Bayer's Essure System for Permanent Birth Control now comes with a new label update to ensure that women considering it are fully informed about its health risks and benefits.
In 2016, the U.S. Food and Drug Administration required the manufacturer to add a boxed warning, as well as a patient decision checklist to the product's packaging. However, plenty of women were still given the birth control device without being adequately informed of its potential dangers.
As a solution, a restriction was issued on April 9 to limit Essure's sale only among doctors and healthcare providers who use the newly approved "Patient-Doctor Discussion Checklist - Acceptance of Risk and Informed Decision Acknowledgement."
Under this mandate, medical professionals need to review the checklist together with their female patients and allow them to sign it before implantation of the contraceptive.
Risks Of Using Essure Birth Control Device
So far, Bayer's Essure System is the only birth control device available on the market, which is offering women with permanent protection without having to undergo a surgical procedure.
The contraceptive comes with permanent coils that are inserted into the patient's fallopian tubes. After three months, new tissue forms around the site, creating a natural barrier that keeps the sperm from reaching an egg cell.
Approved for general sale and distribution by federal regulators back in 2002, the product received flak in 2016 after thousands of female patients came forward with complaints.
They reported that the non-surgical and non-hormonal birth control method had caused depression, accidental pregnancies, uterine bleeding, and abdominal pain. Some also claimed to have experienced device migration.
Bayer's Stand On FDA Restrictions
All of these cases match up with Bayer's statement, which says that risks vary according to the length of time that a patient has been using the contraceptive. It did note some reports of migration, where women complained about their device being dislocated in the pelvis or lower abdominal area.
"No birth control method is 100% effective," says the pharmaceutical company behind the controversial contraceptive. "Ectopic pregnancies (pregnancy outside the uterus) may occur with Essure. This can be life-threatening."
Despite the strong backlash, Bayer remains confident that its permanent birth control device is "safe and effective" option that can benefit female patients. According to the company, this claim is backed up by scientific evidence gathered by the FDA itself.
Besides issuing packaging restrictions, the agency monitored Bayer's Essure System through surveillance studies centering on its safety. The last one was conducted on September 2, 2016, with the results available for viewing online.