Category Archives: We Are Quoted

Health Care Industry Spends $30 Billion a Year on Marketing

Liz Szabo, Kaiser Health News: January 8, 2019.


Spending on health care marketing nearly doubled from 1997 to 2016, soaring to at least $30 billion a year, according to a study published Tuesday in JAMA.

The FDA is Still Letting Doctors Implant Untested Devices into Our Bodies

Jeanne Lenzer and Shannon Brownlee, Washington Post: January 4, 2019.


Ten years ago, Kathleen Yaremchuk raced to the bedside of a patient inexplicably gasping for breath. Chair of the department of otorhinolaryngology (ear, nose and throat) at Henry Ford Hospital in Detroit, Yaremchuk performed an emergency tracheotomy on the woman, cutting a hole in her windpipe, inserting a breathing tube and saving her life. When Yaremchuk began getting more calls over the following months for mysterious cases of respiratory distress, she launched a study to figure out what was going on.

All these patients, it turned out, had a small device implanted in the top of their spines to relieve pain. The object, used to hold a protein that stimulates bone growth, was cleared for sale by the Food and Drug Administration in 2003 without clinical testing in humans. When Yaremchuk and her colleagues reviewed the records of all 260 patients implanted with the device at Henry Ford Hospital between 2004 and 2009, they found that a significant number developed airway obstruction, trouble swallowing and respiratory failure, in some cases leading to death.

The neck implant is just one of the products associated over the past decade with 1.7 million injuries and more than 80,000 deaths. A searing global investigation last year by the International Consortium of Investigative Journalists places much of the blame on significant failings in the FDA’s oversight. The agency’s laissez faire attitude has resulted in artificial hips that cause cobalt poisoning (which can damage the heart and brain); surgical mesh that cuts through flesh and organs, causing infections and hemorrhage; and defibrillators that repeatedly shock patients beyond human endurance. Safety problems have led to recalls of devices implanted in hundreds of thousands of people. And the devices can be difficult or impossible to remove if they go bad. No wonder many patient advocates cheered when the FDA announced in November that it planned to make “transformative” changes in the way more than 80 percent of medical devices are cleared for sale in the United States. Some 32 million Americans walk around with such products in their bodies.

But the promised transformation is mere window dressing. Two key loopholes still exist, allowing most products to be approved for sale without clinical trials in humans. Although the FDA insists that high-risk devices undergo “stringent” testing to win approval, few actually do. A recent study, for example, found that only 5 percent of the highest-risk implantable cardiac devices were subjected to clinical trials on par with the testing required for drug approval.

In 1976, when medical devices first came under the regulatory control of the FDA, the agency simply grandfathered in all devices that were already on the market. Under this provision, known as the 510(k) pathway, new artificial joints, cataract lens implants and thousands of other devices developed after 1976 can win approval for sale (or “clearance” in FDA parlance) if the product is shown to have “substantial equivalence” to a previously cleared “predicate” device.” Four out of five devices are cleared for sale this way. Of those, at least 95 percent were cleared without clinical studies, according to research by Diana Zuckerman and her colleagues at the National Center for Health Research.

For some devices, that makes sense. You don’t need a clinical trial to test a new tongue depressor or hospital stretcher. But the agency also lets higher-risk devices through based on predicate devices, some of which have been recalled for safety problems. A recent study by researchers at the University of Oxford discovered that 16 percent of surgical meshes cleared for sale in the United States between 2013 and 2015 were based on products previously removed from the market because of serious complications. When one of us asked the FDA how this could happen, officials answered that the agency doesn’t evaluate the performance of the predicate when clearing devices for sale, just that there is (or was) a predicate.

According to the FDA, the “most impactful” change it is considering is recommending (not mandating) that companies cite predicate devices no older than 10 years. Yet device-makers could still cite predicates that were themselves based on earlier devices that may date back well past 10 years, something the FDA acknowledged in an email to us, stating that “devices cleared under a 510(k), regardless of how long the predicate has been on the market, have met the 510(k) regulatory review standard.”

The second loophole is the supplement pathway, which applies to new versions of the highest-risk devices, such as artificial hips, deep brain stimulators and spine implants. This process allows manufacturers to inform the FDA that they want to market an updated version of a device with minor changes — once again, allowing them to circumvent clinical trials. Researchers at Harvard found that 99 percent (5,829 of 5,906) of implanted cardiac devices, such as pacemakers and defibrillators, were approved through the supplement pathway from 1979 to 2012.

The supplement pathway has led to a number of disasters, such as one involving Medtronic’s Sprint Fidelis defibrillators, which are implanted in the chest to shock the heart if it goes into a deadly rhythm known as ventricular fibrillation. The company told the FDA in 2003 that it had updated the device to use thinner electrical leads into the heart. But the new wires were prone to fracture, hitting some patients repeatedly with shocks when their hearts were fine, and not delivering shocks to others who needed them. Doctors put the Sprint Fidelis into Bridget Robb, a patient from Pennsylvania in her early 30s. It shocked her 31 times in a span of minutes in 2007. She said in congressional testimony that it felt like being shot in the chest by a cannon at close range.

By the time Medtronic recalled the defibrillator in 2007, about a quarter-million were in circulation worldwide. Individuals implanted with it live under a sword of Damocles: They risk electrocution and possible death if they leave the Sprint Fidelis alone — and they risk death if their heart stops and the product fails. If they choose to have it removed, they face a 12 to 16 percent rate of serious complications or death from the surgery, according to a study published in 2010 in the journal Circulation.

Cases like these have received widespread coverage in the press but have had virtually no effect on FDA policy. Even a damning 2011 report by the Institute of Medicine (requested by the FDA), which deemed the agency’s 501(k) pathway so flawed it should be thrown out, fell on deaf ears.

Part of the problem lies in whom the agency believes it serves. At a recent meeting in Utah, the FDA’s device director repeatedly referred to manufacturers as the agency’s “customers” and showed a slide proclaiming “90 percent customer satisfaction.” Another slide documented the agency’s shorter and shorter approval times over the past eight years. These might not be the priorities of patients and taxpayers if they knew how often devices go on to harm people.

The FDA has become a captive agency. In 2007, Congress passed the Medical Device User Fee Amendments (MDUFA), which requires manufacturers to pay for device approvals. (Similar legislation, the Prescription Drug User Fee Act, directs money from drug companies to the FDA.) By 2018, 35 percent of the FDA’s budget for regulating devices came directly from the companies that make them. Zuckerman says that to continue collecting user fees under the MDUFA, the agency has to meet “performance goals” for faster approvals — leaving less time to evaluate products before they go on the market. It’s an inherent conflict of interest exacerbated by the revolving door of directors and commissioners who come from industry to the FDA and then go back. Before being appointed by President Trump to head the agency, Scott Gottlieb was paid millions of dollars for consultancies, directorships and other ties with some 20 health-care companies. He is a vocal supporter of Trump’s deregulation drive, arguing in 2013 that “the FDA’s caution is hazardous to our health.”

