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How to Research a Device, by Medical Device Problems

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Repost from Medical Device Problems 

by Amanda Dykeman

Head Research Coordinator and Administrator of Essure Problems/Vice President of ASHES Nonprofit

Find out the specific name of your device

Before beginning your research, ask your physician to print out for you the specific name of the device at hand and its manufacturer. You will need this important information throughout the research process.

As you get ready to begin your research, it’s important to organize yourself and create a central place to save and store all necessary files, such as google drive or Dropbox. It should be an online location that is easy to access and share by different people in your group.

File a FOIA request for anything and everything on that device

You can file a FOIA (Freedom of Information Act) request with the FDA. Be as specific as possible and file multiple requests in different offices. For example, the original manufacturer of the Essure device, Conceptus Inc, was headquartered in Mountain View, California. I knew that prior to obtaining a license to manufacture their medical device, they had to undergo an inspection by the local Department of Public Health, so I filed a FOIA request with that office as well. Do some research to determine who manufactures your device, where they are headquartered, and which public office is in charge of inspecting and licensing them. Every government office has a Freedom of Information Act division to process your requests either electronically or by mail.

What is a FDA Form 483 and why is it important

One document I would specifically ask for in a FOIA request is any and all FDA Form 483s issued to a device manufacturer. These forms usually cite violations of the Food Drug and Cosmetic (FD&C) Act and related Acts. Observations are made when in the investigator’s judgment, conditions or practices observed would indicate that any device has been adulterated or is being prepared, packed, or held under conditions whereby it may become adulterated or rendered injurious to health. You can find more information about 483s here. You may also be able to find warning letters issued to medical device manufacturers here.

How to get clinical trial information

ClinicalTrials.gov is a database of privately and publicly funded clinical studies conducted around the world. It is an easy resource to find any clinical trials that have been done on specific devices. If your device is a Class II and approved under the 510K process, it is likely there may have been very little to no clinical trials done. You may need to visit FDA.gov and type “device name/510K” in the search bar or go to a direct search. Because devices approved under the 510K process only need prove they are like predicate devices, you may have to follow a very long trail of devices to get to the original device that may or may not have clinical trial information.

How to get FDA meeting minutes for approval

Getting the meeting minutes for approval of a Class 3 PMA device is as easy as visiting fda.gov and doing a quick search. Type in meeting minutes, and the device. You may also obtain these minutes via FOIA request.

How to check for conflicts of interest

Follow the money trail! I have used this resource to do a company search, and then see if there are specific investors that may have underlying conflicts of interests. In addition, the Open Payments Search Tool is used to search for payments made by drug and medical device companies to physicians and teaching hospitals. Honestly, Google and DuckDuckGo are two search engines that can help you the most when trying to find conflicts of interest within an organization. All you need are the right keywords. I have always used the person’s or organization’s name along with “lobby disclosures”, “conflict of interest forms”, or “Form 990s” (which are financial disclosures for nonprofits). “Paid consultant” is also a key phrase. The process can take a bit of trial and error until you find the most accurate search terms.

Other helpful sources of information

The United States Patent and Trademark Office can help you find the patent of a specific device, and provide a wealth of information regarding materials used and the manufacturing processes.

Doing a company search on United States and Securities Exchange Commission can provide you with so much valuable information. By law, manufacturers of medical devices (and other companies) are required to provide accurate and up to date information pertaining to their business in order for investors to make informed decisions. This includes any risks associated with the manufacturing of any specific device.

What You Need To Know About Johnson & Johnson

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This month, a British Medical Journal investigation revealed that Ulm Ulmsted, the inventor of the vaginal mesh implant, was paid $1 million by Johnson & Johnson to manipulate his data to make it seem safe, leading to vaginal mesh being sold as a miracle cure for urinary incontinence and pelvic organ prolapse. This isn’t the only time Johnson & Johnson’s practices have led to patient harm.

Johnson & Johnson CEO Alex Gorsky claims his company’s mission is to help people “live longer, healthier and happier lives.” The truth is, under his watch, Johnson & Johnson medical devices have killed and injured hundreds of thousands of people, all in the name of profit.

