Popular Birth Control Essure Linked to Hundreds of Fetal Deaths

Hundreds of thousands of women have been relying on what they thought was a safe and reliable form of birth control for the past decade or more, but it turns out that the Food and Drug Administration may have purposefully fudged the numbers to sell more units. A private analyst has been investigating Bayer AG's Essure contraceptive device and has found that hundreds of fetal deaths due to the device may have been covered up.

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Essure was approved by the FDA in 2002, as an alternative to a tubal ligation. A small metal coil is inserted into each fallopian tube, which prevents viable eggs from moving from the ovaries to the uterus. It's supposed to be a pretty freaking excellent way to prevent pregnancy, and many women have preferred it over having their tubes tied because it's not considered a surgical procedure and can be done right in the doctor's office.

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However, over 10,000 women have filed formal complaints about "severe symptoms" from using the Essure, prompting an investigation further into the claim that only five deaths have occurred in the 14 years it's been on the market.

Private analyst Madris Tomes (who used to work for the FDA, by the way) looked further into the reports of complications, and found that at least 303 fetal deaths were linked to Essure. Apparently they don't count fetal deaths as deaths in this situation.

As someone who got pregnant on birth control and then miscarried, I can tell you that it was a devastating loss. I hadn't been prepared to have a child when I got pregnant, but after nearly two months of dreaming and planning, I was heartbroken to learn that my baby had no heartbeat.

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Congressman Mike Fitzpatrick (R-Pa.) has even introduced legislation called the E-Free Act, which would force the FDA to remove Essure from the market. In addition, several women testified at a special FDA panel hearing last September and urged it to reconsider its stance on Essure being a safe form of birth control.

To make things even shadier, Rep. Fitzpatrick claims that he received an unsealed complaint from a federal lawsuit against Bayer that points to illegal kickbacks. He says that the manufacturer "provided illegal kickbacks" to health care professionals to push Essure on women considering permanent forms of birth control. The lawsuit alleges that Bayer offered doctors medical equipment valued at $20,000 for free, with the understanding that they would promote Essure above other options to prospective women.

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Of course we know that birth control isn't always effective, but the number of complaints seems super high to me. I also don't like this minimizing of the number of deaths by not including misscarriages and stillbirths. And if the company really did provide kickbacks to doctors to hawk its product -- that seems like its product isn't good enough to stand on its own.

Essure is still on the market (for now), but women who are considering it might want to think twice before opting for it.

 

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