This is not a new problem. Before Gottlieb, President Barack Obama appointed Margaret Hamburg, who was then a director of Henry Schein, a leading medical-device distributor, to head the FDA. And in 2005, President George W. Bush named Lester Crawford, who abruptly resigned after just two months and came under criminal investigation for making false statements to Congress concealing his ties to companies the FDA regulates.

The relationship between the agency and the device industry is so cozy that in 2015, Rob Califf, then the FDA commissioner, met secretly with the Advanced Medical Technology Association (AdvaMed), the industry trade organization, to help craft the 21st Century Cures Act, which lowered the bar of evidence needed to approve devices even further.

Last fall, the FDA and AdvaMed were aware of the planned release of the Implant Files, the report by the investigative journalists’ consortium. AdvaMed executives were so concerned that they held a meeting to discuss strategies for dealing with the anticipated stories, which made headlines around the world in November. The executives promised their member companies that they would “hit back and hit back hard.” One day after the first reports were published, the FDA issued its “transformative” changes to the 510(k) pathway.

If Americans want devices that are safe and effective, they’ll need a new kind of regulation. First, the FDA should recategorize any implanted device as a high-risk or Class III product, which would subject it to rigorous clinical trials. Data from these studies should be made publicly available, or the manufacturer would forfeit the right to sell its product. And implanted devices should be entered into registries that track outcomes; patients should be given access to a website where they can immediately report problems and receive updates.

Lawmakers should also revive the congressional Office of Technology Assessment, which the House of Representatives killed in 1995, during a fit of anti-regulation insanity inspired by Newt Gingrich’s Contract With America. The office provided an invaluable service by independently assessing evidence for a wide range of technologies.

Finally, the FDA commissioner should be a civil servant without financial conflicts, not a political appointee (a practice started under Richard Nixon).

To do all of this, the FDA needs to overcome the constant threat of losing funding if it goes against the wishes of the industry it is supposed to regulate. Congress should repeal the MDUFA (and the prescription-drug equivalent) and fully fund the agency. Until the FDA requires clinical testing of implanted devices, as it does for drug approval, we simply won’t have the evidence to prove that a device is safe or effective.

See the original article here.

Breast Implants: the Trouble is Under the Skin

Radio-Canada Info: November 29, 2018.


Thousands of Canadian women have had silicone breast implants of a new generation approved in 2006 by Health Canada. Apart from some known complications,
these implants were said to be safe for women’s health.

Yet, in recent years, hundreds of women have had their implants removed due to various problems. New studies have shown that silicone implants are associated with the development of autoimmune diseases and a rare form of cancer.
Breast Implant Illness is still controversial.

An inquiry conducted by Enquête, in collaboration with the International Consortium of Investigative Journalists, Radio-Canada, CBC and the Toronto Star, revealed that Health Canada approved the release of these implants without long-term studies and allowed manufacturers to not adequately report breast implant-related adverse events for years.

See published version here.

29-Year-Old Fitness Model Gets Breast Implants Removed after She Says the Silicone Gave Her Seven Years of ‘Brain Fog, Bald Spots and Rashes’

Mary Kekatos, Daily Mail: December 19, 2018.

A fitness blogger said she had her breast implants removed because the silicone was ‘poisoning’ her.

Sia Cooper, the 29-year-old behind the blog Diary of a Fit Mommy, revealed she got implants in October 2011 to boost her self-confidence after weight loss left her with small breasts.

However, over the next seven years, the Florida mother-of-two struggled with extreme fatigue, facial rashes, chest pain, brain fog and even hair loss.

post-explant, 2 weeks

After undergoing multiple blood tests, diagnostic tests and X-rays that came back negative, Cooper was convinced her symptoms were related to what described as  ‘breast implant illness’.

 

FDA Recommends “Modernizing” Review of Devices in Wake of Global Investigation

Jeanne Lenzer, The British Medical Journal: November 27, 2018

The US Food and Drug Administration is making changes to how medical devices are cleared for sale after a scathing investigation into the industry.

The global investigation into the medical device industry by journalists from 36 countries, including The BMJ, BBC Panorama, and the Guardian and led by the International Consortium of Investigative Journalists, unearthed thousands of documents to reveal rising numbers of malfunctions and injuries.

Scott Gottlieb, FDA commissioner, and Jeff Shuren, director of the Center of Devices and Radiological Health, said in a statement that there would be changes to the 510(k) pathway that is used to clear four in every five devices for sale. The pathway approves devices not on the basis of testing in humans but on how similar devices are to previous devices, called “predicates,” some of which were approved decades ago.

Gottlieb and Shuren said that … they were “encouraging” manufacturers to “use more modern predicates,” [….]

However, the reform didn’t go far enough, said Diana Zuckerman, epidemiologist and president of the National Center for Health Research in Washington, DC. She told The BMJ that using more “modern” predicates says nothing about safety or effectiveness. She said that “newer doesn’t mean better” and that “since less than 5% of 510(k) devices undergo any type of clinical trials, there’s no assurance that any devices cleared through that pathway are safe or effective.”

In 1996 the US Supreme Court concluded that “since the 510(k) process is focused on equivalence, not safety . . . if the earlier device poses a severe risk or is ineffective, then the later device may also be risky or ineffective.”

A recent study found that 16% of mesh clearances were based on recalled devices. When the FDA was asked why it cleared mesh implants on the basis of predicate devices that had been withdrawn because of safety concerns, the agency said that it didn’t evaluate the performance of predicate devices when clearing devices for sale.

A study of high risk implanted cardiac devices found that only 5% underwent clinical testing that even partly approximated the testing required for drug approvals.

Nor is safety surveillance reliable. A Government Accountability Office analysis found that 99% of device related “adverse events” were never reported to the FDA and that the “more serious the event, the less likely it was to be reported.”

Read the original article here.

After Years of Complaints, U.S. and U.K. Officials Say They Want to Reform the Medical Device Industry

Amy Martyn, Consumer Affairs: November 29, 2018.

The official who oversees medical device safety for the Food and Drug Administration (FDA) recently said he wants the United States to be the “first” to approve medical devices, raising concerns among public health advocates that the agency isn’t taking efforts to reform the device industry seriously enough.

Dr. Jeffrey Shuren, the director of the FDA’s medical devices division under both the Obama and Trump administrations, earlier this year agreed to speak at a conference attended by medical device executives, according to a new report by the Associated Press.

At the conference, which cost executives $1,000 a head to attend, Shuren reportedly said that the FDA’s goal was to be “first in the world” to approve new devices. He also said he wanted the agency to remove “unnecessary burdens” for companies hoping to get their devices approved.

Such a goal may be at odds with what public health advocates say is a need to reform medical device regulation. Dr. Peter Lurie, a former FDA official who now heads the watchdog the Center for Science in the Public Interest, told the Associated Press that Shuren’s comments essentially offered device executives “an invitation to a race to the bottom for scientific standards.”

“Fatally flawed” system

The medical device industry already faces lower barriers for approval than the drug industry does, despite the fact that many medical devices are intended to be permanent implants or can leave lifelong impacts on a person’s body.

