In May, women from across the nation gathered in the United States Capitol to advocate for the Medical Device Safety Act (H.R. 2669). For many, the trip was an opportunity to seek consumer protection from the very medical devices that harmed them.
Also known as the MDSA, the bill, recently re-introduced in the U.S. House of Representatives, aims to restore patients’ Seventh Amendment rights in regards to Class III medical devices—granting consumers injured by these products the right to present their experience and evidence of harm in court.
The regulation of medical devices in the United States is a national issue, with roots at the federal level. Here’s why the Medical Device Problems coalition is working to improve regulation and protect consumers who aren’t properly informed of medical device risks.
Amanda Dykeman, 37
Co-Founder of Medical Device Problems, Essure Survivor
“I had the Essure device implanted in 2010. I began experiencing symptoms such as chronic migraines, heavy bleeding, blood clots, pain, severe bloating, and fatigue almost right away, but I didn’t correlate my symptoms to the device because my doctors either hadn’t heard of Essure or were told it couldn’t possibly be Essure causing them.
It’s evident and obvious that we’re up against a billion dollar industry and their lobbyists. That’s why every voice is needed, and everyone must do their part by reaching out to their representatives and asking them to support the Medical Device Safety Act and Medical Device Guardians Act.
We’ve made it too far to quit now.”
Angie Firmalino, 47
President at ASHES, Co-Founder of Medical Device Problems, Essure Survivor
“After finding out [the Essure coils] had migrated and embedded in my uterus, I had an unsuccessful attempt at removing them in 2011, followed by a total hysterectomy in 2014 due to the fragments left from the first surgery from the broken device. I now live with systemic autoimmune conditions that significantly impact the quality of my life.
I made the trip to D.C. to meet with members of the House and Senate to tell them about this bill, what it will do for patients harmed by Class III devices, and ask for their support. This is the third time this bill has been introduced and I want to fight to see it get passed into law.
Personally, this will affect the lawsuits women have filed against Bayer for damages caused by Essure. It will prevent future cases from being thrown out due to the preemption issue, and it will allow us to move forward in a more timely manner.
We’re taking something that has harmed us and using that to fuel our advocacy work to prevent others from being harmed. There is always going to be work to do, but over the years, I look at the progress we’ve made and the people we’ve impacted, and I know that I want to continue to do this work.”
Tess Schulman, 48
Medical Device Problems Administrator, Essure Survivor
“I’m a scientist by education, and like so many others I previously had absolute trust that the FDA was approving only safe and thoroughly tested products, especially medical devices that are supposed to be permanently implanted, like Essure.
Learning how device approvals really work terrified me, and I knew something had to be done to correct this system so that the public is aware and so that what happened to me doesn’t happen to other people.
I’ve been lobbying for medical device reforms with the Essure Problems group since 2015, and now I am part of the bigger coalition that focuses on ALL medical devices: Medical Device Problems.
MDSA is important because if the FDA is going to approve poorly-researched products, patients should be able to seek remedy via the courts if those products later prove to be harmful or defective in the post-market.”
Melynda Fitt, 46
“I found out in or around the summer of 2012 that my device, J&J Ethicon Gynecare Prolift Total A&P pelvic mesh for pelvic organ prolapse, had failed and left me with catastrophic injuries and massive nerve damage throughout my pelvis. I was told it was the ‘gold standard’ of care for women’s pelvic surgery.
My experience with the device, which left me permanently disfigured and disabled also leaves me with the question: “If this is the ‘gold standard’ of care, is it any wonder women’s health in the U.S. is sub-par when compared to other developed nations?
I made the trip to Washington D.C. because I felt it was important to show up and let our lawmakers know the truth of what ‘gold standard’ really means. I view it as my civic duty to warn others of the dangers inherent to the current 510(k) device clearance system. Additionally, I went because my daughters and granddaughters deserve better care than devices that maim them.
On this trip, I learned that we are stronger together. I was reminded that even if they are outgunned, outmanned, and outspent, a small group of determined citizens united in a common cause can change the course of history. Our rights will be restored and Americans will be protected from companies that put profits before patients.”
