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!
-Amanda Dykeman
Showing posts with label #FDA. Show all posts
Showing posts with label #FDA. Show all posts
Sunday, March 19, 2017
Tuesday, March 1, 2016
FDA FAILED E-SISTERS
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
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