A recent letter to Congressman Jason Chaffetz, written by Holly Ennis of Ennis Law and various administrators of Essure Problems, contains an Essure investigation and congressional hearing request. The request is backed by a great deal of sound reasoning and good evidence. It is a long piece, compared to our usual stories on LegalReader, but it is an important piece and, therefore, is reproduced in its entirety below.
A recent letter to Congressman Jason Chaffetz, written by Holly Ennis of Ennis Law and various administrators of Essure Problems, contains an Essure investigation and congressional hearing request. The request is backed by a great deal of sound reasoning and good evidence. It is a long piece, compared to our usual stories on LegalReader, but it is an important piece and, therefore, is reproduced in its entirety below.
“Dear Congressman Chaffetz,
Last week we met with members of your office to discuss the necessity of an investigation and possible congressional hearing concerning FDA oversight regarding Essure and other medical devices. Your employees were understandably appalled by the information of the significant harm the Essure device has caused tens of thousands of women, and the conduct of the manufacturer, Bayer, and the FDA in causing such harm. Sean Hayes requested that we provide additional reasons such an investigation should be undertaken. The information below sets forth compelling reasons such an investigation is necessary.
1. Essure’s clinical trials were inadequate and inappropriate from the beginning. The clinical trials were insufficient as they followed too few women for too short a period of time. The premarket approval was based on two non-randomized, non-blinded, prospective studies that lacked a comparator group and enrolled a total of 926 women. The FDA concluded that Essure was 97% successful after one year; however, this result is based on incomplete and skewed data. Women who did not have successful bilateral Essure placement, became pregnant before the 3-month hysterosalpingogram, or underwent subsequent hysterectomy were excluded from the effectiveness analysis. The data was not based on the 926 enrolled women, as it did not account for 181 women who subsequently chose not to undergo the procedure. The declared success rate was based on only 664 (89%) of the 745 women who underwent an implantation attempt. Among the 745 women who underwent an attempted Essure procedure, only 632 (85%) were followed up at 1 year and ONLY 197 (25%) were followed at 2 years, further limiting the evaluation of adverse events and device safety.
Post approval studies were similarly flawed as is more fully set out in the New England Journal of Medicine article here. http://www.nejm.org/doi/full/10.1056/NEJMp1510514
Additionally, allegations have been made by several clinical trial participants that not only were their medical records visibly altered, but the pertinent information relayed to the clinical doctors, concerns and complaints of pain and other adverse events, were not being acknowledged or reported. To date, 27 women from the original trials have joined the support group Essure Problems, and have expressed severe adverse events from Essure, most resulting in post placement surgery.
Several members of the September 24, 2015 Advisory Panel also questioned the clinical trial protocol, particularly concerning the nature of the non-randomized, non-blinded prospective study and the lack of data on nickel allergies:
SCHALOCK: It was a question for anybody who will answer it. How do we not have data on nickel allergy when we have a device that’s 55% nickel, and 20% of women — approximate numbers — are known to be nickel allergic? Why is there no data? How can you put this in your package insert and then have no clue?
SCHALOCK: Well, considering that they listed it as a contraindication themselves. At least from my understanding, if they’re listing it, are we just making this up just for fun, or is there data? Do we have data? That’s what I want to know.
CHAPPELL: Rick Chappell. I do have a parting comment. Because we are not asked, as part of Question 1 or any other question, to provide FDA with advice under general strategy, but the situation we find ourselves in today absolutely demands it because post-marketing studies behind huge clinical trials, I’d say that post-marketing studies are especially good for detecting rare outcomes. A clinical trial even with a couple of thousand could not detect some rare outcomes. But as Dr. Juran commented today, she showed that many of the medical issues faced by the patients we heard from, as severe as they are, are very common in the general population, pain, et cetera. And so we find ourselves in a situation, 13 years after this device was approved by the FDA, of asking ourselves about pain and bleeding irregularities and other very common outcomes. And we are doing so because this was approved on the basis of a so-called pivotal trial which was not randomized, not controlled; it was single armed. And I say so-called dismissively because I don’t see how a pivotal trial can be a non-randomized, uncontrolled trial. Therefore, I recognize the logistical difficulties, the expense, but therefore, I strongly urge the FDA to abide by its own statement, which it made in 1967, that the gold standard is a randomized clinical trial.