Amanda Rusmisell, 46
Secretary of ASHES, Legislative Liaison of Medical Device Problems, Essure Survivor
“Essure completely negatively impacted my quality of life, both physically and mentally.
The current system is not working because thousands of patients have been harmed. This is personal not only because it happened to me but because we, as a country, can do better.
Lobbying for MDSA is empowering because the passion to make our devices safer is that important for the generations to come is important.”
Angela Lynch, 39
ASHES Administrator, Essure Survivor
“It wasn’t until 2012, when I started losing hair by the handfuls, migraines and dental issues, that I put it all together.
I’ve been part of Essure problems since there were little over 100 women. There are now over 42,000 women. Once we learned there’s a law in place that protects device manufacturers, I didn’t see another choice.
I think about my children and how easy it is to be a victim of faulty or just bad devices. I have to change it for them, and for all the innocent people whose quality of life has diminished because of greed or lack of regulation.”
Shannon Walsh, 54
“My career as an Intelligence Analyst with the F.B.I. was destroyed by my illness, and it took away my ability to provide for myself and my daughter.
Over the past several years, I have watched so many women suffering from their own illness and injuries speak out for themselves, and on the behalf of others. The only positive thing I could ever name from having Essure is that I have had the great pleasure of meeting so many brave and strong women that are willing to support each other.
This particular trip was very special to me because I was able to meet with women that have been injured by other medical devices, such as breast and hip implants. By standing together, we not only support each other but our voices grow louder and make it harder to be ignored.”
Tonya David, 46
Medical Device Problems Administrator, Mesh Survivor
“I finally consulted with a urologist in Prescott, Arizona [for my stress urinary continence], who immediately suggested a quick, simple, outpatient procedure called TVT. No other options were suggested, and I was never told about any risks. Nor was I told it was a piece of plastic mesh. I had surgery in June 2007.
I was 34 years old, and my life had changed forever. I had a pretty steady decline in health over the next decade. To my horror, I discovered the exact device that was placed in me. It was the Boston Scientific Obtryx TVTO, which went through my pelvic bones and through my obturator nerves. I believe all mesh is bad now, but when it becomes trapped in nerves with TVTO, its nearly impossible to remove.
When they say one in twenty women may commit suicide from mesh complications, that is real. The FDA has failed the American people, and we must act to force the manufacturers to accept responsibility.
I initially was embarrassed to tell my story. But the more you tell it, the more you realize how important it is. All I ever wanted to do was work in healthcare and help others. I just never realized this would be my path. I must have been chosen for a reason, and I will do my best to honor that.”
Lisa Saenz, 50
New York, NY
“When I was first injured by a medical device, Essure, it was because I wanted to be responsible about making the decision to not have children anymore. Being a mother of three daughters, it became important to me to understand the options that were being offered.
Now, I do advocacy work so as not to have the same thing happen to my daughters, and to protect future generations of women long after I’m gone. It’s hard to share the injury experience, because a lot of it is intimate, and it’s private information. So there are a handful of people who feel like, ‘I can’t say that,’ but there are other groups of women who say, ‘No, we need to tell the world.’
I lost the fear of being shamed or saying something in public a few years back because it’s that important. Everyone needs to know that these things will happen and that women are being harmed by medical devices to prevent pregnancy when they’re trying to be responsible. The ultimate goal becomes so much bigger, and the privacy piece disappears. I need to tell my story, so it can help the next person who may be affected by a medical device implant.
I’m here today to meet with the representatives, and hopefully, get their sponsorship on the Medical Device Safety Act. There’s a lot of important other bills, but this one is equally as important because it provides protection for health—not just women’s health—but health and safety overall.”
Julie Lykins, 56
Breast Implant Survivor
San Diego, CA
“I woke up from my surgery with intense itching all over my body. For the next 20 years, I was fairly healthy. In 2010, I was in a severe car accident. I suspected my breast implants were ruptured. I had to pay for an MRI since they are not covered by insurance, which came back negative. It didn’t detect any ruptures.