“If you’re going to have something implanted in your body for potentially the rest of your life, wouldn’t you like it to be really well-tested beforehand? Is that really too much to ask?” Dr. Diana Zuckerman, a health policy analyst and head of the National Center of Health Research, told ConsumerAffairs earlier this year.

Independent researchers for years have said that the medical device approval process in the U.S. is “fatally flawed.”

More recently, a Netflix documentary called The Bleeding Edge exposed the tragic, life-long effects that four failed medical implants had on nearly 70 patients interviewed for the film.

Looking for improvement

Regulators in the United States and abroad are now promising to put safety at the forefront of medical device regulation.

Shortly before Thanksgiving, FDA Commissioner Scott Gottlieb, who was portrayed in the Netflix film as being in the industry’s pocket, announced new plans for the agency to “create a more robust medical device safety net for patients through better data.”

A similar call to reform medical device regulations is also currently taking place in Europe. In the United Kingdom, the Royal College Of Surgeons recently called for “drastic regulatory changes” after an investigative report by a group of European journalists published yesterday linked 83,000 deaths and 1.7 million injuries to faulty medical devices.

But while medical devices face low scrutiny from European regulators, the socialized healthcare systems abroad are at least more hesitant about allowing such devices to actually be used in surgery, experts say.

“In Europe, it’s very easy to get something on the market, but the national health plans won’t pay for it if it’s not proven to be safe and effective,” Zuckerman of the National Center for Health Research previously told ConsumerAffairs.

It’s not that Europeans aren’t reporting injuries from faulty devices. However, those who do tend to be wealthier people who opted for private insurance over the public plans.

See the original story here.

Here’s What We Know About Breast Implants and This Rare Type of Cancer

Daisy Melamed Sanders, Survivornet: November 2018.

A series of new stories are examining the potential health risks that both silicone- and saline-filled breast implants may carry. The most serious of these is the possibility of developing a type of blood cancer. What’s not yet clear is if the evidence is significant enough for the government to issue a warning.

The blood cancer that implants may cause, called Breast Implant-Associated Anaplastic Large Cell Lymphoma or BIA-ALCL, is a type of non-Hodgkins lymphoma that is not breast cancer. It is rare, and symptoms include pain, redness and swelling around the implant or breast area.

And while getting breast implants certainly does not definitively mean you’ll definitely get this type of lymphoma, it’s a dangerous illness for those who do get it. “ALCL is rare, but for those who get ALCL from their breast implants, it is very frightening and potentially fatal,” says Diana Zuckerman, PhD, President of the National Center for Health Research.

Here’s what we do know: The Food and Drug Administration—responsible for regulating medications and medical devices—has acknowledged that it has known of a potential relationship between breast implants and increased risk of ALCL since 2011. The risk involves both textured and smooth implants but the FDA’s position is that the textured kind may have a higher likelihood of causing the disease. The FDA also notes that incomplete or inefficient monitoring of, and reporting on, these health issues on a national level has meant that many women do not know all the facts when choosing to have implants for either cosmetic or reconstructive reasons.

According to the FDA, “In most cases, BIA-ALCL is found in the scar tissue and fluid near the implant, but in some cases, it can spread throughout the body. Precise risks are difficult to determine due to lack of information about how many patients have received breast implants in the US and worldwide.”

In an interview conducted prior to recent news, Dr. Andrea Pusic, Chief of Plastic Surgery at Brigham and Women’s Hospital, told SurvivorNet that breast implants are generally considered safe—but they do require monitoring by a doctor. The FDA also states that breast implants are “not lifetime devices,” and that the longer a patient has them, the more likely they are to rupture or experience other complications.

With regards to the safety of implants, Dr. Darrick Antell, a private practice plastic surgeon in New York City, cites the rarity of these instances as part of the reason implants are not excessively dangerous. “Textured surface implants have rarely been noted to develop ALCL, at a rate of 1 in 30,000—I would even recommend them to a family member,” he says. “Multiple leading institutions from around the world have shown them to be safe.”

But, as Dr. Zuckerman urges, it’s important to discuss the risk with your doctor before getting implants, because some women felt blindsided and uninformed about the disease possibility. “We know women who, when they developed ALCL, felt betrayed because their doctors hadn’t warned them of the risks.”

Breast implants also have the possibility of causing other health or physical issues. These issues have not been fully studied, but Zuckerman and the NCHR recently released a paper that discusses some of the possible side effects.

The risks that come with implants are real for all women, Dr. Zuckerman tells SurvivorNet, but these risks increase with a personal or family history of autoimmune or connective tissue symptoms or diseases. They can happen soon after getting implants or years later, and are especially likely when a silicone gel implant breaks—most likely after three years. Another issue is that leaking silicone can migrate into the lymph nodes, and, “from there, the silicone can get into the lungs, liver, or other organs.” Broken saline implants, she continues, offer less risk when they leak, but can cause health issues from the silicone shell, other chemicals, as well as from bacteria, fungus and mold issues that develop over time.

This isn’t the first time instance of concern regarding breast implants and potential health risks. Throughout the 1980’s and early 1990’s, a company called Dow Corning was named in a number of class-action lawsuits claiming that their breast implants were the cause of a number of health issues.

In 1992, the FDA mandated that silicone implants be removed from the market, but they were re-introduced in 2006 following stricter regulations around tracking patients for at least 10 years after their surgeries. However, because monitoring the implants and patients with them is not always thorough nor properly reported, it is difficult to know for sure what side effects implants are having in the long term.

The best idea, as always, is to discuss all the possible risks and benefits of implants with your doctor before any procedures, and be on alert for any symptoms that indicate a medical issue, suggests Dr. Zuckerman. “If a woman with implants starts to have any of the autoimmune symptoms that we’ve described in our report, she should consider having her implants removed.”

See the original story here.

US Goal to be “First” on Devices Worries Former Regulators

Matthew Perrone, Associated Press: November 27, 2018

WASHINGTON (AP) — Dr. Jeffrey Shuren was adamant: The United States would never cut corners to fast-track the approval of medical devices.

“We don’t use our people as guinea pigs in the U.S.,” Shuren said, holding firm as the new director of the U.S. Food and Drug Administration’s medical devices division.

Again and again in 2011 — four times in all — Shuren was summoned before Congress. Lawmakers accused the agency of being too slow and too demanding in reviewing new devices like heart valves and spinal implants, driving U.S. manufacturers overseas where products faced less rigorous review. Each time, he pushed back.

And yet the next year, Shuren and his team adopted an approach that surprised even some of his closest colleagues: The FDA would strive to be “first in the world” to approve devices it considered important to public health.

The agency’s shift mirrored the talking points of the $400 billion medical device industry — a lobbying behemoth on Capitol Hill — and ushered in a series of changes that critics say have allowed manufacturers to seek regulatory approval for high-risk devices using smaller, shorter, less rigorous studies that provide less certainty of safety and effectiveness.

Under Shuren, annual new device approvals have more than tripled, while warnings letters to device manufacturers about product safety and quality issues have fallen roughly 80 percent, an Associated Press investigation found.

The assortment of medical devices now on the market includes spinal rods that can leave metal shards in children and a nerve-zapping obesity implant that may not work for many patients.