There were also no studies undertaken regarding any adverse or long-term effects of the PET fibers used in the device to create an inflammatory response, which have been the cause of significant harm to the women. Although Bayer and the FDA claims this type of material has been used in other medical applications, it was not tested for use in the mucosal environment of the fallopian tubes, particularly as the study only followed 197 women at two years.
Following the clinical trials, it was presented that Essure was 99.6% effective in preventing pregnancy. In an article published by Yale, Probability of pregnancy after sterilization: a comparison of hysteroscopic 3 versus laparoscopic sterilization, Aileen M. Gariepy, Mitchell D. Creinin, Kenneth J. Smith, Xiao Xu, they determined that pregnancy in women with Essure was 3 to 4 times more likely than women with traditional tubal ligation. http://essureproblems.webs.com/Yale%20study%20on%20essure.pdf
Another study, one recently completed by Art Sedrakyan from Cornell, concluded that patients implanted with Essure have a similar risk of pregnancy but more than a 10-fold higher risk of undergoing reoperations compared with patients undergoing laparoscopic sterilization. This complete study can be found here. http://www.bmj.com/content/351/bmj.h5162
2. Essure received an “expedited approval” due to relationships between Conceptus and FDA, which created a conflict of interest.
Cindy Domecus served as Senior Vice-President of Clinical Research/Regulatory Affairs at Conceptus from May 1994- December 2003, owned stock in the Corporation and was heavily involved in the development of Essure. Ms. Domecus also served on the Obstetrics and Gynecology Device Panel of the Medical Device Advisory Committee from March 1995-January 2001. Much of Essure’s clinical studies were performed while Ms. Domecus was serving both Conceptus and the FDA. Not surprisingly, Essure received a “fast track approval” from the FDA and was granted “expedited review status.” We have been very appreciative of the Agency’s input throughout the course of the Essure product development and of their willingness to consider the least burdensome and most expeditious route to PMA filing,” said Ms. Domecus. Clearly having your Vice President of Clinical Research serve on the FDA Advisory Panel reviewing your device makes the process more “expeditious” and “less burdensome.”
Ms. Domecus made the actual presentation to the board members, some of which were her [very recent] former colleagues. This is most disturbing as it is clearly a conflict of interests and may have biased a committee member’s view of a product advocated for by one of their recent committee colleagues, as well as undermining the objectivity of the FDA advisory process. The public has high expectations for the integrity of the FDA process, particularly for devices capable of debilitating injuries. The bias created by committee members acting on behalf of companies before the current or former colleagues, undermines the objectivity of the process. Furthermore, Essure apparently received a fast track approval with the FDA. Shortly after the PMA was filed on April 19, 2002, Conceptus received notification that the PMA was deemed “fileable” and it was granted, “expedited review status” at a meeting to be convened on July 22-23, 2002. Essure then received its conditional PMA on November 4, 2002. Although a typical PMA process takes over a year, Essure’s PMA was granted in just seven short months. Why was a birth control device granted such a special status?
The device was rushed to Pre-Market Approval, without adequate clinical testing and follow up. Conceptus had already expedited the process by submitting a written proposal to the FDA requesting that the PMA application be filed with one-year data on 350 women in the Pivotal trial, instead of the previously agreed to 400 women, if an effectiveness rate of greater that 99% could be established, which, not surprisingly it was according to Conceptus. In commenting on the accelerated PMA process, Conceptus CEO, Steven Bacich, stated, “We are delighted that clinical results in the pivotal study to date, combined with the results from our Phase II study are so strong. It is the strength of the data from both clinical studies to date, and the expertise of Cindy Domecus and the entire regulatory and clinical research staffs in working together with the FDA, that enable us to pursue an accelerated regulatory time line.”
However, it appears that an accelerated approval time line was critical to the bottom line and existence of Conceptus, which was in significant financial trouble at the time. On June 4, 2002, Conceptus filed paperwork with the Securities and Exchange Commission (SEC) prior to offering 4,000,000 shares of Conceptus stock for sale. In the prospectus, Conceptus noted that it had a limited history of operation and had incurred significant operating losses since inception. The SEC filing also stated, “Essure is our only product and we are wholly dependent on it. Essure may be unsuccessful, which would harm our business and force us to curtail or cease operations. We will need FDA approval before commercializing Essure in the U.S and clinical trials of Essure for that purpose are still ongoing.” http://www.nasdaq.com/markets/spos/filing.ashx?filingid=1781090
(Note: Also of interest is that Ms. Domecus served on the FDA panel, which approved the ablation device, ThermaChoice, manufactured by Gynecare/Ethicon. Susan Aloyan submitted the PMA for ThermaChoice on behalf of Ethicon. Ms. Aloyan was later hired by Conceptus in 2001 and reported directly to Cindy Domecus. Not long thereafter, on October 30, 2003, Conceptus and Gynecare/Ethicon entered into a Joint Marketing or Co-Promotion Agreement wherein Essure and the ThermaChoice ablation procedure would be heavily marketed and encouraged for use together by sales representatives from both companies. This joint venture was entered into before the parties had obtained FDA approval to utilize the ablation and Essure procedures together. This joint venture ended when it was later determined that Essure and ablation procedures were not suited to be performed together.)
