Ennis & Ennis, P.A.
An Open Letter To The FDA Why Essure’s PMA Must Be Revoked
09/29/2015 - The FDA has indicated a willingness to entertain public input concerning the safety and effectiveness of the Essure System. The question is whether they will truly listen and acknowledge that the FDA is entrusted to protect the public’s health, not line the pockets of pharmaceutical companies. After extensive research on Essure and attending the September 24th hearing, it is imperative that Essure’s conditional PMA be revoked. It is unclear whether Essure ever actually received final premarket approval. However, if so, it was granted on grossly inadequate, improper and fraudulent data with questionable ethical conduct. To fail to revoke the PMA is morally and ethically wrong and the entire integrity of the FDA will come into question.
To begin, there should be serious outrage regarding the FDA allowing a voting member of an FDA advisory committee to both be employed by a company seeking device approval and make decisions regarding devices which are to be presented to the committee for FDA approval. Cindy Domecus served as Senior Vice-President of Clinical Research and Regulatory Affairs at Conceptus from May 1994- December 2003. During this time, she was actively involved in the development of the Essure device. Ms. Domecus also served as the industry representative on the Obstetrics and Gynecology Device Panel of the Medical Device Advisory Committee for the FDA from March 1995 through January 2001.
Much of Essure’s development and clinical studies performed by Conceptus were undertaken while Ms. Domecus was serving both Conceptus and the FDA. Although the final Pre-Market Approval application was filed on April 19, 2002 after Ms. Domecus had left the FDA, Ms. Domecus clearly wore two hats during this development time and obviously had significant influence over the proceedings. “We have worked closely with the FDA during all phases of our clinical trials and, more recently, during our PMA preparations as well. 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.” 
In fact, when Conceptus presented Essure to the FDA during the Pre-Market Approval process, 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 officer, 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.” 
The continued existence of Conceptus depended entirely on the success of Essure. As such, it was imperative that Essure obtain the PMA by whatever means necessary. A Citizen Petition was filed on February 20, 2015 to the FDA on behalf of thousands of women injured by Essure claiming that the PMA Approval Order for Essure was violated as the PMA process was replete with fraud on the FDA including the altering of medical records of trial participants, failure to report 8 organ perforations from the clinical trial and failure to comply with numerous conditions of the PMA order.  It was clear from the meeting, that the allegations of fraudulent altering of medical records during the clinical trials did occur and these allegations should not be treated lightly. These serious allegations, along with over 5,000 adverse event reports filed with the FDA AND the 16,047 Essure complaints that were never reported by Bayer to the FDA mandate that the FDA revisit their prior conditional PMA of Essure and recall the device.
The clinical trials conducted were also GROSSLY inadequate and defective. Several panel members were horrified regarding Essure’s ‘clinical trials’. It is unconscionable that a medical device, which is permanently implanted into a female’s body, would have so pathetically few participants studied for such an inadequate period of time. How can the FDA ensure a product is safe when information was obtained on fewer than two hundred women after two years? How can Bayer have ZERO data on any nickel testing performed to ensure the product was safe? What about studies regarding the PET fibers in Essure? What studies were done on these exact fibers used to ensure they were safe? This alone should MANDATE the PMA to be revoked as the studies grossly fall below any acceptable standards. Certain panel members were appropriately outraged. Dermatologist Dr. Peter Schalock from Massachusetts General Hospital asked in outrage, “How can Bayer and the FDA have no knowledge of nickel allergies? Where did you test these people? How did you test these people? What did you test them with? Are we just making this up just for fun or is there data?” The well-respected president of the National Center for Health Research Diana Zuckerman even accused researchers of falsifying evidence during clinical research, an accusation that Bayer strongly denied.
Other panel members, particularly Richard Chappell of the University of Wisconsin, were understandably quite critical of the FDA for conditionally approving the device in 2002, without having the gold standard, randomized clinical trial before approving Essure. A recent article in the The New England Journal of Medicine also sharply criticizes the premarketing approval of Essure based on the two nonrandomized, nonblinded prospective studies that lacked a comparator group and enrolled a total of only 926 women. Just 197 (25%) of the women were followed for effectiveness at 2 years, despite the fact Essure is designed to remain in place permanently. Again, it is clear that the PMA must be revoked as there was grossly insufficient data regarding its safety prior to its conditional approval. Finally, much of Bayer’s data should be considered skewed. Some of Bayer’s data is based upon the number of Essure kits SOLD and not women actually implanted. Often, it takes multiple devices to actually ‘successfully’ implant Essure so that data based on kits sold as opposed to women implanted is misleading.
At the recent meeting, it was clear that the FDA was considering every possible avenue to keep Essure on the market, rather than doing what is necessary and revoke Essure’s PMA. Many of the panel’s suggestions were simply not feasible. Not only will these suggestions not work for a variety of reasons real women have experienced, insurance will not cover virtually any of the additional testing and procedures the panel suggested. The panel obviously recognized there is a VAST amount of unknown information regarding the safety of Essure. However, it was astounding and disheartening that the panel and the FDA refuses to consider years worth of real patient information that has been meticulously gathered by the thousands of women who have experienced problems with Essure. These women can provide invaluable information regarding so much of what the FDA panel needs to know; yet they are virtually ignored by the FDA.
These women have gathered years of information including CT scans, operative notes, allergy results, tissue studies, toxicology reports, tissue studies, blood work, MRI scans, pregnancy data and much, much more. Yet, the FDA is considering none of this vital information. Why does the FDA have a compelling need to keep a non-lifesaving, not medically necessary birth control on the market, when it is clearly harming thousands of women? Literally, thousands of women are begging to undergo voluntary hysterectomies in order to rid themselves of the painful device. The FDA claims that it is open to commentary by the public, but refuses to acknowledge or entertain the hard facts and figures concerning the myriad of debilitating injuries this device has caused. One has to ask a resounding WHY. Why is the FDA so invested in keeping the device on the market to the detriment of the thousands of women it has injured and will continue to do so? After all, isn’t it their job to protect these women?
Overall, the entire Essure PMA process was replete with conflicts of interests. It is widely accepted that the clinical trials were woefully insufficient and of little probative value. Additionally, there appeared to be significant fraud committed on the FDA during the Essure premarket process. The FDA panel members should be incensed by the scam that has been perpetrated by Conceptus and Bayer. Most importantly, the thousands of women who are suffering from real and debilitating injuries caused by Essure should sway the FDA. These women are real. Their pain is real. The irreparable damage that has been caused to their families is real. Their pregnancies are real. How many injured women is enough to outweigh the alleged benefit. Is it 5,000? 10,000? 20,000? 50,000? At what point is enough? It is now up to the FDA to maintain the integrity of the PMA process, protect the citizens for whom the FDA is entrusted to safeguard and revoke the conditional PMA for the Essure device.