The cheaper and faster medical device approvals began despite multiple, high-profile safety problems involving pelvic mesh, hip replacements and other implants.

An AP analysis of FDA data shows that since 2012, tens of thousands of injury and death reports have been filed in connection with devices that were cleared through a streamlined pathway that minimizes clinical trial testing. The FDA’s database for reporting device problems often includes incomplete, unverified information submitted by manufacturers, physicians, lawyers and patients. Because of these limitations, it’s often unclear whether a device played any role in an injury or death.

In response to questions from the AP, the FDA said its “first in the world” goal was not about a competition with other countries but rather was adopted as part of a strategy that also focused on quickly identifying defective products to ensure U.S. devices “remain safe, effective and of high quality.”

The agency said it has focused on taking steps to reduce the time and cost of device development “that do not compromise our standard of reasonable assurance of safety and effectiveness.”

Warning letters have declined, the FDA said, because the agency is using a new approach that involves fewer warnings but more inspections to oversee companies that violate its rules.

Last week, the FDA announced a new goal to be “consistently first” among the world’s regulatory agencies to identify and address medical device safety issues.

The agency also rejected the idea that Shuren’s approach to regulation has changed over time, saying he has worked for years to improve patient safety.

Still, some current and former FDA officials are worried about the ambition to be first on approvals. They include Dr. Peter Lurie, who calls the agency’s new direction “an invitation to a race to the bottom for scientific standards” seemingly prompted by industry pressure. Lurie held senior posts at FDA from 2009 to 2017 and now heads the nonprofit Center for Science in the Public Interest.

The FDA’s medical device standards are still considered among the highest in the world, requiring “reasonable assurance” of both safety and effectiveness. But by trying to outpace countries with less stringent requirements, Lurie said, the FDA has opened the door to lowering its own standards to achieve its goal.

The FDA’s struggle to find the right mix of regulation and innovation in overseeing more than 190,000 medical devices — from pacemakers to contact lenses to surgical robots — has been chronicled for decades by government inspectors and outside researchers.

For almost as long, the agency has had a symbiotic relationship with industry.

Fees paid by medical device manufacturers for the review of their products now cover about 35 percent of the annual budget of the agency’s Center for Devices and Radiological Health. The last four officials in Shuren’s position have gone on to higher-paid positions in industry.

In addition, Shuren’s wife, Allison, is a former lobbyist who now leads her law firm’s health-care practice group and advises medical device clients, among others, on regulatory and legislative issues. The FDA said Shuren passed a “rigorous ethics review process” before assuming his position that addressed potential conflicts of interest. He also recuses himself from FDA matters involving clients represented by his wife or her firm, the agency said.

Joshua Sharfstein, a former FDA deputy commissioner now teaching at Johns Hopkins University, praised Shuren for balancing the competing demands of protecting the public while promptly approving beneficial new devices.

“I don’t think there’s a viable way to be the head of devices and be in open warfare with industry all the time,” he said.

But some who spent years working under Shuren say speeding up product reviews became the clear priority after 2012.

“Basically, it was ‘We need to find ways to get products on the market quicker, faster and we need to figure out how to reduce the premarket data requirements,’” said Christy Foreman, an industry consultant who spent 22 years at the FDA, including four years leading its device review office.

The FDA notes that laws passed by Congress require the agency to emphasize the “least burdensome approach” to reviewing new devices. But the agency itself helped fashion those laws, working with industry lobbyists and lawmakers on provisions that effectively limit its ability to request additional evidence from manufacturers.

The philosophy of “acceptable uncertainty” is sometimes the price of making life-saving devices quickly available, according to the FDA. At the same time, it acknowledges its main system for tracking problems is riddled with “incomplete, inaccurate, untimely, unverified or biased data.”

“So instead, you have devices of unknown benefit on the market that still harm patients,” said Dr. Rita Redberg, a prominent medical researcher and cardiologist at the University of California San Francisco. “I do feel that the FDA sees their role as making industry happy and not as much protecting the public health.”

___

Every day, patients in the U.S. and around the world benefit from medical technology. The inventions of this global industry include implants that help the deaf hear, implantable lenses that restore sight to the elderly and cardiac pumps that keep failing hearts beating.

For most of the last century, medical devices were not regulated in the U.S. But a series of high-profile safety problems in the 1970s — including deaths, miscarriages and injuries caused by a contraceptive implant — pushed Congress to intervene.

The laws that resulted are both more complex and less demanding than those governing drugs.

To win FDA approval, for example, most new prescription drugs undergo two large, rigorous clinical studies proving they benefit patients. But most new medical devices enter the market with no clinical trial testing.

Historically, more than 95 percent of FDA-reviewed devices on the market went through a streamlined process in which they need only show that they are “substantially equivalent” to a product already on the market. Typically, only devices considered high-risk, like heart pumps, must demonstrate safety and effectiveness in humans, but even those can sometimes rely on existing scientific data as opposed to new studies.

On Monday, the FDA proposed changes to the streamlined system that would push manufacturers to incorporate more up-to-date technology into their devices. But some of the major reforms could take years to implement.

Some experts have long argued that this fast-track pathway was never intended to be permanent. As framed by Congress in 1976, the system was originally meant to be a temporary way to grandfather in thousands of devices already on the market that weren’t considered high-enough risk to require immediate review. But instead of being phased out, it became mainstream.

The industry contends that flexibility is critical to innovation, allowing manufacturers to quickly and cheaply experiment and improve. An FDA review under that process costs about $11,000, compared to $320,000, under the more rigorous standard.

The result, though, is that some medical products barely resemble the decades-old “predicates” they reference in applying for FDA clearance. And even when old devices have been linked to injuries or death, future products are allowed to reference them for approval because the FDA lacks explicit legal authority to swiftly intervene.

In more than four decades, the FDA has banned only two products — powdered surgical gloves, which caused allergic reactions in patients, and fake hair implants, which caused infections and didn’t work. The agency says its ability to ban products is “bound by federal law” and is essentially limited to devices that are either deceptively marketed or unreasonably dangerous.

The U.S. device system is “basically set up to get things on the market, not to get things off the market,” said Larry Kessler, a University of Washington professor and consultant who worked more than a decade in the FDA’s device center.

___

A device used to treat childhood scoliosis illustrates how quickly manufacturers can win FDA approval with minimal clinical trial testing.

The MAGEC rod uses remote-controlled magnets to gradually extend titanium columns implanted in children’s backs to correct debilitating spinal curvature. It is marketed as an alternative to traditional implants, which require frequent surgeries to manually extend the rods as a child grows.

Prior to clearing it for use in the United States, the FDA allowed the MAGEC rod’s California-based manufacturer, Ellipse, to begin exporting its product overseas.

The company enlisted a Hong Kong surgeon to conduct its first human trials after winning European approval in 2009 following experiments in pigs. In a company-funded study published three years later — based on the results of just two patients — the surgeon concluded the MAGEC rod “improves quality of life and is more cost-effective.” The rods were later implanted in patients in Australia, Israel, Korea and elsewhere.

