WASHINGTON D.C. — Essure Problems — an Essure victim advocacy group — is criticizing the FDA for its reported failure to protect consumers from defective devices, according to Fierce Medical Devices.

However, the FDA’s perceived lack of action has led the group to turn their attention to congress to force more appropriate FDA action.

The new strategy has led the group to ask Rep. Jason Chaffetz (R-UT), the leader of the U.S. House Committee on Oversight and Government Reform, to launch an investigation and possible hearing over the FDA’s actions relating to Essure.

The request came in the form of a letter in which the group claimed trials for Essure “were inadequate and inappropriate from the beginning.”

Studies done to compromise the device’s PMA only covered 926 women with only 25 percent being followed for two years after trial completion.

Essure Problems sees this lack of research as an indicating of negligence on behalf of the FDA and Essure’s manufacturer.

Additionally, it is alleged the FDA ignored thousands of complaints dating back to 2010 with nearly 10,000 total FDA complaints. While the multitude of the complaints has led the FDA to order a black-box warning on the devices packaging and more trials to determine device risk, they are still allowing the product to remain on the market.

Essure Problems claim this puts “a whole new group of unsuspecting women on a path to being harmed by the device with absolutely no legal recourse.”

While the FDA is not taking measures that satisfy defective Essure victims, congress is quickly coming to the victims aid. Rep. Mike Fitzpatrick (R-PA) recently sent a letter to the FDA questioning their process in dealing with complaints and later proposing a bill that would ban Essure from all U.S. markets.

Our Essure Birth Control Lawyers Can Help

Our dangerous device attorneys can help if you or someone you care about was harmed by an Essure birth control implant.

Lawsuits have been filed against the device makers by both patients and their families seeking compensation for injuries caused. You may be entitled to a settlement.

We do not charge any legal fees unless you receive a settlement and we pay all of the case costs. If your claim is not successful for any reason, you do not owe us anything. We put it all in writing for you. Our lawyers will help you file your lawsuit.

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