking both your income and expenses is great in curtailing unnecessary spending and getting you out of debt.

Your budget needs to contain all of your expenses incorporated from essentials like groceries, mortgage, medical care and insurance to others such as utilities. While most people struggle to stick to their budget, you can create some margin for flexibility to make it easier for you.

4. Increase your minimum payment

For most credit cards, the minimum payment is approximately 2 per cent of the last month’s balance. But therein lies the problem because if you consistently pay only the minimum, then the lump of that money goes straight to your interest and not the principal.

Paying some extra money every month would go a long way in helping you clear your credit card debt faster and reduce the compounding interest.

5. Ask for a lower rate

It is very possible to negotiate for a lower rate with your bank; only thing is, most people tend not to do so. If you find yourself struggling with paying back your credit card debt, you can reach out to your lender and ask them to offer you a lower rate.

Long-time customers who have a history of making timely payments have more advantage with getting their request approved.

6. Take advantage of a balance transfer promotion

In a bid to entice new customers, lenders run promotions periodically on balance transfers for their credit cards. Basically, these offers involve having a low-interest rate between 0 to 2 per cent for a limited period—usually between 6 to 10 months.

Always be on the lookout for a lender that offers the lowest rates and longest promotional period, which would give you enough time to clear your debt.

7. Switch to a low-interest credit card

Once you have critically examined your spending habit and created a budget, yet it is obvious that you will always carry over a credit card balance, then it is time to switch to a low-interest credit card.

While these types of credit cards usually have little perks, they are quite useful in wiping a couple of percentage points off your interest. Typically, rates on low-interest credit cards vary but they could be as low as half the interest on a regular card.

8. Begin an avalanche

The avalanche method is great for those who have a lot of debt with several creditors. This method means you’d make the minimum payments on all your existing debts and then add any extra income to the debt that has the highest interest rate.

Using the avalanche method allows you to reduce the interest paid while clearing multiple debts.

9. Use the debt snowball approach

Another debt repayment strategy that you should consider is the debt snowball method. In this strategy, you would focus on paying off your small debt first before moving to the larger ones—all whilst still paying the minimum on all other debt—regardless of interest rate.

10. Get an extra income source

Creating additional streams of income goes a long way in helping you clear your credit card debt. By finding a better paying job or choosing a good side hustle, you can easily put down more money towards your debt repayment.

There’s a lot of gigs you can offer today to raise extra money such as writing, graphic design, proofreading, teaching and programming.

11. Use a personal loan

If your credit card balance is quite high, paying it off using a personal loan may be very advantageous. While the interest rates on credit cards can be as high as 29 per cent, with a good credit score you can qualify for a personal loan at a lower rate.

The main advantage of using this strategy is being able to pay off multiple credit card debts and focus on making single but fixed monthly payments on the remaining loan. Also, you spend lesser money on interest costs and repaying the loan in instalment would boost your credit score.

12. Spend more cash

Despite being very valuable items, credit cards can quickly run you into massive debt when not used properly. If you already have some debt yet to be paid, it is better to spend more cash than accumulate more debt on your credit card.

Get a low-interest credit card but only use it in emergencies once you know there isn’t enough money in your bank account to pay off the accumulated debt.

Continue Reading

Anglais

‘Business as usual’ for Dorel Industries after terminating go-private deal

Published

on

By

MONTREAL — Dorel Industries Inc. says it will continue to pursue its business strategy going forward after terminating an agreement to go private after discussions with shareholders.

« Moving ahead. Business as usual, » a spokesman for the company said in an email on Monday.

A group led by Cerberus Capital Management had previously agreed to buy outstanding shares of Dorel for $16 apiece, except for shares owned by the family that controls the company’s multiple-voting shares.

But Dorel chief executive Martin Schwartz said the Montreal-based maker of car seats, strollers, bicycles and home furniture pulled the plug on a deal on the eve of Tuesday’s special meeting after reviewing votes from shareholders.

“Independent shareholders have clearly expressed their confidence in Dorel’s future and the greater potential for Dorel as a public entity, » he said in a news release.

Dorel’s board of directors, with Martin Schwartz, Alan Schwartz, Jeffrey Schwartz and Jeff Segel recused, unanimously approved the deal’s termination upon the recommendation of a special committee.

The transaction required approval by two-thirds of the votes cast, and more than 50 per cent of the votes cast by non-family shareholders.

Schwartz said enhancing shareholder value remains a top priority while it stays focused on growing its brands, which include Schwinn and Mongoose bikes, Safety 1st-brand car seats and DHP Furniture.

Dorel said the move to end the go-private deal was mutual, despite the funds’ increased purchase price offer earlier this year.

It said there is no break fee applicable in this case.

Montreal-based investment firm Letko, Brosseau & Associates Inc. and San Diego’s Brandes Investment Partners LP, which together control more than 19 per cent of Dorel’s outstanding class B subordinate shares voiced their opposition to the amended offer, which was increased from the initial Nov. 2 offer of $14.50 per share.

« We believe that several minority shareholders shared our opinion, » said Letko vice-president Stephane Lebrun, during a phone interview.

« We are confident of the long-term potential of the company and we have confidence in the managers in place.”

Continue Reading

Anglais

Pandemic funds helping Montreal businesses build for a better tomorrow

Published

on

By

Many entrepreneurs have had to tap into government loans during the pandemic, at first just to survive, but now some are using the money to better prepare their businesses for the post-COVID future.