Court records from lawsuits against Johnson & Johnson companies Ethicon and DePuy, which manufacture mesh and metal hips, respectively, reveal they knew their products were harmful before releasing them onto the market.

The Known Dangers of Transvaginal Mesh

Transvaginal mesh is made from woven plastic and used to treat common pelvic floor conditions. After implantation, scar tissue causes the mesh to shrink, damaging delicate tissues and often triggering unrelenting pain.

J & J’s transvaginal mesh product Prolift was not approved by the FDA before being released on the market, court records show. Johnson & Johnson had done studies and knew it wasn’t safe, but rather than let the public know, they just buried the studies.

These problems and more have been a central focus of more than 54,000 mesh lawsuits that patients have filed against Johnson & Johnson, more than any other manufacturer.

Johnson & Johnson’s “Billion Dollar Baby”

Johnson & Johnson’s practices around the manufacturing and marketing of its Pinnacle and ASR metal hips are just as abysmal, and have exposed the company to more than 10,000 lawsuits in the U.S. alone. The hips were not tested in humans before being sold, and while engineers warned the company that metal implants could cause “sudden catastrophic breakdown.” The hips were rushed to market anyway, and generated huge profits for the company.

Only after harming tens of thousands of people was one of their hips, the ASR, taken off the market. But the company saw this debacle as a marketing bonanza – because patients who had to have their defective hip removed could still be sold the other Johnson & Johnson hip, the Pinnacle. They knew the Pinnacle was also defective, yet they covered it up because it became so profitable, earning the nickname “Billion Dollar Baby.” Soon this hip was devastating patients, forcing many to undergo yet another dangerous operation to have a second defective Johnson & Johnson hip removed.

A Record of Greed

Internationally, Johnson & Johnson paid $70 million to settle criminal and civil charges brought under the Foreign Corrupt Practices Act, admitting that some of its foreign subsidiaries bribed doctors in Greece, Romania, and Poland to use their products – and paid kickbacks to the Iraqi regime of Saddam Hussein under the United Nations Oil for Food program.

What does Alex Gorsky think of all this? He refuses to say. Johnson & Johnson continues to insist its products are safe, with a spokesman telling us, “Pelvic mesh has helped improve the quality of life for millions of women” and “Similarly, our hips have helped patients enormously.”

Perhaps Gorsky’s perception is clouded by the $25 billion the company takes in annually on medical device sales, or perhaps he was more focused on his own bank account – in 2017 alone, as Chairman and CEO, Gorsky reportedly earned more than $22 million.

Alex Gorsky and Johnson & Johnson, it’s time to stop putting your greed over patient safety. Or to borrow from one of your own slogans, please, no more tears.

How To Find Out if Your Doctor Has Accepted Payments from Medical Device Companies

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It is legal for drug and device companies to make payments to doctors, though patients and industry professionals have raised questions about the ethics of these payments, and how they may affect patient care. If you want to find out if your doctor has accepted payments from medical device companies, here’s how you can find out.

Find Your Doctor on  CMS Open Payments:

1. Go to https://openpaymentsdata.cms.gov/

2. Type in your doctor’s name into the search bar

3. Scroll through the results

– You can refine your search further by including the address or your doctor’s specialty

4. Once you’ve found your doctor, click on their name.

– You will see a summary of payments you doctor has reported to receive.
– Change the year dropdown to see if your doctor has reported any income from each year.
– You will see how your doctor measures up to the national average, and the industry average. This can help you gauge if the payment amounts are normal or not.

5. Click the Payment Information tab to find what companies are paying your doctor, and the nature of the payments.

– Some companies give doctors goods or services in lieu of payment, i.e. Food and Beverage, Education or travel reimbursement.

Find Your Doctor on Dollars for Docs

1. Go to https://projects.propublica.org/docdollars/

2. Type your doctor’s name in the box saying “Has Your Doctor Received Drug or Device Company Money?”

3. Find your doctor in the results and click on their name

4. You will see a yearly reported payment breakdown, and be able to refine the data by year with the drop-down option.

– Below that you can find a calendar of when the doctors reported receiving the payments, the nature of the payments, specific drugs and devices they have been paid in connection to, and a full breakdown of details for the payments.

