Monday, May 2, 2016

FDA; Federal Deception Agency


Prior to my own failed medical device experience, I had all faith in our FDA. I took their word for it and believed they had the best interest of all american's safety at heart. Never in a million years did I have any reason to doubt that the stamp "FDA approved" meant anything other than "Safe." Now I'm unsure and it scares the hell out of me that American physicians, our doctors, also trust the FDA stamp of approval. 

Let me start off by saying that I'm all for innovation and quickly bringing new medical technology that benefits the majority to market. I actually commend the efforts of FDA regulators working to guide industry on their path to approval. However, I fear some may be taking advantage of the system and playing favorites. 

One example pertains to the controversial female sterilization device known as Essure, and my research reveals troubling information. I wanted to know WHY and HOW?? Why was Essure given special privileges and fast tracked to market? How was the manufacturer always able to predict and obtain FDA approval for its original PMA submission and its subsequently filed supplements. It appears they've always had friends in high places, giving them an extreme advantage over other device manufacturers developing similar technologies.    

Have you ever wondered how silicon valley has raised to medical device "stardom" in recent years? Since the very beginning I noticed a trend that tied in FDA officials, representatives from CMS (Centers for Medicare & Medicaid Services), New Enterprise Associates (Venture Capitalist Firm that funded Essure's start-up),  and Essure developers to Stanford University and its bio-design team. In fact, in recent years the FDA has formalized its collaboration with Stanford to "safely" streamline medical devices to market. 

Recently I discovered a trade association called Medical Device Manufacturers Association (MDMA) based in Washington DC. MDMA provides a platform for the medical device industry to maintain close relationships with key members of Congress, senior staff at the FDA and CMS, and Venture Capital Firms. They frequently hold conferences in fancy hotels conveniently located close to either our nations capital or near the Stanford campus. 

One can't help but wonder what goes on behind closed doors. Innovators and entrepreneurs in the medical device industry, particularly and especially from Stanford, literally have everything they need at their fingertips. In the case of Essure, Conceptus had easy access during pre and post market surveillance to upper FDA officials, Venture Capital Funds, and key CMS officials to grant them the favorable CPT code they desperately needed to gain wide spread market acceptance. 

Realizing this after the FDA has received over 10,000 formal adverse event complaints pertaining to Essure without taking adequate action to protect public safety, one can't help but feel deceived and question the credibility of Essures approval and processes. It's obvious that there is something more to read between the lines in this instance and Conceptus was given an unfair advantage. 

There needs to be further steps taken to improve the transparency of these meetings in order to maintain the publics trust while still inhibiting innovation and promoting streamlined access to medical devices desperately needed to save lives. Closed doors only lead to open minds full of distrust. 
  


written by: Amanda Dykeman
                  opinions are my own

Tuesday, March 1, 2016

FDA FAILED E-SISTERS




While some are satisfied with the decision announced by the FDA regarding Essure yesterday, I personally am not impressed. A black box warning and manufacturer sponsored studies will do nothing to protect women considering this device. I just don't get it. What purpose does the FDA serve if not to protect patients? How can we trust studies when there has already been evidence of fraud in previous clinical trials?
In my opinion black box warnings are useless and nothing more than a cop out for physicians. It's a way for them to avoid lawsuits by claiming they disclosed the warnings to patients and they consented. However, in my experience, they don't always disclose that a drug or device carries the warning. For example, many women were never told that Depo-Provera was given a black box. Its prolonged use can cause osteoporosis and it thins out the lining of the vaginal wall, making you more susceptible to disease and infection. How many women would still prefer that form of contraception during the 3 month waiting period after Essure implantation had they been fully informed??
As for the requirement of more clinical research to further understand if there is a better patient selection suited for Essure, well that's just bullshit! There isn't a single woman on this planet that deserves to be implanted with Essure and I wouldn't wish it on my worst enemy.
For decades researchers have been trying to develop an occluding device intended to sterilize women without incisions and they have all failed due to safety concerns and placement failures. Essure is no different. There are literally hundreds of adverse event reports documenting device migration in the FDA MAUDE database and according to one FOIA document obtained by Essure Problems several have gone unreported... 
     

