Category Archives: We Are Quoted

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 When the FDA was asked why it cleared mesh implants on the basis of predicate devices that had been withdrawn because of safety concerns, the agency said that it didn’t evaluate the performance of predicate devices when clearing devices for sale.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.

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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.”

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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.

Concerns That Public Hearings on Breast Implants Will Favor Implant Manufacturers

Kris Pickel, CBS News: October 4, 2018.

PHOENIX (3TV/CBS 5) — The Food and Drug Administration has agreed to hold a public hearing on Breast Implant Illness. It’s a victory for women who petitioned the FDA but CBS 5 is investigating concerns the hearings will be stacked to favor implant manufacturers.

Breast Implant Illness (BII) is not recognized as a medical condition.

It is a term used by thousands of women to describe a wide range of unexplained symptoms experienced by women who believe their implants made them sick.

Symptoms of Implant Illness

 

 

 

 

 

 

 

 

 

 

CBS 5 has been investigating BII for almost two years and has seen the number of women coming forward increase by the tens of thousands.

When our first investigation aired, the Facebook group Breast Implant Illness and Healing with Nicole, had 17,000 members. It now has more than 51,000.

News reports and social media are connecting women who believe they suffer from BII.

They are finding strength in numbers.

More than 21,000 women signed an online petition demanding the FDA hold public hearings.

The FDA agreed to meet privately with a small group of women who believe they suffer from BII.

Among the women who traveled to the District of Columbia for the September meeting at FDA headquarters were breast cancer survivors, women who believe implants made them sick, experts on breast implants and women who recently played a role in having the birth-control device Essure pulled off the market.

Women in the group say the FDA set the terms for the meeting: No cameras, no recording, no reporters allowed.

Following the September meeting, the FDA released a statementdisputing a study linking implants to illnesses.

Buried at the end of the statement, the FDA announced they would hold a public hearing on breast implants next year.

Nicole Daruda founded the website HealingBreastImplantIllness.com and the closed Facebook group Breast Implant Illness and Healing with Nicole.

Daruda say some of the issues they want to address include taking textured implants the FDA has said might be linked to the potential for a rare cancer off the market, comprehensive studies and requiring surgeons to give women a checklist of potential risks at least a week before surgery.

In the FDA’s public hearing, an advisory panel will hear from industry representatives, experts, women who believe their implants made them sick and members from the public.

Following the public hearing, that advisory panel will vote on recommendations to make to the FDA. The panel does not have the power to make changes. It will only make recommendations.

Dr. Diana Zuckerman on CBS News

Dr. Diana Zuckerman is president of the National Center for Health Research in D.C. and is responsible for a dozen Congressional investigations on a various health issues.

Zuckerman says in the past, the FDA has stacked the panels with plastic surgeons who have a financial interest in protecting breast implants. 

“Having surgeons whose entire livelihood, or almost entire livelihood, is based on breast surgery, with breast implants, can’t possibly be objective,” Zuckerman said.

She says she has witnessed multiple times where plastic surgeons advocate for implants and dominate the hearings.

“I’ve seen situations where a statistician, for example, says, ‘Look at how unsafe these products are,’ and the plastic surgeon says, ‘No. No. No. We put these in all the time and they are very safe.'”

We contacted the FDA a several times during this investigation and asked if they would be looking at the panel to eliminate possible conflicts of interest.

They responded with a link to their application for panel members, which includes a section that addresses conflict of interest.

Conflict of Interest

The FDA website lists the core group of eight voting members on the advisory panel.

CBS 5 was able to confirm at least two of the doctors perform breast implant surgeries and a regulatory expert who previously worked for Johnson & Johnson, which owns implant manufacturer Mentor.

Zuckerman says in the interest of ensuring an unbiased panel, people should contact their elected officials in Washington and ask them to  pressure the FDA to make sure no one with financial ties to the implant industry sits on the advisory panel.

One Woman’s Story

Robin Towt shares her story

Cancer survivor Robyn Towt was in the group of women who met with the FDA.

When diagnosed with breast cancer, Towt immediately opted for a double mastectomy.

She says her health issues, including anxiety and insomnia, started the day her implants were put in.

Having survived cancer before, radiation was not an option.

Towt chose not to do chemotherapy, leaving no explanation as to why she was getting sicker.

“I have been never been that miserable in my entire life and in that dark a place,” she said. “I feel horrible because my family suffered. My husband suffered. I was not a happy person. I was not a healthy person. I had no quality of life. I was desperate. I was sleep deprived.”

