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The Bleeding Edge Hero of the Week: Jeanne Lenzer

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“The FDA is supposed to protect the public interest. Unfortunately, their behavior shows that they have been captured by industry.”
—Jeanne Lenzer

Jeanne Lenzer is a renowned award-winning medical investigative journalist and author, whose critical investigations have previously appeared in outlets such as the Atlantic, the BMJ, USA Today, New York Times, and Huffington Post.

Her first book, The Danger Within Us, is a ground-breaking exploration of the medical device industry, and how its financial influence may undermine public health. Her research helped provide important facts for “The Bleeding Edge” documentary, offering eye-opening statistics about the harms caused by poorly tested medical devices.

With an estimated one in ten Americans slated to be implanted with a medical device over their lifetime, Lenzer has continued to bring forward the issue to the American public via her book and recent articles in outlets such as the New York Times and Discover Magazine. Lenzer is also a fierce advocate for responsible journalism around medical device safety, explaining that “journalists should refrain from covering medical devices unless they have the time and expertise to take a deep dive…’industry is good at concealing bad outcomes…it takes a lot of time and effort to suss out what’s true and what’s not.’”

“The Bleeding Edge” filmmakers are grateful to Jeanne Lenzer’s commitment to exposing the grave issues in the medical device industry, and her steadfast dedication to educating the American public on it.

Watch Jeanne Lenzer  in the Netflix Original documentary, “The Bleeding Edge”, and read The Danger Within Us.

The Bleeding Edge Hero of the Week: Michael Carome

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“Most people probably believe when they get a medical device implanted–be it a pacemaker or a joint–that those medical devices have undergone appropriate testing to demonstrate that they are safe and effective before they came on the market and doctors started using them. But for most moderate and high-risk devices, that is not the case.”
—Michael Carome

As the Director of Public Citizen’s Health Research Group, Michael Carome works to improve public health by calling for corporate accountability and helping people make informed medical decisions. After working for decades as a medical doctor and a senior leader with the U.S. Public Health Service, he moved into the nonprofit world to fight for patient safety.

Carome is especially determined to hold corporations accountable for putting dangerous drugs and devices on the market, and challenging the U.S. Food and Drug Administration’s approval process for these medical products. With his leadership, Public Citizen has been instrumental in pressuring the FDA and other government agencies to uphold patient safety over corporate profits.

“Companies can develop new products that may not be safer and more effective than other products already on the market, but they will certainly heavily promote them to doctors, to hospitals, to drive up their profits,” he said in “The Bleeding Edge”.

Carome has made it his mission to expose the risks carried by these new products, and particularly by products marketed to women such as Essure and transvaginal mesh. “The FDA clearly has been reckless in failing to remove [transvaginal mesh] from the market,” he told Drugwatch.

“The Bleeding Edge” filmmakers celebrate Michael Carome for championing the rights of all people to make safe, informed decisions about their health.

Watch Michael Carome in the Netflix Original documentary, “The Bleeding Edge”.

Patient safety before corporate greed: Breast Implant Victim Advocacy’s story

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Jamee Cook, Chandra DeAlessandro, and Raylene Hollrah are co-founders of the Breast Implant Victim Advocacy group. The group was formed from their personal experiences and frustrations with breast implants, and under the guidance of the National Center for Health Research, has since grown into one of the most robust online resources on the issue. All three women saw their health deteriorate at the hands of this medical device and decided to take action, becoming advocates for patients’ rights and promoting education around breast implants. Below, Jamee, Chandra, and Raylene shed light on breast implant safety and encourage others to take part in the medical device safety movement.

Diana Zuckerman, Chandra DeAlessandro, Jamee Cook, Raylene Hollrah, and Terri McGregor

The Netflix Original documentary The Bleeding Edge is bringing the question of medical device safety to the forefront. Light is being shed not only on newer devices, but also on devices like breast implants—devices that have been around for decades.

While we hear quite often that breast implant safety has been proven and was only questioned in the nineties, that simply isn’t true. Women are complaining of the same symptoms today as they did thirty years ago. Despite innovation in breast implant manufacturing, patients are still being harmed. Women are sick, frustrated, disabled, and left with very little recourse to fight back against device manufacturers.

