Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements. All clinical trials must report all data.
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Saturday, January 25, 2014

Bayer Essure harms young mothers: Erin Brockovich fights for their civil rights!

By Marisa Kabas
January 22, 2014 at 10:40 am

When it comes to choosing a method to make sure you don’t accidentally get pregnant, there are a host of options. And for women looking to avoid pregnancy for a sustained period of time, there are more permanent solutions, one of which is called Essure. You probably haven’t heard of this method, but it’s causing a whole slew of problems, and Erin Brockovich (the real one, not the Julia Roberts one) has stepped in.
On the surface, Essure sounds great. It’s a procedure that involves the placement of small, metal coils in the fallopian tubes which cause the body to form scar tissue and, in turn, blocks the tubes and prevents fertilization. The coils are inserted via catheter through the uterus, and it does not require surgery, anesthesia or a hospital stay. Easy peasy.
But it turns out that this miracle birth control, often prescribed to healthy, young mothers not looking to have any more children, could have nightmarish side effects. Cosmopolitan spoke to a number of women who have used Essure, including Mari Hall who was 21 and had just had her second child when she gave it a go.
“I had never heard of it, but my doctor was extremely adamant that it was the safest, quickest and most pain-free route for me,” says Hall, who lives in Tucson, Ariz. “She presented it as my only option.”
She had Essure placed 11 weeks after her daughter was born. Three months later, Hall’s health began to deteriorate. She felt sharp pains in her cervix, fatigue overwhelmed her, and migraines made her black out. And there was the bleeding.
Until recently, Hall thought she would need a hysterectomy. She is now seeking a second opinion.
Apparently the bleeding — along with depression and suicidal thoughts — caused by Essure can be so awful that a woman can literally feel like she is on the brink of death. “At least once a month, I have someone tell me they want to kill themselves,” says Desa, a founder of one of the Essure Problems Facebook Group
The problem here is that women experiencing these horrific side effects have no legal recourse, and that’s why Brockovich stepped in.
According to the Facebook page:
Currently, we CANNOT sue to the manufacturer because Essure is classified as a class three device by the FDA and qualifies for preemption which bars law suits being brought against the manufacturer. Until we change the law, no one can sue. With the help and support of Erin Brockovich, yes THAT Erin Brockovich, we are determined to fix this. Our goals are to have Essure pulled of the market, have the classification of class 3 rescinded by the FDA and get the federal preemption laws changed. These will not be easy tasks, but the membership is committed to making this happen!
Brockovich is using her gumption and know-how to unite the women suffering as a result of Essure, even though the FDA insists there is no link between the procedure and their symptoms.
Brockovich is leaning on members of Congress to investigate not just the Essure device, but also the preemption law that protects it. And she has created a petition to urge Essure’s manufacturer, Bayer HealthCare, to pull the product from the market, an outcome she admits is unlikely.
“We’re probably going to die trying,” she says. “If something does happen, it will happen in years to come. My way to help those who have been harmed is to get them unified, help them use their voices to get somebody’s attention, and to wake up the other consumers to make more informed choices.”
Desa and another administrator have been invited to testify at the shareholder’s meeting for Bayer, the producer of Essure. The meeting is in April in Germany, and they’re currently raising funds to make the trip.
While there are still some doctors who believe Essure is a viable option, the link must be made between the procedure and the devastating side effects. The most important thing when it comes to drugs and procedures is education, and hopefully Brockovich and other leaders will be able to at least educate prospective Essure users so that when they possibly need to have a hysterectomy at 30, it won’t be a total surprise.

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