Bayer AG (ETR:BAYN) will see some sales restrictions put on its Essure birth-control implant by the U.S. Federal Drug Administration to ensure that women considering using it are given “adequate risk information.”
The FDA said in a statement yesterday it will require new labeling on the product and restrict the sale and distribution of the device only to health-care providers and facilities that provide information to patients about the risks and benefits of the device.
Every patient should fully understand the associated risks
A brochure on the risks and benefits of the device must be reviewed by the prospective patient and it must be signed by the patient and physician performing the process, it said.
Essure is the only permanently implanted birth-control device for women in the market that doesn’t require a surgical incision, the FDA said in the statement.
“Despite previous efforts to alert women to the potential complications of Essure, we know that some patients still aren’t receiving this important information,” the FDA said. “That is simply unacceptable. Every single woman receiving this device should fully understand the associated risks.”