Towt says a friend in a cancer support group suggested she look into her implants as a source for her health problems.

After connecting with women on social media, Towt had her implants removed just four months after having them put in.

She says her symptoms disappeared within 48 hours.

CBS 5 Investigates has uncovered that while implant manufacturers are required to publish informational booklets that include warnings on potential risks of implants, plastic surgeons are not required to give the booklets to women.

Towt says after her implants were removed, she went back and asked her surgeon for the booklet so she could compare the warnings to the consent forms she signed.

Towt says the warnings in the booklet were stronger when it came to certain risks, including cancer associated with breast implants.

“I kind of felt duped when I was comparing them because if I had read the information in that booklet to start with, I would have never ever considered it,” she said.

Towt’s plastic surgeon did not return calls to CBS 5 inquiring when the booklets are provided to patients.

A date for the FDA’s public hearing has not been set.

The FDA says it will happen sometime in 2019.

 

Read the original article and watch the news segment here.

FDA Rarely Uses Its Power to Recall Dangerous Medical Devices. Why Not?

Meg Bryant, MedTech Dive: August 31, 2018.

The FDA has the authority to recall dangerous and risky medical devices, but it has rarely done so, largely relying on manufacturers to take necessary actions when a product defect or spike in serious adverse incidents occurs.

Since Congress passed the medical device amendments to the Food, Drug & Cosmetics Act in 1976, the agency has used its 518(e) mandatory recall authority just a handful of times. In 1991, the FDA ordered Medline to recall its Dynafeed enteral pump due to design flaws and failure to comply with good manufacturing practices. The agency issued three mandatory recall notices the following year and in 2008, recalled Nebion’s MRI device, citing lack of FDA approval and safety and effectiveness data, as well as noncompliance with GMPs.

There have been some recalls under federal consent orders, and the FDA has in four cases taken the unusual step of banning a medical device. The first time was in 1983 when it banned prosthetic hair fibers used to treat baldness because of serious risks including infections. Then in 2016, the agency simultaneously banned powdered surgeon gloves, powdered patient examination gloves and absorbable power used for lubricating surgeons’ gloves. The danger: Residue from the powder could be left behind in the body cavity, causing inflammation and scarring that could lead to complications later on. In addition, bits of latex from the gloves could bind the powder and be inhaled, putting people with latex allergies at risk.

Given Bayer’s recent decision to stop selling the Essure birth control device, following years of unmitigated safety concerns and mounting patient lawsuits, and the release of the Netflix documentary, The Bleeding Edge, many are questioning why the FDA seems so reluctant to wield its recall authority.

“The FDA has not taken them off the market, has not rescinded approval for specific uses, has not done a mandatory recall and has tried to put out [a] warning that the agency knows is not going to be effective,” said Diana Zuckerman, president of the National Center for Health Research. “They do that all the time.”

‘Insurmountable threshold’

“Once products are on the market, it’s almost an insurmountable threshold to get the agency to take action to pull them from the market,” said Michael Carome, director of Public Citizen’s Health Research Group. “In the case of [Bayer’s] Essure, had the company not voluntarily acted, I suspect FDA would not have pushed them to pull it from the market, based on statements they made over the last few years in the face of concerns.”

Approved in 2002, Essure was associated with serious risks including persistent pain, perforation of the uterus and fallopian tubes and migration of the device into the pelvis or abdomen. The FDA required the addition of a boxed warning and patient decision checklist to the product’s labeling and in April restricted sales of Essure, but did not call for its withdrawal from the market.

That’s not unusual, says Jodi Scott, partner in Hogan Lovells’ Denver office and former FDA counsel. “By and large companies are pretty responsive to a very direct FDA request to take action,” she tol MedTech Dive. “And while I’m sure it doesn’t work in 100% of the cases, I will tell you it probably works 99% of the time.”

Mandatory recalls are also costly for FDA to take. According to the agency, the estimated annual reporting burden associated with section 518 actions is 1,098 hours.

As a last resort, FDA will order a recall, but it’s a lot easier to “look the company in the eye and tell them we think you need to do a recall and have them do it voluntarily,” Scott said. “And it happens much faster. To go to court and get an order takes a lot of time.”

It can also take time to sort out signals detected through the agency’s MDR reporting and Sentinel systems. If officials think there is an imminent risk of harm, they will do an analysis to determine whether the company needs to take some field action, which may or may not involve a recall. “You have to balance the risk and benefits,” Scott said, noting implants are often left in place and monitored when issues arise because of the risks associated with taking them out.

