Category Archives: In the News

Medical Professors are Supposed to Share Their Outside Income With the University of California. But Many Don’t.

For nearly two decades, Dr. Neal Hermanowicz has led the movement disorders program at the University of California’s Irvine campus, where he earns more than $380,000 a year in salary and bonuses. The widely respected expert on Parkinson’s and Huntington’s diseases adds to his income by consulting for drug companies.

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In recent years, internal audits at the university’s Irvine and San Francisco campuses have both found that, of a sample of health science faculty, about one-quarter weren’t disclosing all of their outside income. ProPublica’s investigation and the audits show that campus administrators fail to monitor or enforce the rules adequately, and that they rarely penalize violators — a testament, critics say, both to the power of tenured faculty and the university’s desire to accommodate pharmaceutical companies that fund academic research. The underreporting at the UC campuses contrasts with the increase in researchers’ disclosures of potential conflicts in academic journals.

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After Nuplazid hit the market, reports of deaths associated with the drug surged. “It’s a very high number” of deaths, said Diana Zuckerman, president of the National Center for Health Research. While it’s difficult to determine why there are so many fatalities, she said, the drug’s benefit isn’t worth the risk. In hundreds of cases, patients’ hallucinations, which are supposed to subside with the drug, were instead aggravated.

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Some faculty members do take pains to comply with the university’s policy on outside income. Dr. Anjay Rastogi, a professor and clinical chief of nephrology at UCLA medical school, meticulously tracks all payments he receives from industry in a centralized spreadsheet — and remits the required portion, which he said funds academic enrichment, teaching or research.

“We need to disclose everything, I disclose more rather than less,” he said. “In my opinion, it’s fair that we help the university, and they help us as well.”

Read original story here.

Not Just Blowing Water — Vaping Presentation Will Sort Myth and Reality

“We keep calling it vaping, and calling it vapor,” Amy Osterman said. “But it’s an aerosol. It’s more like hairspray.”

That’s an image Osterman, youth marijuana and tobacco prevention coordinator for Walla Walla County’s Department of Community Health, likes to share with parents and teens.

Osterman is one of a trio of specialists presenting a vaping prevention and education night for parents and young adults on Monday.

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Vaping is not safe for teens, kids and young adults, the federal agency has decreed.

School districts nationwide have been caught flat-footed and struggle to banish vaping on campuses, said Diana Zuckerman, author and president of the National Center for Health Research.

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Read original story here.

How Minnesota Schools are Doubling Down on Anti-vaping Efforts

As teen vaping rates continue to rise, Minnesota educators are monitoring their classrooms and hallways for well-disguised vaping devices.

Some are shaped like USB flash drives that students can charge by plugging them in to their laptop. Others double as pens and highlighters. Some are even less conspicuous: shaped like a smart watch, an ID badge attachment and even a replacement hoodie string.

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‘We’re trying to rewrite the script’

In the Forest Lake Area Schools district, J.P. Jacobson, a middle-school principal, says the anti-vaping push has continued to focus on arming students with “good information, so they can make a good choice when there’s not an adult right there.”

That means talking about the health implications with students during advisory periods, reaching students in health classes and putting up anti-vaping posters.

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Building out recovery resources

Working with students in the Wayzata Public Schools district, Ali Wobschall, director of Partners in Prevention, says the addictive qualities of vaping make it particularly concerning.

“I think that’s one of the most difficult aspects of this,” she says. “Because the vape is so highly concentrated with nicotine, addiction is happening faster than with other substances our coalition works to address.”

So while last year’s anti-vaping campaign focused on getting information to students, educators and parents at the secondary level, she says, the focus this year has been on getting students into recovery.

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A less punitive approach

Likewise, in the Rosemount-Apple Valley-Eagan district, health staff are looking at ways to build out a more holistic approach to dealing with vaping in schools — a less punitive approach that’s better fit to address any related mental health issues.

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Health officials have linked recent vaping-related lung injuries to THC and vitamin E oil, mostly found in illegal vaping products. But even legal ingredients — like nicotine and formaldehyde — are “potential carcinogens and very toxic” says Zuckerman. And manufacturers aren’t required to list all of the ingredients, since they’re considered trade secrets.

