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The History Behind TVM

TVM was introduced into the market in 1996 when Boston Scientific released the ProteGen bladder sling. This was sold as an answer to prayer for the 15 million adult women in the U.S who suffer from the embarrassing condition of urinary incontinence (bladder leakage) due to pregnancy, childbirth or menopause. This new innovation also had the potential to earn huge profits to Boston Scientific considering that stress urinary incontinence (SUI) affects over 200 million women worldwide. But surgical mesh wasn’t something new to the medical industry. It had been used since the 1940s when Wallace Carothers, a chemist at Dupont, invented Nylon which was a catalyst for the creation of new polymers in this decade. In the 1960s, Dr. Richard Newman had performed over 1600 inguinal hernia repairs using the versatile plastic polypropylene and by 1987, Dr. Irving Lichtenstein published a report boasting of this innovative plastic’s high success rate making polypropylene for hernia surgery the norm.

So why wouldn’t this same material work in the vagina for those who are struggling with bladder leaks to support the weakened muscles? This was the idea that Boston Scientific had with their ProteGen bladder sling and how they influenced the FDA to expedite approval through the 510(k) process. Here’s how this process works: if there’s a similar or existing product on the market, the medical device company can submit a Premarket Notification 510(k) which explains how, “the device is substantially equivalent to one legally in commercial distribution in the United States: (1) before May 28, 1976 [according to the Medical Device Amendments to the Food, Drug and Cosmetic Act] ; or (2) to a device that has been determined by FDA to be substantially equivalent.” This benefits the pharmaceutical company in that an expensive clinical trial is not required and the medical device can be “fast tracked” onto the market within several months to start generating profits sooner.

Boston Scientific was able to get their TVM sling on the market quickly by saying that theirs was similar to several hernia mesh implants that were currently on the market including Trelex Natural Mesh, Supple Peri-Guard, Gore-Tex Soft Tissue Patch, Marlex Mesh and Mariselene Mesh. The problem is that all of these brands of surgical mesh were used for hernia repairs and were never tested in a vagina before being approved. Worse yet, other companies like Johnson & Johnson/Ethicon, Coloplast, C.R. Bard, Endo/American Medical Systems and Mentor followed suit and put their vaginal mesh kits on the market shortly thereafter. But remember,  this device was never approved for vaginal use and was still put in millions of women around the world without anyone fully knowing the long term effects it would have for this new purpose.

Transvaginal Mesh Versus Hernia Mesh

In order to understand why this issue is so crucial, we must first discuss what surgical mesh actually is. As previously mentioned, it’s made from a plastic called polypropylene and it looks similar to the screen mesh that’s found on windows. Various brands and types of surgical mesh can range in thickness, coatings and how they are woven. At the crux of the problem is that both treatments involve mesh. Common complaints include mesh erosion, nerve damage, scarring, mesh migration, chronic pain, infection, mesh shrinkage and organ perforation. One clear flaw to the FDA’s 501(k) process is that the FDA can approve the equivalent device even in cases where the new product repeats the identical flaws of the earlier model (even if it has been recalled).

Secondly, hernias and urinary incontinence are two very different medical conditions with the abdomen and vagina being completely different environments. Hernias occur when tissue or organs push through a weakened spot in muscle tissue. Hernia mesh is attached to the tissue over the tear to reinforce the weakened muscle. SUI is when physical activity puts pressure on the bladder causing urine to leak out. A bladder sling or vaginal tape (both made out of mesh) are meant to support the urethra or bladder neck since the muscles have been weakened.

Moreover, the environment in the vagina is vastly different than the abdomen. According to obstetrician-gynecologist Dr. Donald Ostergard, “The vagina is a clean-contaminated environment, and it is not possible to insert polypropylene mesh devices without bacterial contamination, despite standard antibiotic usage. Once inserted, the host tissue immediately attaches to the polypropylene and attempts to defend it from bacterial invasion, but if the bacteria have already reached the surface of the device, then dislodgement is difficult. The devices with larger surface areas result in greater bacterial contamination, more polypropylene degradation, increased inflammatory response, fibrous tissue stimulation, and erosion.”

Like a time bomb waiting to go off, the FDA found that nearly two-thirds of all complaints against Boston Scientific were due to complications involving TVM after just one year on the market. By 1999, Boston Scientific recalled its ProteGen bladder sling. Unfortunately, there were (and still are) many other synthetic TVM options from which doctors can choose.

The Problem with TVM Settlements

C.R. Bard was the first TVM manufacturer to lose a court case and withdrew its transvaginal mesh devices from the market in July 2012. To date, hundreds of thousands of women have been affected by this faulty medical device, making transvaginal mesh lawsuits the largest and most complicated mass tort case in history. The cases involve many different medical device manufacturers (such as Ethicon/Johnson & Johnson, Boston Scientific Corp., C.R. Bard, Inc., American Medical Systems, Inc., Coloplast Corp., Cook Medical, Inc., and Neomedic 2440) and have been consolidated for pretrial proceedings in the U.S. District Court for the Southern District of West Virginia under Judge Joseph Goodwin.