It is clear the device should not have been approved in the first place, clearly not in an expedited fashion. Additionally there were no contingent plans of action should the product found to be ineffective at preventing pregnancies or cause harm to the user.
From the transcript of the PMA approval meeting in 2002:
SEIFER: If in five years, the failure rate looks greater than anyone expected, could then there be some kind of contingency plan to follow that for another X amount of time?
ROY: The private investigators would find each of us, bring us back here, and ask us why we approved this.
(Laughter.)
3. The FDA is complicit in actions by the medical device industry it knows to be unethical. For example, the Essure device received its PMA approval with a contraindication regarding sensitivity to nickel as follows:
CONTRAINDICATIONS: Known hypersensitivity to nickel confirmed by skin test (see Warnings section below for patients with suspected hypersensitivity to nickel).
WARNINGS: Patients with suspected hypersensitivity to nickel should undergo a skin test to assess hypersensitivity prior to an Essure placement procedure.
However, when it became inconvenient to have the contraindication, Conceptus applied for and the FDA agreed to have this contraindication simply removed from the product labeling, and a warning implemented instead. The FDA was just as complicit in this egregious conduct as was Conceptus, which based its action on greed in order to gain an edge over its only competitor at the time. “This FDA label decision will further strengthen our competitive advantage and leadership in the permanent birth control market, and we are pleased that we were able to secure it,” said Mark Sieczkarek, president and chief executive officer of Conceptus. “The upgraded label change significantly diminishes the biggest competitive selling point of our competitor’s hysteroscopic sterilization product against Essure, which was the nickel hypersensitivity contraindication. We will be aggressively marketing this IFU change to the OB/GYN community, and especially to those physician accounts that are trialing the competitor’s product primarily because of potential nickel allergy in patients,” said Mr. Sieczkarek. https://globenewswire.com/news-release/2011/08/04/453229/228677/en/Conceptus-R-Announces-FDA-Approval-to-Remove-Nickel-Contraindication-From-the-Essure-Procedure-Instructions.html
4. Known complaints and adverse events regarding Essure go unheeded by the FDA.
Despite knowledge by the FDA of thousands of complaints and serious injuries caused by Essure, the FDA has been recalcitrant in taking any corrective action. As long ago as 2010, the FDA was aware of thousands of complaints regarding Essure made to Conceptus, but which were never reported to the FDA. Excerpts from the attached FOIA report show that on two random site inspections, the FDA discovered over 32,000 complaints, but failed to take any corrective action [note: the FOIA report is not attached to this article]. Additionally, there have been nearly 10,000 Adverse Events Reports filed with the FDA, which is well recognized as under-reported. Members from the Essure Problems Group fought for several years to even obtain a meeting with the FDA to discuss the significant injuries to thousands of women implanted with the device.
5. The FDA’s own reporting system is inaccurate or data is being intentionally misrepresented in order to deceive the public.
The FDA database does not contain accurate information in order for the public to access and ascertain the true dangers of the Essure device. Until very recently, the FDA had listed 5 fetal deaths associated with Essure. Pursuant to an analysis of the data by former FDA employee Madris Tomes of Device Events, the number was actually 303. The FDA recently acknowledged this error in a letter dated to Congressman Michael Fitzpatrick dated April 19, 2016.
More significantly however, Ms. Tomes recently uncovered an unethical practice by Bayer, in unilaterally changing Adverse Event reports it received directly from physicians to make them appear as though they had come from other sources so that less credibility and weight would be attributed to them. Coincidentally, this practice began just after the September 24th hearing was announced on July 17, 2015. A copy of Congressman Fitzpatrick’s letter to the FDA regarding this unethical and possibly illegal activity clarifies this inappropriate behavior.
