The federal watchdog agency issued new comments on Essure, saying that real-world results don’t support reports of extreme fatigue, depression, weight-gain and other issues associated with the implant.
The FDA said that it reviewed adverse event and complications reports, 5-year post-approval study results and clinical literature on Essure, concluding that there was no reason to believe that the device was connected to the new complaints. The agency added that Essure is 99.83% effective as a means of permanent sterilization, and that rare cases of sterilization failure, as well as certain post-treatment problems, are known issues listed in the product’s labeling.
That’s good news for Bayer and its Conceptus (NSDQ:CPTS) subsidiary, which have come under fire for Essure, even getting the attention of consumer advocate Erin Brockovich, the activist made famous by Julia Roberts’ portrayal in a 2000 blockbuster film. Brockovich wants the device taken off shelves and for Bayer to launch a complete investigation into patient injury claims, she told ABC News.
Brockovich has taken on Essure complaints as an area of investigation, having launched a dedicated website to gather testimonials after her organization was inundated with hundreds of inquiries from women who claimed Essure left them with injuries and chronic pain, including colon perforations caused by movement of the device, implants that have been lost and are no longer visible on scans, pregnancies despite the presence of the implants and debilitating headaches.
Essure is part of the product portfolio that Bayer acquired in the $1.1 billion buyout of Conceptus, which the companies announced earlier this year. Conceptus won FDA approval for Essure in 2002.
Essure is a permanent form of birth control, comprised of flexible inserts that are implanted in the fallopian tubes where scar tissue forms around them. Essure is the only permanent contraceptive option that requires no incisions, the FDA said, and the device contains no hormones and can be placed without need for anesthesia.