Holly Kelly Ennis
Bayer and Essure Back in the Hot Seat
Bayer has certainly struck out this week with negative information concerning Essure being released which was long overdue. First, the FDA released its Interim Results from a required Essure Post Market Surveillance Study, which clearly revealed that Essure patients incurred significantly more problems than patients who underwent a tubal ligation. Next, Bloomberg reported yesterday that Bayer AG failed to report thousands of complaints of injuries caused by the Essure device according to newly unsealed documents. Finally, hundreds of documents were recently made public which had been produced in litigation, but sealed under a confidentiality order. Included in these documents were discussions regarding what Bayer and Conceptus knew about the safety of the Essure device and when they knew it.
Wednesday, the FDA released the Interium Results from a required Essure Post Market Surveillance Study which studied the risks and benefits of women undergoing permanent sterilization with the Essure device compared directly with women having tubal ligation surgery. According to Terri Cornelison, director of the FDA's Health of Women Program in the Center for Devices and Radiological Health, "Early results show that Essure patients tend to have higher rates of chronic lower abdominal and/or pelvic pain and abnormal uterine bleeding compared to women who had laparoscopic tubal ligation. Also, patients with Essure had higher rates of gynecologic surgical procedures-including surgery to removed Essure-than patients who had tubal ligation."
The study enrolled a total of 1,128 patients (340 in the Essure arm and 788 in the laparoscopic tubal sterilzation (LTS) arm). The reliance rate, which represents the number of patients told to rely on the device was 91/8% for the Essure patients and 99.6% the bilateral tubal ligation group. The overall adjusted incidences of reported chronic lower abdominal pain and/or pelvic pain was 9.1% in the Essure group and 4.5% in the LTS arm. The abnormal uterine bleeding was 16.3% in the Essure group and 10.2% in the LTS group. Hypersensitivity and allergic reactions and new automimmune disorders (unadjudicated) was 22.3% in the Essure group, nearly double that of the LTS group of 12.5%. Finally patients undergoing additional gynecologic surgical procedures was 19.7% in the Essure group and 3% in the LTS group. The above results clearly depict the significantly higher incidence of pain, allergic reaction and additional surgery rates with Essure as compared to LTS, depsite Bayer's warranties to the contrary. Essure was heavily marketed as a safer alternative to LTS.
Additionally, yesterday Bloomberg and other new sources reported that Bayer AG failed to report thousands of complaints of injuries allegedly caused by the Essure device to the FDA, according to new unsealed documents. It is noted that even after acquiring Conceptus, the original manufacturer of Essure, Bayer continued the illegal practice of failing to report complaints to the FDA. Conceptus had a backlog of open complaints as early as 2003 and which continued after Bayer started selling the Essure. As far back as 2008, an internal audit by an independent consulting firm warned that the very large backlog of unresolved complaints could be a violation of FDA requirements.
This information has just recently been made public after Bayer sought to have over 99% of the documents it has produced in the Essure litigation, designated as confidential. Dr. Joseph Ross, a physician concerned for public safety, sought to have many of these documents unsealed and the court has permitted hundreds of documents to be unsealed. Included in these vital documents are discussions and evidence concerning whether Essure is safe, what Bayer and Conceptus knew about the device and when they knew it, and what was and should have been shared with the FDA.
What is clear from the revelations this week is the public has an absolute right to know this information that Bayer has been withholding for so long. Additionally, even the Interium Post Market Surveillance Report shows the signigicantly higher injuries caused by the Essure device which typically become worse over time. We should expect to see even higher adverse incident numbers at the 4 year mark on 9/2/2020 and the 5 year final report on 9/1/2021.