If you find your doctor listed, don’t panic. It is common for drug and device companies to attempt to “woo” doctors with paid meals, travel or consulting jobs. Compare your doctor’s payments to the industry or national average (available on CMS Open Payments) to determine if the amount is normal or not.

If your doctor has received payments above the industry or national average, you may want to have a conversation with them about the nature of these payments and if they affected your care. Dollars for Docs has tips for how to prepare for this conversation, and questions to ask.

 

Facing the Mesh Crisis – Sling The Mesh Guest Post

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Kath Sansom of the United Kingdom launched Sling The Mesh as a support group for women suffering pelvic mesh pain and complications. It began with 20 women in 2015 and has now become an important patient-advocacy group with more than 6,600 members from around the world, including a growing number of men and women with hernia mesh complications.

 

 

Mesh implants are made of plastic material which can change once implanted. They can shrink, go brittle, and twist. Fragments can fall off during insertion or after implantation. This is what is causing catastrophic and life-changing injuries for patients who are mostly ignored or misunderstood when they present to doctors or surgeons, many of whom do not understand the impact of mesh-implant pain.

The saddest part of this story is that if independent national registries were used in every country, this catastrophe would have been detected much earlier. It would have saved thousands of people from needless suffering caused by an operation sold as a simple, minimally-invasive, quick fix.

An independent registry means every single patient would be logged and tracked for their lifetime. I am told this would add around an extra £20 to a person’s treatment cost; a small price to pay for robust patient safety.

There are now national registries in the U.K. for metal hips and breast implants following scandals involving their use. However, that is a classic case of shutting the gate after the horse has bolted. Registries need to be brought in as standard for all new medical devices so that trends can be picked up immediately and investigated accordingly.

Instead, in the mesh implant disaster, we see a catalogue of 20 years of harm. In those two decades, surgeons have lost the old-fashioned skills needed to perform pelvic floor or hernia repairs using a person’s own tissue. What a sad place we are in that new surgeon trainees mainly only know how to use mesh and older surgeons have fallen out of practice of a safer type of surgery.

Here in the U.K., Sling The Mesh is pushing for a total overhaul of surgeon training programmes for newcomers. We know of training courses hastily teaching old-school repairs without mesh. This must happen globally, because if traditional skills are lost, they are gone forever. The result would be catastrophic.

In December 2017, Canadian patient Chrissy Brajcic, 42, died of sepsis after she became antibiotic-resistant from a four-year battle against urinary tract infections caused by her TVT mesh to fix mild incontinence after having babies. In the end, no antibiotic worked and every time she got a new infection she would go to the hospital for strong medication to be fed via a drip. Eventually even that failed.

Sling the Mesh ran a survey of 540 women which shows more than half suffer constant UTIs and one in 12 women are becoming antibiotic-resistant, so they are at risk of sepsis.

In August, Scottish patient Eileen Baxter, 75, died from a prolapse mesh implant – the type surgeons insist is safe, as it was inserted abdominally instead of vaginally. She suffered sepsis, multiple organ failure, rectal perforation, and chronic inflammation of her pelvis. Her son told The Scotsman newspaper that Eileen tried to explain to medics she was in pain but was sent for counseling to teach her how to handle it better.

The Medicines and Healthcare Products Regulatory Agency in the U.K. lists 11 mesh-related deaths, and on the TVT Worldwide registry it lists three deaths from the TVT Secur alone, a particular model of mesh to fix incontinence, now not in use.

In the U.K. there is currently a suspension of mesh implants to treat stress urinary incontinence until April 2019, while an independent safety review is carried out by senior Tory peer, Baroness Julia Cumberlege. New National Institute for Health and Care Excellence guidelines are due out in the same month which will outline recommendations for mesh implant use for incontinence and prolapse and analyze if benefits do not outweigh the risks.