One of those businesses is Del Friscos, a popular family restaurant in Dollard-des-Ormeaux that, like many Montreal-area restaurants, has had to adapt from a sit-down establishment to one that takes orders online for takeout or delivery.

“It was hard going from totally in-house seating,” said Del Friscos co-owner Terry Konstas. “We didn’t have an in-house delivery system, which we quickly added. There were so many of our employees that were laid off that wanted to work so we adapted to a delivery system and added platforms like Uber and DoorDash.”

Helping them through the transition were emergency grants and low-interest loans from the federal and provincial governments, some of which are directly administered by PME MTL, a non-profit business-development organization established to assist the island’s small and medium-sized businesses.

Konstas said he had never even heard of PME MTL until a customer told him about them and when he got in touch, he discovered there were many government programs available to help his business get through the downturn and build for the future. “They’ve been very helpful right from day one,” said Konstas.

“We used some of the funds to catch up on our suppliers and our rents, the part that wasn’t covered from the federal side, and we used some of it for our new virtual concepts,” he said, referring to a virtual kitchen model which the restaurant has since adopted.

The virtual kitchen lets them create completely different menu items from the casual American Italian dishes that Del Friscos is known for and market them under different restaurant brand names. Under the Prasinó Soup & Salad banner, they sell healthy Greek options and their Stallone’s Sub Shop brand offers hearty sandwiches, yet the food from both is created in the same Del Friscos kitchen.

Continue Reading

Chat

Anglais4 semaines ago

12 strategies to manage credit card payments and debt

Affaires1 mois ago

Prudence avec le passeport vaccinal

Affaires1 mois ago

Le secteur touristique autochtone s’attendait à beaucoup plus du budget fédéral

Affaires1 mois ago

La fintech canadienne Mogo ajoute 146 autres Ethereum à son portefeuille de crypto

Affaires1 mois ago

Les entreprises canadiennes estiment que l’épuisement professionnel nuira au résultat net des entreprises cette année, selon une nouvelle étude de Sage au Canada

Affaires1 mois ago

Chaire de recherche du Canada sur les matériaux de construction multifonctionnels durables

Affaires1 mois ago

Les Canadiens seront vaccinés

Affaires1 mois ago

Samsung Canada et Tim Hortons poursuivent la transformation numérique des services au volant en prévoyant la mise en place de 2 600 écrans extérieurs dans tout le Canada d’ici la fin de 2021.

Affaires1 mois ago

Le Canada mise sur le nucléaire pour réduire les GES

Affaires1 mois ago

Les mesures sanitaires font reculer les ventes de Tim Hortons

Affaires1 mois ago

L’Université de Montréal a caché un laboratoire nucléaire pendant la guerre

Affaires1 mois ago

Économie : les postes vacants coûtent 8 M $ par jour au secteur de la transformation alimentaire

Opinions1 mois ago

J’ai peur du projet de loi 59

Opinions1 mois ago

La protection de nos enfants, c’est aussi l’affaire du municipal

Opinions1 mois ago

Crise du logement : le Parti libéral du Québec en mode solutions

Opinions1 mois ago

Des témoins condamnent le comportement de certains députés envers elles

Opinions1 mois ago

Québec solidaire demande à ses membres de se prononcer sur une faction du parti

Opinions1 mois ago

Chevaliers de la «libarté»

Opinions1 mois ago

Se taire ou faire usage de sa liberté d’expression citoyenne?

Opinions1 mois ago

Contrer les féminicides: de la considération à la préoccupation!

Anglais3 années ago

Body found after downtown Lethbridge apartment building fire, police investigating – Lethbridge

Styles De Vie3 années ago

Salon du chocolat 2018: les 5 temps forts

Anglais2 années ago

This B.C. woman’s recipe is one of the most popular of all time — and the story behind it is bananas

Santé Et Nutrition3 années ago

Gluten-Free Muffins

Anglais2 années ago

27 CP Rail cars derail near Lake Louise, Alta.

Anglais2 années ago

Man facing eviction from family home on Toronto Islands gets reprieve — for now

Santé Et Nutrition3 années ago

We Try Kin Euphorics and How to REALLY Get the Glow | Healthyish

Anglais2 années ago

Ontario’s Tories hope Ryan Gosling video will keep supporters from breaking up with the party

Anglais2 années ago

A photo taken on Toronto’s Corso Italia 49 years ago became a family legend. No one saw it — until now

Anglais3 années ago

Condo developer Thomas Liu — who collected millions but hasn’t built anything — loses court fight with Town of Ajax

Styles De Vie3 années ago

Renaud Capuçon, rédacteur en chef du Figaroscope

Anglais2 années ago

This couple shares a 335-square-foot micro condo on Queen St. — and loves it

Mode2 années ago

Paris : chez Cécile Roederer co-fondatrice de Smallable

Anglais3 années ago

Ontario Tories argue Trudeau’s carbon plan is ‘unconstitutional’

Styles De Vie2 années ago

Ford Ranger Raptor, le pick-up roule des mécaniques

Affaires2 années ago

Le Forex devient de plus en plus accessible aux débutants

Anglais3 années ago

100 years later, Montreal’s Black Watch regiment returns to Wallers, France

Anglais3 années ago

Trudeau government would reject Jason Kenney, taxpayers group in carbon tax court fight

Technologie2 années ago

YouTube recommande de la pornographie juvénile, allègue un internaute

Anglais2 années ago

Province’s push for private funding, additional stops puts Scarborough subway at risk of delays

Trending