The company had assumed it would need to conduct a large clinical study including American children to win FDA approval for use in the United States, Dr. Behrooz Akbarnia, a San Diego-based surgeon and company consultant, said in an interview.

But in early 2014, the FDA informed the company it could seek approval via the streamlined process, Akbarnia said. Ellipse claimed its device was “substantially equivalent” to a mechanical implant developed in the 1950s. It was cleared for use in the U.S. by the FDA in just 35 days.

“That was one of the things that surprised me,” Akbarnia said, “because it was so fast.”

The approval also “shocked the spine industry,” according to an article by Ellipse’s former vice president of engineering Tiger Buford, who did not respond to repeated requests for an interview.

More than 2,000 children have been implanted with MAGEC rods worldwide, according to company filings by Ellipse, which was purchased by Nuvasive in 2016 for roughly $400 million.

Anthony Wainess was 9 when he became the first U.S. child to have MAGEC rods implanted in 2013 under a “compassionate use” exemption by the FDA. The rods temporarily helped the boy’s spine grow correctly, but began breaking within a year and were removed in 2016.

Anthony’s doctors theorized his body might be having an allergic reaction to the metal rods, according to his father, Steven Wainess.

The FDA told the AP that the MAGEC rod was cleared based on laboratory testing, animal studies and a clinical study “to demonstrate the device is safe and effective.”

The agency said it requires makers of all spinal implants to include warnings about potential risks, noting that the MAGEC rod’s labeling warns that it can break, move, corrode, cause pain and should not be used by patients with metal allergies.

Researchers in Europe have identified cases of metallosis in children with the rods, the tissue around their spines stained black by titanium shards and debris.

The long-term effects of titanium metallosis are not yet known, but metal debris in patients with chrome and cobalt hip implants can cause bone and tissue damage. The all-metal hip implants, also cleared through the FDA’s streamlined path to market, were implanted in an estimated 500,000 Americans before the FDA reclassified them as high-risk in 2016. Today, they have largely been recalled or phased out.

In a paper published in January in the medical journal, Spine, British orthopedic engineer Thomas Joyce said all 34 MAGEC rods examined by his lab at Newcastle University showed signs of metal wear, which could lead to debris spreading throughout children’s bodies.

The level of metal debris from MAGEC rods is about 100 times the levels he’d previously seen with hip implants, “a shocking amount,” he reported. Joyce has worked as an expert witness for lawyers suing metal hip makers. He donates his payment to his employer, per university rules.

Nuvasive said in a statement that its device has been shown to be effective in helping avoid the “pain, elevated complication rates, and psychological distress” of traditional spinal rods.

“While no technology in these patients is without risk, we have also seen MAGEC rebuild patient and family lives,” the company said.

Joyce said Nuvasive initially cooperated with his research, providing materials to help with his tests. But after his research was published, he said the company sent a letter to spine doctors worldwide questioning its validity.

Joyce said he’s simply trying to answer basic safety questions that haven’t been addressed by the company or regulators: Why does the MAGEC rod cause metallosis, and what are the long-term effects on children?

A device that claims to treat depression by beaming rapid-fire bursts of magnetic energy into the brain’s prefrontal cortex had a similarly smooth path to market, even though its benefits were unclear.

Between 2012 and 2016, former U.S. military members participated in a Department of Veterans Affairs study of the transcranial magnetic stimulation device, or TMS. As of 2018, the VA has spent more than $3.4 million acquiring dozens of the machines and related supplies, based on the FDA’s approval.

The FDA cleared TMS technology for the U.S. market in 2008 even though the agency’s own advisers said data submitted by the original manufacturer failed to establish its effectiveness. In fact, the advisers called its effect “marginal,” ?borderline” and “questionable.”

The experts did note that TMS therapy appeared “reasonably safe,” producing only minor complications such as headaches and scalp pain. That compared favorably to older devices used for hard-to-treat depression, including electro-shock therapy.

The FDA eventually approved the device through a pathway reserved for “low to moderate” risk devices that are not equivalent to previously approved devices.

Under Shuren’s tenure, six more TMS manufacturers have come on the market, mainly by piggy-backing off the original FDA clearance.

This June, when the VA published the findings of its study , they echoed the results of a decade earlier: TMS made almost no difference in patients’ depression. The authors offered several explanations, including that veterans often have multiple psychiatric problems that complicate treatment.

The American Psychiatric Association’s guidelines describe TMS as offering “relatively small to moderate benefits.” And even when TMS treatment is successful, its long-term durability has not been established in rigorous patient studies.

Still, with persistent marketing from manufacturers, TMS has gradually won acceptance as an alternative to antidepressants. Some clinics also advertise unapproved uses of the device, including for autism, Alzheimer’s and post-traumatic stress disorder.

More than 800 U.S. clinics have the devices, according to a filing from the original TMS manufacturer, Neuronetics Inc. The firm tells doctors they can recoup the cost of a machine by treating just 12 patients, with a typical course of treatment costing up to $10,000 for 30 or more sessions over four to six weeks.

“The clinics are proliferating, the insurance is reimbursing, but we still don’t exactly know what kind of patients should be receiving this intervention,” said Dr. Dost Ongur, a Harvard Medical School psychiatrist and editor of the journal that published the VA study.

TMS can be effective for certain patients, Ongur and other psychiatrists say, but identifying them can be challenging.

The FDA said it approved TMS after determining that its benefits outweighed its risks. The device’s approval is limited to patients who have failed to respond to drug therapy with at least one antidepressant, the agency noted.

Neuronetics said in a statement that its device has been proven effective in studies of more than 900 patients and is covered by more than 65 private insurers and the government’s Medicare plan. And Magventure, which makes the device used in the VA study, said TMS’ impact on the brain is “a well-established fact,” though researchers are still exploring the “optimal way” to treat different patient types.

But skeptics remain. The Blue Cross Blue Shield network’s unit for reviewing medical devices has assessed TMS three times, most recently concluding in 2014 that the studies “do not provide convincing evidence.” The group is considered a pioneer in evaluating medical technology.

Foreman, the former FDA review chief, said the “least burdensome” requirements that bind FDA reviewers make it difficult to demand better evidence for devices like TMS. In such cases, the agency’s position is generally “the device isn’t going to hurt anybody so let’s put it out there and let the consumer use it,” she said.

But even ineffective treatments for depression can be harmful, according to Diana Zuckerman, a depression researcher and president of the nonprofit National Center for Health Research, which assesses the quality of outside research and conducts its own.

“If you are going five days a week for a month, spending all this money and you feel you’re no better than when you started, you could end up more depressed,” Zuckerman says.

A new analysis of the TMS literature by Zuckerman’s group concludes that the treatment “is not shown to be beneficial compared to typical placebo effects.”

___

One of the rationales FDA cites for accepting uncertainty in new device safety and effectiveness is “patient preference,” which holds that the agency should consider patient opinions in its approval decisions.

Former FDA regulators say Shuren has repurposed that idea to justify putting even more devices on the market.

“Jeff tells wonderful stories in terms of ‘We’re doing this to make sure patients have this greatly improved technology,’” Foreman said. “But there’s another side to it, too.”

