Essure Problems 

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Essure Problems Press Release 4/18/17

Essure Problems Rallies 2017


FOR IMMEDIATE RELEASE


For more information or questions, please contact [email protected]


DATE: 4/18/17


Women from around the country who have been harmed by the medical device Essure will be holding 20 nationwide rallies on Saturday, May 6, 2017. The main rally site will be San Diego, California, where dozens of women plan to rally outside of the annual ACOG convention. The Essure Problems women have rallied outside of ACOG and AAGL conventions in the past, working to educate physicians about the significant problems with Essure. This year, they decided to make it a national event. The rallies will be peaceful, raising awareness on the dangers of Essure and protesting the continued use of the device. The women will be equipped with photos, banners, flyers, picket signs, and business cards to share information with doctors and passers by. They want to see Essure removed from the market, and won't stop fighting until it is.


To date, 20 locations have rallies scheduled. Details on the rallies can be found on the  Essure Problems Rallies FB Page . The rallies are as follows:


Little Rock, Arkansas; Mesa, Arizona; San Diego, California; Berkeley, California; Denver, Colorado; Jacksonville, Florida; Meridian, Idaho; Portage, Indiana; Kansas City, Missouri; Missoula, Montana; Las Vegas, Nevada; Whippany, New Jersey; Raleigh, North Carolina;  Dayton, Ohio; Austin, Texas; Dallas, Texas; Houston, Texas; Midland, Texas; San Antonio, Texas; and Norfolk, Virginia. Media is invited, and welcome at all locations.


The group also wants to bring attention to legislation being introduced in the US House of Representatives that aims to better protect American consumers’ rights in regards to medical devices. The Bill is entitled the Medical Device Safety Act of 2017.  It will remove immunity from manufacturers of all Class III medical devices, (over 150)  including Essure. This would restore the rights to consumers of Class III medical devices. If harmed, they could seek justice in a court of law. Several members of the Essure Problems group will be lobbying in DC seeking to gain support of The Medical Device Safety Act on May 3rd and 4th. They are fundraising to cover their costs of travel.


The bill reads as follows:


A BILL

To amend the Federal Food, Drug, and Cosmetic Act with respect to liability under State and local requirements respecting devices.

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

This Act may be cited as the ‘‘Medical Device Safety Act’’.

SEC. 2. LIABILITY UNDER STATE AND LOCAL REQUIREMENTS RESPECTING DEVICES.

(a) AMENDMENT.—Section 521 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360k) is amended by adding at the end the following:

‘‘(c) NO EFFECT ON LIABILITY UNDER STATE LAW.—Nothing in this section shall be construed to modify or otherwise affect any action for damages or the liability of any person under the law of any State.’’.

(b) EFFECTIVE DATE; APPLICABILITY.—The amendment made by subsection (a) shall—

(1) take effect as if included in the enactment of the Medical Device Amendments of 1976 (Public Law 94–295); and

(2) apply to any civil action pending or filed on or after the date of enactment of this Act.


For more detailed information on the bill click here http://www.ashesnonprofit.com/mdsa17-hr2164



In an email sent out by Fitzpatrick/Slaughter today:




Cosponsor the Medical Device Safety Act

Sending Office: Honorable Brian K. Fitzpatrick

Sent By: [email protected] gov

 

 

Request for Cosponsor(s)



Dear Colleague,
 
Essure is a permanent sterilization device for women. This medical device is a nickel-based metal coil designed to be inserted into the fallopian tube and cause tissue scarring. It was approved through the Food and Drug Administration’s most rigorous approval process known as Premarket Approval (PMA) in 2002.
 
For tens of thousands, the personal decision to pursue this non-surgical method of permanent contraception left them with debilitating pain, allergic reactions to nickel, loss of teeth and hair, and countless other complications. What’s worse, the defective device led to at least four women’s deaths and nearly 300 miscarriages. Tragically, because of how current law is written, the manufacturer cannot be held liable fortheir deaths or the harm and suffering the device has caused for tens of thousands of other victims.
 
Due to an oversight in a 1976 law, the PMA granted by the FDA bureaucracy completely shields the manufacturer of the device from liability should the device cause severe patient harm or even death. The Supreme Court upheld that interpretation of the law in a 2008 case calledRiegel v. Medtronic.
 
The Medical Device Safety Act, introduced in the 114th Congress, will resolve this injustice and ensure that medical device manufacturers are incentivized to maintain the safest and most effective products for all patients. Nearly 30,000 women have been harmed by the Essure device whose stories have gone unheard. This bill also would ensure that any future PMA device that causes severe injury or death is not exempt from having to answer to the victims.
 
Some may say this will stifle innovative new devices. There is no doubt that innovative medical devices are saving lives every day. The Medical Device Safety Act will do nothing to stifle that innovation. In fact, it will start to align device laws with drug laws, which currently do not get the same blanket liability protection device manufacturers currently receive. Second, this law only affects a small number of devices that are approved each year by the FDA. The vast majority of medical devices, over 4,000 per year, come to the market via an expedited approval pathway known as 510(k). Meanwhile, all of the 510(k) cleared devices currently are subject to liability should they harm or kill patients. Again, the Medical Device Safety Act would simply align that current law and apply it to 60 devices that receive a PMA each year from the FDA.
 
For more information or to cosponsor, please contact Charlotte Pineda in Rep. Fitzpatrick’s office ([email protected] / 5-4276) or Colleen Bell in Rep. Slaughter’s office ([email protected] / 5-3615).
 
Sincerely,

Brian Fitzpatrick  
                                                              Louise Slaughter