There are currently over 45,000 women in Facebook support groups alone who have been harmed by breast implants. Adverse event reporting to the FDA on breast implants is on the rise. Cases of Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL), a cancer of the immune system, are on the rise. Lawsuits are being filed for women with BIA-ALCL, those who have developed cancer at the hand of devices that should be under stronger scrutiny. Breast Implant Victim Advocacy works on a national level to raise public awareness on illness and complications that can accompany both silicone and saline breast implants, including BIA-ALCL.

We encourage women to be fully informed of all risks and to explore all reconstructive and enhancement options. If you have developed unexplained illness or symptoms after breast implants, we would love to help you find a good support system of women who understand you.

We are happy to be a part of a coalition fighting for justice. Social media and platforms like The Bleeding Edge documentary are empowering patients to question the safety of all medical devices. We stand with other harmed patients to fight for better regulation, unbiased studies, stronger post market surveillance, and transparency in chemical components of medical devices. Corporate greed should not supersede patient safety.

If you or someone you care about has been adversely affected by breast implants, please visit the Breast Implant Information website, or connect with the Breast Implant Victim Advocacy Facebook group.

Watch The Bleeding Edge on Netflix to join the conversation on medical device safety.

Tammy Jackson

The Bleeding Edge Hero of the Week: Tammy Jackson

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“I’ve been told that I need to be quiet sometimes. They can take my sex life, they can take my job, they can take my farm, but they’re not going to take my voice.”
—Tammy Jackson

Tammy Jackson

Tammy Jackson and husband Byron in The Bleeding Edge

After giving birth at the age of 41, Tammy Jackson began to leak from her bladder while at work. Her doctor suggested a transvaginal mesh implant, which he described as a simple 45-minute procedure. That’s when Tammy’s nightmare began: instead of solving her problems, the mesh caused a slew of new ones, including pain, discomfort, and severe fatigue.

Eventually, Tammy found a doctor who said there was a problem with her mesh. But he told her, he was only trained to put mesh in, not take it out. Mesh is designed to be a permanent implant, and removing it can be dangerous, if not impossible. Tammy had a partial mesh removal, but her health complications have continued.

Tammy found that the mesh not only caused her physical pain, but also impacted her ability to be the wife and mother she longed to be. As someone who previously used to water ski, ride dirt bikes, and had even skydived and scuba dived, she suddenly didn’t even have the energy to play with her daughter, who in turn wondered if she was to blame for Tammy’s condition. Mesh also interfered with Tammy’s ability to be sexually intimate with her husband, Byron.

Despite all of these hardships, rather than turning inwards, Tammy felt compelled to help others with similar experiences. She and Byron became leaders in a support group founded by Lisa Mason on Facebook, Mesh Awareness Movement, for mesh survivors and their partners. She wanted the group to provide a space for partners, like Byron, to also be able to find community. “It’s hard for men to talk about,” she explains in The Bleeding Edge. “This is a safe place for us.”

Today, Mesh Awareness Movement (MAM) provides resources and support for mesh survivors and their loved ones. In addition, MAM has grown to be a platform for grassroots activism against the multinational corporations that manufacture this dangerous product. Alongside Lisa, Tammy has led rallies across the country, calling for better testing of devices and for corporate accountability for the hundreds of thousands of women harmed by mesh. In 2017, Tammy led a day-long protest outside the Johnson & Johnson’s shareholders meeting, gathering survivors from around the country and demanding the company consider the women as more than just “the cost of doing business”. She fearlessly asked stockholders as they entered the building, if they knew “they were investing in women’s pain and suffering”.

Tammy recently had to have a kidney removed because of ongoing complications from her mesh, and is in declining health. However, she is still a leader in the fight against mesh, and recently even helped host a screening of The Bleeding Edge in Independence, Kentucky (her home state). Tammy wishes there weren’t so many people experiencing the pain of dealing with a mesh implant, but she’s grateful for a space for survivors to come together and advocate for their right for safe medical care. She has told the filmmakers of The Bleeding Edge that she will never stop fighting to protect women and to stop the sale and use of pelvic mesh.

Watch Tammy Jackson tell her powerful story in the Netflix Original documentary, The Bleeding Edge, available on July 27.

The Facts in The Bleeding Edge

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The medical device industry has responded to the malfeasance exposed in our investigative documentary The Bleeding Edge.

Here are the facts:

The facts set forth in The Bleeding Edge are accurate and have been rigorously vetted by extensive research and multiple experts.

