Holly Kelly Ennis
FDA "Updates" Webpage Regarding Essure Sterilization Device; But Little Changes For Essure Victims
This week, the Food and Drug Administration (FDA) updated its webpage regarding the Essure Sterilization Device to reflect the activities and actions taken by the FDA over the last year concerning Essure. Despite requiring a black box warning for the device, the FDA continues to take the illogical position that the benefits of the device outweigh the risks, as long as women are appropriately informed of the risks. The FDA has taken the following actions to monitor the safety of the device.
After considering feedback from the September 24, 2015 Advisory Meeting and comments received through open public dockets, the FDA issued its final guidance on October 31, 2016 for "Labeling for Permanent Hysteroscopically-Placed Tubal Implants Intended for Sterilization." Panel members and the public had made it abundantly clear that the medical device labeling for Essure was not clear and most patients do not receive enough information prior to making a decision. Panel members recommended changes to the patient and physician labeling and more aggressive methods to ensure patients are informed of the risks prior to choosing a birth control method. The FDA created content and format for information to be included in patient and physician labeling regarding the risks of this device including:
*A boxed warning with safety statements to provide the significant side effects or complications associated with the device and potential need for removal. (black box warning) and:
* A Decision Checklist with key items about the device, its use, and safety and effectiveness outcomes. (Patient Decision Checklist)
Unfortunately, as physicians are not "required" to advise patients of the black-box warning, nor provide the patient-decision checklist to the patient, many women are still being implanted with the device without adequate warnings of the risks associated with the device. This hardly meets the level of "aggressive methods" the panel and the public envisioned. Again, the FDA does as little as acceptable to appease public outrage while still trying to placate the pharmaceutical and medical device industries.
The FDA also ordered Bayer to conduct a postmarket surveillance study to gather more data about Essure's risks and benefits. The FDA approved the parameters of the study on September 2, 2016 and will update the study's progress on its website. The study is supposed to commence on May 29, 2017. However, as of today, the study indicates it is not yet open for recruitment. https://clinicaltrials.gov/ct2/show/NCT03127722?term=essure&rank=3. Should be interesting how Bayer plans to enroll 2,800 women to participate in the study by the start date of May 29, 2017. The FDA also completed its evaluation of the Trade Complaint concerning allegations of clinical trial misconduct, including the altering of participants' medical records and other violations of the terms of the PMA. The FDA found that although modifications clearly occurred, this did not evidence that the sponsor purposefully modified patients' responses to create more favorable data and that other allegations, particularly concerning labeling would be addressed with the labeling changes.
The FDA noted that it continues to rely on a variety of postmarket surveillance sources to monitor the safety and effectiveness of the device including adverse event reports submitted by patients, physicians and the manufacturer. It noted the most frequently reported patient problems were pain/abdominal pain(10,746), heavier painful periods (5,377), headache (4,396), fatigue (3,560) and weight fluctuations (3,270). Most reports listed multiple patient problems in each report. There were also reports regarding the device itself including patient-device incompatibility (2,402) migration of the device (1,485), device breakage (617) and multiple problems concerning the difficult in inserting and removing the device. The FDA has also received reports of 1,113 pregnancies with women implanted with the permanent sterilization device. The FDA noted it would continue to monitor and evaluate all past and ongoing data regarding the safety and the efficacy of Essure, and will still likely take no action.
Women seeking more information regarding the Essure device may contact attorney Holly Ennis at Holly@Ennislaw.com, call us at 1-800-856-6405 or visit us online at www.ennislaw.com.