It wasn’t what many had hoped for – that the FDA would force Bayer to remove the Essure contraceptive device from the market. However, based on feedback from 1300 patients and advocates who left comments at the agency’s website, the FDA has updated and finalized the package warnings to reflect what is known about the adverse events attributed to Essure.
Essure, which as been touted as a “non-surgical alternative” to procedures such as tubal ligation, consists of coils that are inserted into a female patient’s Fallopian tubes. This results in scarring, which prevents the egg from descending into the uterus, thus preventing fertilization.
The FDA has received thousands of reports of side effects that include allergic reactions and hair loss, inflammation, interference with menstrual flow, unusual bleeding, and chronic abdominal pain and fatigue in patients who have received the device. These reports resulted in a meeting a year ago in order to get testimony from patients and medical professionals. This past February, the FDA ordered Bayer to conduct a post-marketing study in order to compare outcomes between Essure patients and those who had undergone tubal ligation.
At that time, the federal regulatory agency also came up with a preliminary draft of a proposed label warning. The original warning noted that “adverse effects have been reported.” The final version now says “patients have experienced numerous adverse events.”
Another change addresses surgical removal of the Essure device, explicitly warning that “if the device needs to be removed to address such an adverse event, a surgical procedure will be required.” Finally, there have been revisions to the patient checklist. This has been divided into headings, each of which addresses specific topics such as alternative contraceptive methods, risks of unintended pregnancies, and other possible long-term side effects.
The language has also been simplified and the section reduced to half a page. According to a spokesperson for the FDA, the new checklist will aid patients to better understand the risks associated with using Essure and make more informed decisions.
Despite the growing number of adverse event reports, Bayer still has apologists for the product among members of the medical community. Surprisingly, these are the Association of Reproductive Health Professionals (ARHP) and the American College of Obstetricians and Gynecologists (ACOG). In comments, both organizations claimed that both the box warning and the patient checklist were based on “anecdotal evidence” rather than the result of scientific study. The ACOG “strongly recommends that the proposed black box warning language for hysteroscopic sterilization devices be revised to reflect only supported clinical data, or eliminated from the labeling requirements.” They would also like to see the checklist eliminated entirely.
Bayer recently received FDA approval to move forward on a post-marketing clinical study that will include 2400 patients. The study will evaluate data on adverse events that have been reported.
Meanwhile, Essure manufacturer Bayer faces over 1000 lawsuits – and a recent decision by two U.S. District judges remanding the cases to state courts may open the door to thousands more. After an attempt to have lawsuits dismissed on grounds of preemption, judges ruled that allegations against the company do not interfere with any federal law protecting it from lawsuits. At the same time, Representative Mike Fitzpatrick (R-PA) has introduced a bill in Congress that would force Bayer to remove Essure from the market and take away any protection under federal preemption laws.