Guinea declared a new Ebola outbreak on Sunday, as tests came back positive for the virus after at least three people died and four fell ill in the country’s southeast — the first resurgence of the disease there since the world’s worst outbreak from 2013 to 2016.
The seven patients fell ill with diarrhea, vomiting and bleeding after attending a burial in Gouéké sub-prefecture. Those still alive have been isolated in treatment centres, the Health Ministry said.
It was not clear if a person buried on Feb. 1 had also died of Ebola. She was a nurse at a local health centre who died from an unspecified illness after being transferred for treatment to Nzérékoré, a city near the border with Liberia and Ivory Coast.
“Faced with this situation and in accordance with international health regulations, the Guinean government declares an Ebola epidemic,” the ministry said in a statement.
The 2013-16 outbreak of Ebola in West Africa started in Nzérékoré, whose proximity to busy borders hampered efforts to contain the virus. It went on to kill at least 11,300 people, with the vast majority of cases in Guinea, Liberia and Sierra Leone.
Fighting Ebola again will place additional strain on health services in Guinea as they battle the coronavirus. Guinea, a country of about 12 million people, has so far recorded 14,895 coronavirus infections and 84 deaths.
The Ebola virus, which causes severe vomiting and diarrhea, is spread through contact with body fluids. It has a much higher death rate than COVID-19, but unlike the coronavirus it is not transmitted by asymptomatic carriers.
The ministry said health workers are attempting to trace and isolate the contacts of the Ebola cases and will open a treatment centre in Gouéké, which is less than an hour’s drive from Nzérékoré.
The authorities have also asked the World Health Organization (WHO) for Ebola vaccines, it said. The new vaccines have greatly improved survival rates in recent years.
“WHO is ramping up readiness & response efforts to this potential resurgence of #Ebola in West Africa, a region which suffered so much from Ebola in 2014,” Dr. Matshidiso Moeti, WHO’s regional director for Africa, said on Twitter.
The vaccines and improved treatments helped efforts to end the second-largest Ebola outbreak on record, which was declared over in Democratic Republic of the Congo last June after nearly two years and more than 2,200 deaths.
But on Sunday, DRC reported a fourth new case of Ebola in North Kivu province, where a resurgence of the virus was announced on Feb. 7.
Dental hygienists say new provincial health guidelines around protective wear for safety during dental procedures are confusing at best and may not go far enough, despite the provincial health officer’s reassurances that patient screening provides an added layer of protection.
Many provinces, like Alberta, require dentists and assistants to wear N95 masks for any service that produces aerosols, but that’s not necessary under new BCCDC guidelines published late Friday.
Provincial Health Officer Dr. Bonnie Henry said careful pre-screening should be used to weed out infected patients, and mask and face protections should keep people safe during procedures.
But the possibility of a leaky mask or an asymptomatic patient concerns members of the B.C. Dental Hygienists Association.
A shortage of N95 masks and other protective wear has dogged this sector’s plans to reopen and the B.C. Dental Association says it’s reviewing the newest provincial guidelines on behalf of its members.
The College of Dental Surgeons of B.C. guidelines, based on guidance from The B.C. Centre for Disease Control, published last Friday, May 15, stipulate that an N95 mask and eye protection is needed, plus gloves and a gown for any “aerosol generating” procedures, but only with patients who have suspected or confirmed COVID-19.
But it does not say that level of protection is needed for other patients, despite the fact some may be asymptomatic.
In a statement, a spokesperson for the college said the plan is intended to guide a “careful restart,” but the college “does not expect any dental professional to provide treatment unless, in their professional opinion, it is safe to do so” for patients and the dental team.
Last week, the B.C. Dental Association advised patients that dental offices would not be opening regular practices May 19 — the initial provincial target date — and full dental services would resume as it becomes safe, depending on access to personal protective equipment. Despite that, some offices are opting to open this week.
Andrea Burton, the executive director of the Dental Hygienists Association, said each individual dentistry office is a business and the owners in each case decide what works for them.
BC hygienists feel ‘a little bit like guinea pigs.’
Burton described the new guidelines released Friday as confusing and too vague.
“Why are we the ones that are being asked to go back to work with less [suggested protective gear] than what they have in Alberta? Dental hygienists in British Columbia feel a little bit like guinea pigs. Maybe it’s fine. But maybe is a tough word when you are talking about your health.”
Burton said that while some dental offices are reopening, others are waiting a few weeks to see how things go.
Health officials have said the key will be pre-screening patients to make sure they do not have symptoms.
In an interview, Henry said for most procedures, even on a person infected with COVID-19, “you can safely provide care” wearing a mask and face protection, such as goggles or a face shield.
But it is the level of mask that hygienists want clarified.
Vancouver dental assistant Megan Cymbaluk said N95 masks were such a “hot commodity” that her employer was proactive and found alternate respirator-type masks that painters would use that can be wiped down and sanitized between appointments.
“That is what we felt comfortable with. Then, to find out that we are not needing [that level] of mask for all-day wear or every patient is a little bit shocking,” she said.
Cymbaluk said she is not convinced she is safe with a regular surgical mask, even with an additional face shield, given how close she works all day to droplets from dental patients’ mouths.
“There are gaps between your eyebrows, on the side by your temples — and on the sides of your cheeks — it’s not an airtight seal,” she said.
While her office pre-screens, she worries about asymptomatic COVID-19 carriers.
“We don’t have access to proper testing. Our main defence is word of mouth and a handheld thermometer,” she said.
Cymbaluk said she is not sure if she will remain in the dentistry profession now.
“I’m not sure if this is a job that I could realistically continue doing — walking into that level or risk every day and to not be sure if I’m bringing anything home with me.”
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 NonieWideman 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.
BioethicistBryn 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."
South Sudan has gone 15 months without a single reported case of Guinea worm disease, the nation’s health minister said Wednesday, suggesting a major victory for global health officials trying to eliminate the debilitating affliction.
Also, the Carter Center said only 30 cases were reported last year in isolated areas of Ethiopia and Chad. That’s a real achievement for efforts to eradicate a disease that only 30 years ago affected 3.5 million people a year in 21 countries across Africa and Asia.
Contracted by drinking infected water, Guinea worm disease affects some of the world’s most vulnerable people. The meter-long worm is asymptomatic and incubates in people for up to a year before painfully emerging, often through extremely sensitive parts of the body.
Unlike other diseases that are controlled by medicines or vaccines, Guinea worm can be eradicated through education, by training people to filter and drink clean water.
South Sudan was one of nine countries still affected when its eradication program began in 2006. At the time, the disease was endemic in more than 3,000 villages, and the country tallied more than 20,500 cases.
South Sudan’s progress against Guinea worm, announced at the centre by its health minister, Dr. Riek Gai Kok, is being touted as one of the few successes to emerge from the young nation while it battles a five-year civil war, starvation and human rights atrocities.
The global campaign to wipe out guinea worm was launched by the World Health Organization and the U.S. Centers for Disease Control and Prevention. Former U.S. President Jimmy Carter has led these efforts since 1986, when the Carter Center and UNICEF joined the campaign.
Only one human disease has ever been successfully eradicated: smallpox. As with guinea worm, there is also a continuing effort to eradicate polio, but such efforts often face their greatest obstacles in the last phase of stopping the disease.