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Read the original article here.

Report Claims More Women than Men Injured by Medical Devices

Steps had to be taken to identify the gender of those within the database as although the FDA gathers information on the sex of patients, this data is not made publicly available. Therefore, in order to overcome this obstacle, the ICIJ realised that the sex of patients was sometimes disclosed through pronouns and adjectives within the incident reports submitted to the FDA.

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Talking about the findings, the ICIJ stated: “The trend we noticed is consistent with studies that have shown that women experience higher rates of hip-implant failure than men and have stronger immunological reactions to metal-containing devices.”

Other experts within the industry were keen to voice their opinion over the importance of looking at the effects of medical devices on different genders. Diana Zuckerman, president of the National Center for Health Research commented: “Having information about sex is very important because some products differ in safety between men and women.”

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Read original story here.

FDA Challenged Over Metal Implants ‘Public Health Travesty’

Sasha Chavkin, International Consortium of Investigative Journalists: November 14, 2019


Patients who suffered debilitating immune reactions after being implanted with metal-containing devices have joined doctors, scientists and industry representatives to testify before a United States government advisory panel probing the risks of immunological responses to metals placed inside the body.

The hearing represented the most systematic look by the U.S. Food and Drug Administration at the issue of adverse reactions to metals, a problem that affects a minority of implant patients but one that can cause severe pain, neurological damage and cognitive impairments.

“I’m in a great deal of pain, so please bear with me,” testified Sue Francis, a hip implant patient who has experienced severe health effects stemming from her reaction to metal. “We need to recognize that these metals from day one are interacting with our bodies.”

Metals are a major component of common devices such as artificial hips, spinal fusion implants and the contraceptive coil Essure, but there is limited scientific research on auto-immune and allergic responses to them.

The International Consortium of Investigative Journalists reported extensively on hip implants and Essure as part of its global Implant Files investigation, which revealed massive gaps in medical device oversight that left patients vulnerable to flawed and poorly tested products.

Patients and their advocates urged the FDA to order more detailed disclosure of the metals used in devices, to require device labels to disclose the risks associated with metals, and to send a letter to doctors across the country alerting them to the threat of adverse metal reactions.

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Unlike hearings earlier this year on breast implants and vaginal mesh that focused on specific products and regulatory steps, yesterday’s hearing focused on trying to understand and improve the state of scientific knowledge on metal reactions.

As such, it is unlikely to result in the short term in dramatic steps such as banning products from the market.

Experts urged the FDA to make the hearing the beginning of a sustained effort to gather data on the problem of metal reactions, including their differential effects among patients of different gender, age and socioeconomic status.

For example, the substantial majority of adverse responses to metal devices occur among women, who are generally more vulnerable to auto-immune, rheumatic and thyroid disorders.

“There’s a need for more and better pre-market research,” said Diana Zuckerman, the president of the National Center for Health Research. “We need to really have better data on diversity of patients.”

Read the original article here.

FDA Advisers Hear About Problems, Research Needs With Metal Implants

Mary Jo M. Dales, MedPage Today: November 14. 2019


Reports of adverse events related to metal-containing implants are on the rise. While still rare on a proportional basis, the numbers are increasing as the sheer volume of surgical implants has expanded, an FDA advisory committee was told Wednesday.

At the first day of a two-day meeting of the Immunology Devices Panel of the Medical Devices Advisory Committee, members heard from experts that it isn’t easy to tease out which patients are likely to have an adverse event. While patients with a known metal allergy might be an obvious risk group, the ability to screen for these allergies is limited.

And while these devices each have a unique identifier, the metallic components within individual devices are seldom detailed in this labelling further limiting the patient’s ability to avoid a known metal allergy, based on public testimony given during the meeting. Over 50 registered speakers were granted speaking time at the two-day meeting.

In a discussion of an array of histologic, imaging, and serologic studies that might be useful for selected out patients at risk for metal-related adverse events, experts pointed out that these measures alone fell short. Abnormal test results do not reliably predict adverse events. Further, the combinations of tests that might be indicative would be prohibitively expensive to perform on a large population of patients to determine a small sub-population at risk.

