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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 (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.

Our in-house legal counsel, Matthew J. Daher, earned his Bachelor of Arts degree from the University of Utah and his law degree from the University of Missouri – Columbia School of Law. Matt has devoted his entire practice to civil litigation, and has spent his career representing the rights of individuals who have been injured by pharmaceuticals, medical devices, medical malpractice, defective products, and motor vehicle accidents. As in-house counsel for Periscope Group, Matt leads our internal legal team and liaises with our external partners.

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LATEST ARTICLES

Sling Vs. Mesh: What’s the Difference?

Talking about transvaginal mesh (TVM) can be confusing. There are words like “polypropylene,” “mesh migration,” and “pelvic organ prolapse” that can be difficult to understand. Additionally, sometimes words seem interchangeable like “sling” and “mesh.” Here are a few things that you need to know if you have or are thinking about having a TVM implant.

Sling Vs. Mesh: What’s the Difference?

Slings vs. Mesh

First of all, transvaginal mesh – commonly abbreviated to TVM – covers both slings and mesh. TVM is usually made out of a plastic called polypropylene. It looks somewhat like a window screen and the plastic itself is many times used to make fishing line.

Slings are mainly used for stress urinary incontinence (SUI) and are commonly referred to as “tapes.” This is because the mesh is cut into a long, thin strip much like a piece of scotch tape. SUI occurs usually in women who have given birth and in women who are 44 years old and older. SUI is when a woman laughs, coughs, or sneezes and then experiences urine leakage. The sling supports the tube that urine passes through (called the urethra) and the neck of your bladder (where your bladder connects to your urethra) to help prevent leaks.

There are also two types of slings: pubovaginal and suburethral. A pubovaginal sling has a minimally invasive surgery involving a small vaginal incision where the sling is placed under the urethra to support the organ. A suburethral sling sits around the urethra and is actually attached to the abdominal wall. This is a more invasive procedure and requires a couple of days in the hospital following the surgery.

Now let’s talk about mesh which is primarily used for pelvic organ prolapse (POP). POP is when some of the vaginal walls are weakened and then the bladder, rectum, small bowel and/or uterus sag near or in the vaginal opening. As you can imagine, it’s going to take a bit more than a skinny tape-like device to hold all these organs back where they belong. Mesh can be used to support these organs like a hammock.

Mesh Complications

Slings and mesh sound great, right? I mean, who wants to leak pee or have their organs protruding from their vagina? However, tens of thousands of complications have been reported among TVM patients including mesh erosion (when the mesh breaks apart), migration (when the mesh moves around in the body), tissue and organ damage (which happens when the sharp edges slice surrounding areas), and dyspareunia (where the mesh lodges in the vagina and causes painful sex). There are other procedures and devices – such as colporrhaphy and pessaries – that don’t have these harmful lasting adverse effects. When you think about it, women have been having babies and have been aging for thousands of years without using harmful TVM. Why is this dangerous device being put in women at all?!

TVM is truly a crime against women. This defective plastic breaks, slices, and creates irreparable damage causing women to no longer be able to work or function in daily tasks due to the excruciating pain. It also harms relationships because of the physical and mental stress it imposes and due to the lack of physical intimacy resulting from broken mesh (if it moves into the vagina, the sharp edges can slice the penis). These women are suffering, embarrassed, angry, and have lost so much… all so that big pharmaceutical companies can make a lot of money.

If you had complications that needed mesh removal, please contact Periscope Group today. We would love to hear your story and we want to help you if we can. TVM is a dangerous product that was never fully tested and has ruined tens of thousands of women’s lives around the world. It’s time that your voice is heard!

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Sources
“Talking about Slings and Meshes. There is a difference!”. Central Florida Urogynecology. Accessed July 30, 2018. http://www.cfurogyn.com/articles/prolapse/SlingsAndMeshes.html
“Sling vs. Mesh: What You Need to Know”. Urogynecology University of Colorado. Accessed July 30, 2018. https://urogyn.coloradowomenshealth.com/blog/sling-vs-mesh
“Colporrhaphy”. Encyclopedia of Surgery. Accessed August 6, 2018. http://www.surgeryencyclopedia.com/Ce-Fi/Colporrhaphy.html

Medical Device Companies Fail to Accurately Report Health Complications to FDA: Are You At Risk?

