Emotional testimony at FDA hearing on safety of contraceptive linked to pain
WASHINGTON (KGO) -- There was emotional testimony at an FDA hearing about the safety of a birth control device implanted in a million women.
Essure is marketed as the only non-surgical form of permanent birth control. The label warns about possible pain and allergic reactions.
VIDEO: Protesters in SF demand Essure be taken off the market
Some women testified their pain was so intense, they required invasive surgery to have it removed. They want Essure pulled from the market.
The manufacturer, Bayer, says it's standing by its product.
"Our assessment concludes the overall benefit/risk profile of essure remains positive," said Dr. Patricia Carney, Bayer's medical director for Essure.
Texas resident Christine Cervantes disagrees, "I'm here to say enough. Women deserve and demand better than what this is doing to our bodies."
The panel recommended more research into allergic reactions, adjusting the label, and more training for doctors.