TVM is clearly an unsafe medical device and on January 4, 2016, the FDA announced in a press release that they have decided to, “reclassify these medical devices from class II, which generally includes moderate-risk devices, to class III, which generally includes high-risk devices, and a second order that requires manufacturers to submit a premarket approval (PMA) application to support the safety and effectiveness of surgical mesh.” However, the problem is that hundreds of thousands of women already had these devices inserted into their vaginas and were experiencing life-changing adverse effects. Even with so many complaints, the FDA still doesn’t take this dangerous product off the market, nor are women being told that this is a “high-risk” device that most likely cannot be taken out if problems arise.

More Questions Than Answers

The bigger issue here is not just about transvaginal mesh. It’s a snapshot into the inadequacies of the FDA, the greed of pharmaceutical companies and the powerlessness that still lingers over much of the female population.

There are several factors that complicate this issue of TVM. First of all, how could the FDA fast track a device that was never tested for the purpose for which it was designed? Moreover, how could more devices for SUI and POP be introduced onto the market when this initial product was never proven to be safe and was recalled within two years?

Secondly, how can hundreds of thousands of women be victims of insufferable pain without the population knowing about it? Why has TVM been pulled from the market in New Zealand, Australia and the UK – countries which obviously realized that mesh had irreversible, disabling qualities, resulting in irreversible vaginal mutation – but not from the United States? We are far from being a third-world country and we claim that women have equal rights as men, and yet these female victims are enduring permanent pain, disabilities that prevent them from working, injuries that result in infertility and many have described broken relationships (the mesh can migrate into the vagina and slice the penis during intercourse). Even with these published reports, millions of American women are still being advised to have this procedure done without being told of the risks to their health and their future. This a critical issue against the healthcare system since it is maiming the very people that system is supposed to help and heal; it’s a women’s issue because it steals our potential to bear children, connect with our partners and live a full life; and it’s a financial issue because those with the biggest bank accounts (aka: the pharmaceutical companies) are silencing those who are victims.

Next, why has TVM litigation taken so long to settle? Our legal system clearly puts the big pharma companies at the advantage as these cases are dragged out until patients are either too tired or too discouraged to continue (lawyers call this “case fatigue”). There’s another big reason why these companies drag their feet to get to court–most states have a statute of limitations from when a patient has been diagnosed with a complication to when they can file a claim against the company. The longer the company waits to settle, the less people will file claims. Specific to TVM cases, these medical devices can erode in the body. That means that serial numbers and identifying marks are destroyed and cannot be linked back to the manufacturer responsible for the faulty product, thereby allowing them to avoid responsibility.

Furthermore, another way that TVM companies can deny accountability is due to the roadblocks that many patients have upon retrieving their medical records. Each state has a different amount of time that medical professionals are required to retain patient records (California has one of the longest at seven years). That means that after the designated time period, doctors’ offices are allowed to destroy patient records. While we live in a digital age and assume everything is stored in the Internet cloud, many of these TVM operations occurred before giant computer databases existed so there is no account of the patient’s surgery or the device inserted. Additionally, a name change due to marriage, having the surgery performed by a doctor no longer in practice or even if a doctor’s secretary forgets to send your medical records can all nullify a patient’s case if there is no paperwork to be found.

Lack of evidence is one reason why the settlements that are being awarded are so low. Only a small percentage of the women who are irreparably damaged can prove which brand of vaginal mesh is in their body to make a claim. The medical device companies are literally getting away with murder because their victims are helpless to get the medical help, necessary evidence and financial compensation they need.

Akin to Removing Rebar from Cement

You may be thinking, “If vaginal mesh is so harmful, painful and destructive, why don’t these women just have it removed?” It’s just not that easy. In September 2011, Dr. Michael Thomas Margolis, a pelvic surgeon and urogynecologist, was invited by the FDA to testify during its Hearing for the Obstetrics and Gynecology Devices Panel on complications caused by transvaginal mesh for pelvic prolapse and stress incontinence. He compared removing vaginal mesh to, “taking a hammer and chisel and trying to remove the rebar from a sidewalk while leaving the cement otherwise intact and not damaging the water mains and power lines below. It is difficult if not impossible to remove all the mesh and do it safely.”

