Dive Brief:
- Bayer's Essure is the only FDA approved non-surgical permanent birth control device. Approved in 2002 and sold to up to hundreds of thousands of women, the FDA recently called for an outside panel to review Essure's safety after thousands of women complained of various complications. Some of these include heavy bleeding, pain, depression, hair loss and fatigue.
- The device consists of two nickel-titanium alloy coils. One inserted into each fallopian tube causes scar tissue to permanently block the tube.
- The National Center for Health Research's president Dr. Diana Zuckerman said although Essure is supposed to be 99% effective, recent research suggests it may fail up to 10% of the time.
Dive Insight:
Bayer defends the device's safety. Edio Zampaglione, vice president for women's healthcare, said, "there's a significant amount of data out there regarding the safety and efficacy of Essure. What we believe and feel is that these women represent the small percentage of women who have had a bad experience with it. There's nothing that we do or take in the medical world that is 100% adverse-event free." In a company press release from July, Bayer stated, "The safety profile and efficacy of Essure is supported by more than a decade of science and real world clinical experience."
However, Dr. Zuckerman said there needs to be new research: "What we'd like to see is new research that's carefully monitored that can actually tell us how often women have these serious complications from Essure and how often the product does not work to prevent pregnancy."