...factor in all of the perforations that is said to be the most common complication in any operative hysteroscopic procedure and I would say the percentage rate of any subset of women eligible to receive Essure falls around ZERO!! It's no coincidence that Conceptus did not consider the migration complaints in their risk analysis for the design of Essure. They KNEW that the biggest challenge they would face would be migrations and tried to conceal that information! 
This is unacceptable and the FDA has once again failed us! We will not be silenced and we will continue to flood the FDA with information as well as pull in support from our representatives in Congress to have Essure removed from the market. We will rally our sisters to Boycott Bayer and we will call for the resignation of Dr William Maisel, chief scientist and deputy center director for science at FDA's CDRH. 
Maisel has no business calling the shots in women's health as he has no regard for women's safety, proven by his arrest when he was convicted of hiring a prostitute. During our meeting with members of the FDA last month Maisel is the only person in that room that made me feel completely uncomfortable. I could tell by his mannerisms and the way he defended Essure and rushed us through our meeting that he had absolutely no intentions of taking what I had said into consideration. That was proven when he allowed Essure to stay on the market. 
Make no mistake, E-Sisters will not back down and we will stop at nothing to protect the lives of women and their unborn children. Our gloves are off.



*These views are my own and do not necessarily represent the views of Essure Problems. -AD



Tuesday, November 10, 2015

My Speech in Support of the E-Free Act





Good Afternoon,

        My name is Amanda Dykeman. I am one of the original administrators who run and manage the Essure Problems Facebook group. We have over 24,000 members and are growing daily. I am Vice President of our newly formed non-profit organization ASHES, and I am also a victim of Essure.  I was implanted with Essure in 2010 and developed an allergic reaction so severe it caused me to undergo a hysterectomy at age 31.

Angie Firmalino, who I am very proud to call my friend, started the Essure Problems group in 2011.  Angie suffered life-altering injuries, which required several surgeries due to her Essure coils migrating and embedding into her uterus. Angie started the group to warn friends and family members about Essure. Slowly but steadily, the group has grown, as thousands of women with similar horrific stories, has joined to share how Essure has injured them and altered their lives. As our numbers grew and our research intensified, we realized that many things regarding this device and its approval by the FDA, was very, very wrong. Additional administrators were added to manage the growing number of women members, and thus the grassroots movement to advocate about the dangers of Essure began.

As I stand here before you today, this very minute there are 13 women across the country, just from our group, undergoing major surgery in hopes of restoring their health and reversing the pain and agony brought on by Essure.We have over 3,000 of these procedures documented to date, and thousands of women who need surgery but cannot afford it or cannot find a physician to properly remove the Essure devices. Some say we are the minority, but I would like to know where and when in America have we accepted the sacrifice of a ‘minority’ of unsuspecting women simply for the sake of choice and convenience in birth control?  At what point do our severe injuries and surgeries begin to count?   Is it at 10,000 injured women? 15,000? 25,000?   We are women. We are all important. We are NOT sacrificial!


We have been repeatedly lied to. We were told that once the devices were confirmed to be in place that we would never have to worry about unplanned pregnancy again. That was a lie. We were told that because Essure does not contain hormones that there would be no side effects. That was a lie. And we were told that Essure is a safe non-surgical procedure. Also a lie.   These and multiple other lies have led to debilitating, catastrophic, life altering side effects that have not only destroyed our lives, but also the lives of those who love and depend on us.

After years of inaction by the FDA, we are standing before Congress today asking for help. Diverse women from all different backgrounds, beliefs, and political affiliations have been harmed. This campaign is not about choice, and it’s not about being anti birth control. This movement concerns the tens of thousands of women around the world being avoidably harmed by a dangerous and defective medical device, yet the manufacturer remains shielded by its PMA status, a status we believe was fraudulently obtained.

The E-Free Act is designed to revoke Essure’s pre-market approval status. This is an important step that would restore our civil rights, which have been stripped away by the FDA’s expedited approval of this dangerous device. It will allow those harmed by Essure to seek compensation for further medical treatment so desperately needed, and which is currently unavailable to them. The device has irreparably harmed thousands of women and families; yet the manufacturer bears zero liability or responsibility to any of us. They have no incentive to remove it from the market as they profit greatly from the sales without the fear of any liability or accountability to the victims. The manufacturer can act with impunity and it does.  Because of this,  Essure’s Conditional Premarket Approval should be INVALIDATED and REVOKED!

Therefore, we are urging all members of congress, regardless of their political affiliations, to please do what is right by women and support the E-Free Act. We are real. We could be your mother, your sister, your daughter, or someone else that you love, and we deserve to live out the rest of our lives in the best health we could possibly regain after having it stripped away by corporate greed and lies.

Thank you!