Still, she insists FDA “is not shy” about telling companies when reparative actions fall short and they need to do more. “But it’s all sort of informal, not invoking the mandatory recall authority,” she added.

Problem begins in premarket process

Critics say the real problem precedes FDA’s failure to act once a device is on the market and lies with the process used to bring most moderate and high-risk devices to market. Under the 510(k) premarket notification, companies need only to demonstrate that a device is substantially similar to another product in the market in terms of its intended uses and technological features. In most cases, no clinical trials are required.

Even when clinical trials are required for novel devices subject to premarket approval, they aren’t always randomized. And in cases where devices are given conditional approval and required to undergo postmark testing, the FDA is often lax about seeing that companies complete studies in a timely manner, they argue.

“They allow these studies to drag on for years and years and years, and by the time the studies are done, or if they are ever done, nobody needs the information anyway anymore because the product’s not on the market anymore or the product has changed so much that the information you have about the product that was being sold three years ago is not relevant to the product being sold today,” Zuckerman said.

Zuckerman pointed to the case of breast implants. The FDA approved two silicone gel-filled breast implants in 2006, with the proviso the manufacturers — Johnson & Johnson’s Mentor and Allergan — each would study 40,000 women for 10 years. Neither completed the studies, which involved cumbersome online questionnaires and did not provide any incentives for women to complete them. 

Too close to industry?

“Ultimately, the agency is too industry-friendly,” Carome told MedTech Dive. “They view the industry as a partner rather than a regulated entity.” He believes the adoption of user fees has made the situation worse by allowing industry to negotiate benchmarks for FDA product reviews and other activities in return for payments for reviewing product submissions and other services.

Meanwhile, a 2016 proposal to ban electrical stimulation devices intended to treat people with mental or behavioral disorder that who exhibit self-injurious or aggressive behavior has yet to be finalized.

At the time of the proposed ban, only one facility in the U.S. was using the devices: the Judge Rotenberg Educational Center in Canton, Massachusetts. “Our primary concern is the safety and well-being of the individuals who are exposed to these devices,” William Maisel, chief scientist and deputy director science at CDRH, said at the time. “These devices are dangerous and a risk to the public health — and we believe they should not be used.”

No one is arguing the FDA should recall or ban every device that poses an imminent risk of harm, Zuckerman said. But in cases where FDA opts to keep a product on the market despite well-known risks, it should use the powers it has to require timely and well-designed studies that demonstrate safety and effectiveness versus available alternatives. The agency should “use the teeth it has,” she argued. […]

Read original article here.

The Human Tragedy of Poorly Regulated Medical Devices Gets the Spotlight in a Netflix Film

Amy Martyn, Consumer Affairs: July 27, 2018.

The motel where Ana Fuentes arrives one evening with her young daughters charges $110 for a single night and doesn’t offer weekly discounts. Fuentes asks the cashier for a moment so she can think about it.

Outside, the camera captures an anguished look on her face. It’s clear she can’t afford the expense. She books the room anyway. “Do you like it?” she asks her girls as they excitedly unpack their bags.

The family used to have an apartment, but Fuentes had to visit the emergency room so often that she lost her job, her daughters explain on camera.

Such situations aren’t rare in the United States, where experts have repeatedly warned that millions of Americans have almost nothing in savings and are a single medical disaster away from financial ruin. The problem is compounded nationwide by costly healthcare, lack of access to paid sick leave in the workforce, or a combination of the two.

But Fuentes’ story, like dozens of others featured in an upcoming expose about the medical device industry, has a particularly cruel twist. She says in the film that she was healthy until a doctor convinced her to undergo what was supposed to be a routine, non-surgical medical procedure — getting small birth control implants permanently embedded into her fallopian tubes.

The $155 billion medical device industry has mostly avoided the type of scrutiny that drug companies and health insurers sometimes face from elected officials and others. On Friday, a documentary about the device industry and patients like Fuentes called The Bleeding Edge is set to go live on Netflix, bringing what advocates hope will be widespread attention to an industry increasingly characterized by lax safety standards, enormous power in the operating room, and horrific side effects.

“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?” says Dr. Diana Zuckerman, a health policy analyst who has worked in the White House and as a staffer in Congress.

The current president of the National Center for Health Research, Zuckerman and the other researchers at her non-profit are among the few to have taken interest in faulty medical devices.  

Diving into the medical device industry

Hollywood directors Kirby Dick and Amy Ziering knew they wanted to make a documentary film about preventable medical injuries, Dick tells ConsumerAffairs, but that was about it.