Unfortunately, while there are countless doctors who can implant TVM, there are only a handful of doctors worldwide who have the experience and training to remove mesh since it’s such a complicated procedure. Most women don’t have the access or the funding to be able to travel halfway across the world to get this complicated procedure done. Some patients have subsequent surgeries to remove parts of the mesh, but rarely does this solve the most painful and harmful problems. Once the damage is done, it is irreversible and women have to live the rest of their lives with the pain and complications (and again, it hasn’t been recalled and is still being put into millions of women who aren’t being told of the potential consequences).

Can Mesh Victims Still Take Legal Action?

If you or a loved one are suffering from TVM, you may still be able to receive significant financial compensation if:

  1. You had a vaginal mesh product implanted for POP or SUI that was implanted vaginally (this doesn’t include hernia repair).
  2. Your TVM implant surgery was completed between 2010 and the present.
  3. You had at least one revision surgery (preferably within last two years) to fix implant surgery complications or you have a revision surgery scheduled. If you haven’t had revision/excision surgery yet, you must have a firm date set within the next 60 days. (Unfortunately, trimming the mesh in the doctor’s office DOES NOT count as a revision surgery. You must be admitted into the hospital to undergo general/regional anesthesia.)
  4. You haven’t contacted an attorney yet and have not previously received a settlement or compensation in reference to the current TVM injury.

Previous settlements have reserved millions of dollars for patients who are still coming forward to share their painful story about TVM. If you are suffering from this dangerous medical device, you still have time to receive the potential compensation that you deserve.

The Future of TVM

As we look back at the battlefield of TVM settlements and destroyed lives, what will happen to the women who have or will have TVM implants? Hopefully the United States will follow suit to the UK and Australia and ban them from being used. One can dream that the understaffed FDA will create stricter regulations for 501(k) medical devices. Settlements are on the calendar and many are still pending, so justice may still be served (although one cannot truly be adequately compensated for the loss of health and happiness).

We’re living in a unique time where women’s voices are getting stronger. We’re speaking out against sexual assault and we’re demanding that our bodies deserve respect. Women are speaking, and change comes when we all listen and act. As many are saying in Hollywood, “Time’s Up.” The time is up for the men who have silenced, harmed and tossed aside women and ignored their cries for help. The time is now for women to speak up, speak out, and speak on behalf of next generation. The time to act is now… what will you do?

Written by Christina Morales & Jennifer Stanich-Banmiller. Originally published on January 19, 2018.

Transvaginal Mesh Warnings In The News

BREAKING (8/5/19): Ex-FDA Czar Says J&J Mesh Paperwork Left Out Risk Info

A former U.S. Food and Drug Administration head testified Monday in California’s pelvic mesh lawsuit against Johnson & Johnson that subsidiary Ethicon applied for a series of FDA product approvals without ever mentioning numerous adverse events that finally appeared on labels in 2015.

Read More Now

 

BREAKING (7/31/19): Ex-J&J Doctor Testifies She Told Bosses About Mesh Issues

A former Johnson & Johnson medical director alerted higher-ups that patients complained of complications from the company’s pelvic mesh that weren’t listed on warning labels, she testified Wednesday in California’s suit alleging J&J falsely marketed the products.

Read More Now

 

BREAKING (7/29/19): J&J Lied In Mesh Marketing, Surgeon Tells Calif. Judge

Bay Area pelvic surgeon and urogynecologist Tom Margolis took the stand before San Diego County Superior Court Judge Eddie Sturgeon and said removing pelvic mesh devices became a specialty of his practice. California Attorney General Xavier Becerra alleges that J&J subsidiary…

Read More Now

 

BREAKING (7/28/19): J&J Hit With $500K Verdict In Latest Philly Mesh Case

A Philadelphia jury handed down $500,000 in damages against a Johnson & Johnson unit on Friday after finding that design defects in a pelvic mesh implant left a woman suffering significant pain.

Read More Now

 

1/31/19: Vaginal Mesh Survivor Wins $41 Million Verdict Against Johnson & Johnson

Suzanne Emmet recently won her case against Johnson & Johnson for the life-altering injuries she sustained from having vaginal mesh implants. Find out more here.

Read More Now

9/25/18: The Truth Behind The New York Times’ Transvaginal Mesh Coverage

The NYT’s transvaginal mesh coverage has been condescending and overgeneralized. Learn where they went wrong with the truth behind one of the biggest scandals in the history of women’s health.

Read More Now

7/26/18: Ireland Halts Use of Transvaginal Mesh

Ireland is now the most recent country to halt the use of transvaginal mesh (TVM). Health Minister Simon Harris just announced that his department’s Chief Medical Officer (CMO) has requested that the Health Service Executive (HSE) – the agency that provides health and personal social services for the citizens of Ireland – pause use of this dangerous medical device. This order is in effect until future notice.

