Health: PA Congressman Says FDA Should Take Popular Form Of Birth Control Off The Market
PHILADELPHIA (CBS) -- It was supposed to be a permanent form of birth control, but a local woman says it didn't work and nearly killed her. There is new evidence about potential dangers linked to a popular contraceptive used by hundreds of thousands of women. There's an urgent call for action from a Bucks County congressman, who says this device is putting lives in jeopardy.
The device is supposed to help women, but the congressman says the FDA's own data shows it is dangerous. One Montgomery County mom says it nearly ruined her life.
"They're my babies," said Tara Carter. After having three children, Tara and her husband decided they didn't want any more, so she took her doctor's advice to get a permanent form of birth control called Essure. Tiny coils are inserted into the fallopian tubes to prevent pregnancy.
"It was horrible," Tara said. Not only was it painful, Tara, who lives in Montgomery County, says the device slipped. She ended up getting pregnant, and there were life-threatening complications.
"I ended up having a complete hysterectomy," Tara said. "I was 20 weeks pregnant. With that, I lost the baby, lost my uterus."
Devastated, Tara turned to Facebook, where she found Essure Sisters, thousands of women who also had horror stories about the device.
"The FDA needs to take the device off the market to do further studies," said Congressman Mike Fitzpatrick of Bucks County. "If the FDA won't act, Congress should."
Rep. Fitzpatrick says there are hundreds of adverse events linked to Essure reported to the FDA.
"The risks of this device are so great that unborn children have been killed, women have lost lives, tens of thousands have suffered symptoms that they now attribute to the device," said Rep. Fitzpatrick.
In response, Bayer, the maker of Essure, said in part: "Bayer is particularly concerned about statements that may be creating an atmosphere of unfounded fear. The safety and efficacy of Essure is supported by more than a decade of science."
"I'm angry," Tara said. She shares her agony with the Facebook group as she tries to cope with her devastating ordeal.
"It was a nightmare for the whole family," Tara said. "Very hard telling our kids the miracle baby we thought we were going to have was not going to happen. We found out it was a girl. It was very tough."
An estimated 750,000 women have the device. It does have a warning label about potential risks.
The FDA has also issued warnings about Essure over the years for things like potential allergic reactions and slipping out of place. The results of the agency's current investigation are expected in late February.