We at Sling the Mesh know the benefits do not outweigh the risks to public safety, and now call for the device to be banned in the U.K.. We are urging for the suspension to become a total ban once the independent review chaired by Baroness Cumberlege is completed. We are asking that a full investigation and audit be carried out as to how many women have been affected by vaginal mesh and tapes. We are calling for a mandatory independent National Register for all new medical devices, so patients can be tracked for their lifetime, and adverse events and trends be picked up immediately. There is a long road ahead, and we will continue to offer support to the thousands of patients around the world that have been affected by this crisis.

The Bleeding Edge Hero of the Week: Helen Haskell

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Helen Haskell is a cornerstone of the patient safety movement. Following the death of her son due to a medical error, Haskell became a leading voice in the campaign to prioritize patients in the medical system with the founding of her nonprofit, Mothers Against Medical Error. Haskell’s advocacy aims to improve and promote medical education, rapid-response access for patients, medical error disclosure and patient empowerment.

Her tireless advocacy has resulted in monumental accomplishments for the patient safety movement, with the passage of multiple pieces of legislation, including the Lewis Blackman Patient Safety Act. This law, named after her son, required healthcare provider identification and patient access to emergency response in hospitals – a significant victory for the patient safety movement due to its call for transparency in healthcare.

In addition to Haskell’s work with Mothers Against Medical Error, she trains patients to navigate the medical system and teaches them how to get the most out of the care they are receiving. Haskell sits on the board of various healthcare and patient safety organizations in which she uses her voice to endorse initiatives that promote patients over profits, including the Institute for Healthcare Improvement, the National Patient Safety Foundation, and the International Society of Rapid Response Systems. Haskell is a World Health Organization Patient Safety Champion, and was named one of Modern Healthcare’s “100 Most Powerful People in Healthcare.”

“The Bleeding Edge” filmmakers celebrate Haskell’s dedication to patient empowerment and the incredible accomplishments she has achieved in the patient advocacy field.

The Bleeding Edge Hero of the Week: Lisa McGiffert

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“It would be great if the regulators of hospitals and doctors were more diligent about responding to harm to patients, but they’re not, so people have turned to other people…This is what happens when your system of oversight is failing patients.”

—Lisa McGiffert

Named one of Modern Healthcare’s “100 Most Influential People in Healthcare,” Lisa McGiffert has spent her career, and now her retirement, fighting for patient safety. She was most recently the Director of Consumer Union’s Safe Patient Project, advocating on an array of patient safety issues, including preventing medical errors, and improving the safety of medical care and devices. Prior to Consumer Union, McGiffert analyzed policy and legislation for the Health and Human Services Committee for the Texas State Legislature. One of her biggest priorities was the development and implementation of a state health and human services policy.

McGiffert is a relentless advocate who has helped push forward patient safety laws across the country. In 2003 she started a campaign to encourage states to require hospitals to report hospital infections. Thirty states have since adopted the policy, and now Medicare, the country’s largest insurer, has adopted infection rate disclosure legislation as well.

McGiffert is passionate about patient safety and incorporating patient’s voices into the decision-making and approval processes. She advocates to have patients present at FDA committees and hearings, as this promotes effective patient safety measures. Now that McGiffert is retired, she is heavily involved in with the Patient Safety Action Network (PSAN) leadership committee, a national coalition of patient advocates focused on promoting transparency and accountability as a vehicle to safer healthcare. To mark Patient Safety Day, which was celebrated on July 25, she authored a blog to educate consumers about PSAN’s List of Top Patient Safety Opportunities relating to medical devices safety.

“The Bleeding Edge” filmmakers are grateful for Lisa McGiffert’s pioneer patient safety initiatives, and champion her role in fostering a coalition of patients, their caregivers, and activists and its immense impact in the medical device safety movement.

The Bleeding Edge Hero of the Week: Dr. Rita Redberg

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“Just because you have a new technology doesn’t mean it’s innovation. Too often I hear people say, ‘Oh, you’re going to stifle innovation.’ They’re not talking about stifling innovation; they’re talking about putting untested devices on the market. That’s not innovative.”

