ASHES

  Advocating Safety in Healthcare

E-Sisters

Anecdotal Evidence Counts

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 doesn'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 changed, 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