The FDA has slapped a black box warning on Essure, but many critics and Essure victims say this strictest warning is not enough - they want the permanent birth control device permanently removed from the market.
Along with Essure’s heightened risk warning, the FDA is ordering Bayer to conduct a clinical study, or postmarket surveillance study, to measure the “real-world safety record” of the device. Many complaints to the agency regarding Essure safety have called for the device to be removed from the market until proper clinical trials have been conducted. A consumer petition claims that original Essure clinical trials weren’t conducted properly, and the device shouldn’t have been approved in the first place.
In a statement issued last month, the FDA explained that Essure is an “appropriate option for the majority of women,” but that “some women may be at risk for serious complications,” especially if the device shifts out of position and punctures the uterus or other organs.
And from Dr. William Maisel, chief scientist for the FDA’s device center:
“More rigorous research is needed to better understand if certain women are at heightened risk of complications.”
But how many women are “some” and “certain” women whose lives may be at risk?
Many Essure victims say they were unaware of any risks and didn’t even know that the device required surgery to remove it before having the implant.
One reason that this device is causing serious complications is due to the clinical trials, where specialists are experienced at implanting the coil. The average surgeon may not have experience or training. As well, complications with permanent devices (such as transvaginal mesh) can occur years later.
After Emily suffered many Essure side effects, she needed the Essure coil removed, but it wasn’t that easy.
“My current doctor said he wasn’t familiar with Essure and won’t risk removing it,” said Emily. “I told him that it has to come out because I can barely take care of my three boys with this constant pain. I can’t pick them up without doubling over. He gave me a choice: I could either get hormonal therapy or a hysterectomy. He could find a doctor to remove the coil but a piece of metal could be left behind. After all the research I have done, I tend to agree with him.”
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Meanwhile the Facebook page “Essure Problems” has over 27,000 members, increased from 14,000 last year. If these members are anything to go by, a conservative estimate of members after the three-year clinical trial could total about 60,000 women with Essure complications. The FDA, however, has received about 10,000 complaints of adverse effects since the device’s approval in 2002.