Essure is a permanent birth control device meant to help women.
Yes, I said permanent... as in sterilization. They are meant to serve as a low risk substitution for having laparoscopic surgery to block or "tie" their Fallopian tubes.
However, for quite some time, women have been complaining that the Essure devices are causing health problems. The device consists of two metallic coils that are implanted in a woman's Fallopian tubes. They are implanted through the vaginal canal and work by blocking eggs from moving into the uterus. Since hitting the market 13 years ago, there have been over 750,000 Essure devices implanted in women, primarily in the United States. The only studies that have ever been done on them, were done in 2002, when the producer, Bayer Healthcare Pharmaceuticals, Inc., went through the process of gaining approval and launching the product.
Now, the Food and Drug Administration (FDA) is looking into the safety concerns after so many complaints by women. The complaints range all over the board, from allergic reactions to the metal to severe abdominal pain.
Dr. Art Sedrakyan of Weill Medical College of Cornell University led the study, comparing 8,048 women who got Essure implants to 44,278 that had surgical sterilization. They found that 10 times as many women had to have their Essure products surgically fixed in comparison to the women who had surgery in the beginning. This is a huge problem. The women who chose the Essure device, did so in because it is marketed as a surgery free option. However, many of these women wound up right where they didn't want to be - on an operating table, having a second procedure!
"And that surgery is likely to be much more complicated than the laproscopic approach that they should be considering," said Dr. Sedrakyan.
The study team also discovered that, even though these women were not supposed to need general anesthesia, as many as HALF of them were put under at the time of the implantation of the devices. The process of "going under" is dangerous in its own right, with the risks including confusion, pain, lung infections, stroke, heart attack, and death. What is the point of choosing a non-surgical option, if you still need to be put under anesthesia?
While the FDA has stated that this is a "high priority issue", they currently have no plans to pull the product out of use. Bayer states that Essure is safe and they believe their product is fine for most women, even though their own website states that the device may not only cause pain, but could also snap in half and puncture the Fallopian tubes. (Say WHAT?)
Guess how that has to be repaired... you guessed it: Surgery.
Dr. Sedrakyan has no desire to force Essure to be pulled from shelves, but urges that women need to know the truth about the real risks from having the devices implanted. With so many complications, there is no way that Essure should still be marketed as a low risk, minimally invasive option.
Also, all women should be tested for metal and nickel allergies before they have the coils implanted. The simple tests should be a pre-procedure routine. However they aren't being done at all right now.