Sitting in on one patient advocacy meeting for research, they caught a presentation that Zuckerman gave about the medical device industry and the ease with which questionable products get on the market. They decided that they had found their story.

The team interviewed approximately 70 patients to make their film, Dick tells ConsumerAffairs. The film also includes interviews with numerous whistleblowers, such as doctors, former Food and Drug Administration (FDA) researchers, and one medical device sales rep who requested anonymity in exchange for speaking on camera.

Dick and Ziering were previously nominated for an Oscar for The Hunting Ground, their documentary about sexual assault on college campuses. Another earlier film, The Invisible War, is an expose about sexual assault in the military.

But persuading people to speak out against the device industry made for the most challenging interviews they’ve done, Dick tells ConsumerAffairs. (A medical device industry lobbyist touts in one scene that the industry is more powerful than some national governments.)

The “E-sisters”

As the film and the research it is based on shows, the problem is bigger than any single device. The Bleeding Edge captures the story by focusing  on four implants — three of which were used exclusively women’s reproductive organs.

The narrative is driven forward by the story of the “E-sisters,” or the activists who say that they suffered debilitating side effects after receiving the permanent birth control implant Essure.

For years, the “E-sisters” have organized a grassroots campaign to convince regulators to ban Essure from doctors’ offices. That goal seemed like an uphill battle until last week, when Bayer suddenly released an announcement that Essure will no longer be sold in the United States by the end of the year.

Bayer frames the move as a “business decision.” The announcement came one week before the Netflix documentary was scheduled for release.

“I’m very glad that these issues are getting this kind of attention, and I hope that Bayer’s decision to take Essure off the market won’t take away from the bigger message of the film,” says Zuckerman, “which is the whole process for devices that makes no sense at all.”

“Why in the world would you want to have a regulatory agency in our government, the FDA, having much lower standards for devices than they do for prescription drugs?”

Essure implants

The story of Essure, in particular, only saw the light-of-day thanks to the “E-sisters,” who count 30,000 people in their Essure Problems Facebook group and have convinced numerous elected officials, doctors, and even early clinical trial participants to join their cause.

“One of the things that is disturbing to me is that these issues only came to light because of the work of victims,” former Representative Mike  Fitzpatrick (R-Pa.) said in an interview several years ago.

Women who agreed to participate in clinical trials for Essure in the late 90s have said that they there were sold on a pitch to get a free, non-hormonal, and permanent birth control that was already proven safe.

A nickel coil, the size of a ballpoint pen, would be placed in each fallopian tube. That was designed to create an inflammatory response so that the coils would become permanently encased in the resulting scar tissue.

Regulators with the FDA approved the device in 2002, despite admitting that they knew little about the long-term side effects of such a procedure, as footage that the E-sisters had obtained captures. What’s more, numerous clinical trial participants later said that their painful side effects were not included in the company’s official data.

Doctors not long after began using the devices without questioning potential risks. “For some reason we did that to women. And I did that, too,” Dr. Shawn Tassone, an Austin-based gynecologist, tells ConsumerAffairs.

Insurance and profit margins

The sales representatives who taught doctors how to place the devices — something that Bayer has defended as a common industry practice — offered no instructions on how the device should be removed if there were side effects.

“We were just told from the very beginning that even if they’re misplaced, you don’t have to remove them,” Tassone remembers.

The role that insurance coverage may have played isn’t examined specifically in The Bleeding Edge, but testimony from patients and doctors suggests that getting insurers to cover Essure proved much easier than getting them to cover removal.

Tassone remembers that both private plans and Medicaid paid fairly generously for the Essure procedure, especially considering that inserting Essure was much cheaper and less labor-intensive than tubal surgery, the older sterilization procedure.

“If you think about a tubal ligation where you go to the operating room, it’s $400 [in profit] give or take,” he say. “Essure in the office, after you subtract the amount of the device, it’s probably $1100.”

Treating any resulting side effects proved impossible for women navigating unfamiliar territory. Angie Firmalino, the New York City mail carrier who founded the E-sisters network, initially seeked help from a doctor who morcellated the coils into small pieces — sending the nickel elsewhere in her body.

Connecting patients with doctors who are willing and able to properly remove the devices, as well who are able to code it correctly so that insurance will pay, has since become one of the E-sister’s major tasks.

Tassone, for his part, implanted his last Essure device in 2013. He says it was a call from another doctor who convinced him not to perform the procedure anymore; a woman with Essure apparently had gotten pregnant, he was told, which can be extremely dangerous for both the baby and the mother. One researcher has counted 303 fetal deaths linked to the device.