6. A recent FDA safety alert regarding the dangers of Lubricious Coating Separation was determined not to be applicable to the Essure catheter despite it being the same material and having the same risks. http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm473924.htm
An inquiry from Diana Zuckerman, President of the National Center For Health Research regarding why Essure did not require a warning as it contains the same lubricious coating which can separate yielded this response from the FDA:
‘From: Prasad, Salina (FDA) [mailto:Salina.Prasad@fda.hhs.gov] Sent: Wednesday, December 02, 2015 5:03 PM To: Diana Zuckerman Subject: RE: FDA announcement re device coatings
Hi Diana –
You are correct–Essure does have a lubricious coating. However, the November 23rd Safety Communication focused only on intravascular medical devices that are commonly used during minimally invasive procedures in the cerebrovascular, cardiovascular and peripheral vascular systems. The examples listed in the DSC included intravascular catheters, guidewires, balloon angioplasty catheters, delivery sheaths, and implant delivery systems.
I hope this helps clarify, otherwise I’m around either tomorrow (limited) or Friday for a chat.
Thanks Diana!
Salina’
7. FDA is failing to address blatant Misrepresentations and Warranties by Bayer.
Conceptus and ultimately Bayer have engaged in highly aggressive marketing tactics, saturating the public and medical community, which have been the subject of two whistleblower lawsuits. Additionally, in said marketing materials, Bayer makes various warranties and representations regarding Essure, which are false and misleading. Such misrepresentations include false statements regarding the number of reported pregnancies, that Essure is a nonsurgical or surgery-free option, that Essure is a “gentle procedure that can be performed in a doctor’s office in less than 10 minutes, that Essure is the most effective form of birth control, that there is little to no downtime, that physicians performing Essure procedures must have achieved ‘signed off’ training, and many other false representations. The FDA has taken no activity to address or reprimand Bayer for such marketing tactics despite having done so on other products. For example, the FDA previously fined Bayer for false and misleading advertising for both its Yaz birth control pills and it’s One a Day vitamins.
8. The FDA should avoid even the appearance of impropriety.
Other questionable FDA conduct potentially protecting Essure has occurred at the highest levels. In March 2009, Senator Charles Grassley publicly admonished acting FDA Commissioner and former Chief Scientist, Frank Torti Sr., for an email sent to FDA employees, which was clearly intended to silence whistleblowers. The email came just after nine FDA scientists wrote a letter to President Obama requesting sweeping reform to clean up the “corrupt” FDA. After this letter was sent, the staffers said the FDA spied on their private emails, harassed them and in some cases fired the whistleblowers. Internally the group was known as the “FDA Nine”. Some of the highest-ranking officials were later sued in a lawsuit brought by the aggrieved employees, including Margaret Hamburg, Jeff Shuren and William Maisel.
Torti basically ordered FDA employees not to respond to requests for information under the Freedom of Information Act or even to Congressmen seeking information. What is particularly interesting is that Frank Torti’s son, Frank Torti Jr., had recently joined the venture capitalist firm, New Enterprise Associates (NEA). NEA was a major contributor for the startup of Conceptus. It is imperative for venture capitalists to recoup their investments, particularly in medical devices. Accordingly, any problems with medical devices are often underreported as negative information can impact sales and the ultimate purchase of a medical device company. As such, it was imperative to the Torti family to keep any negative information concerning Essure and other devices under wraps for as long as possible to keep stock prices high.
Furthermore, after Frank Torti’s quick departure from the FDA, Margaret Hamburg was appointed as FDA Commissioner in May 2009. Margaret Hamburg is married to Peter Brown, CO-CEO of Renaissance Technologies. At times, Renaissance Technologies was one of the largest shareholders in, you guessed it, Conceptus. Margaret Hamburg and her husband, Peter Brown, were recently sued in US District Court for the District of Columbia. Hamburg and Brown were sued in their individual capacities, claiming that they had both substantially financially benefitted by Hamburg’s failure to order more adequate information to be put on the label of a controversial antibiotic, Levaquin, because of her husband’s stock interests in Renaissance Technologies. A similar argument can be made concerning the Essure device. Concerns regarding Essure have been virtually ignored until the FDA was finally forced to hold a public hearing on September 24, 2015 after Hamburg stepped down as FDA Commissioner.