– Dr. Rita Redberg

 

For more than ten years, Rita Redberg has studied medical device surveillance issues and adverse event reporting, being fearlessly vocal on many fronts, including fighting against proposals to delay reporting medical device malfunctions to the FDA and questioning low-dose CT screening for lung cancer as well as power morcellation.

When she’s not holding the FDA to task for a weak and inadequate medical device adverse event reporting system, Redberg, an editor for JAMA Internal Medicine, is also a professor of medicine and cardiologist at the University of California San Francisco.

Redberg’s pioneering studies focus on the medical device regulatory process, and its relationship to public health policy. In “The Bleeding Edge”, Redberg’s expertise revealed how risky devices get FDA clearance through the 510(k) process – a loophole in which a device can be cleared if it is substantially equivalent to a previously cleared device, even if the previously cleared device has been recalled for safety issues. Redberg’s trailblazing research on the matter was crucial to exposing the risk medical device companies hand to patients without their knowledge.

Redberg takes a strong stand in emphasizing the need for high-quality data to accompany the approval and marketing of a new device as a means to ensure patient safety. As part of her relentless advocacy, Redberg has testified before Congress numerous times to promote the necessity of strong and accurate data to support the often lax medical device approval process.

As an editor for JAMA Internal Medicine, she led the publication to devote their efforts to patient safety and health care reform, as part of her focus on the groundbreaking less-is-more approach to medicine, which aims to reduce patient harm by preventing unnecessary intervention. In explaining her less-is-more approach to previous “The Bleeding Edge” Hero, Jeanne Lenzer, Redberg said, “We have been told for decades now that detecting cardiac disease early is better than waiting for symptoms to appear, which on the surface sounds reasonable. However, years of experience belies this supposed axiom, and in fact some screenings, in the guise of ‘early detection,’ can be downright dangerous.”

Redberg shares her expertise in the many books she has written, edited and contributed to, including “You Can Be a Woman Cardiologist,” and “Coronary Disease in Women: Evidence-Based Diagnosis and Treatment.” She has been interviewed countless times and contributed to significant pieces on health related topics in various outlets, such as  The New York Times, Wall Street Journal, and National Public Radio.

Redberg’s tenure and impact in the medical field reveals her unrelenting commitment to patient health and safety. Her work illustrates that safety does not need to be sacrificed in the name of innovation, but in fact, innovation thrives when coupled with strong evidence.

“The Bleeding Edge” filmmakers commend Dr. Redberg for her dedication to exposing the flawed regulatory process through her work in academia and research, and promoting a patient centered approach to medicine.

Watch Dr. Rita Redberg in the Netflix Original documentary, “The Bleeding Edge”.

The Bleeding Edge Hero of the Week: Dr. Marty Makary

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“We attract good people in healthcare, but there’s this tremendous hunger to have the latest gadgets, the newest technology, without the proper evaluation of that technology. So we shouldn’t be surprised when some of the healthcare goes wrong.”

– Dr. Marty Makary

 

Dr. Makary is one of the nation’s leading advocates for healthcare transparency and a renowned surgeon at the John Hopkins University School of Medicine. With a vested interest in the responsible creation and evaluation of healthcare innovations, Dr. Makary’s lifelong work has focused on measuring health care quality, health care costs, and advocating for vulnerable populations.

Dr. Makary has led initiatives such as The Surgical Checklist, and has served in leadership roles as part of the United Nations’ WHO Safe Surgery Saves Lives Initiative. He speaks nationally and internationally on the need for patient-centeredness in healthcare and the dangers of business-centered health care.

He explains the issue in “The Bleeding Edge” documentary, “…[how] the [da Vinci] robot came into healthcare is the story of what’s wrong with medicine in America today. Massive adoption of new technology with little evaluation of the outcomes.”

A frequent commentator on television, Dr. Makary has successfully brought the conversation of medical device safety and consumer safety into American households. In addition, he is the author of hundreds of articles for outlets such as The Wall Street Journal, USA Today, the New England Journal of Medicine, and JAMA.  He is the New York Times bestselling book, Unaccountable, which sheds light on the crucial role healthcare transparency holds in empowering patients and revolutionizing medicine, and was turned into the hit TV medical series THE RESIDENT which debuted on Fox in January 2018. His newest book on the Money Games of Medicine hits bookstores in early 2019.

