Essure Failed To Obtain Valid Premarket Approval
Oct. 9, 2016
There has been an ongoing debate whether the female birth control sterilization device, Essure, legitimately obtained final Premarket Approval from the FDA. The original manufacturer, Conceptus, Inc., filed the Premarket Approval (PMA) for Essure with the FDA as a Class III medical device. PMA is the FDA process of regulatory and scientific review to determine the safety and effectiveness of Class III medical devices. Class III medical devices are ones that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of injury. It was the first time in FDA history that any birth control or female sterilization device was approved for as class III medical device.
The FDA granted original manufacturer Conceptus conditional pre-market approval (CPMA). Conditional Approval provides that the device may be marketed in the US as long as the manufacturer complies with a specified list of conditions. If the conditions are complied with, the device is considered to be preempted, meaning that no state law tort claims can proceed against the manufacturer. While the Medical Device Amendments Act does not expressly prohibit lawsuits based on state law claims, a 2008 US Supreme Court decision interpreted the statute to mean preemption applies and remains the current prevailing law. However, preemption is not always absolute. In order to circumvent preemption, claimants must prove that the approval process was flawed and therefore invalid.
There has been much testimony claiming Conceptus, Inc., committed fraud during the clinical trials, violated the terms of the FDA’s conditional premarket approval of the device and violated several federal laws in the manufacturing and marketing of Essure. Additionally, it is important to note that the Essure PMA was only “conditional.” All conditions were not met, thereby voiding any final PMA. A New England Journal of Medicine (NEJM) article released today was highly critical of the PMA process for Essure and, clearly shows that the initial clinical trials regarding Essure were significantly flawed AND that Conceptus, Inc., failed to comply with the conditions required to obtain final Premarket Approval.
First the clinical trials associated with the conditional approval of Essure were based on two nonrandomized, nonblinded, prospective studies that lacked a comparator group and only implanted 745 women of the 926 enrolled in the trial. The NEJM article found significant fault with the studies (as did several members at the September 24, 2015 FDA panel hearing,) as it considered only women who successfully underwent the procedure. (Data showed a 14% failure rate for first attempt at bilateral coil placement.) Due to the exclusion of 181 enrolled women who were not implanted, the reliability rate was only based on 89% of the study. Additionally, a mere 197 women (25%) were followed for effectiveness at 2 years. Despite the fact that Essure is a foreign object containing nickel and PET fibers is to be permanently implanted; very few women were followed more than one year. It is inconceivable that any intelligent data concerning long-term risks could be obtained from this ‘clinical trial.’
Additionally, final PMA approval was conditioned on Conceptus completing two required post approval studies providing 5-year follow-up data on patients in the premarket approval studies. One study was just published in 2015, 13 years later and 7 years after alleged completion. The other required study remains unpublished. Additionally, the FDA required as a condition of approval a third study evaluating 40 newly trained physicians and their attempted Essure implantations in 20 patients each or 800 patients. This study was not registered and FDA reports show the trial was stopped after enrolling only 514 women. The device was successfully placed in only 458 (89%) of the women. There were 38 device malfunctions, 13 periprocedural adverse events, and no follow-up. This is woefully short of the required 800 procedures to be evaluated.
Finally, the FDA conditionally approved a new model of Essure in 2007. As a condition of this approval, another study with 800 patients was required. Despite the 2007 FDA Amendments Act requirement, this study was never registered at ClinicalTrials.gov. Astoundingly, the FDA permitted this study to be stopped prematurely at Conceptus Inc.’s request after implantation was attempted in only 578 patients. No follow-up data was collected and a significant portions of the study results are redacted on the FDA website. Accordingly, there is virtually no relevant information to be gleaned from these studies.
Clearly Conceptus, Inc., failed to fulfill the required and mandatory conditions as set forth by the FDA in order to obtain the Premarket Approval for the Essure device. Given the grossly inadequate premarket studies and clinical trials, the allegations of fraudulent conduct on behalf of Conceptus, Inc., in altering medical records of clinical trial participants, and the blatant failure to complete the required studies as mandated by the FDA, it is patently clear that the Essure device never achieved valid Premarket Approval. The FDA provided clear conditions and requirements that were to be met by Conceptus, Inc., yet failed to enforce these requirements and conditions. As such, it is clear that Essure never achieved valid Premarket Approval and any conditional PMA should be revoked at this time.
If you or a loved one has been injured by an Essure device, contact attorney Holly Ennis at Ennis & Ennis, P.A. for a free confidential consultation or visit us online at www.EnnisLaw.com and fill out an online form.