AMARILLO, TX (KFDA) - Complaints from patients across the country have the FDA calling for a new study of a popular birth control method.
Essure is a form of permanent birth control that works by inserting small coils into the Fallopian tubes that permanently block them off, preventing pregnancy. It is the only non-surgical permanent birth control method that can be inserted in 10 minutes without anesthesia.
This method has been around since 2002.
Now, the FDA is noting an abnormal amount of complaints regarding the method, including fatigue, irregular bleeding, cramping, and pelvic and abdominal pain.
"[These] are all things you can find in individuals who work 40 hours a week," said Dr. Brian Eades, an OB/GYN in Amarillo. "Or are between the ages of 35 and 45 when most people are having permanent birth control done."
Eades has inserted around 100 Essure devices in his career and said only one of his patients has reported experiencing pain.
But the pain can get so bad that women have to get the device removed, which requires surgery, often a hysterectomy.
That's why the FDA is stepping in and requiring Bayer, the manufacturer, to conduct a new study.
"The question is, is this a little more risky than traditional tubal ligation," said Dr. Robert Kauffman, Director of Reproductive Medicine and Infertility at TTUHSC. "That's important information that we as physicians need to counsel our patients on, and right now we just don't have any good quality studies showing that is better or safer than traditional tubal ligation."
Patient error is a big factor in why no effective studies have been conducted.
"You need to have an X-ray study three months after the procedure to see if it's effective," said Kauffman. "One of the large issues in this country is a lot of women don't present for that study and we have no idea what the true failure rate is with this because we don't know how many women actually had good tubal blockage with this device."
Bayer will conduct a five to ten year study to track the success and safety of the product.
The FDA is also issuing a black box warning for the product, and requiring Bayer to include an insert with the device that lists out potential dangers.
Physicians will also be required to go through a checklist with patients before agreeing to use Essure.