Bayer claims the portrayal of its harmful birth control device Essure in The Bleeding Edge “lacks scientific support” and is “inaccurate and misleading.” These claims are false.

The truth is that Essure was approved under an “expedited review” without randomized, nonblinded studies or a comparator group. These studies followed most participants for only 18 months, even though Essure is supposed to remain implanted for a woman’s lifetime. Some of the patient forms in the Essure studies were altered to reflect a more positive outcome than what was reported by the patient. Conceptus, the original manufacturer of Essure purchased by Bayer, hid more than 32,000 adverse events regarding Essure from the FDA.

Bayer’s attacks on three of the experts in The Bleeding Edge are without substance. There are no conflicts of interest regarding any of the experts in our film.

Dr. Diana Zuckerman is president of the non-profit National Center for Health Research (NCRH.) As an expert witness discussing her survey of Essure patients, she requested that the plaintiff’s attorney pay $375 to the NCRH. This represents no conflict because she says nothing about Essure in the film. Dr. Zuckerman has been quoted in the New York Times, the Washington Post and other media describing the need for well-designed, long-term research on Essure.

Dr. Julio Novoa is an experienced OB-GYN who surgically removes Essure from women who have been harmed by the device. For Bayer to suggest that he has “a financial interest in recommending the removal of the product” because he is being paid for doing his job is both cynical and false. Madris Tomes, a former public health analyst for the FDA, provides FDA public data and trends of adverse event reports to clients. Tomes has provided data expertise to the Essure Problems Facebook group pro bono.

On July 20, one week before The Bleeding Edge was released on Netflix, Bayer announced it would stop selling Essure after 2018.

In response to the film, Johnson & Johnson stated “providing safe and effective products is always our top priority.” This is contradicted by the fact that they released cobalt metal-on-metal hips as well as pelvic mesh despite knowing that there were significant safety risks with both.

Court records show that in 1995 a scientist from DePuy, whose parent company is J&J, warned about the dangers of their cobalt metal hip. After it was put on the market, surgeons, researchers and health officials repeatedly informed J&J that their hip device was harming patients, but it wasn’t until 2010 that J&J finally recalled the product, after it harmed tens of thousands of people.

Additionally, court records show that J&J also knew their pelvic mesh would injure women, but J&J chose to put the device on the market anyway. There are now tens of thousands of lawsuits filed against them by women harmed by mesh.

In response to the film, the FDA stated, “Often the true benefit-risk profile of a device cannot be fully understood until it can be evaluated when used in routine clinical practice.” This is far too late. To protect Americans, the FDA must establish that a device is safe before it is put on the market.

The FDA claims that it has taken “many steps” in recent years regarding Essure, but the FDA never took the most important step: recalling this flawed and dangerous device from the market in the U.S., especially after it had been taken off the market in the rest of the world.

The FDA, Bayer, Johnson & Johnson all declined to be interviewed for the film.

For deeper insight into the medical device industry, watch The Bleeding Edge on Netflix.

Diana Zuckerman

The Bleeding Edge Hero of the Week: Diana Zuckerman

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“About 95% or more of [medical devices] have not been required to be proven safe or effective in clinical trials…. Whether it’s a hip implant, or a breast implant, or certainly a cardiac implant, you would want to assume those have been studied in patients to make sure that they’re safe and that they work. But that isn’t the case.”

Diana Zuckerman, in an NPR interview

Throughout her career, Diana Zuckerman has courageously spoken out on the need for policy change and quality, comprehensive research to improve American healthcare. Currently President of The National Center for Health Research, a nonprofit organization that promotes the health and safety of adults and children, and provides consumers with free information about the risks of specific medical devices (at info@center4research.org). Diana previously spent ten years as a Congressional staffer in the House and Senate, as a scientist working in the White House, and at the U.S. Department of Health and Human Services. She conducted research while on the faculty at Vassar and Yale, and at Harvard.

Diana’s work specifically focuses on drawing attention to dangerous medical devices and corporate-sponsored medical research. In 2011, along with Paul Brown and Dr. Steven Nissen, she was the lead author on a groundbreaking study about the dangers of medical devices, determining that most devices recalled by the U.S. Food and Drug Administration (FDA) for being potentially deadly or high-risk were not thoroughly researched before being put on the market. In 2014, she was the lead author of the first study to determine that most medical implants were being sold in the U.S. without any publicly available evidence that they will benefit patients.