Read More Now

7/12/18: UK Suspends Transvaginal Mesh

The National Health Service (NHS) in England – the equivalent to our FDA – has accepted a recommendation to temporarily suspend vaginal mesh implants for the treatment of stress-urinary incontinence (SUI) until March 2019 based on the evidence presented that the risk to patients far exceeds the benefits.

Read More Now

 

5/30/18: Will Scotland Be the Next Country to Ban TVM?

On May 26, 2018, Wael Agur, advisor to the Scottish Government’s mesh safety review board, recommended that transvaginal mesh (TVM) devices made after 2012 which contain Chinese sourced resin should be withdrawn immediately. This mesh, which was sourced by Boston Scientific, has been known to shrink inside the body up to 50% and can erode within months.

Read More Now

5/15/18: 60 Minutes — The Medical Device That Has 100,000 Women Suing

A common surgical implant has generated the largest multi-district litigation since asbestos. 60 Minutes reports on one of the device’s manufacturers, Boston Scientific, now facing 48,000 lawsuits.

Watch The Segment Now

4/11/18: Allegations of pelvic mesh shrinkage considered in C.R. Bard trial

 

An attorney for Mary McGinnis in her lawsuit against C.R. Bard said during trial that the pelvic mesh McGinnis had installed in her pelvic region in 2009 shrunk and distorted, while the defendant contends it can be tissues attempting to heal that causes mesh shape change, not the mesh.

Read Full Article

 

4/11/18: Bard Hustled Defective Meshes To Market, Jury Told In Closing

 

C.R. Bard pushed a pair of pelvic mesh devices to market without proper testing or warning, counsel for a woman alleging harm from those devices told a New Jersey jury during Wednesday closing arguments, and Bard countered there isn’t evidence the devices harmed the woman.

Read Full Article

 

4/8/18: Australia bans mesh after Scots’ evidence

 

Politicians there have been “shocked” at the crippling injuries suffered by women, with one describing mesh implants as “a torture device”.

The inquiry has issued a scathing report on the use of mesh implants to treat bladder and pelvic organ prolapse, ordering a register to be set up to track all implant and mandatory reporting of all complications, and help for affected women.

Read Full Article

4/1/18: 11 Horror Stories From The Australian Pelvic-Mesh Implant Report

“It felt like barbed wire inside me.”

Australia is currently weathering what Senator Derryn Hinch has told the Australian Broadcasting Corporation is “one of the biggest medical scandals Australian women have ever been subjected to” after a government report found that 10,000 to 15,000 people incurred serious side effects after receiving transvaginal mesh implants.

Read Full Article

3/29/18: Transvaginal mesh use should be suspended, health groups say

Alliance of six state and territory consumer bodies say full audit of complications is needed.

The devices are surgically implanted to treat pelvic organ prolapse and stress urinary incontinence, common childbirth complications. It’s estimated about 150,000 women have undergone the procedure in Australia.

Read Full Article

3/29/18: Australia investigates implants that left some women with ‘rotting pelvises’

Like more than 100,000 Australian women, Linda Schulz had a pelvic mesh implant to treat complications from childbirth that resulted in her bowel and bladder prolapsing.

The mesh was meant to be a quick fix, but the aftermath was worse.

Read Full Article

3/28/18: Vaginal Mesh Leaves Australian Women With Rotting Pelvises And Other Complications

Vaginal mesh in Australia has been found to be used as a routine procedure instead of a last resort. Many women were having issues with the vaginal mesh, and the Australian senate found that this procedure was being used without properly informing the women about the issues that may arise.

The government stepped in after hearing complaints of many women who had a vaginal mesh implanted.

Read Full Article

1/30/18: Government to Review Thousands of Harmful Vaginal Mesh Implants

The Government has pledged to review tens of thousands of cases where women have been given harmful vaginal mesh implants. In a major win for campaigners, the Department of Health and Social Care has committed to look at every case back to 2005 to determine the true extent of serious complications that can leave women in agony.

Around 100,000 women are estimated by NHS England to have a mesh device fitted and this is the first review to follow patients from the initial condition that required an implant to subsequent treatment for complications.

Read Full Article

1/22/18: Johnson & Johnson Withdraws Pelvic Mesh From Australian Market

Pharmaceutical giant Johnson & Johnson has withdrawn from the Australian market its supply of the vaginal mesh device that is the subject of a class action before the federal court.

On Tuesday a spokeswoman for Australia’s medical devices regulator, the Therapeutic Goods Administration, confirmed to Guardian Australia that the mid-urethral vaginal sling devices, used to treat stress urinary incontinence in women, were no longer being imported.

Read Full Article

9/30/17: Vaginal Mesh 'Disaster' Could Be 'Worse Than Thalidomide', Experts Warn

An operation to treat incontinence performed on tens of thousands of women across the UK could be hiding a scandal worse than Thalidomide, a leading expert has warned.

