text_1: Five-Year Follow-Up Study Further Supports Effectiveness and Safety of the Essure® Procedure as a Non-Surgical, Non-Hormonal Option for Permanent Contraception
text_2: In this news release Bayer HealthCare summarizes a long overdue post-market report on the safety, effectiveness, and tolerability of Essure, an implant and procedure designed to bring about permanent contraception in women. It is the first permanent sterilization alternative to tubal ligation. The Essure implant is a small metal and polyester-like coil that when placed in the fallopian tubes causes an inflammatory response. The resulting scar tissue that develops over a three-month period prevents sperm from entering the fallopian tubes. Given mounting concerns about the safety of this device, it is crucial for any news release addressing safety to present a complete and balanced portrait of clinical research findings. But this news release is unacceptably one-sided. It never mentions that nearly a third of the women originally enrolled in this study dropped out for various reasons that could reflect a bad experience with the device (e.g. adverse events or pregnancy). It also understates the levels of pelvic pain reported by women who did complete the five-year study, and it never discloses that the study’s lead author (and source quoted in the news release) is a paid consultant to Bayer. When Essure was approved in 2002, the FDA required the original manufacturer to monitor the outcomes of women who were enrolled in a clinical trial, upon which the agency’s approval was based, for an additional four years. While this news release summary of the report portrays a successful product and process with few serious side effects, several news stories published days before the news release paint a very different picture. According to articles in the New York Times and other media, thousands of women are now asking the FDA to remove Essure from the market and inform the public about risks associated with the implant. Several others have filed legal action against Bayer, which acquired the implant from Conceptus in 2013. The Times article stated that the FDA has received more than 4,000 adverse event reports on Essure and that the original manufacturer received 16,047 complaints from women who had undergone Essure implants. In addition, ABC News in San Francisco reported that dozens of women staged a protest outside an obstetricians meeting while calling for the implant to be removed from the market. Another ABC affiliate in Arizona reported that the FDA will respond to a “Citizen’s Petition” signed by more than 2,100 women asking that Essure be taken off the market. It’s important that the safety of the device be given a fair public hearing so women considering sterilization can make informed judgments about the implants vis–à–vis tubal ligation. It should be noted that Conceptus, the original manufacturer, failed to report the outcome of the five-year study and that the results were submitted for publication a year after Bayer acquired the device. It’s a disappointment that this summary report was delayed nine long years after the study was completed and 13 years after the FDA approved the device.