As device implantation has grown in recent years, so have problems tied to them. In 2012, for instance, the FDA held a two-day advisory committee meeting to address failure rates and adverse effects from metal-on-metal hip implants. That led the agency a few months later to put restrictions on these products. Still, issues remain around management of patients who received them. And that’s just one type of metallic implant, of which there are hundreds if not thousands.

Earlier in 2019, the FDA announced efforts to further evaluate the safety of specific materials used in medical devices and how to better identify patients who might be at increased risk of experiencing a hypersensitivity response. The agency is accepting public comment on the issue until December 16.

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In public testimony Wednesday, Karin Pacheco, MD, MSPH, an allergist at National Jewish Health and the University of Colorado in Denver, presented data on 1,500 patients with unexplained joint failure referred by their orthopedic surgeons who have ruled out infections and mechanical issues. The findings indicate that half of these patients are sensitized to something in the joint — about a quarter of them to the relevant metal in their implant, about 20% to bone cement, and a smaller proportion to both components.

Further, people with allergies and revised to another implant with different components do “extremely well,” she said. The implications are that sensitization to implant components is a cause of joint failure. “We think that nickel, cobalt and chromium, and maybe titanium, are the culprits, but we need more research.”

“If you have a history of skin reactivity [to device components], then you probably need to be tested” before receiving an implant, she said. Pacheco emphasized that over a million joint replacements are done each year in the U.S. and more of them are going to people ages 45-64.

Diana Zuckerman, PhD, president of the nonprofit National Center for Health Research, urged comparative effectiveness research.

“If certain implants seem to be causing certain reactions with certain kinds of patients, wouldn’t it be very important to know how that compares to other alternatives of the same kind of implants? We can’t treat all hip implants that are polyethylene and metal as if they’re all the same,” she said.

“We can’t treat all metal-on-metal implants as if they’re the same. We need to compare different models, different implants made in different ways with different materials by different companies and get some kind of real data” that patients and physicians can use to make informed decisions, Zuckerman added. Until then, figuring out how much is due to patient vulnerabilities and how much is the difference between various devices will remain challenging.

Several speakers detailed their personal experiences of adverse events, including neurologic and rheumatologic events that followed their receiving an implant. Linda Radach said she received a metal-on-metal hip implant requiring two subsequent revision surgeries, concluding, “The bottom line between all the harm is the materials. Go after that. Set rigid standards for biocompatibility testing.”

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The Immunology Devices Panel will hear additional comments on Thursday, especially in regard to dental amalgam, and will respond to a series of questions posed by FDA staff.

Read the original story here.

FDA’s Special Treatment Of Big Tech Faces Mounting Scrutiny

Kevin Stawicki, Law360, November 12, 2019.


The U.S. Food and Drug Administration is taking heat from prominent lawmakers over a special approval pathway for health software products sold by Apple, Samsung and other major tech companies, opening the door to a congressional showdown over whether the agency has the right to start such a program.

The FDA has spent two years working with nine tech giants and health companies to test a new approval route for rapidly evolving health software such as artificial intelligence applications to make treatment plans, calculate heart rates and track insulin levels. In addition to Apple Inc. and Samsung Electronics Co. Ltd., participating companies include Fitbit Inc., Johnson & Johnson and Roche Diagnostics Corp.

But lawmakers and legal experts have increasingly complained that the pilot program is shrouded in secrecy. In an Oct. 30 letter, several Democratic senators — including presidential contender Elizabeth Warren of Massachusetts and Assistant Democratic Leader Patty Murray of Washington — asked the FDA whether streamlined approvals are turning Americans into guinea pigs.

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The pilot program is called Digital Health Software Precertification, or simply Pre-Cert. It covers digital health products, such as mobile medical apps, that generally fall outside the agency’s traditional approval pathways.

A key component of the pilot program is known as an “excellence appraisal.” If a company undergoes the appraisal and is deemed a reliable producer of safe, high-quality software, it becomes eligible for streamlined approvals.

