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.


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Public Comments (2,062)
Jan 11th, 2019
Patricia S. from San Tan Valley, AZ writes:
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Breast implants causing body damage for years. The damages done are too many to list. As long as manufacturers continue to supply them, with no warnings of the dangers innocent victims will continue to trust the medical industry to implant these bags, and end up with toxins, mold, fungus and so much more destroying their lives, and won't have a clue why they feel so awful all the time.
Jan 6th, 2019
Christina B. from Phoenix, AZ writes:
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I have been harmed by breast implants. I have been terribly ill with a multitude of issues the last many years and now know tens of thousands of other women have become sick since getting implants. I had my impla ts removed after havibg them for 12 years amd finally feel better and have a little hope for finally being able to restore my health someday. Breast Implants are dangerous and need to be outlawed. Women all over the world, including myself, are made to believe that these are safe and there are no risks involved to your health. That is just not true and laws need to be in place to hold manufacturers responsible for producing products that harm peoples health.
Nov 28th, 2018
violeta C. from Huntington Beach, CA writes:
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I’m a mother of four that had essure implanted in 2015. My health started declining with in a few months. I have suffered with crimpling shocks in my Pelvis. My stomache extension has increased dramatically , I look like I’m 5 months pregnant. I have had continued joint pain to extreme headaches. I have brain fog and loss of eye sight. My health continues get worse and worse. I felt like I was lied to and made to feel as though this was a safe and effective way to avoid having children. I hate Bayer for continuing to supply doctors with the tools to harm women. How could the FDA continue to ignore the countless women who came forward with symptoms that all mimicked each other’s?
Nov 12th, 2018
Jamie H. from Phoenix, AZ writes:
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MENTOR BREAST IMPLANTS-SALINE AND SILICONE are slowly rotting in women all over the world and killing us. Please help stop this savage esthetic practice that is "elective". We wouldn't have signed up if we would have been told, you will look great but you will slowly die and fade away... devastated in AZ.
Oct 9th, 2018
Someone from Lake Katrine, NY signed.
Sep 3rd, 2018
Someone from Inver Grove Heights, MN writes:
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My issues started with Essure in 2003 when I was implanted with the medical device from hell . I was a heathy mother of 5 until I was implanted with the demonic device that earned me several more surgeries ... DNC / Ablation / pelvic and bladder mesh surgery and then a hysterectomy / along with countless other ailments in between ... How do companies get by with throwing these sub-par devices into the market with short term testing and data . Then when the device starts to fail they just keep selling it to unknowing victims . All along the way Dr.’s are hearing the complaints and keep implanting these devices and reap the rewards from their patients needing endless follow-up surgeries . Greed in this country is killing us !!!!
Aug 24th, 2018
Maria M. from Los Angeles, CA writes:
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I am victim from Essure device this has harmed my health has destroy my hopes my dreams and my plans for the future and my children’s life I want to change my culture by going back to school get a career but because this device I cannot do or work because all the time I have pain always there is something wrong with me is like my whole body is falling a part I wanted to teach my child by been a sample we could change but the only my children see her mother suffering and pain they help me and take care of me is not fare no child should see a mother suffered
Aug 23rd, 2018
Someone from Endicott, NE writes:
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Our daughter was definitely harmed by the mesh. It has now been nearly a year since she had the mesh removed from a Las Vegas doctor who is experienced in doing this procedure. She is disabled to the point where she is in terrible pain every day. Pain pills are a necessity to live, which is not good. This is not good to live this way. Why is this mesh still on the market? With so many lawsuits by injured people, whoever manufactured this mesh should not be in business. What a horrible way to live from unbearable pain each and every day.
Aug 23rd, 2018
Melissa A. from Washington, PA writes:
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Essure has taken away my life. My husband left, I had to have a full hysterectomy & thanks to that, medication I was on was no longer effective because the entire chemical makeup of my body changed due to surgical menopause. I’m no longer the woman/mom/wife I once was. And I’m in pain. Everyday.
Aug 22nd, 2018
Someone from Hancock, ME writes:
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One of many Essure victims. I was perfectly healthy never went to the doctor for any abdominal pain or feeling like I had the flu every single day until I had Essure. After that my whole life changed and not for the good not to mention how hard it was for my children to me the way I was physically and emotionally. I had never had surgery and didn’t want to if I could help it. Essure gave me THREE surgeries! After my second surgery which was a full hysterectomy I had internal bleeding and I had to go back into surgery because I was loosing blood faster than they could give it to me. The first surgery was to remove large cysts that were plastered to my ovaries. That was 4 hours. This is just my one story out of thousands of other women who have been injured by Essure.

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