Tag Archives: recalls

Artificial Intelligence Is Rushing Into Patient Care – And Could Raise Risks

Liz Szabo, Kaiser Health News,


Health products powered by artificial intelligence, or AI, are streaming into our lives, from virtual doctor apps to wearable sensors and drugstore chatbots.

IBM boasted that its AI could “outthink cancer.” Others say computer systems that read X-rays will make radiologists obsolete.

“There’s nothing that I’ve seen in my 30-plus years studying medicine that could be as impactful and transformative” as AI, said Eric Topol, a cardiologist and executive vice president of Scripps Research in La Jolla, Calif. AI can help doctors interpret MRIs of the heartCT scans of the head and photographs of the back of the eye, and could potentially take over many mundane medical chores, freeing doctors to spend more time talking to patients, Topol said.

Even the U.S. Food and Drug Administration—which has approved more than 40 AI products in the past five years—says “the potential of digital health is nothing short of revolutionary.”

Yet many health industry experts fear AI-based products won’t be able to match the hype. Many doctors and consumer advocates fear that the tech industry, which lives by the mantra “fail fast and fix it later,” is putting patients at risk—and that regulators aren’t doing enough to keep consumers safe.

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Relaxed AI Standards At The FDA

The FDA has come under fire in recent years for allowing the sale of dangerous medical devices, which have been linked by the International Consortium of Investigative Journalists to 80,000 deaths and 1.7 million injuries over the past decade.

Many of these devices were cleared for use through a controversial process called the 510(k) pathway, which allows companies to market “moderate-risk” products with no clinical testing as long as they’re deemed similar to existing devices.
In 2011, a committee of the National Academy of Medicine concluded the 510(k) process is so fundamentally flawed that the FDA should throw it out and start over.

Instead, the FDA is using the process to greenlight AI devices.

Of the 14 AI products authorized by the FDA in 2017 and 2018, 11 were cleared through the 510(k) process, according to a November article in JAMA. None of these appear to have had new clinical testing, the study said. The FDA cleared an AI device designed to help diagnose liver and lung cancer in 2018 based on its similarity to imaging software approved 20 years earlier. That software had itself been cleared because it was deemed “substantially equivalent” to products marketed before 1976.

AI products cleared by the FDA today are largely “locked,” so that their calculations and results will not change after they enter the market, said Bakul Patel, director for digital health at the FDA’s Center for Devices and Radiological Health. The FDA has not yet authorized “unlocked” AI devices, whose results could vary from month to month in ways that developers cannot predict.

To deal with the flood of AI products, the FDA is testing a radically different approach to digital device regulation, focusing on evaluating companies, not products.

The FDA’s pilot “pre-certification” program, launched in 2017, is designed to “reduce the time and cost of market entry for software developers,” imposing the “least burdensome” system possible. FDA officials say they want to keep pace with AI software developers, who update their products much more frequently than makers of traditional devices, such as X-ray machines.

Scott Gottlieb said in 2017 while he was FDA commissioner that government regulators need to make sure its approach to innovative products “is efficient and that it fosters, not impedes, innovation.”

Under the plan, the FDA would pre-certify companies that “demonstrate a culture of quality and organizational excellence,” which would allow them to provide less upfront data about devices.

Pre-certified companies could then release devices with a “streamlined” review—or no FDA review at all. Once products are on the market, companies will be responsible for monitoring their own products’ safety and reporting back to the FDA. Nine companies have been selected for the pilot: Apple, FitBit, Samsung, Johnson & Johnson, Pear Therapeutics, Phosphorus, Roche, Tidepool and Verily Life Sciences.

High-risk products, such as software used in pacemakers, will still get a comprehensive FDA evaluation. “We definitely don’t want patients to be hurt,” said Patel, who noted that devices cleared through pre-certification can be recalled if needed. “There are a lot of guardrails still in place.”

But research shows that even low- and moderate-risk devices have been recalled due to serious risks to patients, said Diana Zuckerman, president of the National Center for Health Research. “People could be harmed because something wasn’t required to be proven accurate or safe before it is widely used.”

Johnson & Johnson, for example, has recalled hip implants and surgical mesh.

In a series of letters to the FDA, the American Medical Association and others have questioned the wisdom of allowing companies to monitor their own performance and product safety.

“The honor system is not a regulatory regime,” said Jesse Ehrenfeld, who chairs the physician group’s board of trustees. In an October letter to the FDA, Sens. Elizabeth Warren (D-Mass.), Tina Smith (D-Minn.) and Patty Murray (D-Wash.) questioned the agency’s ability to ensure company safety reports are “accurate, timely and based on all available information.”

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Read original story here.

When Recalls Fail: Many harmful products remain in homes and stores. Why that happens, what needs to change, and how to protect yourself.

Rachel Rabkin Peachman, Consumer Reports: October 31, 2019


Antibiotic-resistant strains of salmonella are linked to contaminated chicken, sickening many and hospitalizing more than 200 people for almost a year and a half, though it was known that the plants processing the chicken had failed federal food safety standards. Why did the outbreak go on for so long before the unsafe chicken was pulled from store shelves?

breast implant lacking premarket safety research is linked to a rare cancer, but years pass and women die before regulators acknowledge the connection and a manufacturer recalls the devices. Why did it take patient outcry before the potentially deadly implants were taken off the market?