“Let the buyer beware before getting an implant in their body, because there may be no evidence the implant is going to benefit them and no study done in case it might harm them,” she explained.

Diana has also championed the rights of patients considering Essure to have access to the information they need to make informed choices. She has called for a “well-designed long-term study of women who underwent Essure sterilization compared to tubal ligation,” research she notes would be “long overdue.”

The Bleeding Edge filmmakers were inspired to make the documentary after seeing her speak, and are grateful for her stalwart dedication to medical device safety. They celebrate Diana and her steadfast advocacy for the rights of individuals to be fully aware of medical risks, and for patients to be valued over profits.

Watch Diana Zuckerman and her powerful call for quality medical device research in the Netflix Original documentary, The Bleeding Edge, available on July 27.

Victory! Bayer pulls Essure from the U.S. market

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Breaking news —

Seven long years after the E-Sisters began their fight against Essure, Bayer has now withdrawn the device from the US market!

This victory comes one week before the release of our film, and days after the E-Sisters rallied and hosted a preview screening outside of Bayer’s headquarters in New Jersey.

Watch the film that helped make this happen. On July 27, The Bleeding Edge premieres on Netflix.

Congratulations to Angie Firmalino and the E-Sisters for standing up to Bayer and protecting women from future harm.

Jennifer Nelson

Our Lives Are a Gift: Jennifer Nelson’s Story

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Jennifer Nelson is a member of Unplug the Robot, an awareness group for those harmed by da Vinci robotic surgery and those considering the surgery. In the founding member’s own words… “Unplug the Robot was formed out of frustration and concern for others. Frustration from our injuries. Frustration that they knew the potential existed for these injuries. Frustration that this Intuitive Surgical, the device’s manufacturer, puts profits before patient safety. By bringing public awareness to this issue and telling our own personal stories, it is our desire to bring light to this darkness. We sincerely wish for no one to suffer these truly horrific injuries or death as a result.”

Jen Nelson

Photo courtesy of Jennifer Nelson

I no longer fear death, and I am also a lot stronger than I ever thought I could be.

I am very thankful to see factual and well-researched documentaries, such as the Netflix Original film The Bleeding Edge, telling our stories and exposing the lies, negligence, and corruption of medical device companies.

Intuitive Surgical’s da Vinci robot has a laundry list of recalls and an even longer list of deaths reported, known-product defects, and current trending failures (including breaking conductor wires in their robotic instruments, welding flaws, arcing, etc.). The very design of the da Vinci robot is defective as Active Electrode Monitoring (meant to detect insulation failures) is missing, and stray electrical currents burn and kill innocent patients. It is all there for the public to read in the FDA’s medical device adverse event database.

There was no education of the dangers of robotic surgery when I went in for my consultation with the OBGYN oncology surgeon prior to my total hysterectomy. I had a very large fibroid and several smaller ones within my uterus, and the recommendation for my ongoing bleeding and discomfort was to have this surgery. The clinic offered no options for this procedure other than the da Vinci, and I assumed that this must be the way all hysterectomies are performed. I went to the top clinic in the world for my surgery, so I believed them and asked no questions, as I assumed they were the subject matter experts.

To make a long and macabre story short, as a result of my da Vinci surgery I had three reparative surgeries, a colostomy, treatment for severe sepsis, a drain inserted for the abscesses, and a lot of physical therapy. I have pain always, deal with fecal impact since my colostomy reversal, can only sleep on my back, and live daily with a stomach that resembles what the Bride of Frankenstein’s might look like. I am lucky to have found other da Vinci survivors through Unplug the Robot. Many da Vinci survivors suffer painful long-term nerve damage. I believe I am one of the only survivors fortunate enough to be able to return to work full time. Most da Vinci hysterectomy survivors cannot sit for long periods of time, can never sit on hard surfaces, wake up with numbness in extremities, and have nerve damage that can bring them to their knees. I am lucky to have regained some semblance of a normal life, unlike many of the other survivors, who have not been able to resume anything resembling the life they once enjoyed.

