Many women who are suffering from pelvic mesh aren’t aware of how it was invented, approved, and promoted for market. They just know that they live in pain, they’re not sure what help is available to them, and they’re doing their best to make it through each day. The crux of this tragedy lies in the hands of a medical system that has a too-cozy relationship between doctors and pharmaceutical companies, that allows those who have a financial interest in medical devices to conduct and publish their own biased studies, and that fails to accurately track the usage of a new medical device.
The women who are suffering from pelvic mesh – and those who love them – need to know the story behind the scandal to not only to seek justice for the pain that they are enduring but to also ensure that this corruption doesn’t happen again.
Doctors and Pharmaceutical Companies: A Dangerous Relationship Based on Financial Gain
For as long as women have had babies and have grown older, stress urinary incontinence (SUI) and pelvic organ prolapse (POP) have been around. Before pelvic mesh, women had to either live with these conditions, use a pessary (a removable, soft plastic device that supports the organs), or undergo a complicated colposuspension surgery which involves placing sutures in the vagina on either side of the urethra and attaching these sutures to ligaments to elevate the vagina.
Then in 1996, Swedish obstetrician and gynecologist Ulf Ulmsten published a paper explaining his revolutionary new procedure using tension-free vaginal tape (TVT). This option required a less invasive surgery and a shorter recovery time than a colposuspension surgery with seemingly comparable success rates.
Every product or drug has to get tested before it can be approved for market, right? Well, here is the first part of the system that fails patients worldwide. While medications and medical devices DO need to be tested and reviewed, much of the time these reports are conducted by the doctors, scientists, and companies who have a huge financial stake involved. With TVT, Ulmsten’s first paper reported that 84% of the women in his study who suffered from SUI were completely cured and 8% were “significantly improved”. By March 1997, Ulmsten and his colleague, Jan Claren, applied for a U.S. patent for this device and a month later, Johnson & Johnson agreed to pay them $1 million if they could create a second study that had similar high results like the first. In a U.S. trial determining the safety of mesh, Michael Thomas Margolis, assistant clinical professor in the department of obstetrics and gynecology at University of California, Los Angeles, accurately portrayed the conflict of interest as follows: “Prove … that this procedure works and it is safe, and we’ll pay you money … If you don’t prove it, you don’t get paid.” Margolis termed this “wallet driven research.”
Unfortunately, biased research promoting pelvic mesh didn’t end there. Ethicon, a subsidiary of Johnson & Johnson that made and distributed mesh, funded elaborate conferences, gifted incentives, and persuaded doctors and surgeons to promote TVT to their patients. Furthermore, the Ethicon Foundation Fund provides grants, donations, and funding to many of the top surgical colleges in the U.K. and Ireland. One study even found that over 80% of doctors in the U.S. received gifts from mesh companies and another 28% accepted payments. Jonathan Gornall, an investigative journalist for The BMJ, also reported that in the U.S., “Ethicon Endo-Surgery paid out $29.4m in general payments and $1.5m in research. Medtronic paid out $94.2m in 110,000 transactions and invested £5.9m ($7.75m) in over 1000 research initiatives. Boston Scientific paid $33.5m in general payments and $15.5m in research.” These companies have spent more than twice as much money on marketing as they have on research!!!
Marketing Above Testing
Surgical mesh had been used for decades before it was used in the vagina. Polypropylene, a type of plastic, was invented in the 1950’s and by the 1960’s it was used in hernia surgery to reinforce abdominal muscles to prevent organ protrusion. In the U.S., the FDA has a way to fast track products to market if there is “substantial equivalence” to an existing product [this is called a 510(k) clearance]. Pelvic mesh was approved based on hernia mesh. However, the abdomen and vagina provide two very different environments and vaginal mesh was strongly promoted before the true nature of it was fully observed.
- 1998-99 just 214 women in England had treatment for SUI. By 2009, the number rose to 11,365.
- In 2000-2001, 3719 patients underwent colposuspension surgery. By 2016-2017, only 205 patients had this type of procedure.
- By 2014, 29 different vaginal mesh products were offered and between 2005 and 2013, more than 3.6 million vaginal mesh devices were sold worldwide.
These numbers tell us some important facts. First of all, mesh was marketed so thoroughly that it was inserted into millions of women before being properly tested. Next, the safer, tried-and-true method was tossed to the wayside because it was deemed more important to perform surgery quickly with a dangerous device. Finally, mesh is a worldwide epidemic. Not only was it fast-tracked on the U.S. market, but other countries such as England, Australia, and Ireland have heard public outcry from tens of thousands of women who have been irreparably harmed by vaginal mesh.
Living with Mesh
Currently, mesh is either banned or halted around the world except for in the U.S. While great strides have been made, the battle is far from over.
Common sense may cause one to think that if mesh can be inserted with a simple surgery, then a quick surgery is all that’s required to remove it. That’s far from the case. “Because transvaginal mesh is considered a permanent implant, surgery to remove the mesh can be difficult and may increase a woman’s risk of additional complications or symptoms,” explains UCLA Health. “Over time, the tissue grows into and around the mesh, so removing the mesh without damaging the surrounding tissue and organs is a delicate process.”
“[Removal] of vaginal mesh is akin 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,” explained Margolis to the FDA advisory panel in September 2011.
The Agony of Pelvic Mesh
These 20 years since the approval of pelvic mesh, we now know that polypropylene breaks apart in the body. This means that sharp shards of plastic can migrate slicing tissues, organs, and nerves. It can travel into the vagina and slice a penis during sexual intercourse. It can cause chronic pain from internal damage. Pelvic mesh is highly prone to infection due to the bacteria in the vagina causing severe health complications. AND SO MUCH MORE.
Vaginal mesh is banned or halted around the world, but it’s still legal and commonly used in the United States. There are many lessons that we can learn from the devastations of TVM:
- Eliminate pricey incentives that motivate doctors to use a certain medical device above safer methods of care
- Limit influential funding that a Big Pharma company can donate to medical colleges
- Ban “wallet driven research” by monitoring third-party researchers that test drugs and medical devices
- Create a usable patient network in which all side effects and adverse effects can be clearly monitored to review the efficacy and safety of all drugs and medical devices
- Retire the FDA’s 510(k) process which is fast-tracking medical devices based on loosely linked existing products
- Hold Big Pharma accountable financially by requiring payment for patient medical bills and lost wages that have been linked to their health complications to a specific medical device or bad drug
Now, will any of the above happen? That depends on us, the people who are fed up with a system that doesn’t work and an industry that puts profits before people. It’s time we write to our politicians, research the medical products and procedures that our doctors suggest we use, and put our differences aside to unite as one voice.
We may not be able to change the past and the harm that transvaginal mesh has done, but we CAN fight for those who are currently injured and do our best to ensure that future generations are safe from dangerous drugs and devices.