But what the appraisal process looks like in practice is an open question. The agency lists product safety, proactive culture, clinical and cybersecurity responsibility as the model’s main categories and insists that there should be “flexibility in the specific mechanisms by which excellence can be demonstrated.”

In a 2018 letter, the senators were among the first to ask the FDA what that flexibility entails. The agency in June replied with a 19-page letter, but the senators apparently weren’t satisfied, responding with 10 pages of additional questions and requests in their Oct. 30 follow-up.

“The agency stated that it is ‘exploring what types of data are appropriate to demonstrate excellence,'” the senators said, adding that the agency made no attempt to “provide any additional detail on the data or evidence it used to determine companies’ adherence to the excellence principles.”

The senators aren’t alone in demanding more details.

“When it comes to medical devices, anything that’s subjective results in very low standards,” Diana Zuckerman, president of the National Center for Health Research, told Law360.

“You have this idea of precertifying companies on the basis of somebody deciding they have confidence about the company’s standards,” Zuckerman said. “But we know from experience that many times prestigious companies have covered up information about risks of their products.”

Some big-name companies that aren’t participating in the pilot program have said the metrics need work.

Lisa Bollinger, a vice president at biotech Amgen Inc., told the FDA in a letter last year, “It is not clear how an organization can demonstrate consistent, adequate evidence generation for clinical effectiveness based on the proposed appraisal elements for pre-certification.”

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Read full article here.

How the FDA and EPA’s failure to communicate could put patients in danger

Sarah Karlin-Smith, Annie Snider, and Sarah Owermohle, Politico, November 7, 2019.


For decades a chemical used to sterilize medical devices and surgery tools has been the only option to ensure safe devices for billions of critical health care procedures.

But the chemical, ethylene oxide, has been shown to cause cancer, and growing panic among people living near plants that sterilize medical devices has led to a major crackdown and the shutdown of the factories in several states.

Now the Food and Drug Administration is warning that closure of the facilities where ethylene oxide is used could threaten the lives of patients and limit their access to everything from pacemakers to equipment for hip replacements and feeding tubes that save the lives of premature babies.

The story of how American lives may be threatened over the use and production of this chemical is an example of what happens when two bureaucracies — the FDA and the Environmental Protection Agency — fail to work together. The situation raises questions about whether federal health authorities were too slow to connect the dots between the environmental concerns around the cancer-causing gas — which EPA first disclosed five years ago — and the potential consequences to the medical device industry, which uses the gas to clean roughly half of all sterile devices, or more than 20 billion products a year.

“We need to harmonize our federal agencies so they are in sync, so that one isn’t causing problems that the other has to try and fix,” said Diana Zuckerman, president of the National Center for Health Research, a watchdog group that conducts health research it can use to influence policymakers. The organization accepts no money from medical treatment companies.

Already, one sterilizing facility in Illinois has shuttered under pressure from state authorities to cut the emissions, and a second in Michigan has said it will end its sterilizing operations by the end of year. Meanwhile, the state of Georgia has temporarily closed two facilities and lawmakers there are pressing for the closure of a third.

“Without [this sterilizing technique] … the sickest patients would be most at risk,” FDA wrote in briefing documents ahead of a two-day meeting that kicked off Wednesday to obtain expert recommendations about how to reduce or eliminate ethylene oxide emissions in medical device sterilization without compromising the availability of devices.

Caught flat-footed, FDA is now scrambling to find alternative sterilizing processes, as the Environmental Protection Agency and states consider tightening emissions standards for these facilities, potentially threatening the industry’s ability to continue operating. Experts say it is unclear if the technology even exists to reduce facilities’ emissions enough to protect nearby communities from elevated cancer risks, according to EPA’s calculations.

“Inadequate sterilization would threaten modern medicine as we know it,” said Kara Mascitti, an infectious disease specialist at St. Luke’s University Health Network, at Wednesday’s FDA meeting.

As EPA takes its time to update national emissions standards for sterilizers, states are stepping in to use their authorities to crack down.

