Health & Fitness

A new documentary, “Shady Implants: The ‘Guinea Pigs’ of the Medical Industry,” exposes the corruption in the medical device industry. The film, produced by the German Public Broadcast Service DW, reveals that the number of health problems associated with medical devices has risen significantly in recent years.

This is strongly tied to a lack of government regulation, particularly in Europe, where medical device manufacturers get away with bringing potentially harmful products to market without conducting adequate safety testing.

In addition to sidestepping product safety testing, medical device manufacturers also pay surgeons big bucks to use their products, as well as encourage them to recommend the medical devices to their colleagues. The business model is similar to the pharmaceutical industry in the U.S., which often markets drugs to doctors by offering them perks such as free meals and travel.

The featured film reveals that a number of different medical devices have been linked to serious health problems. Some of these devices include artificial spine disk implants, breast implants, hip replacement devices, bone graft devices and insulin pumps.

The health problems linked to defective medical devices are often very severe and have resulted in sterility, paralysis, cancer, chronic pain and death. Even more disturbing is that patients report having no knowledge of these potential health risks.

‘It’s an Absolute Disaster. This Never Should Have Happened’

In the film, the first example of someone harmed by this act of gross negligence is Thomas Woska. He tells the film’s producers that he had an artificial disk implanted in his back that disintegrated into lots of tiny plastic pieces. His back is now full of plastic scrap from the defective device, and it’s extremely difficult to have removed. He is in so much pain he can no longer work.

Woska is one of 113 patients in Germany who received the defective artificial disk. Two-thirds of those patients had to undergo additional major surgeries to correct the damage caused by the defective disk.

The film shows Wosk visiting Dr. Karsten Ritter-Lang, a specialist in orthopedic and trauma surgery at STENUM Orthopedic Clinic in Ganderkesee, Germany. Ritter-Lang, who has treated dozens of patients harmed by complications from the defective disk implants, said:

“They are in a lot of pain. First of all, there’s the actual physical discomfort caused by the defective disk. And then, there’s the psychological distress, because they know they’ve got this ticking timebomb in their body.”

The corrective surgery that Wosk needs is a dangerous one. Trying to remove the tiny bits of plastic, some of which have become lodged behind Wosk’s spine, carries a risk of accidentally cutting in to vital organs and blood vessels.

The shattered device severely damaged his vertebrae, and removing it is like pulling out old pieces of chewing gum, says Ritter-Lang. It’s an absolute disaster. This never should have happened, he adds.

Medical Device Maker Ignores Problems in Animal Studies

The spinal implant that Wosk received was manufactured by Ranier Technology, based in Cambridge, England. The company is one of thousands of small businesses in Europe trying to break into the medical device market.

Ranier tested the plastic disks on baboons, and the results were later leaked by a whistleblower. The film shows Ritter-Lang reviewing the animal test results, which showed serious problems with the disks. He says:

“It’s clear from these studies that the implants did not become properly integrated into the spinal system. Later, I noticed similar complications in my patients who had been given these disks.”

Ranier ignored red flags about its spinal disk implants. Shockingly, it continued to the next phase of the approval process and began performing clinical tests on humans. Ranier tested the product on people for three short months before it received approval from the British Standards Institution (BSI) for two implants, Cadisc-L and Cadisc-C. The BSI did not consider the animal studies or the brevity of the human clinical trials.

Defective Spinal Disk Left One Man Sterile, Unable to Work

Twenty-nine people signed up for the disk surgery. One of them was Andreas Rode, a butcher who enjoyed boxing. In 2010, he was suffering from a herniated disk, for which his doctor recommended an implant. Although the disk had not yet been officially approved, he agreed to the surgery in hopes it would resolve his pain.

Rode felt fine after the surgery. But just like what happened to Wosk, the plastic disk broke apart. It did not integrate into his body like it was supposed to. Rode had to have emergency surgery to remove the tiny pieces of plastic that had broken away from the disintegrating disk.

He needed several more operations to remove the plastic. His outcome was catastrophic. Rode can no longer have children and he can’t work as a butcher anymore, nor can he box. His nerves are damaged and he is physically incapacitated. Rode says all he wants is for someone to admit they made a mistake, but he doesn’t see that happening any time soon.

Ranier Technology Files for Bankruptcy

While Rode lay in the hospital recovering, doctors in Germany continued to use the plastic disks. The German government received many reports about serious reactions to the devices, but for years it never did anything to stop the disks from being sold.

A head physician at one of the clinics who was using the plastic disks was later fired for accepting illegal payments from Ranier. The British manufacturer has since filed for bankruptcy.

