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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 (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

BREAKING (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

BREAKING (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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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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