Over the next 5 and a half years, my health took a serious turn for the worse. I developed almost 50 symptoms and I saw over 50 medical professionals. None of them could figure out what was wrong with me. Thankfully, I saw a story on Facebook about breast implants and it listed all of my symptoms. When I got my implants removed, they were both ruptured.
Three years later, I am now about 85% better. But I still have a few symptoms that could possibly be BIA-ALCL or from silicone that has migrated throughout my body.
I hate to think of others suffering the way I did and not knowing it is their medical device causing their problems. The manufactures need to be held accountable to produce safe, effective devices. Without any accountability, unsafe devices can stay on the market causing harm to many people.”
Michela Boodry, 47
State Administrator for Arizona Essure Group, Essure Survivor
Phoenix Metro, AZ
“I had the Essure device in my body just shy of 6 years. I had a long list of symptoms. After I connected my failing health to the device, I had surgery to remove it. It was discovered during my hysterectomy that I had missing body parts and a strangulating uterus.
Imaging done prior to surgery didn’t show the severity of my condition. I woke up from surgery feeling alive, and the majority of my symptoms were gone. Unfortunately, like many, I have residual health issues. I was recently diagnosed with a rare autoimmune disease. It only fuels my passion and drive to be a voice for others that have been harmed by a medical device industry that is allowed to run rogue
I was outraged that American lives were pawns for these politicians. This 2019 trip was different, the atmosphere has completely changed. Many were familiar with our documentary “The Bleeding Edge” and it was acknowledged that they understood action needed to be taken within the medical device industry sooner than later to protect the American public.
Our representatives are listening. They hear our voices. They encouraged us to keep going and tell others that they want to hear from their constituents. Your weekly letters and calls do make a difference.
When you see what we see on a daily basis—the cries for help, the lives being destroyed, the relief that one has when they realize they’re not alone—it makes everything I have gone through worth it. I’m real, not a faceless number. I want my children to know that no matter what the future brings, I stood, I fought and I made a difference.”
Maria Gmitro, 44
Breast Implant Survivor
“I was harmed by breast implants, which were placed to correct asymmetry in 2014. At the time, I felt confident in my research. I selected the new Mentor Silicone Memory Gel implants. My surgeon said they had fixed all of the issues from the ’90s and these implants were completely safe and newly FDA approved.
Within six months of implanting, I started developing strange symptoms such as fatigue, cognitive issues, skin rashes, and insomnia. Within two years I was so ill, I had to stop teaching to try to focus on my health.
Upon proper explant, I started to regain my health. It was very frustrating to me that I had to give my teaching career for this medical device because doctors could not figure out why my health was failing.
In the spring of 2019, I shared my personal experience with breast implants in front of the FDA at a public hearing. Learning about how medical devices are approved and classified, how adverse reactions have been under-reported to the public, and how the manufactures were protected, I knew it was time to take action.
I witness thousands of people like me harmed by medical devices with no help from industry and the medical field due to lack of awareness, accountability and legal protection.”
Madris Tomes, 46
CEO of Device Events
“When patients can’t sue a manufacturer of a Class III (high risk, implanted device) then physicians are often held liable. Many times these physicians have not been told of the true risks of a device.
The FDA data holds a lot of weight with members of Congress, but it’s very difficult to make it meaningful. I travel to D.C. to help advocates present the data about problems with their devices, but I also go to help educate the members about how device approvals differ from drugs.
It’s a very important message because, until the public and our legislators understand the difference, they will not tighten regulations on device manufacturers.
I learn from every meeting and from every advocate. Even after a device affecting them has been pulled from the market, they are still there to advocate for safer medical devices for all patients.”
If you’re interested in supporting the Medical Device Safety Act, you can email your representatives in Congress using the link below. Follow MedTruth to stay up to date on the legislative developments following the MDSA’s recent re-introduction to the House of Representatives.