Can Your Hip Replacement Kill You?

When a Dr.'s right hip gave out in 2006, he asked his surgeon to implant an artificial one — specifically, a metal-on-metal hip called the ASR XL, made by a company. He knew what he was talking about: As an orthopedic surgeon, the Dr.  specializes in complex hip replacements. But what he knew wasn’t enough to protect him from a defect in the device.

Five years after his surgery, and in excruciating pain, the Dr. underwent more surgery, this time to have the device replaced. When the surgeon sliced into his hip, what he saw looked like a crankcase full of dirty oil. Tissue surrounding the hip was black. Cobalt leaking from the ASR hip had caused a condition called metallosis, destroying not only local muscle, tendons and ligaments, but harming Dr.'s  heart and brain as well.

Despite Dr.’s repeated efforts to warn his colleagues and the company that the implants were harming patients, the company continued to market metal-on-metal hips. While it withdrew the ASR XL model from the market in 2010, citing slow sales, it continued to sell another, similarly problematic model, the Pinnacle, until 2013.

More than 9,000 patients filed suit against the company, and on Nov. 16, six New York patients won a 247million $ verdict for serious harms caused by the Pinnacle hip implants and for failing to warn doctors and patients about its dangers. These suits and others are pulling back the curtain on what some doctors call the Wild West of medicine: the untested and largely unregulated medical device industry.

About 32 million Americans — or about one in 10 — have at least one medical device implanted, from artificial joints to cardiac stents, surgical mesh, pacemakers, defibrillators, nerve stimulators, replacement lenses in eyes, heart valves and birth control devices.

These devices have helped countless people, and some have saved lives. But many others are harmed — and doctors and patients are at the mercy of manufacturers’ claims about the safety and efficacy of the devices. Medical interventions are now the third-leading cause of death in the United States, and devices play an increasing role in that statistic.

Many people assume that the Food and Drug Administration requires rigorous testing of medical devices before they are approved, the same as the lengthy approval process it requires for new drugs. In fact, most high-risk devices on the market, including implants, have undergone no clinical testing at all.

Although the standard for approval of a new drug usually calls for two randomized, controlled clinical trials, the standard for many medical devices is no standard at all. Since medical devices didn’t come under regulatory control until 1976, the agency simply grandfathered in all devices that were already on the market under a provision known as 510(k), which allows manufacturers to sell most new devices without requiring any clinical testing as long as the manufacturer says its product is “substantially equivalent” to an existing device.

In addition to the 510(k) pathway, medical device companies can avoid clinical testing for the highest risk devices through the supplement pathway by telling the agency, they made a minor change to a previously approved device. The use of these loopholes is widespread: A study published in 2009 found that only 5 percent of high-risk implanted cardiac devices even partly met the standard for drug testing.

Metal hips are far from the only devices with catastrophic consequences. In October 2007,  a leading medical device manufacturer, recalled the lead wires in its defibrillator after they were found to fracture and misfire, harming or even killing patients. The devices had not been clinically tested and were approved for sale by the F.D.A. through the supplement pathway. But in this case, the “minor change” was a fatal one; the new wire was thinner and prone to fracture.

By the time of the recall, 268,000 leads had been implanted in patients worldwide. After the recall, many patients rushed to have the devices removed, but removal posed its own dangers, causing major complications in 15 percent of patients.

Even when devices are subjected to trials, the agency sometimes ignores danger signs detected by those studies. In 1997, during the approval process of the vagus nerve stimulator, a device made by a company to treat epilepsy, an adviser voiced concerns about a high death rate noted in patients with the device. But the agency didn’t stop the device from going to market. Instead, it awarded conditional approval, meaning that the company would have to conduct safety studies after the device was on the market.

The agency didn’t even require the company to inform patients that there was concern about the death rate, or that they were effectively being made unwitting guinea pigs. When the company finally submitted five studies that it said proved the device was safe, it failed to include death data for any of the studies, a move the agency defended, saying the agency hadn’t asked the company to count deaths, only to “characterize” deaths.