Even though EPA found in 2014 that ethylene oxide was linked with breast cancer, leukemia and other cancers at much lower exposure levels than previously thought, and finalized that conclusion in 2016, it wasn’t until EPA released new monitoring data in August 2018 that emissions from sterilizing facilities caught the attention of state and local regulators and the public.

An outcry arose in the Chicago suburb of Willowbrook in August 2018 after the Chicago Tribune used that EPA data to report that the community faced an elevated cancer risk, thanks to a Sterigenics sterilizing facility located in the neighborhood. The facility became a major issue in Illinois’ 2018 gubernatorial election, in part because the incumbent Republican Gov. Bruce Rauner’s former private equity firm owned Sterigenics.

But it wasn’t until the newly elected Democratic governor took office in Illinois in 2019 and banned the facility from using ethylene oxide that the issue hit FDA’s radar, said Suzanne Schwartz, the deputy director of the office of strategic partnerships and technology and acting office director in FDA’s Center for Devices and Radiological Health.

Outside experts say the situation represents the pitfalls that can occur when federal agencies do not properly communicate with each other.

“EPA has had this on their radar screen, they’ve known that there is a problem. They’ve been talking about it. And somehow as far as we know that information either did not get to the FDA or did not get to the FDA in a way that anyone at the FDA said, ‘Ah, if we don’t look into this we could end up with a shortage of devices that are lifesaving and important devices,'” Zuckerman said. “How could this have not been of concern to them years ago?”

FDA says it has proactively addressed the issue since it commenced working with EPA, states and the device industry following the Willowbrook plant closure in early 2019. The agency notes it helped prevent a shortage of critical breathing equipment by working with one device manufacturer to quickly find a new sterilization site. FDA also launched two contests to develop new sterilization techniques and figure out how to minimize pollution from ethylene oxide sterilization. FDA will work with contest winners to accelerate the availability of the technology. Those initiatives are already bearing fruit, and FDA told POLITICO it believes there may be new short-term mitigation strategies that it will be able to announce in the next few months.

FDA stressed that regulating air pollution falls outside of its jurisdiction and it told POLITICO the agency doesn’t get alerted if facilities that produce medical products it oversees are violating air regulations and posing a safety concern. Therefore, Schwartz said, there’s little it could have done to foresee this crisis sooner given that EPA never changed its standards for ethylene oxide emissions.

“As part of the processes that occur with manufacturing, there are various toxins that are emitted. The key here is for the EPA to be establishing what are those standards that are allowable so that the manufacturers that are responsible for producing these products and have emissions can then be compliant with the emissions [regulations],” said FDA’s Schwartz. “Otherwise it’s outside FDA authority.”

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Read full article here

FDA Keeps Brand-Name Drugs on a Fast Path to Market ― Despite Manufacturing Concerns

Sydney Lupkin, Kaiser Health News and Daily Beast: November 3, 2019.

After unanimously voting to recommend a miraculous hepatitis C drug for approval in 2013, a panel of experts advising the Food and Drug Administration gushed about what they’d accomplished. What the panelists didn’t know was that the FDA’s drug quality inspectors had recommended against approval.

They issued a scathing 15-item disciplinary report after finding multiple violations at Gilead’s main U.S. drug testing laboratory, down the road from its headquarters in Foster City, Calif. Their findings criticized aspects of the quality control process from start to finish: Samples were improperly stored and catalogued; failures were not adequately reviewed; and results were vulnerable to tampering that could hide problems.

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Against that backdrop, the FDA has repeatedly found a way to approve brand-name drugs despite safety concerns at manufacturing facilities that had prompted inspectors to push to reject those drugs’ approval, an ongoing KHN investigation shows. This happened in 2018 with drugs for cancer, migraines, HIV and a rare disease, and 10 other times in recent years, federal records show. In such cases, how these issues were discussed, negotiated and ultimately resolved is not public record.

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Problems with drugs can take years to discover ― and then only after patients are injured. So, many health researchers say, more caution is warranted.

“They’re doing so few of these [FDA] inspections pre-market,” said Diana Zuckerman, president of the nonprofit National Center for Health Research. “The least they can do is listen to the ones they’re doing.”

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.