In recent years, patient preference information has been used to push approvals through the FDA’s pathway for high-risk devices, even in a case where the manufacturer failed to meet its own study goal.

In early 2015, the FDA approved a first-of-a-kind obesity device — an implantable stimulator that shoots electricity through the nerves connecting the stomach and brain. But less than a year earlier, the Maestro Rechargeable System had received a mixed review from the agency’s scientists and outside advisers.

To demonstrate effectiveness, the FDA and the manufacturer agreed Maestro patients would need to lose at least 10 percent more excess body weight than patients who received a sham treatment. But one-year data showed patients with the device lost only 8.5 percent more of their weight.

FDA scientists cautioned that long-term complications from removing and adjusting the device were not known. And some agency advisers said the demographic of study participants was unacceptable, since 93 percent were white and U.S. obesity rates are highest in African-Americans and Hispanics.

Still, the agency approved the device, citing a survey that showed patients were willing to accept the risks.

The patient survey, for which the FDA paid $280,000, is being used by regulators to “define minimum clinical effectiveness to evaluate new weight-loss devices,” the agency said, adding, “The FDA recognized obesity as an area of unmet patient need.”

The device manufacturer, ReShape Lifesciences, did not respond to requests for comment.

Earlier this year, Shuren addressed a conference of medical device industry executives, each of whom paid about $1,000 to attend.

Armed with dozens of PowerPoint slides, he explained how the FDA was approving more new devices in less time and credited his “north star” — the FDA’s goal to be “first in the world” to approve new devices.

He highlighted the agency’s new focus on “customer service,” including removing “unnecessary burdens” for companies and streamlining clinical trials.

“We all know that premarket clinical trials can be very costly, very time-consuming and, in some respects, of limited value,” Shuren said.

He explained that the FDA was now using easier-to-produce data to approve a variety of devices, including artery-opening stents, spinal implants and diagnostic tests.

Meanwhile, warning letters to device makers over safety, marketing and other issues have fallen to their lowest level in over a decade. The FDA says it has offset warnings with increased inspections and that companies continue to fix their violations at the same rate.

The stepped-up approvals and modified enforcement have the endorsement of President Donald Trump and his appointee, FDA Commissioner Dr. Scott Gottlieb, who has highlighted “acceptable uncertainty” as a key concept to “modernize” device regulation.

In September, the FDA began codifying that concept in draft guidelines for manufacturers, which would ease pre-market testing standards for certain devices, in exchange for companies conducting larger follow-up studies, even though the FDA’s own data show that many studies are not completed until five or more years after approval.

The FDA said in a statement that all devices carry a level of uncertainty, even after extensive testing. It said its guidance focuses on “breakthrough” devices, where “it may be appropriate to accept a little more uncertainty,” while still meeting FDA standards.

Lurie and other former regulators worry that the FDA is laying the groundwork for a “sliding scale” of medical evidence that will leave patients even more uncertain about the safety and effectiveness of devices.

“This guidance is basically a ‘come hither’ to industry, inviting them to ask FDA for the lower standards of evidence,” he said.

See original article here.

Breast Implant Injuries Hidden As Patient’s Questions Mount

Meghan Hoyer, AP News: November 26, 2018.

WASHINGTON (AP) — To all the world, it looked like breast implants were safe. From 2008 to 2015, the U.S. Food and Drug Administration publicly reported 200 or so complaints annually — a tiny fraction of the hundreds of thousands of implant surgeries performed each year.

Then last fall, something strange happened: Thousands of problems with breast implants flooded the FDA’s system. More than 4,000 injury reports filed in the last half of 2017. Another 8,000 in the first six months of 2018.

Suddenly, women like Jamee Cook had evidence suggesting their suffering might be linked to their breast implants. An emergency room paramedic, Cook had quit her job because of a vague but persistent array of health problems that stretched over a decade, including exhaustion, migraines, trouble focusing and an autoimmune disorder diagnosis.

Why had it taken so long for complaints like hers to see the light of day?

Makers of breast implants were required to track patients and their health. But for more than a decade, manufacturers with high numbers of recurring problems — in the case of implants, ruptures that required surgery to remove — were allowed to report issues in bulk, with one report standing in for thousands of individual cases and no way for the public to discern the true volume of incidents.

That agreement stood even as the FDA began closely monitoring a rare type of cancer and acknowledged in 2011 that it might be linked to breast implants.

“It looked like these devices had become safer, but they hadn’t,” Cook told The Associated Press. “The data was hidden. It’s a deceptive practice.”

Once Cook’s textured saline implants were removed, she said the majority of her symptoms disappeared. Her experiences prompted her to become a patient safety advocate, lobbying lawmakers and organizing groups of women online who have concerns about breast implants.

Public health advocates who’ve watched the debate over breast implant safety rage for nearly three decades say summary reporting is yet another way that information about the devices has been elusive for patients.

“They were told those devices were safe — the FDA would go back and say ‘We only have this many reports,’” said Madris Tomes, a former FDA staffer who founded a company to analyze medical device reports. “But data was coming in another way that wasn’t public. It leaves the patients demoralized — they don’t understand how many other people are suffering.”

The data came to light after the FDA instructed manufacturers in mid-2017 to go back and file individual reports in each case of patient injury, in response to a lawyer’s discovery that reports from his clients weren’t represented in the agency’s data. Patient advocates took up the issue, complaining about a lack of transparency and voicing concerns about a host of autoimmune problems they believed stemmed from their implants.

But even as the FDA was dealing with the problems of how breast implant manufacturers had used summary reporting, the agency was moving to expand device makers’ flexibility in how they report problems, saying it was trying to reduce the industry’s paperwork requirements.

This August, the agency began allowing roughly 90 percent of all medical devices — including all breast implants and more than 160 types of other high-risk implanted devices like artificial hips and replacement heart valves — to report malfunctions in a quarterly tally, instead of individually. They will not be able to report cases involving deaths or injuries that way, however.

The FDA rejected claims that expanding summary reporting could harm public health by making problems with devices less transparent, saying the plan “will also yield benefits . such as helping FDA process malfunction reports more efficiently and helping both FDA and the public more readily identify malfunction trends.”

FDA officials also said that the agency has closely monitored the breast implant industry in the past decade and issued updates about potential risks.

Two of the largest breast implant manufacturers, Mentor and Allergan, said they stood behind the safety of their products, citing years of studies that have led to inconclusive evidence that autoimmune problems are linked to breast implants.

“Our medical devices undergo extensive laboratory testing before they are submitted to government health experts for a science-based review,” Mentor spokeswoman Mindy Tinsley said. “Many of our devices undergo careful reviews by not just one, but multiple regulatory bodies around the world.”

Still, it can be hard for breast implant patients and advocates to track problems that do arise.

Insurance claims make no mention of the specific device or model implanted in a patient, and patients’ electronic health records aren’t required to record that either. In addition, products sold overseas can be renamed or carry a different model number, making international recalls or tracking across borders nearly impossible.