During Hamburg’s tenure, the FDA clearly knew or should have known of complaints regarding the device. Two separate facility inspections performed by FDA employees revealed thousands of unreported complaints to Conceptus regarding Essure. During an inspection ending on January 6 2011, FDA investigator, Timothy Grome, reviewed an excel spreadsheet containing 16,581 complaints received on Essure during a 24 month period from 1/1/2008 through 12/6/2010. Additionally, on a subsequent inspection ending on January 26, 2013, the FDA investigator also reviewed an excel spreadsheet depicting complaints received during the 24 month period from 1/1/2011 and there were 16,047 additional complaints. It is unfathomable that the FDA would simply ignore over 30,000 complaints regarding the Essure device. As such, it begs the question, was Hamburg ignoring such complaints, keeping stock prices high? Shortly after the second investigation ended on January 26, 2013, Bayer purchased Conceptus for an astounding $1.1 billion dollars in April 2013.
Finally….. Examples of conflicts and questionable conduct by the FDA are many and varied. Suffice it to say, the FDA no longer serves to act in the best interest of the public, but has become a virtual puppet of the pharmaceutical and medical device industries. NYU professor, Charles Seife summed it up best when stating, “The sworn purpose of the FDA is to protect the public health, to assure us that all the drugs on the market are proven safe and effective by reputable scientific trials. Yet, over and over again, the agency has proven itself willing to keep scientists, doctors and the public in the dark about incidents when those scientific trials turn out to be less than reputable. It does so not only by passive silence, but also by active deception. And despite being called out numerous times over the years for its bad behavior, including from some very pissed-off members of Congress, the agency is stubbornly resistant to change. It’s a sign that the FDA is deeply captured and drawn firmly into the orbit of the pharmaceutical industry that it’s supposed to regulate. We can no longer hope that the situation will get better without firm action from the legislature.”
For the above stated reasons, we believe it imperative that an investigation be opened into the FDA’s actions concerning Essure. This is an urgent situation because on February 29, 2016 the FDA announced their irrational and illogical decision to leave Essure on the market while simultaneously ordering new clinical trials from the manufacturer for the device and placing a black-box warning on the packaging. Please bear in mind that the FDA’s own advisory panel convened for the September 2015 hearing on Essure stated the following:
- the original trials upon which PMA was granted were inadequate (Dr. Chappell’s statement, transcript from hearing, page 265), and
- it would be impossible to go back and properly conduct those trials now because it would take too long (Dr. Chappell, page 267-268)
As such, the FDA has willfully ignored the advice of the experts on its own advisory panel. Not only has the FDA tasked Bayer with managing these new clinical trials (which is unreasonable because of their financial conflicts of interest), but the FDA also gave them an additional 15 months to start conducting them, all while the original PMA status stands!
This puts a whole new group of unsuspecting women on a path to being harmed by the device with absolutely no legal recourse while Bayer simultaneously restarts their original clinical trials on which Essure’s PMA was based. Fraud and/or negligence in the original trials is either being outright condoned at worst or ignored at best, and this is unacceptable when women’s health is at stake.
Due to this outrageous decision on the part of the FDA, the Essure Problems group once again returned to DC last week to meet with members of Congress on various committees to request intervention in this matter. While we were still requesting your support for H.R. 3920 (The E-free Act), we also requested Congress to exercise its oversight powers via the following actions:
- convening a congressional hearing regarding the FDA’s and Bayers’ handling of the Essure crisis
- investigating the overall state of post-market device safety and liability issues, including but not limited to Essure
- revisiting the amendment to the 1976 Medical Device Act introduced by Kennedy, which dealt with liability issues for devices with PMA status, particularly in instances where the original trials used to grant a device PMA status are proven to be inadequate/negligent/fraudulent and have a conflict of interest.
The FDA also ordered more post-market studies and surveillance on Essure in addition to brand new clinical trials. However, the adverse events on Essure in the MAUDE database submitted by Bayer have evidence of soft-coding and downgrading, which is also concerning as more fully set forth above. It is unreasonable to rely on a system which is either deeply flawed or being openly exploited by Bayer to disguise the harm this device is causing.
In essence, the FDA oversight and regulation of this device is failing on several levels, and women all over the United States are bearing the costs of these failures. We are paying with our health, our relationships, our families, and, in some cases, our lives. We are turning to Congress as our only hope in resolving this crisis. Thank you on behalf of the tens of thousands of women suffering with this device.
Holly Ennis, Hckennis@ennislaw.com
Essure Problems Administration
https://www.facebook.com/groups/Essureproblems/
http://essureproblems.webs.com/”
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