How it’s possible to characterize deaths without including any actual data on deaths is anyone’s guess.

With such shockingly lax regulations, it’s no surprise that device recalls have risen over the years; in 2003, there were eight Class 1 device recalls, which the agency defines as indicating “a reasonable probability” that a device will “cause serious adverse health consequences or death.” In 2016, that number rose to 117, affecting hundreds of thousands of patients.

Loose oversight of devices poses a threat to public health. This presumes that such speed and innovation is actually lifesaving or life-enhancing. The number of device-related deaths shows how dangerous that presumption is.

The fact that the agency has allowed lax practices like the 510(k) loophole to continue, despite calls for reform by institutions, poses the question of why the agency would put profits ahead of safety. 

Returning to a system in which the agency commissioners are civil servants is perhaps a first step, but it needs to be the first of many. As a government agency, the agency is supposed to serve as a bulwark between corporate profiteering and the public welfare. Its continued allowance of regulation loopholes like 510(k), despite the significant demonstrated cost to public welfare, calls into serious question the agency’s fulfillment of its stated mission to protect public health by ensuring safety, efficacy and security.

THIS IS ONLY FOR INFORMATION, ALWAYS CONSULT YOU PHYSICIAN BEFORE HAVING ANY PARTICULAR FOOD/ MEDICATION/EXERCISE/OTHER REMEDIES.    
 
PS- THOSE INTERESTED IN RECIPES ARE FREE TO VIEW MY BLOG-                      
HTTP:GSEASYRECIPES.BLOGSPOT.COM/

FOR INFO ABOUT KNEE REPLACEMENT, YOU CAN VIEW MY BLOG-                                                                       

HTTP://KNEE REPLACEMENT-STICK CLUB.BLOGSPOT.COM/
FOR CROCHET DESIGNS
HTTP://MY CROCHET CREATIONS.BLOGSPOT.COM

Physical activity doesn’t improve post-hip replacement surgery

A new study has brought the purpose of a hip replacement into question. The research from the University of East Anglia (UEA) shows that, surprisingly, patients’ physical activity does not increase following hip replacement surgery.

Total hip replacement is one of the most common elective operations, with more than 620,000 procedures performed in the UK from 2003-2013. The most prevalent cause for needing surgery is osteoarthritis (93 per cent).

This study is the first systematic review specifically to examine the differences in physical activity pre-surgery compared to post-surgery hip replacement.

According to lead researcher Tom Withers, “The most common reason for a hip replacement is to reduce pain on movement. We expected that the amount of physical activity post-surgery would therefore increase. What we found surprised us.”

“Our study looked at data from about 1,030 patients who had received hip replacements. Indicators for physical activity after surgery included whether patients were walking longer distances, walking more quickly, cycling and climbing stairs,” he continued. 
“We found that there was no clear evidence of a change in physical activity following surgery.”

“The benefits of regular physical activity following a hip replacement are well known, so this research is important for healthcare professionals because it suggests that patients need to be encouraged to be more physically active,” Withers added.

The research used existing research papers measuring pre- and post-operative measures of physical activity.

Toby Smith, lecturer in physiotherapy in UEA’s School of Health Sciences, said, “The lack of significant difference in physical activity after patients undergo such a common procedure suggests there is a need for further research, including further investigation into how other personal characteristics or pre-existing conditions might also influence the results.”

“Healthcare professionals and researchers need to better understand this lack of change and how patient’s perceptions of physical activity might be modified to increase their engagement in physical activity post-operative,” Smith added.

The study ‘Is there a difference in physical activity levels in patients before and up to one year after unilateral total hip replacement?’ has been published in the journal Clinical Rehabilitation.

 this is only for your information, kindly take the advice of your doctor for medicines, exercises and so on.

https://gscrochetdesigns.blogspot.com. one can see my crochet creations
https://gseasyrecipes.blogspot.com. feel free to view for easy, simple and healthy recipes

https://kneereplacement-stickclub.blogspot.com. for info on knee replacement