Meanwhile, the FDA’s main database on medical device problems, which requires manufacturers to report patient deaths and serious injuries to the government within 30 days, relies on hand-typed entries from a variety of people — from patients to device manufacturers — to help track troubled products. That can lead to underreporting, along with missing and flawed data.

Tomes said accurate, complete and publicly accessible data is crucial to identifying problems quickly and making sure devices are safe. The FDA numbers, she said, offer the lowest possible count of reports about problems with breast implants.

“You can assume that the numbers are probably much, much higher,” she said.

A Duke University report funded by the FDA in 2016 found that even though the agency collected data on device malfunctions for more than two decades, “reliably and efficiently tracking the medical device safety and effectiveness outcomes of most interest to patients remains a generally unfulfilled promise” that “significantly affects the public health.”

Insurers, auto buyers and regulators all use a car’s VIN number to track a vehicle’s history, down to the line it was manufactured on at a specific factory, and the FDA’s own pharmaceutical drug oversight works similarly. But medical devices didn’t have a similar unique identifier until 2015, and many of the least-risky devices won’t put an ID into use until 2020. On top of that, experts say it could be years before their use is required in patient records, on insurance claims and in the FDA’s own data.

What are the most common makes and models of breast implants reported as having caused injury? The FDA’s answer is still quite often “Unknown.”

___

The FDA requires manufacturers and medical facilities to file a report when any kind of medical device causes serious injury, death or malfunctions.

The resulting database — called MAUDE, for Manufacturer and User Facility Device Experience — is available online to the public, so consumers can search for a device type, manufacturer, the details of an incident and the date on which it occurred. That is, if the forms are filled out properly.

But categories often are left blank, with no indication of the model or who submitted the report. And device names and manufacturers also are often misspelled, making it nearly impossible for users to find all the reports of problems with a specific device or company. For example, the data contains roughly 2,000 variations of the name Medtronic plc, one of the world’s largest medical device manufacturers.

Overall, the MAUDE data contains reports of more than 1.7 million injuries and nearly 83,000 deaths over the past 10 years for all types of medical devices, according to an analysis of FDA data by the International Consortium of Investigative Journalists, which collaborated with the AP on a global investigation of medical device safety.

But in looking at problems with the MAUDE data, the investigation found an additional 2,100 cases in the past five years where people died but their deaths were misclassified as “malfunctions” or “injuries.” Of those, 220 deaths could be directly linked to medical device failure; the other reports did not include enough information to determine conclusively if the device played a role.

Beyond the misclassified data, FDA inspections at 17 hospitals in 2015 and 2016 found that only a fraction of “adverse events” were even being reported anyway. The review —which included major facilities in Los Angeles, New York, Boston and Chicago — found more than half failed to report deaths of patients with medical devices, as required by the agency’s rules. Jeffrey Shuren, the head of the FDA’s device division, said at the time that underreporting problems from hospitals was widespread. The agency enhanced compliance training for hospital employees nationwide as a result.

Part of the problem, advocates say, is that the FDA’s guidelines for reporting problem devices is vague — the agency states that reports are required from manufacturers within 30 days of an event when evidence “reasonably suggests” that a device was involved, allowing companies to make their own judgments.

S. Lori Brown, now a retired FDA senior researcher, used MAUDE for years in her studies of breast implants, ruptures and possible links to rare forms of cancer and a host of autoimmune disorders.

“It’s a difficult database to use, because there’s no good way to confirm what’s reported, and there’s no denominator — you don’t know how many people have received breast implants,” Brown said. “The MAUDE database was just not very helpful in finding out how frequently things happened or how severe the impact was.”

Where it was helpful, she said, was in gathering patient stories and seeing general trends. In the 1990s, even as manufacturers claimed breast implants were durable enough to be run over by a car without breaking, MAUDE showed silicone implants leaking gel into thousands of women’s bodies.

“As a signal, it was a burning bush, for sure,” Brown said. “Because there were so many reports of ruptured implants from every manufacturer.”

After the FDA removed silicone breast implants from the market in 1992, the public attention around ruptures and leaks resulted in a huge spike in the number reports about problems. During the 1990s, silicone implants represented the third-highest number of adverse events reports in MAUDE. At the time, the data show patients also complained about other symptoms, with hundreds of reports about chronic fatigue, headaches, autoimmune problems and fibromyalgia.

In 2006, silicone implants returned to the market, under the requirement that companies track patients for at least a decade. Although more than half the women dropped out of the studies within the first two years, researchers at the University of Texas MD Anderson Cancer Center in Houston released a study this September using the data the companies did collect and found that certain rare health problems — including immune system and connective tissue disorders — might be more common with silicone gel implants. The FDA, which mandated the original data collection, later criticized the study, citing “inconsistencies in the data.”

Last year, the FDA did confirm a link between breast implants, particularly textured saline or silicone models, and anaplastic large cell lymphoma — a rare cancer documented in only a few hundred cases.

On its website, the FDA also noted more common problems with implants, such as ruptures, which can send silicone gel throughout the body. And the agency warned that implants “are not lifetime devices,” but will likely need to be removed or replaced at some point.

The return of silicone implants, which advocates say feel more natural, has fueled a surge in surgeries. The American Society of Plastic Surgeons reported 400,000 procedures took place in 2017, up nearly 40 percent since 2000.

More than three-quarters of the implant surgeries were for cosmetic, not reconstructive, reasons. And there were about 20 percent fewer removals compared to 2000, the data show.

The increase in implants worries Diana Zuckerman, a medical researcher who was a congressional staffer during the earliest contentious House hearings on breast implant safety. She said poorly performed studies, research funded directly by manufacturers and the lack of data have left most women in the dark about the risks involved.

“Somehow, it’s the most studied device and we have almost no useful information about it,” said Zuckerman, the president of the National Center for Health Research, a nonprofit think tank that performs its own research, assesses the quality of others’ research and works with patients.

Zuckerman’s center reviewed more than 20 studies it says has been used by the industry to claim there is no evidence breast implants cause connective tissue problems and other long-term illnesses. She said almost all the studies were too small to detect rare diseases and conditions, only one required that participants have a medical exam and most didn’t focus on patients who had implants long enough for problems to develop.

In September, Cook and 19 other breast implant patients-turned-health-advocates visited Washington to lobby the FDA for more stringent regulation, testing and reporting on breast implants. Among their requests — that all types of textured implants, which are more closely associated with lymphoma, be banned from the market, and that manufacturers be required to disclose the chemicals in silicone implants’ shell and gel filling, which the makers claim is a trade secret.

The FDA has scheduled an advisory committee hearing for early 2019 on breast implant safety to address some of the U.S. group’s concerns and determine whether additional actions are needed to protect public health. The agency did not rule out the possibility of including a “black box warning,” the notification it puts on its most dangerous devices to draw attention to serious risks.

However, the FDA said in a statement: “The agency continues to believe that the weight of the currently available scientific evidence does not conclusively demonstrate an association between breast implants and connective tissue diseases.”

Cook, who leads several breast implant groups on Facebook from her home near Dallas, said she chose to get her implants, but did so with almost no information on the potential dangers.