16,000 complaints involving Essure – a coil-like permanent birth control device- were reported to its manufacturer, Conceptus Inc., between January 2008 and December 2010. However, during that same time period of time, Conceptus (which was acquired by Bayer AG in 2013) filed only 182 reports of patient harm with the FDA. That’s a mere 1.1%. Worse yet, 750,000 Essure implants were sold worldwide until Bayer voluntarily – no, not recalled – pulled it from market in 2018 due to a 70% decrease in sales. So how can a medical device company get away with only reporting a small fraction of complaints to the FDA? Why was Bayer not penalized by the FDA for their negligence in reporting which put hundreds of thousands of women at risk?

Medical Device Companies Fail to Accurately Report Health Complications to FDA: Are You At Risk?

Problems with the FDA Reporting System

According to an intensive study conducted by the International Consortium of Investigative Journalists (ICIJ), there are three major flaws involving device companies and the process of reporting to the FDA:

  1. “FDA inspections have found more than 4,400 violations by device companies of its rules for handling complaints and reporting device problems in the last decade. Each violation can include hundreds or even thousands of mishandled complaints.”
  2. “Manufacturers and others required to report adverse events have classified more than 2,200 episodes in which patients died not as deaths but as injuries, malfunctions or other less severe events in the last five years.”
  3. “The FDA has allowed companies to obscure thousands of injury reports using a program called alternative summary reporting that allows them to keep the information from the public.”

Clearly there are far too many loopholes in the approval and management of medical devices that by far benefit the pharmaceutical companies at the cost of patient health. For example, it can be a grey area to determine if the device itself caused a patient death since the body can shut down at various levels. In the case of the manufacturer Thoratec Corp., a patient had a HeartMate II implant which provides circulatory support to patients with advanced heart disease. When the patient died, two suspected causes of death were reported: “suspected pump thrombus,” a device failure caused by a blood clot that blocks the pump, and multisystem organ failure. Thoratec’s report mentions the patient’s death, but cites the incident as an injury and faults organ failure as the cause of death. The obvious question here is did the mechanical failure cause the organs to shut down? One (of the many) problems is that with hundreds of thousands of complaints reported to the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database, it can be an insurmountable task to thoroughly evaluate each reported event. However, pump blockages were a common enough problem with this device that the FDA issued a safety warning for them in 2015.

Foreign Medical Device Companies

While there’s a laundry list of things wrong with the FDA and how it manages the medical device industry, it’s important to mention that it’s the best agency of its kind in the world. In fact,  Europe’s Eudamed adverse events database is accessible only to regulators and industry professionals, in Chile reporting adverse events is voluntary, and in Mexico this data is hidden from the public. So this brings us to another problem: if the U.S. is having trouble managing its own medical device companies, how are we monitoring foreign made products?

Last year in May 2018, 60 Minutes ran an important story exposing Boston Scientific (makers of transvaginal mesh) and how they smuggled counterfeit polypropylene material from a company in China due to a shortage in the U.S. And there are many layers to this story: not only is polypropylene a fragile material that can erode, migrate, shrink and cause many painful health complications, but an unverified foreign product increases the potential for injuries. When Boston Scientific compared the U.S. approved plastic with the foreign one, this is what they found: “They analyzed 11 different parameters, looking at the two plastics side by side, done, the same tests. Nine of those were different,” cites the 60 Minutes program. “Two were the same, nine were different. And of those nine that were different, four of those parameters were very different. And somehow, from that, they concluded that it was the same material.” Boston Scientific denied all allegations, but more than 48,000 lawsuits have been filed against the company on behalf of injured women.

Do You Have a Medical Device?

Not all medical devices are bad nor are they beneficial. As patients, our job is to be our best advocate. Research your surgery procedure and potential medical device online. Visit your doctor with a list of prepared questions or email your doctors to get the answers that you’re looking for. Weigh the risks and benefits to any procedure to determine the best choice for your health. We also need to speak out against bad medical device companies and FDA loopholes… our health depends on it.

 

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Sources
“How medical device harm is concealed”. ICIJ. Accessed January 30, 2019. https://www.icij.org/investigations/implant-files/how-medical-device-harm-is-concealed/?fbclid=IwAR0IfmV3sL4dcf7KWT_gP5Ta5XGtjfj-_UD1SVdE6TcKNIrj2ouLPxLGK9c
“Women sounded alarm on Essure birth control device. Now the FDA is cracking down.”. NBC News. Accessed January 30, 2019. https://www.nbcnews.com/health/womens-health/women-sounded-alarm-essure-birth-control-device-now-fda-cracking-n865531
“CBS News’ 60 Minutes Interviews Dr. Duane Priddy for Gynecological Polypropylene Mesh Investigation”. MarketWatch. Accessed January 30, 2019. https://www.marketwatch.com/press-release/cbs-news-60-minutes-interviews-dr-duane-priddy-for-gynecological-polypropylene-mesh-investigation-2018-05-17

Important Information You Should Know About Medical Implants

From knee replacements to breast implants to IVC filters, there are countless medical devices that are being implanted into millions of people every year. (Kind of reminds me of the 1970’s show The Six Million Dollar Man with Lee Majors.) Even though these types of procedures seem almost commonplace, every surgery is nerve wracking and comes with a certain amount of risk. It’s also important to realize that every medical device and implant comes with benefits and risks beyond the actual surgery itself. Here are some common questions and answers that patients have concerning these devices.