Professor Carl Heneghan, who specialises in evidence-based medicine, said some of the devices used in vaginal mesh implants had not been clinically tested and, “unlike in the Thalidomide scandal, you are unable to see the extent of the women’s injuries”.

Speaking about the scale of the scandal, he said: “I think this is the worst one that we’ll ever see in my lifetime because of the scale of the number of women affected.”

Read Full Article

8/14/17: Lamborghinis, Ski Trips Used to Market Controversial Mesh Implant to Surgeons, Documents Show

Lamborghinis and ski trips to the Swiss Alps were among the incentives a pharmaceutical giant developed to market a surgical device that has ruined the lives of hundreds of Australian women.

Documents obtained by the ABC show the extent to which Johnson and Johnson oversold its surgical mesh products, which are used to treat incontinence and prolapse after childbirth. They paint a picture of a company that tried to sell surgeons a jet-setting lifestyle where they could insert four devices “before lunch” and notch up $10,000 in surgeries in a single morning.

The mesh devices have left at least 3,000 Australian women with serious side effects including chronic pain, infections and inability to have sex, and are the subject of both a Senate inquiry and a class action.

Read Full Article

Filed Transvaginal Mesh Complaints & Damages

8/31/12: In Re Ethicon Inc., Pelvic Repair System Products Liability Litigation
Defendants had a legal duty to insure the safety and effectiveness of their pelvic mesh products by conducting adequate and well controlled studies on their products prior to marketing. Defendants deliberately chose to manipulate the only studies that were conducted on their products and by so doing provided doctors and patients with false and misleading information about the safety and effectiveness of their pelvic mesh products. Furthermore, Defendants made a conscious decision to forego performing studies and creating registries that would have provided doctors and patients in the United States with accurate information regarding the lack of proof of the safety and effectiveness of their pelvic mesh products.

Read Full Case

Transvaginal Mesh Settlement Information

GET YOUR FREE TRANSVAGINAL MESH CASE REVIEW TODAY

Transvaginal Mesh settlements are now being negotiated, but there is a limited window to pursue help. If you think you, a friend, or a family member may qualify, get your free case review today… before it’s too late!

  • * Submit now to learn if you may be eligible for a cash settlement or call (800) 511-3838 now.

Free Guide Download

The Step-By-Step Guide To Taking Action

How to File for Financial Settlement After Injury from an Unsafe Drug or Device

Free Guide Download

The Step-By-Step Guide To Taking Action

How to File for Financial Settlement After Injury from an Unsafe Drug or Device

LATEST ARTICLES

No Testing, Fast Approval, Injured Patients: Is the FDA Finally Listening to Mesh Survivors?

Dr. Chris DeArmitt, who is a consultant to the top technology firms in America, told Sky News: “I see an absolute disregard for proper testing. Testing is way less than you would see on a vacuum cleaner or a washing machine. It’s shocking. I’ve never seen anything like it in my career.”

No Testing, Fast Approval, Injured Patients: Is the FDA Finally Listening to Mesh Survivors?

You might be wondering “Testing for what?” You would probably be shocked to find out that “more than 90 percent of medical devices do not require proof that they have been clinically tested and found to be safe and effective prior to FDA clearance for distribution or sale,” shares Consumers Union project director Lisa McGiffert in an article from the Fowler Tribune.

This loophole in the FDA is called the 510(k) process and it has allowed millions of patients to be irreparably harmed – and even killed – by the very device that was intended to help them. Now after several decades of patient injuries, billions of dollars being fought over in court, and countless devices being pulled from market (too little, too late, we might add), the FDA is only now looking into changing this horrific flaw in their system.

What is the FDA’s 510(k) Process?

The FDA’s 510(k) process allows medical devices companies to quickly fast-track a product to market based on a pre-approved product. This idea came about decades ago with the purpose to promote innovation but has instead become a way for big companies to slip their products to market for high profits while avoiding expensive testing. This has caused several inexcusable problems to arise. Here’s one tragic example: 

Transvaginal Mesh

A medical device can be approved for market based on a previous model, even one that was recalled. This is what happened in the huge debacle involving vaginal mesh. Protegen was the first vaginal mesh product on the market, but was recalled due to patient harm. However, even after it was pulled, dozens of additional mesh devices were sold and implanted in patients based on this poor design. Currently, hundreds of thousands of women are suffering from mesh and many will have to live with chronic pain, the impossibility of holding down a job, and the inability to have sex with their partners for the rest of their lives. 

But this story includes many more products beyond vaginal mesh-like IVC filters to prevent blood clots, Essure female sterilization devices, hip replacement products, and countless others.  The New York Times reports that these fast-tracked devices have caused 80,000 deaths and more than two million injuries.