An inclined sleeper for babies is put on the market without adequate safety testing or adherence to infant sleep guidelines. Over the next decade, as the sleeper becomes a best seller, dozens of babies die while using it. Why did it take public exposure before the manufacturer recalled the product?

In 21st century America, it’s easy to assume that the products we put on our plates, in our homes, and in our bodies are safe and effective. Many people expect that we have robust consumer protections in place—a system that vets products thoroughly before allowing them to be sold and that recalls products swiftly if they prove to be dangerous.

But product safety regulation and the recall process are part of a complicated and imperfect system that varies widely depending on the type of product, the industries involved, and the government agencies tasked with overseeing it. For instance, a recall does not get put into motion automatically when a product is known to cause harm. Recalls, if they happen at all, can take years to be initiated, often only after public protest and sometimes following injuries or deaths.

Moreover, when a recall is issued, consumers often aren’t made aware. Almost 70 percent of Americans said that they had not heard about a recall in the past five years for any product they own, according to a Consumer Reports nationally representative survey of 1,010 adults, though millions of products are recalled each year. And only 21 percent of Americans said they had heard about a recall and responded to it in that time frame. Of those, about two-thirds said the issue had to do with their car, 19 percent said it involved food, 9 percent a health product, and 9 percent a children’s product.

That disparity is not surprising, says David Friedman, CR’s vice president of advocacy and a former acting administrator of the National Highway Traffic Safety Administration. Unlike other federal agencies, NHTSA requires manufacturers to notify car owners directly about recalls. To track recalls, it helps that every car has a unique vehicle identification number and every owner has a registration. Other agencies—the Food and Drug Administration, the Department of Agriculture, and the Consumer Product Safety Commission—generally have fewer tools and requirements for recalls. In some cases, laws can actually shield agencies from accountability and protect companies from liability, Friedman says.

Even when consumers learn about a recall, they often aren’t given simple, effective ways to respond. Some entail disassembling and mailing in part of the product for a refund, or not using the product until a replacement part is mailed—a process that can take months. As a result, many recalled products remain in use, risking further injury.

How, then, can consumers ensure that the products they buy have been safety tested and have not caused problems since their release? In some cases, it’s impossible to fully know. But the examples described here provide a sense of how regulatory oversight sometimes works for—and against—consumers. Plus, we share steps you can take to protect yourself and your family.

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Dangerous Breast Implants

Raylene Hollrah was 33 years old in 2007 when she was diagnosed with breast cancer and underwent a mastectomy. A year and a half later, when she was ready for reconstructive surgery, she chose a silicone-filled implant with a textured surface made by Allergan. Hollrah, from Hermann, Mo., believed a selling point of the implant was that she’d automatically be enrolled in a 10-year study “so I could help other women,” she says.

What Hollrah didn’t know is that medical devices—including breast implants, artificial joints, and pacemakers—are subject to much less rigorous premarket testing than drugs are. That’s partly because the FDA didn’t begin regulating medical devices or requiring research on their efficacy and safety until 1976, after many devices were already in use.

Silicone breast implants were introduced in the 1960s with little to no safety research, says Diana Zuckerman, Ph.D., president of the National Center for Health Research. Even after the FDA began regulating them, the agency didn’t require premarket studies until 1991—when it determined there was insufficient safety research, and soon after put a moratorium on sales.

In 2006, when the FDA did approve silicone implants, it was on the condition that manufacturers conduct post-market studies, one of which included Hollrah. But that wasn’t made clear to her early on. And as time passed, more problems emerged. In 2011, the FDA announced a link between silicone- and saline-filled implants and a form of cancer called anaplastic large cell lymphoma (ALCL).

But Hollrah didn’t learn about breast implant associated ALCL, or BIA-ALCL, until 2013, when one of her implants swelled and she tested positive. “I removed breast cancer,” Hollrah says, “and then I put something right back in my body that gave me cancer again.”

Around the time of Hollrah’s diagnosis, Allergan dropped her from its post-approval study. In fact, Allergan lost track of many participants, in part because it was difficult to follow up with the women, who were given no real incentives to stay involved in the studies, Zuckerman says. As a result, the research was never completed. Yet the FDA did not penalize manufacturers or recall the implants.

Fortunately for Hollrah, her cancer was caught early. She had her implants removed in 2013 and is now cancer-free.

But it wasn’t until July 2019 that the FDA announced the recall of Allergan’s textured implants due to a reported worldwide total of 573 BIA-ALCL cases, 481 of them from Allergan, including 33 deaths.

When asked why it took eight years after the FDA acknowledged the risk of BIA-ALCL for the agency to request a recall, an FDA spokesperson said it took the action after learning, in the spring of 2019, of “a significant increase in known cases of BIA-ALCL.”

