In what many would consider a long overdue move, the FDA has recommended a black box warning for Bayer’s Essure contraceptive device. The move comes after an ongoing public outcry and an FDA hearing last fall. The black box warning, if it does indeed make it to the Essure label, is the strongest warning that can be placed by the FDA and is designed to call attention to serious and life-threatening risks posed by a product.
In addition to placing the warning on its product, Bayer has been ordered to conduct additional clinical studies on the safety of Essure as well as include a “patient decision checklist” in the product’s packaging. The goal of the checklist is to “ensure women receive and understand information regarding the benefits and risks of this type of device.”
To the disappointment of many however, the FDA has not required a recall of Essure nor did it remove legal protections to the product that clear the way for Essure lawsuits.
Essure is as a nonsurgical form of permanent birth control. The device consists of two-inch long flexible coils which are inserted into the fallopian tubes via the vagina and cervix. Scar tissue forms around the coils, thereby preventing sperm from traveling down the fallopian tubes and inseminating an egg in the uterus.
The device was first approved for use in the U.S. in 2002. Since that time, the FDA says it has received more than 10,000 complaints about Essure, ranging from pain and abnormal bleeding to tearing of the uterus or fallopian tubes caused by migration of the coils. In addition, more than 600 women have reported becoming pregnant with the device in place and nearly 300 reported pregnancy losses.
According to the FDA, the public and industry will have 60 days to comment on this draft guidance. Given the public scrutiny this device has received from women across the U.S., the FDA is very likely to receive some feedback on its recommendations, especially given the noted absence of an Essure recall.