Change is in the Air 

Fortunately, with documentaries like The Bleeding Edge, social media groups criticizing the FDA’s process, and advocacy groups, the FDA is reevaluating how it approves devices for market. According to the JAMA (Journal of the American Medical Association) Network,

“For premarket review of 510(k) devices, on February 1, 2019, the FDA released a Final Guidance Document for the ‘Safety and Performance Based Pathway.’ This optional pathway consists of using criteria that involve conformance to FDA-recognized consensus standards, FDA guidance, and/or special controls. It enables 510(k) clearance for certain medical devices if the device meets these specific criteria, which should include safety and effectiveness (as opposed to the often ill-defined ‘substantial equivalence’ to predicate devices). The decision to use this new pathway is determined by manufacturers, although the FDA can disagree with this determination.”

While this is a step in the right direction by requiring device companies to prove safety and effectiveness, many think that these changes don’t go far enough towards protecting patient health. For instance, JAMA suggests that “legislation should mandate that 510(k) devices show improved safety and effectiveness compared with marketed devices for the same clinical purpose, using meaningful clinical criteria to gain clearance. Although these criteria will differ based on the intended use of the device, all criteria should be based on patient-oriented clinical outcomes.”

Additionally, once a product is approved for market, many times the post-market surveillance falls to the wayside. Medical devices should have a registry so that patients can know what devices are implanted in them, doctors can properly treat problems that may arise, and companies can monitor their products more effectively. Car parts are meticulously tracked, shouldn’t medical devices be all the more!?!

Too Little, Too Late

It’s great that the FDA is reviewing it’s 510(k) process that has been grossly overused and under monitored for decades, but what about those who have already been harmed by an agency that favored billion-dollar medical device companies over the health and wellness of patients?

One way that this FDA change was brought about was through the voices and bravery of those who were injured by these faulty medical devices. If you or a loved one had vaginal mesh and had corrective surgery, your voice needs to be heard. Please call Periscope Group today at (800) 511-3838. It’s time to hold medical device companies accountable for the unbearable pain they caused you. We want to hear your story and we want to help you if we can.

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Sources
“Vaginal mesh: Tests on plastic material ‘way less’ thorough than on washing machine”. Sky News. Accessed August 5, 2019. https://news.sky.com/story/vaginal-mesh-tests-on-plastic-material-way-less-thorough-than-on-washing-machine-11772530?fbclid=IwAR0ieT27Sh1V8q53Vt7y3BH2PK1M9akqoLCAFvnf1JskMeAOu10yvzgEi20
“Moving From Substantial Equivalence to Substantial Improvement for 510(k) Devices”. JAMA Network. Accessed August 5, 2019. https://jamanetwork.com/journals/jama/fullarticle/2744408?fbclid=IwAR04Fkrn-A1NbJDUkuOOOU-EhA55G5kkXUYJWGIb8y-MftOdFTQ0hrk_Bl0
“Medical Device Testing: Too Much, or Not Enough?” ADMET. Accessed August 5, 2019. https://www.admet.com/medical-device-testing-too-much-or-not-enough/

Can Talcum Powder Really Cause Mesothelioma?

For many years there has been speculation concerning whether Johnson & Johnson’s Baby Powder causes ovarian cancer. Many cases have gone to court, and in July 2018, J&J was required to pay $4.69 billion to 22 women who blamed the talc-based product for causing their ovarian cancer. 2019 isn’t looking any better for J&J as they are expected to face almost three times as many trials involving their baby powder. However, there’s a bit of a spin on a few of these cases: instead of the plaintiff’s alleging that baby powder caused ovarian cancer, some plaintiffs are going after the billion-dollar company with accusations that their mesothelioma diagnosis is linked to baby powder use from decades ago. Is there merit to this claim?

Can Talcum Powder Really Cause Mesothelioma?

What is Mesothelioma?

“Mesothelioma is a rare, aggressive form of cancer that develops in the linings of the lungs, abdomen, heart or testes. The only known cause of malignant mesothelioma is asbestos, though there are other potential risk factors. Due to a long latency period, symptoms may take 10 – 50 years to develop after exposure,” explains Mesothelioma.com. 

What makes mesothelioma especially tragic is that it’s usually discovered in an advanced stage causing there to be few options for treatment. Medical professionals will do their best to help the patient to be comfortable, but traditional go-to’s like surgery, radiation, and chemotherapy offer only minimal hope to extend life expectancy. However, each person is different so it’s critical to discuss these options, along with alternative treatments and possible outcomes, with your doctors.

What Causes Mesothelioma?

Mesothelioma is only caused by asbestos. Asbestos refers to six naturally occurring minerals that have been used for decades for its abilities to resist fire, insulate buildings, it’s anti-corrosion properties and more. By the 1970s, however, asbestos became a hot topic in the news for the health hazards it created.  

So what does asbestos have to do with baby powder?

