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

Take Action! First, Enter Your ZIP Code


Public Comments (2,104)
2 days ago
Someone from South Lyon, MI writes:
Quotation mark icon
Breast implants were poisonous to my body. Had them removed 11 months ago and just started feeling somewhat better
2 days ago
Someone from South Lyon, MI writes:
Quotation mark icon
Breast implants were poisonous to my body. Had them removed 11 months ago and just started feeling somewhat better
2 days ago
Someone from South Lyon, MI writes:
Quotation mark icon
Breast implants were poisonous to my body. Had them removed 11 months ago and just started feeling somewhat better
Mar 16th, 2019
Nicole Z. from Portland, MI writes:
Quotation mark icon
Ive had silicone cohesive gel implants for 9 years and for 9 years, my health has been deteriorating. I was once a fit, healthy, and active young mother juggling college, a full-time job, and 3 kids- on my own. One of those kids I gave birth to the summer before my senuor year of high school. I still managed to graduate, and continued my education, transferring from a community college to a university about a year before i got my implants. I had been a hard worker since age 14, determined not to be like my parents. But now, I'm 34 and ive lost EVERYTHING due to my health. It stafted with a capsular contracture immediately after my surgery. Soon I started developing severe pain throughout my body, and fatigue that never ceased. My capaular contracture was diagnosed as a baker stage 3 just one month after my surgery. I could not afford the revision as I had just devoured my savings, so i put it to the back of my mind. It wasnt long though before i could no longer keep up at school. The pain and fatigue were just too strong. I dropped out 3 months after implants. 3 years after implants, I lost my well paying job. That was 2013. I have not been abke to work since. Fortunately my grandparents have been able to help me to survive, but, ive now drained theur savings as well, and my health is only getting worse. I have developed strange rashes/eczema/hair loss/acne; severe muscle aches/cramps/weakness; every joint in my body is painful & weak; tendonitis in my elbow/wrists/ankles; TMJ disorder and it locks up frequently; heart palpitations; chest pains; shortness of breath; fatigue so severe that I usually sleep the majority of most days; severe anxiety, so much so I rarely leave my house and do not socialize AT ALL; my eyes are dry and my contacts hurt them badly, so much I can only wear them a few hours at a time; daily headaches; night sweats; nausea; my period stopped for 3 years, then when it returned it was extremely painful for the first tine in my life and I had a miscarriage; my Epstein-Barr resukts are always positive; my blood pressure is high; ive gained 40 lbs, my once fast metabolism that kept me muscular and strong has ground to a halt; thyroid issues; cant think clearly, forget words all the time, and cant concentrate. I get overwhelmed by sounds and I'm sensitive to tempurature extremes. It even hurts to brush my hair! Im even sure ive forgotten some things bc I forget everything, those are just the symptoms I can think of off the top of my head. Doctors have had no explanation for why ive been so ill. Most have concluded its just in my head, but once i heard avout breast implant illness, i knew that was the cause. Everyhting, my entire life, was torn to shreds once I got these. Ajd the horrible part is that my symptoms are KNOWN to be associated to silicone implants! The manufacturers own studies showed this- yet I STILL cant get insurance coverage for their proper, safe removal sunxe the FDA has concluded they are "safe". Everyone involved with implant studies knows that is not true even a little bit, yet womens insecurities are still be exploited, lives ruined- kids cheated out of mothers, all over MONEY. Every single person in government who allows this to continue should be ashamed of themselves! I'm 33 and my 89 year old grandma gets around better than i can- that is ridiculous! These need to be banned and insurnace needa to start covering the treatments to allow us to get better. I cant even get a loan to help myself at this point! So, in destined for a life of pure misery since I have no financial resources. If ANYONE reads this who could spare $1, i have a GoFundMe set up: it is "Implants are poisonous" by Nicole zander. Id appreciate any help I can get since our government is failing us at every turn!
Mar 11th, 2019
Someone from Mentor, OH writes:
Quotation mark icon
My implants have been gradually poisoning my body for 11 years . While yes this was an elective surgery, the implants are fda. Insurance covering the explant would certainly cost them less than dozens of symptoms will cost them over the remainder of my life. Please, for all women suffering, please help!
Mar 10th, 2019
Allyse K. from Cottonwood, AZ writes:
Quotation mark icon
I had sientra texture implants and was in so much pain. My brain fog, muscle pain, bladder pain, dryness everywhere, hair falling out, rashes, constant infections, and diagnosis of autoimmune diseases where unbearable... They should be held accountable for the the suffering of many women who went through and are going through this. Help!
Mar 10th, 2019
Allyse K. from Cottonwood, AZ writes:
Quotation mark icon
I had sientra texture implants and was in so much pain. My brain fog, muscle pain, bladder pain, dryness everywhere, hair falling out, rashes, constant infections, and diagnosis of autoimmune diseases where unbearable... They should be held accountable for the the suffering of many women who went through and are going through this. Help!
Mar 9th, 2019
Lisa G. from Harrison Township, MI signed.
Mar 7th, 2019
Jarred S. from Marysville, CA signed.
Mar 7th, 2019
Jarred S. from Marysville, CA signed.

(c) Petition2Congress, all rights reserved. For web site support: email info@rallycongress.com or call (202) 600-8357