Tens of millions of Americans have medical implants, but what do we really know about these devices? If you have one or are planning to have surgery, read more here.

Is there a difference between a medical implant and medical device?

It seems that these two words are interchangeable, but they can mean different things in the medical world. Generally speaking, a medical implant is something that goes inside your body or connects to your body such as a hip replacement or a mechanism that internally delivers medicine such as a chemotherapy port.

A medical device is the general term that can include implants, but may also be used when referring to medical tools that are used in surgery, bandages to cover wounds, and a wide variety of other medical equipment.

Additionally, drugs are NOT included in either category (although an implant may deliver a drug into the body). If you visit the FDA’s website, you’ll notice a distinct tab for “drugs” and another for “medical devices.” This separation could help you if you plan to research your procedure or if you have to file a complaint down the road.

I’m considering getting a device. What should I research?

Before getting an implant, ALWAYS do your research. It seems simple enough to take your doctor’s advice, because after all, he’s the one with the medical degree and experience, but you are your best advocate and you need to know the benefits and risks to your procedure. For example, millions of women had vaginal mesh put in them and have had to undergo repeated surgeries to fix complications. The mesh is made out of polypropylene which can erode, break apart, migrate, shrink, and cause other painful complications. Equally alarming is that it wasn’t properly tested before becoming the “gold standard” for repairing pelvic organ prolapse or stress urinary incontinence. Knowing these facts could have prevented women around the world from unnecessary pain and devastation.

So here are a few ways to research the safety and effectiveness of your implant:

  • The FDA’s website is a good place to start. At the top right corner you’ll see a search box that says “Search FDA.” Type in the type of implant you’re planning on having (like breast implant, hip implant, vaginal mesh, etc.) and you’ll see a list of topics pop up. Choose the overview page first. If there are any warnings or FDA safety notifications about the product, you’ll see red highlighted text at the top of the page discussing the risks and problems that this device may be having. Scroll down and you’ll usually find what types of implants are available (such as metal, plastic, biologic, etc.), how to prepare for surgery, what risks and adverse effects to be aware of, and how the surgery will be done. But here’s a big problem: The FDA is underfunded and overwhelmed, so the website isn’t always up-to-date!!!!
  • Talk to your surgeon ahead of time and ask what specific brand and model of implant he or she is planning on using, then look it up. Find out how long it’s been on the market, if it was properly tested, can the device be removed if needed, how long will it last, how long did it take for others to start experiencing problems, and if there are lawsuits or recalls on it. You may also want to look into whether there are other options available that are safer and have less risks. Write down all of your questions and concerns and make an appointment to discuss them with your doctor.
  • Check out social media – As you may or may not know, there are specialized groups on social media and where you can ask people who have gone through the procedure about their outcomes. For instance, on Facebook you can type in “hip replacement” and you’ll see links to videos, groups, articles, and photos. You can even join a group and ask questions about recovery time, complications, and more.

My medical device is having a negative effect on my health. How do I report it?

First of all, call your doctor right away if you have any concerns at all. Fever, vomiting, increased pain and other symptoms may the start of a bigger problem. The sooner you address the issue, the better chance you have at recovery. Secondly, ALWAYS get a copy of your medical records whether you’re having complications or not. Not only will they detail your procedure, but it will have a card in it stating exactly what medical device you have including the brand, model, and serial number.

The FDA has a program called MedWatch where you can file a complaint form online. Click the button that says “Consumer/Patient” and you will be guided through a set of questions to share what implant you had and the complications you experienced. This is so important not only to track your own injuries, but to inform the FDA so that they can potentially analyze the data to protect others from harm.

 

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Sources
“Implant Files: Frequently asked questions and resources for readers”. https://www.icij.org/investigations/implant-files/resources-for-patients-and-frequently-asked-questions/

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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© All Rights Reserved • 2017 • Periscope Group, 4155 Blackhawk Plaza Circle, Suite 100, Danville, CA 94506 Legal Disclaimer

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