Looking back again tonight I decided to reread an article posted in the New York Times last November about the updated labeling for Essure. The FDA recommended in addition to a Black Box Warning that Bayer, the manufacturer of Essure, should also develop a new checklist of risks for doctors to review with patients before implanting the device.
The checklist is not mandatory, and according to the article Planned Parenthood has said they will inform patients of the risks and benefits, but will not ask them to sign the checklist out of concern that it is intrusive and burdensome. They also fear it may dissuade physicians from using the implants, and is based on anecdotes rather than scientific clinical trial data.
In a statement referring to the black box warning and the patient checklist Dr Christopher M. Zahn, Vice President of practice for the American College of Obstetricians and Gynecologists stated “Decisions like these should be made based on data that’s appropriately vetted, not a series of anecdotal reports."
Let me first say that to an extent, I absolutely agree. It is extremely important to make decisions in medicine based on sound data. However, the frustration on some of the panel members faces as Bayer repeatedly stumbled through paperwork and mumbled "We don't have that data with us" as they asked questions at the FDA safety hearing organized to reevaluate the safety of Essure in September of 2015, made it apparent that sound and data don't even belong in the same sentence in regards to Essure.
As a result of that meeting, the FDA also ordered Bayer to conduct a post market surveillance study to better understand certain outcomes and events that may be associated with the device when compared to women who undergo traditional tubal ligation. Ummmm.. Should this data not have been collected PRIOR to a massive marketing campaign claiming to be the most effective form of permanent birth control was ignited by Essures original manufacturer, Conceptus Inc? One would think that comparative data to the most internationally performed method of contraception, traditional tubal sterilization, would be imperative.
If this isn't enough to make you question if anecdotal reports filed as adverse event reports by physicians and very real women with serious side effects and complications are more credible then Essures "sound data," then continue reading.
In a 483 recently obtained by Essure Problems it was found during an FDA investigation in December of 2015 that Dr Cindy Basinski, a paid clinical investigator for Essure from Indiana, failed to follow the signed agreement and investigational plan by not reporting serious adverse events to the IRB in a timely manner, and records of each subject's case history was not all accurate and current. It was found that approximately 21% of her 33 subjects reviewed had incomplete medical history screening information at the time of screening for the question "Is there anything remarkable in the subjects health history that has not been recorded?" For example, in one subjects record "menorrhagia" was added to the subjects medical history on 9/2/15, however the screening occurred on 4/3/14. Why go back and add these events to a clinical trial participants prior history? Could it be because they were reported during the clinical trials AFTER Essure placement and Basinski wanted it to appear the event wasn't related to the device?
One could speculate, but you know what they say... First time shame on you, second time shame on me. This would be the second time that some sort of fraud was suspected during clinical trials for Essure. The first was reported in a citizens petition filed with the FDA in February of 2015. In it were claims that medical records from the original trials were altered to reflect favorable data, birth dates were change, and most egregiously, clinical trial participants’ answers were physically crossed out and changed by the applicant as it related to affirmative findings of pain, adverse events, and unusual health related events. These claims were supported by sworn testimony of several of the actual clinical trial participants for Essure (then the STOP device) which the PMA was based on.
I could further prove my objective by pointing out all of the paid consultants and stock holders from Bayer or Conceptus Inc filling positions on editorial boards or publishing pro-essure articles in major gynecological publications like the one Conceptus used to have the nickel contraindication removed from labeling. I could even talk about the physician, Dr Rupal Juran, that spoke from the audience at the FDA safety hearing that claimed to have no conflict of interest even though she came from the exact same co-owned office as the woman sitting on Bayers side of the red tape, Dr Cindy Basinksy. How about the fact that Brazil just suspended commercial distribution of Essure reportedly due to unanswered emails requesting more data to accentuate the safety profile of Essure after receiving several reports from women claiming to suffer from changes in their menstrual bleeding, unwanted pregnancies, chronic pain, perforation/migration of the device, and allergy/sensitivity/autoimmune-type reactions?
Instead, I think I'll just leave you to decide who you would rather trust. There are now over 15,000 adverse event reports associated with Essure filed with the FDA. These reports stem from the unnecessary and avoidable infliction of pain and suffering upon thousands of unsuspecting women. Sadly, most of the reports came only after an awareness campaign was started and women who experienced the pain and suffering themselves stepped forward, did the research, and spoke the truth.
Instances like this show that anecdotal evidence absolutely counts in medicine, and warning flags should be waved and taken seriously. Instead of making patients feel like their life doesn't matter or their voice doesn't count by asking for "sound data" from an extremely biased source, believe them for they are the ones with pure intentions and no conflicts of interest to report.
After all they ARE the data!
Sunday, March 19, 2017
Monday, May 2, 2016
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.
Tuesday, March 1, 2016
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 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.