Tassone has since switched sides, counseling the E-sisters online and in the operating room. He estimates that he has conducted 600 Essure removal surgeries.

Trust remains despite ban

In recent years, the advocates have convinced the FDA to add a black box warning to Essure. Later on, they were able to help pass a rule which requires doctors to give patients more detailed warnings about the product.

But that didn’t appear to stop most doctors from trusting the device. The American College of Obstetricians and Gynecologists continues to say on its website that lasting pain from the procedure is “rare.” By contrast, nearly 27,000 reports have been filed to the FDA’s “adverse event” report database describing health problems caused by Essure and 16,000 lawsuits have been filed here. An estimated 750,000 women worldwide have undergone the procedure.

Now that Essure is off the market, doctors may be more willing to attempt removal surgery, Tassone says, something he thinks is necessary but frightening

“They’re going to think its not a big deal to take out,” he worries. (More detailed advice about removal surgeries is offered on the Essure Problems page).

Generally, before any major surgery involving a permanent implant, researchers advise patients to press doctors on the specific devices that will be used. Zuckerman, the health policy analyst who helped inspire the Netflix film, recalls that even she struggled to get specific answers when she asked a doctor what brand of hip he would choose for her own surgery.

The procedure ultimately went well, she says, but trying to search for good data comparing brands beforehand was nearly impossible.

“In the vast majority of cases, the surgeons are still quoting the company data,” Zuckerman says. “The company’s data on humans is nonexistent —  at least publicly.”

Are Your Breast Implants Poisoning You?

Johane van den Berg, Longevity: June 18, 2018.

Victoria Beckham, Crystal Hefner, Pamela Anderson, Yolanda Hadid, Melissa Gilbert and Heather Morris. What do these famous women have in common with thousands of other women worldwide? Well, for one thing, they all decided to get breast implants when they were younger. And now all of them have decided to remove what many are referring to as their “toxic bags”.

After their arrival on the cosmetic-surgery market in the 1960s, both silicone and saline breast implants quickly became the most popular plastic surgery procedure for women. According to the American Society of Plastic Surgeons, breast augmentation is still the number one surgical procedure for women, ranking above liposuction, nose reshaping, eyelid surgery and the tummy tuck. The problem, explains Dr Diana Zuckerman, Ph.D. and President of the National Centre for Health Research in the United States, is that surgeons who administer breast implants often minimize the risks associated with this procedure. Consequently, the majority of women don’t realize that a few years after the procedure, they may need to have their implants removed. Additionally, they are unaware that removal costs at least as much as implantation. […]

Now, about 50 years after breast implants were first introduced globally, un-tracked numbers of women are complaining of a recognizable pattern of health problems, which they attribute to their implants. Those suffering from these symptoms generally refer to the condition as Breast Implant Illness or BII (although non-medical, this term is widely used). Various social media groups and organizations have been formed by these women, most notably Healing Breast Implant Illness and The Implant Truth Survivors.

Symptoms of this condition – which Dr Zuckerman explains, is a pattern of health problems likely caused by an autoimmune reaction to the implant – include mental confusion, joint pain, hair loss, dry eyes, chronic fatigue, and persistent flu-like symptoms. “In some cases,” she says, “silicone gel is leaking into their bodies and causing the autoimmune reaction. When the gel leaks into organs such as the lungs and liver, it can’t be removed surgically.”

In addition, a lot of women experience what is called capsular contracture. This occurs when the scar tissue around the implant (inside the body) gets tight and hard. This can make the breasts look abnormal and cause chronic pain and hardness.

Are there any forms of breast implants that are considered safe?

“There are no breast implants on the market that never cause side effects or complications,” says Dr Zuckerman. “In general, breast implants filled with saline are less likely to cause serious injury than those filled with silicone gel, but we know many women who have become ill because of saline implants.”

Often, when a woman chooses to undergo this procedure, she is persuaded by her plastic surgeon (or breast surgeons after mastectomy) that breast implants are safe devices. Although there are thousands of stories of women whose health deteriorated as a result of their implants, the voice a plastic surgeon will more than often outweigh the information. This is because patients tend to hear what they want instead of making a decision based on information from both sides.

“Then, when women experience these complications,” explains Dr Zuckerman, “they are furious at themselves for making a decision based on limited information and furious at their doctors for not warning them of the risks. The women who are most harmed by breast implants are the ones that don’t realize that their health is deteriorating because of their implants, or don’t have $8,000-10,000 to get their implants removed by an experienced explant surgeon.” […]

Read the original article here.