Though the recall is a victory for women affected by BIA-ALCL, other concerns remain. For one, “when medical devices are recalled, there’s typically not a rigorous process to reclaim the flawed products,” says Lisa McGiffert, a co-founder of the Patient Safety Action Network and a former patient-safety expert at CR.

There’s also no established system for device manufacturers to find and notify doctors and patients about a recall. Hollrah notes that she has yet to receive a recall notification from Allergan.

For its part, Allergan says that “patient safety is a priority” and that it is committed to ensuring the safe and effective use of its products.

Still, hundreds of thousands of women are estimated to have a recalled device in their bodies and no easy choices. The FDA recommends implant removal only for women with a diagnosis of BIA-ALCL. But women don’t always have obvious symptoms. “Although BIA-ALCL is treatable if caught early, no one wants to wait to see if they get cancer,” says Sara Castro, an attorney at Farr law firm in Punta Gorda, Fla., who is working with affected women.

Another hurdle: Though Allergan will pay for replacement implants in the case of a cancer diagnosis or implant defect, it doesn’t cover the surgical costs of preventive implant removal. Most insurers won’t cover it, either.

Scot Glasberg, M.D., past president of the American Society of Plastic Surgeons and a consultant for Allergan, says that “if a woman has any concerns whatsoever, she should see a plastic surgeon who is board certified,” specializes in breast implants, and is knowledgeable about BIA-ALCL to go over her screening and testing options.

Women considering breast-implant surgery (or any medical device procedure) should ask their surgeon for an informed consent form that details what the device contains, and known risks. “This form is not mandated yet,” says Hollrah, who did not have that protection before her surgery and has since worked with Zuckerman, Glasberg, and others to develop a patient form and clearer warnings. And they have made progress on that front: On October 24, 2019, the FDA recommended that patient labeling for breast implants include a patient decision checklist, a boxed warning, an information booklet, and a patient device card. A final decision on that recommendation isn’t expected until 2020 at the earliest. 

Madris Tomes, a former program manager at the FDA who now runs Device Events—which gathers adverse event reports on medical devices—recommends researching your device. One free source is an online FDA database called MAUDE (Manufacturer and User Facility Device Experience). “Two-thirds of all recalls begin as an adverse event report,” Tomes says.

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Read the original article here.

How the FDA Handles Recalls of Life-Saving Implants Could Put People at Risk, Patients Say

Nicole Carr, WSBTV; May 20, 2019



Jonesboro resident Geraldine Robinson is one of millions of Americans who use an implanted medical device to improve, and possibly extend her life.

In 2013 she was implanted with a defibrillator to help with her congestive heart failure. She went to the doctor for checkups every six months. Robinson thought her device would keep her healthy for years. But last month the hospital called to tell her that device’s battery was failing. Robinson rushed to the emergency room.

“I was scared they wasn’t going to get to me in time,” Geraldine said.

The next day doctors replaced her device. The reason for the surgery noted on her patient information card was, recall.

Channel 2’s Nicole Carr searched the FDA recall database and found Robinson’s device had been recalled two years earlier. The manufacturer’s suggested course of action was to monitor the device.

While Robinson said she had no idea her device was recalled, her hospital said she was mailed a letter to notify her. Robinson said she never got that letter.

Diana Zuckerman, president of The National Center for Health Research, said she wasn’t surprised that Robinson’s recalled device remained implanted for years.

“This is the doctor having to say to the patient, ‘This implant in your body has been recalled but we don’t think you should have it removed unless you’re having obvious problems with it,” Zuckerman said.

Zuckerman was also said Robinson is most likely not alone in her confusion, and often patients don’t learn their device is recalled.

“Perhaps the patient has moved and the doctor or even the hospital doesn’t know where that patient is anymore,” Zuckerman said.

Linda Radach, an implant recipient herself, said she believes the recall process needs an overhaul.

“The FDA is very, very slow to use their authority to issue a recall instead requiring warning letters and requiring post market surveillance studies. Most of which are never completed,” Radach said.

According the FDA website they hardly every issue a recall, instead trusting manufacturers to self-report. An FDA spokeswoman said recalls are not the only way they get dangerous products off the market.

There are several patient resources available for medical device recipients, including questions to ask your doctor about the approval process.

Radach said a 2006 metal on metal hip replacement failed leaving dangerous cobalt chromium debris in her system.

“I’ve now had six total hip replacements,” Radach said. She said her issues were never reported to the FDA by her doctors and her device was never recalled. She did her own research and found her device had been approved for market three years after it was put in her body. “That alarmed me enough to realize this was much, much bigger than just me.”

Radach told Channel 2 Action News many of the parts that made up her implant were cleared through the 510k process which rarely requires clinical trials on human patients. The process has been in place since 1976.

Zuckerman said the 501K process it’s not enough.

“All those companies have to do is prove that their new device is substantially equivalent to a device that’s already on the market,” Zuckerman said.

In 2011 Zuckerman co-authored a report that found from 2005 until 2009, 113 recalls were class one. Only 21 of those recalls went through clinical trials. She said things haven’t improved.

“Instead of saying ‘let’s be more stringent and require clinical trials for more implants,’ they’re doing exactly the opposite,” Zuckerman said. […]

See the original story here.