Asbestos and talc are often formed in nature near each other. Talc is a silicate made up mainly of magnesium, silicon, and oxygen. Asbestos is also a group of silicate minerals that share the same fibrous nature. Both are extremely soft and can be broken down into microscopic pieces.

Between the 1950s and 1970s, studies were conducted which found that baby powder samples were contaminated with asbestos. By the end of the 1970s, the demand for asbestos peaked with 25 countries producing nearly 4.8 million metric tons annually. Nonetheless, asbestos was banned in many countries because of the health risks that it caused including mesothelioma.

Mesothelioma occurs when microscopic fibers of asbestos get inhaled into the lungs. These particles settle into the lung’s lining and can’t be removed. Over many years, the fibers can cause enough irritation and damage to cause lung cells to turn cancerous which is why diagnosis can take years and even decades.

Law360 explains the basis for this most recent case against J&J: “The trial, which began on July 15, involves claims that Will Ronning, Douglas Barden, David Etheridge and D’Angela McNeill-George were exposed to asbestos in the baby powder when they were babies, which caused their terminal cancer.”

Seem far fetched? Consider these findings from a 2014 study conducted by a group of scientists in New York: 

  • “Through many applications of this particular brand of talcum powder, the deceased inhaled asbestos fibers, which then accumulated in her lungs and likely caused or contributed to her mesothelioma as well as other women with the same scenario.”
  • “Initial bulk analyses of 50 samples of this product in Laboratory A showed that all of the samples contained asbestos fibers. Eighty percent contained only anthophyllite asbestos, 8% only tremolite asbestos, 8% anthophyllite and tremolite asbestos and 4% anthophyllite, tremolite, and chrysotile asbestos.”
  • “We have traced the asbestos in the talc to the mines from which it originated, into the milled grades, into the product, and finally into the lung and lymph nodes of the users of those products, including one woman who developed mesothelioma.” 

Johnson & Johnson’s Responsibility

“We do not have any organized program to settle Johnson’s baby powder cases, nor are we planning a settlement program,” Ernie W. Knewitz, a company spokesman, said in an emailed statement in the Los Angeles Times. “Rather, we will continue to vigorously defend the safety of Johnson’s baby powder in the courtroom.”

“In 2019, there are at least 21 trials on court calendars targeting J&J over tainted talc, including more than 15 in California’s courts and one in Georgia set to start in March,” states the Los Angeles Times.

Prop 65 Cancer Warning Label

The current warning label for Johnson’s Baby Powder states: “WARNING: Keep powder away from child’s face to avoid inhalation, which can cause breathing problems. Avoid contact with the eyes. For external use only.”

J&J continues to deny the results of many studies and the claims of thousands of plaintiffs that their product creates an increased risk of cancer. In fact, there may be a potential trial in California over whether or not J&J’s Baby Powder should carry a Prop 65 warning label on its bottle to provide “a ‘clear and reasonable’ warning before knowingly and intentionally exposing anyone to a listed chemical” which may cause cancer.

Should baby powder have a warning label for cancer? We’d love to hear your thoughts! Please comment on our Facebook page or share on social media (links below) with your input.

If you or a loved one were diagnosed with ovarian cancer or mesothelioma after exposure to Johnson & Johnson’s Baby Powder, please call Periscope Group today at (800) 511-3838. We want to hear your story and help in any way that we can.  

 

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Sources
“J&J Tried To Invade Atty Privilege In Talc Case, Judge Told.” Law 360. Accessed August 1, 2019. https://www.law360.com/articles/1183789/j-j-tried-to-invade-atty-privilege-in-talc-case-judge-told
“Talcum Powder as a Cause of Mesothelioma?” Mesothelioma.com. Accessed August 1, 2019. https://www.mesothelioma.com/blog/talcum-powder-as-a-cause-of-mesothelioma/
“Johnson & Johnson’s baby powder risk expands: It faces triple the cancer trials in 2019”. The Los Angeles Times. Accessed August 1, 2019. https://www.latimes.com/business/la-fi-johnsons-baby-powder-20181225-story.html
“Mesothelioma”. Mayo Clinic. Accessed August 1, 2019. https://www.mayoclinic.org/diseases-conditions/mesothelioma/diagnosis-treatment/drc-20375028
“What Is Asbestos?”. Asbestos.com. Accessed August 1, 2019. https://www.asbestos.com/asbestos/
“J&J Would Rather Fight a Cancer-Warning Lawsuit Than Let It Drop”. Bloomberg. Accessed August 1, 2019. https://www.bloomberg.com/news/articles/2019-07-27/j-j-would-rather-fight-a-cancer-warning-lawsuit-than-let-it-drop

“Asbestos in commercial cosmetic talcum powder as a cause of mesothelioma in women”. NCBI. Accessed August 1, 2019. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4164883/

Xeljanz and Risk of Amputation: What You Need to Know

One of the most despicable things about Big Pharma is when they know that a drug or medical device could cause a terrible health complication, and yet they fail to warn patients of this potentially life-changing problem. This is what’s happening in a current trial involving 68-year-old Arkansas resident Marilyn Stube. She took Xeljanz for four years to help her rheumatoid arthritis and ended up having both arms and legs amputated due to sepsis. Pfizer, the makers of Xeljanz, knew the risks but chose not to warn U.S. patients. 

