A Digital Publication for the Practicing Medical Specialist, Industry Executive & Investor

No Carolina / New York

FDA Posts Additional Postmarket Information for Essure

Essure: The following quote is attributed to Benjamin Fisher, Ph.D., director of the Reproductive, Gastro-Renal, Urological, General Hospital Device and Human Factors Office in the Center for Devices and Radiological Health  

“The FDA continues to take concerns about Essure very seriously. Consistent with our previous updates, we are committed to continuing our postmarket evaluation of this device and providing updated information periodically. In that spirit, today, the FDA posted the first spreadsheet of adverse event reports pertaining to information received from certain social media sources, in relation to ongoing litigation about this device.

As this information is based on social media posts, these reports may reference information already reported to the FDA and do not necessarily represent new adverse events. The limited information provided in the reports prevents the ability to draw any conclusions as to whether the device, or its removal, caused or contributed to any of the events in the reports. The FDA reviewed the first spreadsheet of reportable events, and the nature and severity of the reports remain consistent with Medical Device Reports (MDRs) received for Essure since 2017.

The FDA received these reports from Bayer, who manufactured and sold this device until 2018. Bayer will continue to provide monthly spreadsheets of reports through April 2021, as well as provide quarterly and final analysis reports evaluating the events reported and how the information compares to other MDRs for Essure. We will continue to ensure that all reportable adverse events identified from this information are submitted to the FDA and made publicly available.”

Additional Information:

  • On April 24, 2020, the FDA granted, in part, Bayer’s request for a variance from some medical device reporting requirements subject to the conditions outlined in a letter issued to Bayer. The variance is limited to MDR-reportable events for Essure that Bayer is, or becomes aware of, from information received November 2016 through November 2020 in connection with litigation regarding Essure and that originated from certain social media information.
  • Although Essure is no longer available for implantation in the U.S., the FDA remains committed to evaluating long-term safety information in women who have received the device, including data from an FDA-required postmarket surveillance study, sometimes referred to as the 522 study.
  • From 2017 to 2019, the majority of MDRs received from Essure were related to potential device removal, as were the majority of reports in the spreadsheet posted today. The FDA expects to have more real-world data from the 522 study about Essure removal, including better information on the reasons for removal and follow-up of patients after removal to assess outcomes. On July 8, 2020, the FDA provided interim results from the 522 study on the Essure 522 webpage.
  • The link to the data file for the first spreadsheet of reportable events is available on the FDA’s “Problems Reported with Essure” webpage. We will post future spreadsheets on this same webpage after the information is received from Bayer and reviewed by the FDA. Bayer submitted a summary of the information in the first spreadsheet through FDA’s Manufacturer and User Facility Device Experience (MAUDE) database.
  • Over the last several years, the FDA has taken a number of actions to monitor the safety of Essure. The agency regularly updates the public about these actions and remains committed to sharing new information as it becomes available.

Additional Resources:

Medical Device News Magazinehttps://infomeddnews.com
Medical Device News Magazine provides breaking medical device / biotechnology news. Our subscribers include medical specialists, device industry executives, investors, and other allied health professionals, as well as patients who are interested in researching various medical devices. We hope you find value in our easy-to-read publication and its overall objectives! Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

More News!

Dr. Sachita Shah, Sr. Director, Global Health, Butterfly Network, "Butterfly is proud to continue improving maternal health equity through Phase Two of the largest-scale handheld ultrasound distribution and training ever conducted in Sub-Saharan Africa. South Africa is an emerging market that continues to have disproportionately high rates of maternal mortality and stillbirth. Patients need easier access to antenatal imaging, and clinicians need better capabilities for screening high-risk conditions that lead to disproportionately worse pregnancy outcomes in rural areas in the public sector. Together with CHAI and GUSI, we can tackle this by making ultrasound much more accessible, so high-risk conditions can be identified earlier in care, which is known to improve outcomes.”
The clinical Study will enroll up to 97 patients at up to 12 European investigational sites. Completion of the study is expected this year, and results will support CE mark and pre-market approval submissions reports Vivasure Medical.
Dr. Michael Newman, Indaptus’ Founder, Chief Scientific Officer, and lead author, commented, “The new data are consistent with our preclinical animal tumor model studies and provide evidence for our hypothesis that patented Decoy bacteria can activate a wide range of innate and adaptive human immune cells involved in fighting tumors.  This aligns with what we’ve observed in our ongoing Phase 1 clinical trial of Decoy20 – broad immune activation, as evidenced by transiently increased levels of many key cytokines and chemokines following single dose administration. These findings bolster our confidence in Decoy20's potential as a multifaceted immunotherapy.”
To further understand the impact of platforms like TikTok on nutrition trends, MyFitnessPal partnered with Dublin City University on a research and experimental study that examined diet and nutrition content on TikTok. The study analyzed over 67,000 videos using Artificial Intelligence to compare them against public health and nutrition guidelines
Leveraging the power of Apple Vision Pro to seamlessly blend digital content with the physical world Osso Health brings the operating experience to life via detailed, clinically accurate workflows of common procedures.

By using this website you agree to accept Medical Device News Magazine Privacy Policy