The Medical Device Safety Act H.R. 2164

The Medical Device Safety Act 2017 H.R. 2164 #MDSA17

The Medical Device Safety Act of 2017 was introduced in the house on April 26, 2017 by Congressman Brian Fitzpatrick. It is a bi-partisan bill currently co-sponsored by Rosa DeLauro, Louise Slaughter, and Jan Schakowsky. The bill would amend the Federal Food, Drug, and Cosmetic Act with respect to liability under State and local requirements respecting all Class III devices. Including, but not limited to, essure, nerve stimulators, hip implants, defibrillators, pacemakers, infusion pumps, surgical mesh, cochlear implants, and breast implants.

There are over 157 Class III medical devices on the market in the USA. Class III medical devices currently fall under federal preemption protection. This is due to the Riegel vs Medtronic supreme court ruling in 2008, when a United States Supreme Court case held that the preemption clause of the Medical Device Amendment bars state common-law claims that challenge the effectiveness or safety of a medical device marketed in a form that received premarket approval from the Food and Drug Administration.

What does this mean? It means that patients who are harmed by Class III medical devices have a very difficult, if not impossible, time pursuing litigation if injured, disabled, or killed by a Class III medical device. The manufacturers are, in essence, protected. Most Class III cases get thrown out on the grounds of Federal Preemption.

The purpose of this bill is to restore a patient’s right to litigation should he/she be harmed by a Class III medical device. Even decades after the FDA’s pre market approval of a Class III device, if it is proven to be ineffective or proven to cause harm, individuals still cannot hold the manufacturer liable for injury, even in the case of a recall.

We are asking for your support of The Medical Device Safety Act 2017, H.R.2164, as our representatives. Please consider co sponsoring in the House, or introducing/sponsoring in the Senate! We are tens of thousands of consumers who have been harmed by, disabled by, or lost a loved one to a Class III medical device. We all deserve the same rights as consumers. Help restore our rights by supporting this bill! Thank you.

