The FDA has just announced that surgery-free sterilization device for woman, Essure, can have some nasty side effects, according to BuzzFeed News. These include reported pain, perforation of the uterus and pregnancy. CNN reports that Essure will now require a “black box warning” label, meaning that using it is extremely dangerous.
Because of the new FDA restrictions, the company that manufactures Essure will now be required to complete extensive studies on the product.
Many women say that the strong warning that the FDA has given simply isn’t enough. Essure has been on the market for fourteen years and has since accumulated a coalition of 27,000 women against the product on Facebook.
“We are outraged that it appears as if the FDA is going to leave Essure on the market,” the group said. “These studies could take several years, and leaving the device on the market will only put more women’s lives at potential risk.”
The product itself is a metal coiled that it non-surgically inserted into the fallopian tubes. The body builds up scar tissue around that coil, which blocks sperm from ascending the fallopian tubes and fertilizing eggs. A lot of women choose this option because there’s no surgery involved, which definitely seems like a good reason. After all, why go under the knife if it’s not necessary? But according to one study cited by BuzzFeed News, women who have Essure are actually 10 times more likely to need follow-up surgeries than women who have tube-tying surgery in the first place. That’s upsetting news.
What’s even worse about Essure is that because it’s meant to be a permanent birth control device, there’s no clear protocol on how to remove it if problems arise. Extreme measures can be taken to remove it, such as hysterectomy or removal of the uterus and ovaries—more surgeries that the women who chose this product were hoping to avoid.
“I feel as if the FDA truly failed these women,” Madris Tomes, a former FDA contractor, told CNN. “My hope was that they would recommend a recall. How can we trust the FDA to make good decisions regarding safe and effective devices?”
Tomes has been analyzing FDA data on Essure, and presented the agendy with data showing that hundreds of women have had miscarriages, stillborn pregancies, and other problems while using the device, causing more than 300 fetuses to die.
For now, this definitely doesn’t sound look like the most promising birth control option.