The Guardian reported in 2018 that Ranier sought approval for its spinal disk in Europe because the process was easier than in the U.S. Like many medical device makers, Ranier hoped getting approval in Europe would help fast-track approval in the U.S. A large body of research on defective medical devices known as the Implant Files, reported:¹

“Like Cadisc-L, the regulatory strategy for Cadisc-C is to penetrate Europe first and follow up in the USA … On the whole the regulatory process and required testing tends to be more stringent in the US compared with the EU.”

Faulty Medical Devices Killed 83,000 in the U.S. in 10 Years

Between 2015 and 2018, regulators in the U.K. received 62,000 reports of adverse reactions to medical devices, according to a 2018 report by the Guardian.² A third of those cases resulted in serious health problems, and 1,004 of them died.

The U.S. FDA has received 5.4 million “adverse event” reports in the last decade. Injuries were reported in 1.7 million cases, and 83,000 people died. Nearly 500,000 underwent additional surgery to remove the device.

The data, which make up the Implant Files, are derived from 252 journalists and 59 media organizations across 36 countries that uncovered major problems with medical devices, an industry that totals $400 billion worldwide.

Breast implants are another medical device linked to health problems. An estimated 500,000 women globally have been affected by defective breast implants made of cheap industrial silicone, the same type of silicone used to seal windows, according to the film.

The implants are made of a textured, Velcro-like surface that attaches to the breast tissue. They have been linked to anaplastic large cell lymphoma, a rare form of Non-Hodgkin lymphoma that affects the immune system.

Defective Breast Implant Maker Convicted of Aggravated Fraud

Since 2015, 1,200 women in the U.K. have been seriously harmed by the defective implants.³ Complications with the implants were reported across Europe and in the U.S. and Canada. A series of investigations by the International Consortium of Investigative Journalists found that a poor design and a lack of safety testing are what led to health problems in patients.

Poly Implant Prothèse was one of the manufacturers of the textured breast implants. It was accused of selling hundreds of thousands of defective breast implants in 65 countries. A lawsuit against the company resulted in a conviction of aggravated fraud for its founder, Jean-Claude Mas, as well as four former employees, according to a report by The New York Times.⁴

Prosecutors in the case accused Mas of using a gel for the breast implants that was seven times cheaper than an alternative, and testing showed the company’s breast implants ruptured more easily than others. Around 7,000 women have sued Poly Implant Prothèse for damages. The company was accused of ruining thousands of lives, and using women as lab rats.⁵

EU Warned 10 Years Ago of Medical Devices’ Serious Threat

For at least a decade, some officials in the EU have warned about the dangers posed by medical devices. Dagmar Roth-Behrendt, former Germany MEP and special adviser to the EU Commission for Health and Food Safety, has called for more studies and better testing for medical devices.

Unfortunately, her efforts have been met with opposition from the medical device industry. Roth-Behrendt says medical devices should be regulated similarly to medications and be subjected to stricter quality control measures before receiving market approval. In the film she says:

“The problem is that the certification agencies are privately run, not government run. That’s led to a kind of business tourism, where companies come to Europe where they can get certifications for their products quickly and cheaply.

That’s bad enough for a hairdryer or a mixer. People want those products to be safe so that they don’t explode when they use them. But what about medical products that are placed inside your body? If something goes wrong with them, they can cause serious physical damage.”

Medical device manufactures are fighting that proposal. They think the current regulations are enough to keep people safe and that stricter laws would threaten hundreds of thousands of industry jobs.

Journalist Shows How Easy Medical Device Approval Is

In 2014, a Dutch journalist showed how easy it is to get approval for a medical device in Europe. In the film she says:

“We’re designing a device that’s not safe at all, a mesh implant that helps to stabilize the uterus. We found all the component parts at the supermarket, and took some photos. Now it’s ready to go.”

Because similar products are already on the market, the journalist did not need to sign up for human clinical trials. Up to 90% of high-risk medical devices do not have to undergo medical trials, she says. The journalist made an appointment at a certification center in Vienna, Austria, where they filmed the meeting with a hidden camera.

To their astonishment, the secret film shows that the official doesn’t care to see the actual product itself. Instead, he relies on the documents provided by the journalist. No doctors are present during the meeting. The undercover video shows the approval officer saying, “There is a clinical necessity, there is clinical evidence, there are well-known materials, so why not?”

