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Essure Woman Used as Human Guinea Pigs

The FDA requires very little in the way of pre-market testing for Essure and other medical devices

Friday, August 10, 2018 - Essure patients will be shocked and dismayed at some of the hidden facts surrounding the FDA testing requirements for the Essure birth control device and how Essure women have effectively been used as "human guinea pigs." According to the Netflix documentary film "The Bleeding Edge" oncologists, as well as their patients, have been kept in the dark as to the fact that very little human pre-market testing of Essure was ever conducted. Most of the Essure doctors interviewed by the documentary assumed that Essure had been tested in human beings and moreover passed pre-market testing on humans to make sure the device was safe before offering it to the public. It was not. According to Dr. Carole, the Director of Public Citizen Health Group" most doctors and patients assume that medical devices have undergone appropriate testing to demonstrate that they are safe and effective before they came on the market and doctors started using them, but for most moderate and high-risk devices, that is not the case."

Essure is a 4 cm coil that is inserted into the vagina, through the uterus and placed inside the Fallopian tubes. Each Essure coil is interwoven with polypropylene fibers that are intended to irritate the Fallopian tissue and create enough scar tissue to block a man's sperm from reaching a woman's eggs.

The film quotes former FDA chairman and whistleblower David Kestler who is on record as opposing the FDA's 501 (k) fast-track program. Kessler states that when it comes to approving a medical device the fast track program was intended to be for exceptions and not the general rule it has become. A medical devices company is able to sidestep pre-market human tests by showing that the device is substantially similar to an already approved device on the market. According to Dr. Kessler "an incredible 98% of all medical devices today use the fast track 501 (k) process." Another doctor went on to say that in many cases FDA approval is "daisy chained" meaning that one device's approval is based on another that was based on another and so forth. Incredibly, some of the devices used in the daisy chain approval process have been recalled from the market because they have failed. A videotape of Essure's approval meeting left many open-ended questions such as what would be a Side Effect of the metal component of Essure on women with metal sensitivity.

Given the FDA's slack in product testing, it should come as no surprise that tens of thousands of Essure women are suffering life-altering side effects of this faulty medical device. According to the film, one Arizona women describe her Essure experience as the device breaking apart inside her making removal impossible and causing auto-immune disorders.

Essure women point out that even though Bayer will remove Essure from the market at the end of 2018, women's adverse health issues may just be starting. Hundreds of thousands of Essure women may be unaware that the health issues they are experiencing are directly related to Essure and are actually Essure side effects. Essure women suffer from so many complications that it is difficult to list all of them. Essure side effects include constant bleeding, severe cramps and pain, organ perforation, infections, allergic reactions, auto-immune abnormalities, migraine headaches and so many more. Essure permanent birth control lawsuits will continue to be filed against Bayer for all the side effects and damage caused to the women that used Essure.

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Onder Law is a St. Louis personal injury law firm handling serious injury and death claims across the country. Its mission is the pursuit of justice, no matter how complex the case or strenuous the effort. The Onder Law Firm has represented clients throughout the United States in pharmaceutical and medical device litigation such as Pradaxa, Lexapro and Yasmin/Yaz, where the firm's attorneys held significant leadership roles in the litigation, as well as Actos, DePuy, Risperdal and others, and other law firms throughout the nation often seek its experience and expertise on complex litigation.