“If you had sat down with me and said ‘this is the list of chemicals you’re about to put in your body and you could get lymphoma,’ no way in hell I would have done it,” she said.

Her implants, a textured saline model made by Poly Implant Prothese of France, were used in the U.S. for four years before the FDA implemented more stringent standards for breast implant approval in 2000. Under the new rules, the FDA denied the company’s application to sell implants in the U.S. after officials toured the company’s French plant and cited 11 major deficiencies in quality control and manufacturing practices.

Poly Implant went bankrupt in 2010 after doctors in France noted abnormally high rupture rates of the implants, which were found to be filled with industrial-grade gel. The company’s president was found guilty of aggravated fraud, and French authorities advised tens of thousands of women to get their implants removed as a precautionary measure.

Cook, 41, said she and others who already had the saline implants never were warned of the FDA’s actions.

“I’m not going to sit back and be embarrassed about my decision when I can try to change the way that the future is going to occur for women younger than me,” she said. “We need to make sure we’re giving that patient the most safe device we possibly can. And above that, we need to make sure she understands what the risks are before she makes that choice.”

___

The FDA may now require an identifying number on medical devices, but Zuckerman and other advocates note one big issue with the code associated with breast implants: The number is not actually stamped on the implant itself, but on the packaging.

“For the most part, these devices don’t cause immediate problems — they cause problems later,” Zuckerman said. “What good does it do to have these numbers if they’re not in your medical records and they aren’t on the implant itself?”

The unique device identifier, or UDI, is intended to help standardize device names and manufacturer information and make it easier to track devices to help in recall efforts and analyses of problems.

But that doesn’t work if the codes aren’t in the FDA’s own database. Tomes, whose company Device Events analyzes MAUDE data, said UDIs are still rarely included in adverse event reports and, even when they are, often are removed from the public data so they can’t be used to identify specific devices.

“The whole point of having a UDI is so that hospitals and providers and insurance companies and anyone else would be able to say ‘I’m seeing a pattern, it’s all this serial number,’” Tomes said. “But it’s redacted.”

Similarly, Tomes and others say the FDA’s expansion of summary reporting and its use of device registries — databases funded and maintained by outside organizations to track a singular specific device — may ultimately make less data available to consumers.

This fall, the agency announced a breast implant registry run through the Plastic Surgery Foundation that will collect patient and device data — including UDI numbers for breast implants — and allow surgeons to track patients’ medical history, complications and follow-up surgeries.

The participation of plastic surgeons in the registry is voluntary, and patients also can opt out. Doctors and researchers will have access to the collected data, but the public will not.

As the FDA weighed its expansion of the summary reporting program earlier this year, Cook and a dozen other patients with medical device problems, along with the patient-advocacy group Public Citizen, urged the agency to rethink its plan.

But the FDA sided with manufacturers and industry organizations, which had asked for easier reporting requirements for malfunctions, freeing them in some cases from filing tens of thousands of individual reports a year. Under the new rules now in place, roughly 90 percent of devices can report malfunctions quarterly.

“Thousands on thousands of consumers are harmed every single year by medical devices and we are discussing making it easier to hide the information that we need to make an informed decision,” Cook wrote in her dissent to the plan.

“While the goal is not to ‘hide’ the data,” she wrote, “in essence that is what is happening.”

Read the original news article here.

Silicone Breast Implants Increase Arthritis Risk 600%, Stillbirth Risk 450% and Skin Cancer Risk 400%, Study Claims

Mary Kekatos, Daily Mail: November 20, 2018.

Silicone implants can increase a woman’s risk of arthritis, stillbirth and even skin cancer, a new study suggests.

Researchers found that women had a 4.5-fold increased risk of having a stillbirth and a four times greater risk of developing melanoma after their procedures.

In comparison with saline implants, women with silicone implants were also two times more likely to have surgical complications, particularly scarring around the implant.

The team, from the University of Texas MD Anderson Cancer Center in Houston, says its study is the largest of breast implant outcomes to date and the findings are important to help women choose the implant they feel is right for them.

The most popular implants approved by the US Food and Drug Administration (FDA) are silicone implants and implants filled with a saline solution.

Silicone implants use shells filled with a plastic gel while saline implants use silicone shells filled with a sterile saline solution.

For breast reconstruction, the rebuilding of a breast, both implants are approved for women of all ages.

For breast augmentation, meant to increase the size or change the shape of a breast, saline implants are approved for women aged 18 or older and silicone implants are approved for women aged 22 or older.

Many women say silicone implants feel more like real breasts than saline implants do, but they pose a greater risk if they leak.

In the early 1990s, the FDA prohibited silicone implants after several health concerns were raised about their association to a risk of cancer, connective tissue disease and autoimmune diseases.

No research established a definitive link between silicone implants and these conditions.

After silicone implants from two manufacturers were approved in 2006, the FDA conducted many postapproval studies, but no researchers had analyzed the database.

For the new study, published in the journal Annals of Surgery, the team looked at nearly 100,000 patients enrolled in large postapproval studies between 2007 and 2010.

Approximately 80,000 had silicone implants and the rest received implants filled with a saline solution.

Additionally, 72 percent of the women had a breast augmentation, 15 percent had a revision augmentation, 10 percent had breast reconstruction, and three percent had revision reconstruction.

Researchers found the women who had silicone implants had a higher risk of several rare adverse outcomes.

This included rheumatoid arthritis; Sjogren’s syndrome, an immune system disorder characterized by dry eyes and dry mouth; and sclerodermia, chronic hardening and tightening of the skin and connective tissues.

All these conditions came with a risk six to eight times higher in these women than in the general population.

Women with silicone implants were also at a 4.5-fold increased risk of having a stillbirth, but not a miscarriage.

Researchers also found that women with silicone implants had a risk of developing melanoma that was four times greater.

Silicone implants were also associated with a higher risk of surgical complications compared to saline solutions.

Around five percent of women had scarring around the implant, known as capsular contracture, compared with 2.8 percent of women with saline implants.

‘We are reporting an analysis of the largest prospective study to date on silicone breast implant safety,’ said Dr Mark Clemens, an associate professor in the department of plastic surgery at MD Anderson Cancer Center.

‘We are sharing critical information on complication rates and rare associations with systemic harms. This data gives women important safety information about silicone breast implants to have real expectations and to help them choose what is right for them.’

The authors noted that although certain risks were more common in women with silicone implants, ‘absolute rates of these adverse outcomes were low’.

‘Women shouldn’t panic but what it does tell us is that there’s something going on and it’s different than what women have been told for the last two decades,’ Dr Diana Zuckerman, President of the National Center for Health Research, told DailyMail.com

‘It’s still cause for concern and you have to think that all those increased risks adds up. Not all women are getting all these diseases but it’s some getting one and some getting another that could be statistically different.’

But Dr Stuart Linder, a plastic surgeon from Beverly Hills, California, is skeptical of the study.

‘I use silicone implants and I have for over 20 year and I haven’t seen anything that has hinted of this,’ he told DailyMail.com.

‘Unless the FDA states the risk is higher, then the products are deemed to be safe and usable in surgery.’

See original article here.