Xeljanz and Risk of Amputation: What You Need to Know

What is Xeljanz?

Xeljanz is a relatively new medication that was introduced to the market in 2012 to address rheumatoid arthritis (RA). There are a variety of drug options available for RA, but Xeljanz works in a different way because it “is an anti-JAK, or Janus kinase inhibitor, which targets a specific cellular process that is involved in the immune response and resulting inflammation in RA. Xeljanz is the first drug of its kind,” explains Healthline. 

Xeljanz was intended to be prescribed for patients who didn’t respond to the existing drug options available for RA. However, while all medications have a risk of specific adverse effects, Xeljanz was found to have the potential to cause more serious risks that caused many doctors to decline to prescribe it to their patients.

Warning Signs

When Xeljanz was first approved to be sold in the U.S. by the FDA, the European Medicines Agency, Europe’s version of the FDA, rejected it. The European authorities deemed that this medication came with higher risks than the other available RA drugs on the market. Some of these complications could include severe infections, liver damage, gastrointestinal bleeding, increased blood pressure and cholesterol, and an increased risk of cancer. And it doesn’t just have the basic warnings that are spoken really fast at the end of a television commercial; Xeljanz has a black box warning – the highest warning given by the FDA – about how it can hinder the immune system causing major infections.

Hiding the Facts

If these dangerous complications weren’t scary enough, Pfizer failed to tell U.S. patients about the possibility of sepsis, a potentially fatal condition in which the patient is fighting a severe infection that has spread throughout the body. If a patient becomes ‘septic,’ they will likely have low blood pressure leading to poor circulation which can harm vital tissues and organs.

This is what happened in the case of Marilyn Stube. “After taking Xeljanz for four years for her rheumatoid arthritis, she started feeling pain, then fever, nausea and other symptoms in March 2017. In April of that year, she was diagnosed with septic shock, multi-organ failure, gangrene and Group A Streptococcus, requiring that she have both arms and both legs amputated at Baylor University Medical Center,” according to the complaint filed in the Western District of Arkansas.

On Xeljanz’s labels outside the U.S., they warn of the potential for sepsis which clearly shows that the company knew about the risk and hid this important fact from the American public. According to Law360, “Stube’s physician has signed a sworn declaration that he would never have prescribed Xeljanz for her if he’d known of the risk of sepsis and other ailments, saying he was relying on Pfizer’s product literature in deciding what medication was safest for Stube’s treatment.”

If you or a loved one are taking Xeljanz, it’s important to discuss the benefits and risks of your unique situation with a medical professional to determine the best medication for your condition. It’s also critical to know the potential adverse effects of each medication that you are taking so that you can know the warning signs; the quicker you can get medical care, the more likely you are to avoid severe complications.

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Sources
“Pfizer Hid Risks Of Sepsis, Amputation On Labels, Suit Says”. Law360. Accessed July 24, 2019. https://www.law360.com/articles/1179862/pfizer-hid-risks-of-sepsis-amputation-on-labels-suit-says
“Another Look At Marketing Vs. R&D In Pharma”. Science Magazine. Accessed July 24, 2019. https://blogs.sciencemag.org/pipeline/archives/2013/05/23/another_look_at_marketing_vs_rd_in_pharma
“Xeljanz: A Blessing or a Curse for Rheumatoid Arthritis Patients?”. Heathline. Accessed July 25, 2019. https://www.healthline.com/health-news/xeljanz-blessing-or-curse-for-ra-patients-100414#1
“Why was this RA med declared safe here, but not in the EU?”. Health Science Institute. Accessed July 25, 2019. https://hsionline.com/2014/08/18/european-medicines-agency/

Periscope Group is not owned by or operated on behalf of any attorney or law firm. We are not affiliated with any drug or medical device companies. We do not host advertisements nor do we accept advertising requests. We are here to help YOU, the consumer, become better educated and supported. You pay absolutely nothing for our help. It’s as simple as that.

Periscope Group is not owned by or operated on behalf of any attorney or law firm. We are not affiliated with any drug or medical device companies. We do not host advertisements nor do we accept advertising requests. We are here to help YOU, the consumer, become better educated and supported. You pay absolutely nothing for our help. It’s as simple as that.

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