Medical Device Makers Favor Europe’s Simple, Cheap Approvals

Under this lax approval process, Europe has approved more than 500,000 medical devices,⁶ but U.S. officials have criticized Europe’s regulatory process for doing so. One congressman went as far as to say that in Europe, “patients are treated like guinea pigs.” Manufacturers in Europe are legally required to report problems that damage people’s health, but they often don’t and face no penalties.

Another manufacturer caught selling defective products was Medtronic, the world’s largest medical device maker. In 2018, it agreed to a $43 million settlement with investors over allegations it made improper payments to surgeons to cover up problems with a bone graft product. Investigative journalist Paul D. Thacker says Medtronic’s business model is to pay doctors to put devices in people or to recommend their device to other doctors.

Medtronic’s bone graft product, Infuse, caused dangerous side effects in patients who had spine infusion surgery. Some of the side effects include nerve injury, increased pain, numbness, paralysis and additional surgery.

Medtronic Infuse Product Leaves One Patient Paralyzed

Medtronic’s Infuse product left Stefanie Clair paralyzed from the chest down. Clair says she had no idea of the risks posed by Infuse. An investigation later found that Medtronic purposely tried to downplay the risks of its Infuse product. Dr. Eugene Carragee, professor of orthopedic surgery at Stanford University Medical Center, said:

“The complications of Infuse weren’t trivial, they were catastrophic, cancer, sterility, life-threatening airway events.”

Medtronic also manufactured an unknown number of defective insulin pumps that caused harm and death in some patients. Germany’s faulty reporting system made it impossible to know how many incidents there were involving the defective insulin pumps.

Despite the problems, Germany continues to use private inspection companies, and attempts to reform this system have been rejected by the government.

Defective Hip Implants

Jurgen Thomas, a technical manager at a wine cellar, had hip replacement surgery. But four years later the device, which had titanium components, had to be removed. The hip implant rubbed against nearby bones, causing metal scraps to break off and end up in the surrounding tissue.

He suspected that the device had not been properly tested, so he filed a lawsuit against the manufacturer, Zimmer Biomet.

Seven hundred people received the defective hip implants. Some filed lawsuits that have been dragging on for years. Attorneys for Zimmer Biomet tried to pin the blame on the surgeons, and even some of the patients. Tim Abele received one of the defective hip implants. The harm caused by the device has hindered his ability to walk more than 500 yards at a time. He also lost his sense of taste and smell.

Investigation Finds Hip Implants Were Not Safety Tested

The plaintiffs suspected Zimmer Biomet knew about the problems with its hip implant. An investigation ordered by the court revealed Zimmer Biomet failed to properly test the implant. Yet it still qualified for certification by submitting tests from a similar but old device. Product testing expert Wolfram Mittelmeier said:

“If we were talking about the automobile industry, it would be difficult to compare one model of the same car with a newer model because the newer design would include some modifications.”

Sure enough, the investigation found the hip replacement defective because it rubbed against the surrounding bone structure. It’s a complication that would have been identified had the manufacturer done the proper safety testing. Even more disturbing is that these health risks had already been widely reported, including in research publications as early as 2003.

On October 15, 2018, a judge ruled that Zimmer Biomet’s hip implants should never have been approved for sale because the health risks were well-known and more testing should have been done.

The judge ordered Zimmer Biomet to pay Thomas 25,000 euros in damages. However, the manufacturer maintains their devices were not faulty and is expected to appeal, dragging out the case even longer.

The film concludes by speaking with an auditor who has worked for various medical device certifiers, who says he has serious concerns about how quality control measures are conducted on various medical devices. One of the problems is that many of the auditors are freelancers and don’t have the expertise to make qualified judgments, he says, adding: 

“None of them is really independent. They almost never decide that a product is risky. If they did, the testing company could get into trouble, and they might lose their job.”

European Law for Medical Devices Doesn’t Go Far Enough

In spite of these obstacles, things are beginning to change, at least somewhat, in Europe’s medical device industry. In 2017, Europe approved new regulations on medical devices that include more clinical studies, more controls and an independent database.⁷ But the new law does not change the root of the problem, which is a lack of independent product testing.

The new rules are set to go into effect in 2020, but the industry is already lobbying hard to delay that deadline. Sadly, Roth-Behrendt concedes in her efforts to create a state agency that would have imposed stricter controls on medical device testing. She says in the film:

“I wanted to draft legislation that would make sure the devices are safe for the patients, and would allow the companies to make money. But the new law doesn’t do that.

It still makes me angry after all these years. It’s like a wound that won’t heal. I’m upset that we weren’t able to make life safer for the around 741 million people who live in the EU. I feel as though I failed, and I take responsibility for that. I’m ashamed of myself and my colleagues. It makes me so mad that I almost want to cry.”