“The Bleeding Edge” filmmakers commend Dr. Makary for his continuous call for more transparency in healthcare, and celebrate his remarkable lifelong service to the medical field.

Watch Dr. Marty Makary in the Netflix Original documentary, “The Bleeding Edge”.

The Bleeding Edge Hero of the Week: Dr. David Kessler

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“’Regulation is bad. Let’s cut regulations. For every regulation we’re going to cut umpteen regulations.’ That bravado may apply to certain fields, but it can’t and shouldn’t apply when you’re talking about putting a device in someone’s body.”

– Dr. David Kessler

 

 

“David is what you hope for in a public servant,” said former Health and Human Services Secretary Donna E. Shalala of former FDA commissioner Dr. David Kessler. “He actually improved public health.”

Dr. David Kessler served as FDA commissioner from 1990 to 1997. He is a pediatrician, lawyer and has an advanced business degree. He was appointed by George H.W. Bush, and re-appointed by Bill Clinton. He became known for his dedication to protecting consumers by focusing on misleading marketing tactics, improving adverse drug reaction reporting systems, food and drug labeling, and tightening regulations on mammography and the use of silicone breast implants.

Following Dr. Kessler’s tenure at the FDA, he became the dean of Yale’s medical school and subsequently Dean of University of California San Francisco, where he discovered a series of financial irregularities, which he courageously brought forth, and was subsequently fired for whistleblowing. An investigation cleared Dr. Kessler of any wrongdoing regarding the irregularities, and he remained a tenured professor of pediatrics and epidemiology.

Dr. Kessler is now an accomplished author, with a variety of books on the body’s relationship to food, such as Your Food Is Fooling You and Hijacked: How Your Brain Is Fooled by Food. He has also written extensively on  the tobacco industry’s grip on American health, which was also an important focus of his during his FDA administration.

Dr. Kessler predicted that medical device regulation would become a problem when he originally left the FDA, saying,  ”The real challenges of the future will be to come to grips with how the Government should oversee the new technology.” He further discussed this in “The Bleeding Edge,” stating, “The FDA does a credible job with the vast majority of products. The problem we have is that when it comes to medical devices we built a system that doesn’t work…[the 510k process], which was meant as an exception–in that sense, a little loophole–that exception
became the rule.”

“The Bleeding Edge” celebrates Dr. Kessler’s career dedication to truthfully protecting consumers, and commends his continued work helping the public learn about industry’s role in healthcare.

Watch Dr. David Kessler in the Netflix Original documentary, “The Bleeding Edge”.

The Bleeding Edge Hero of the Week: Madris Tomes

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“We assume the FDA has the data that they need to crack down on manufacturers that have bad devices, or to recall a product, and they don’t have that…Devices can be on the market for years and cause many deaths, many injuries, before it becomes known to the public.”
—Madris Tomes

Madris Tomes is the Founder and CEO of Device Events, a software company that extracts, consolidates, and provides easy to use data on medical device adverse event reports and recalls that have been filed with the FDA. In other words, her company offers a groundbreaking service to healthcare organizations: up-to-date and reliable data–a key element in the movement for medical device safety.

Madris was previously an FDA Analyst, focusing on Unique Device Identification (UDI) and Adverse Events initiatives. Her experience brings incredible insight to the crucial need for dependable, usable data. Experts agree that the ability to better report and track device adverse event reports will have a remarkable impact in patient safety, uncovering trends, helping avoid delays in recalls and allowing both doctors and patients to make better-informed co-shared decisions about their treatment.

Madris has fought for patient’s rights and data transparency by supporting the efforts of the E-Sisters and other patient groups by offering industry guidance and joining their meetings with the FDA and Members of Congress.

“The Bleeding Edge” filmmakers celebrate Madris Tomes’ career-long commitment to medical device safety and to sustainable and long-term change in the industry.

Watch Madris Tomes  in the Netflix Original documentary, “The Bleeding Edge”.