#MDSA17

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Public Comments (2,037)
May 25th, 2018
Dinorah T. from Hialeah, FL writes:
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If you have the power to save lives please do it pass this bill we deserve to have a good quality of life free from the dangerous side effects we now know are due to essure implants. For the last six years I have been suffering from extreme lower back pain (nothing medically wrong with my back)sometimes I cannot get out of bed, migraine headaches and foggy brain (nothing in scans wrong in my brain), depression (initially shucked off to post partum and later to aging as there is no logical reason a shrink could find), extreme bloating that makes me look pregnant (people just assume I eat unhealthy which is not true), extreme fatigue (no medical reason even when I sleep a lot), heart palpitations ( nothing wrong with my heart) no reason for high blood pressure from time to time as I have low cholesterol etc, sometimes is so bad I have ended up in the ER ( only to be diagnosed with panick attacks in other words is all in my head) but worse of all an excruciating sharp stabbing pain on my right side from the slightest movements or coughing which takes my breath away. Also an unexplained itching scaly skin on my back which has grown in size in the last five years (dermatologist doesn't know cause). Other women have fared worse with implants moving and damaging their uterus. Manufacturers and doctors need to be held accountable for explaining side effects to patients as no one in their right mind would ever get this implanted in their body. Oh and when I asked my obgyn for removal all he said was it's permanent. So now I am left to find a doctor who can remove this from my body and hopefully give me back at least half of my life back as my kids deserve a mom who is not depressed and has horrible mood swings due to these implants.
May 17th, 2018
Lori S. from Auburn, IN writes:
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I'm a survivor of Da Vinci robotic surgery. I heard nothing but what the aggressive advertising wanted me to hear. I was not told of recalls, product liability lawsuits, deaths or injuries associated with its use. It's time these companies stop being allowed to destroy lives and putting profits before patients.
May 17th, 2018
Lori S. from Auburn, IN writes:
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I'm a survivor of Da Vinci robotic surgery. I heard nothing but what the aggressive advertising wanted me to hear. I was not told of recalls, product liability lawsuits, deaths or injuries associated with its use. It's time these companies stop being allowed to destroy lives and putting profits before patients.
May 17th, 2018
Kimberly N. from Osage Beach, MO writes:
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I got breast implants April 2009 & November 2017, I was diagnosed with bia-Alcl. Breast implant associated anaplastic large cell lymphoma. My silicone textured implants caused me to get cancer. December of 2017, I had to get both removed. As of today I am cancer free, I couldn’t be happier to have those toxic bags out of me. I pray they take these off the market so others don’t endure the pain I have.
May 17th, 2018
Lydia M. from Dania, FL writes:
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I got essure placed in aug of 2012. I was pushed that this was the only way to have my tubes tied. I was not informed on any harm this could cause.. I have suffered with inflammation through my whole body, joint pain, severe bleeding, cramping that feels like I am being stabbed from the inside during ovulation and my period, stabbing pain if I bend torwards my right side, swelling in my feet and hands all the time, brain fog, swollen belly, constant back pain, pain after intercourse, itching all over my body and many other things. I am having essure removed in June and that puts me at risks for more complications that should have never had to happen in the first place. As of now they think a coil has migrated into my uterus but won’t know till surgery. This device is not safe for anyone!
May 17th, 2018
Natasha J. from Milwaukee, WI writes:
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I had Essure removed on April 2016, and though I've seen improvements in my health I still have residual effects and see myself oriole doctors because of the damage caused over the8 years I had it implanted in my body. One coil migrated out of my tube and still hasn't been accounted for, the risk of this product is too high. Please don't let any other women suffer at the hands of this device!
May 15th, 2018
Cynthia B. from Johnson City, TN writes:
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Please don't let more lives be destroyed by the unbridled greed. Medical devices are supposed to help us...not torture and destroy our lives. Citizens are unwittingly being used as human Guinea Pigs by huge corporations for their personal profit. The negligence should not be allowed to line their pockets as they destroy our bodies and our lives. Please help protect us as there is no way it can be stopped without your support. It is too late for many of us...but we can all do our best to prevent these horrors from happening to others. irresponsibility from continuing to run rampant. Respectfully, Cynthia Bruce
May 14th, 2018
Tina S. from Virginia Beach, VA writes:
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I had Essure inserted in 2009 while inserting the doctor had to insert then back out 2 different times on my left side my health has declined more and more every day since. I live with constant back pain and pelvic pain. My teeth and gums are decaying I have lots of memory loss and brain fog. I have stabbing pains in my left side daily and so much swelling on the left side that I looked deformed.
May 14th, 2018
Claudia H. from Newport News, VA writes:
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I began experiencing symptoms and side effects of the Essure permanent implant contraceptive 2-3 years ago. I have been dealing with the following symptoms daily: joint pain- elbows, shoulders, feet, ankles, legs, knees, and my ribs are often sore to the touch, Constant inflammation in my abdomen area (I have to buy pants 2-3 sizes bigger), Swelling in my feet and up my legs, Muscle weakness and pain (hands, legs, arms, fingers, and feet), Dizziness, Headaches/migraines, Extreme weight gain in the past 6 months (unexplained- haven’t changed anything that would influence this). Mood swings, Brain fog (It has affected my speech, I confuse words, get tongue tide, or sometimes stutter), Memory loss, Hair loss, Extreme fatigue/No energy, to name a few...I have menstrual cycles that last weeks at a time...I have lost my quality of life. I have a difficult time just functioning normally without experiencing pain in my body. It's so important to pass this bill, so many people are in similar or worse situations than I am. Some have been diagnosed with autoimmune diseases they may never heal from. Doctors have not informed the women properly who they implanted this device in. I guarantee that no woman, fully aware and knowledgeable of the side effects and risks would have EVER agreed to this implant. I was told it was perfectly safe and that I would not experience any issues, that was a lie. Doctors are still lying to patients, medical professionals are not equipped or properly educated to even address the issues and symptoms of women dealing with these side effects and symptoms. Doctors are getting paid while putting our lives at risk. We need your help to put an end to this!
May 14th, 2018
Cathy T. from Neptune, NJ writes:
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The peek cage spinal implant please has absolutely love my life I thought they were using cadaver and they just took me year to find out what they put in me I am now allergic to all plastics in the last six forever more testing needs to be done !!!!

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