FDA recommends 'black box' warning for controversial birth control device

On Monday, the Food and Drug Administration announced it’s asking Bayer, the makers of the permanent birth control device, Essure to conduct more studies to determine if some women using the device face “heightened risks.”

It also issued recommendations for a special “black box warning label” explaining the potential reactions connected with Essure. 

In a Channel 2 investigation, Houston women said the device caused them severe pain and bleeding, which resulted in hysterectomies for some.

There was a congressional hearing to discuss the safety of the product in September, but now the FDA said it will not pull the device from the market, which comes as a disappointment to thousands of women across the  country who filed complaints .

Instead, the FDA issued a checklist for doctors, telling them to warn patients about the possible risks of permanent birth control devices. If you have a complaint about Essure, you can file it online.