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In the past few years, eyelash extensions have become very popular, especially among young women. The extensions, attached by a professional at a salon, are glued individually to existing eyelashes in a process that can take three hours¹ and cost up to $400.²

The glue is made with butyl cyanoacrylate and octyl cyanoacrylate, although some glues may contain formaldehyde — which can potentially cause great irritation and other eye problems.³

The popularity of eyelash extensions stems from the time saved in makeup routines: Mascara does not need to be applied (or removed to prevent "raccoon eyes"), nor is eyelash curling necessary. Extensions are sometimes worn for six weeks before being touched up and, unlike false eyelashes or "falsies," do not fall off during some activities since they are individually anchored.⁴

But now doctors are saying that what many wearers think is the best feature of eyelash extensions — their duration — may be their worst. Left in place for weeks, the extensions' glue and accumulating bacteria can invite mites to move in, especially when the lashes are not cleaned adequately.

Doctors say they are increasingly seeing these tiny parasitic mites, which are sometimes referred to as "eyelash lice," on the lashes of extension users.⁵

What Are Eyelash 'Lice'?

The mites found on eyelashes, aka eyelash "lice," are Demodex folliculorum and Demodex brevis. They are contagious and can potentially spread from one host to another.⁶ They are so small — D. folliculorum is 0.3 to 0.4 mm long and D. brevis is 0.15 to 0.2 mm long — they can hardly be seen by the unaided eye.⁷

While both mites can inhabit the eyelashes, D. folliculorum feeds on skin cells while D. brevis feeds on sebum from oil gland cells. According to the Indian Journal of Dermatology the small size of these mites:

" … makes them invisible to the naked eye, but, under the microscope, their structure is clearly visible. It has a semi- transparent, elongated body that consists of two fused segments. Eight short, segmented legs are attached to the first body segment.

The eight legs of this mite move at a rate of 8-16 mm/h and this is mainly done during the night as bright light causes the mite to recede into its follicle.

The body is covered with scales for anchoring itself in the hair follicle and the mite has pin-like mouth parts for eating skin cells, hormones, and oils (sebum) accumulating in the hair follicles …The mites are transferred between hosts through contact of hair, eyebrows, and sebaceous glands on the nose …

… Demodex mites are present in healthy individuals and may have a pathogenic role only when present in high densities. The infestation may be clinically inapparent, but, under favorable circumstances, these mites may multiply rapidly, leading to the development of different pathogenic conditions."⁸

Eyelash 'Lice' Can Be Tricky to Diagnose

What are the symptoms of those in whom the mites have "multiplied rapidly" as the research above describes? Itching and burning eyes and eyelids are key signs, according to Review of Optometry,⁹ along with a feeling that something's in your eyes and fluctuating blurry vision.

While eye professionals may instinctively treat the conditions with artificial tears, if mites are the culprit, there will be no improvement.¹⁰ Since Demodex mites are so small, the eye conditions can be attributed to other causes, yet if not treated correctly, you can develop the infestation symptoms of redness, inflammation, blood shot eyes and blocked oil glands.

Demodex can also contribute to the more serious eye inflammation conditions of blepharitis, blepharoconjunctivitis and blepharokeratitis.¹¹ Demodex may look like blepharitis,¹² an inflammation of the eyelids from clogged oil glands, and the related conditions of blepharoconjunctivitis¹³ and blepharokeratitis.¹⁴

However, blepharitis and the related conditions are treated with lid hygiene, warm compresses and sometimes antibiotics or steroids, which are treatments that can actually worsen Demodex.¹⁵ Moreover, blepharitis conditions are usually not contagious,¹⁶ whereas Demodex infestations are. Clearly, a correct diagnosis is essential, and it requires an exam by a medical eye professional.

Demodex Are Spread by Lack of Hygiene

Eyelash mites are thought to develop from a combination of the glue used to adhere extensions and the accompanying bacteria when users don't remove their makeup and clean their lashes adequately.¹⁷ Though some wearers favor eyelash extensions for the time they save in makeup routines, time is usually not the reason some don't clean their lashes properly, says one makeup professional.

"There is an increase in women thinking if they … wash them they'll fall out faster," Janet Figueroa, a cosmetologist in Ontario, California, told Fox News.¹⁸ Demodex infestations can also stem from salon staff who fail to adequately clean their tools after each customer.¹⁹ It's very important to choose your salon carefully and read the online reviews of other customers.

