The FDA Must Revoke Essure’s PMA To Maintain Integrity

Ennis & Ennis, P.A. reports that in order to maintain its integrity, the FDA must revoke the Pre-Market Approval of the Essure device.
FORT LAUDERDALE, Fla. - July 2, 2015 - PRLog -- The recent “announcement” by the FDA of an updated Essure Web Page and a scheduled public meeting on September 24th to discuss scientific data and potential recommendations is certainly well-received and a step in the right direction. This validates the efforts of thousands of women injured by Essure whose voices demanded to be heard and warned the public of various risks associated with the device.  However, the integrity of the FDA is clearly in question for allowing the conditional Pre-Market Approval of the Essure device in the first place as the process was replete with fraud on the FDA, conflicts of interests and at a bare minimum, the appearance of impropriety.

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 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 PA filing,” said Ms. Domecus.”1

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. 2 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.

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.”3

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.” 4

It appears that 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. 5 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 Essure PMA process was replete with conflicts of interests. Additionally, significant fraud was committed on the FDA during the Essure PMA process.  It is now up to the FDA to maintain the integrity of the PMA process, protect the citizens and not the corporations, for whom the FDA is entrusted to safeguard and revoke the conditional PMA for the Essure device.

Holly Ennis
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Tags:Essure, Injury, Ennis
Industry:Health, Legal
Location:Fort Lauderdale - Florida - United States
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