One very cohesive and repeating theme in all of our lives is our story.  Our injuries might be different, but our stories all meld together with the same consistent message of education and responsibility.  Our lives have been irreparably changed, thus we are now strong advocates of patient education and corporate responsibility. Our lives are a gift we will not waste. Historically, women have been reluctant to tell stories like ours, and this silence has allowed the medical device industry to get away with, literally, murder, for too long. We are one voice reaching out to hospitals, clinics, and surgeons in educating the importance of warning patients of the dangers of the da Vinci robot; one voice advocating for those still too weak and recovering from the adverse outcomes of their da Vinci surgeries; one voice urging greater forced FDA regulation and quality control, 510(k) testing, recall remediation, and process improvement; and one voice demanding accountability from Intuitive Surgical for the past and present lives destroyed by the da Vinci robot.

If you or someone you care about has been adversely affected by a Da Vinci robotic surgery, please visit the Unplug the Robot Facebook page and send a message with your questions or comments.

Watch The Bleeding Edge on Netflix on July 27 to join the conversation on medical device safety.

patient safety

The Bleeding Edge Hero of the Week: The E-Sisters

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“We won’t stop. They’ve already taken away my health. What else can they take from me? I have nothing to fear from them. This has to come to an end. I don’t know how anyone with a conscience and with any sort of compassion could let this continue to happen.”
Angie Firmalino, Founder and Head Administrator of Essure Problems and President of ASHES Nonprofit

E-Sisters

The E-Sisters in the halls of Congress

Today the E-Sisters, a group of patient activists harmed by Bayer’s Essure birth control implant, are bringing their fight to Bayer’s doorstep, hosting a rally and free preview screenings of the Netflix Original documentary The Bleeding Edge outside of Bayer’s corporate headquarters in New Jersey.

The Bleeding Edge, a gripping expose of the medical device industry and its lax regulation by the FDA, chronicles the E-Sisters’ successful grassroots movement against Essure and its manufacturer, Bayer, while bringing attention to the lax regulations of the FDA.

Founded in 2011 by Angie Firmalino, the Essure Problems Facebook group grew from a small tight-knit group of friends and family to an international community of patient activists. Essure Problems now welcomes more than 36,000 members from around the world, and offers patients and caregivers an outlet for support as well as a wealth of resources and information on patient safety, Essure adverse events, and physicians available for removal procedures.

The E-Sisters have celebrated victories both small and large. From holding protests around the country, to founding a leading nonprofit organization, to lobbying for patient safety legislation in Congress, the E-Sisters have continued to challenge Bayer and fight for patients’ rights.

The Bleeding Edge filmmakers celebrate the commitment, tenacity, and victories of the E-Sisters, and invite you to join their efforts in placing patients above profits.

The E-Sisters’ stories are shared in the Netflix Original documentary, The Bleeding Edge, available on July 27.

E-Sisters rally

The More You Know, The Less You Trust Bayer

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E-Sisters

Bayer has misled women around the world into believing their implantable birth control device Essure is safe and effective, resulting in pain and injury for tens of thousands, and for that, we name them our “Healthcare Villain of the Week.”

The very premise behind Essure is to cause an adverse reaction in a woman’s body: The Essure devices are implanted in a woman’s fallopian tubes, causing scarring that is supposed to serve as a barrier between eggs and sperm, thus preventing pregnancy.

FDA inspection reports show there were more than 32,000 reports of problems or injuries caused by the Essure device between 2008- 2013, including reports of migrations, perforations and pregnancies, which Conceptus/Bayer failed to report to the FDA.

Bayer has also falsely marketed Essure’s effectiveness and safety data, and thousands of women have suffered complications ranging from unintended pregnancy to having hysterectomy to have it removed. Research shows that Bayer’s assertion that Essure is “99%” effective is false, with one study showing that women with Essure have a pregnancy rate that is 16 times higher than what Bayer has cited. Essure has also been linked to hundreds of fetal deaths.

Bayer is headquartered in Germany, but Essure was never sold in Germany. It’s been taken off the market around the world, except for the U.S., where it continues to be sold because Bayer’s profits are so high. In fact, Bayer continued to sell Essure for more than 10 years after knowing it was harming women, and they hid the information from physicians, nurses and patients. Bayer has also refused to meet with patient advocates from “Essure Problems,” a group of women harmed by Essure.

Some of the gripping stories of those women harmed by Essure can be seen in our film, The Bleeding Edge, a Netflix Original which premieres on Netflix July 27.

When will Bayer do the right thing and pull their harmful Essure device off the market?

Join the E-Sisters, a group of patient activists harmed by Essure, for a rally and preview screening of The Bleeding Edge outside Bayer’s corporate headquarters in New Jersey on July 17.