Transvaginal Mesh: 5 Years of Litigation… 5 Years of Frustration
Transvaginal mesh (TVM) isn’t something that most people know about, and yet it is one of the biggest crimes against women in modern history. Amongst the “#MeToo” movement and countless Hollywood sex scandal allegations, there is another portion of the female population that has been kept silent much too long.
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
t 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:
- You had a vaginal mesh product implanted for POP or SUI that was implanted vaginally (this doesn’t include hernia repair).
- Your TVM implant surgery was completed between 2010 and the present.
- 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.)
- 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.