While the mites themselves are not visible, evidence of an infestation can be apparent if you know what to look for, Figueroa said. She has seen -"yellow/flesh-colored buildup of old cells or makeup" in customers who admit they don't wash their lashes regularly.²⁰ The "yellow bulb like bumps on the lashes at the base of the natural lash" that Figueroa described to Fox have a scientific explanation, according to research in Clinical Optometry.²¹

"As these mites have no excretory organs, undigested material is regurgitated and combines with these epithelial cells, keratin, and eggs to form the bulk of the cylindrical lash deposits pathognomonic of Demodex infestation. These deposits, in turn, contain proteases and lipases, which cause symptoms of irritation.

In fact, of all ocular symptoms investigated, the only symptom to correlate directly with Demodex was lid irritation. Specifically, this irritation is caused both directly by biting of the mites and by lipolytic enzymes used to digest sebum, their main food source."

Demodex Is Not Lice, but Lice Can Occur on Eyelashes

Demodex may be mites, not lice, but lice can make a home on the eyelashes too, and can be similarly treated with nontoxic, natural methods. A case study in Experimental and Therapeutic Medicine describes how a patient's inflammatory condition was initially confused with blepharitis and not diagnosed as lice:²²

"Phthiriasis palpebrarum is a rare type of eyelid infestation. In the present study, a 63-year-old woman presented with a case of phthiriasis palpebrarum, which was initially misdiagnosed as anterior blepharitis.

The patient had a 2-month history of repeated episodes of itching and burning sensations and moderate pain in both eyes that were not improved by antibiotic and corticosteroid eye drops.

Slit lamp examination revealed lice and nits anchored to the eyelashes. All eyelashes were removed from the base along with lice and nits. The patient recovered fully within 2 weeks with no further management, and no evidence of lice or nits was found at the follow up.

In conclusion, the findings of the present study suggests that patients presenting with itching of the eyelids and with clinical findings resembling seborrhea accumulation on the eyelashes should be carefully examined by prolonged observation with a slit lamp."

Lice Can Be Removed With Natural Treatments

People who read my newsletters know that I've talked about lice becoming a growing problem because some lice strains have developed resistance to the harsh chemicals used to treat them. That's why I recommend natural treatments that are just as effective as their harsher counterparts.

If you or your children contract lice, which are more commonly found on the head, the following treatments have proven effective.

How to Prevent and Remove Demodex From Eyelashes

Hygiene is the key to preventing Demodex, according to the experts. That's why the mites are seen on users who neglect washing around their eyes and eyelashes. For the record, Demodex is also seen in those without eyelash extensions and in men, for the same reason: lack of appropriate hygiene, which then allows the mites to multiply.²³

The best Demodex prevention is a daily routine of washing around the eyes with warm, soapy water to break up oils that fuel the mites, says Dr. Gregory J. Nixon, associate dean for clinical services at The Ohio State University College of Optometry.²⁴

To treat a Demodex buildup, medical professionals recommend a tea tree oil mixture, a versatile and well-regarded natural product that is available over the counter. Patients can treat themselves at home, according to research published in Clinical Optometry:²⁵

"Patients with Demodex are typically prescribed an eyelid cleanser that contains tea tree oil twice daily in order to eradicate the Demodex mites. They are instructed to cleanse the lids and lashes, as well as smear the lid cleanser onto the eyelash roots of both the upper and lower eyelid margin.

Complete coverage of the eyelash base by the tea tree oil lid cleanser is necessary to be effective so that mites are unable to lay eggs and hatch more Demodex mites. Patients should be instructed to use the wipes on their eyelashes, forehead, eyebrows, and cheeks as the mites live in all of those areas …

… Studies have demonstrated that as low as 5% concentration (when applied to the lids twice daily) and as high as 50% concentration (when applied once weekly) of tea tree oil are effective at reducing Demodex infestation when applied to the lids and base of the eyelash follicle.

A 38% concentration of terpinen-4-ol has been shown to reduce Demodex effectively over a period of 4 weeks."

Tea tree oil should be diluted before use and caution should be used when applying it to sensitive areas around your eyes and eyelids. A holistic health care practitioner who is familiar with essential oils can guide you in its safe usage for Demodex.

The popularity of eyelash extensions will likely not go away. Like hair extensions, they are simply part of today's beauty and glamour landscape. Luckily, wearers can reduce their risk of contracting Demodex mites with simple hygiene.

"Everybody knows to brush their teeth twice a day and don't even think about it," says Nixon. "We know in the eye care field that your eyes are no different. A lot of patients don't necessarily comprehend that."²⁶

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