“Ariel Grace’s Law” Intended to Remove Essure from the Market
In the summer of 2015, Asheville, N.C. couple Kristiana and Travis Burrell were faced with an unimaginable task: getting through a funeral for the child they didn’t plan to have.
Ariel Grace was born at 27-28 weeks gestation due to the failure of Essure, a birth control method that is meant to permanently prevent pregnancy.
Earlier that summer, Kristiana felt what seemed to be a kick in her belly. After having given birth to six children, she knew that feeling all too well, and immediately visited the doctor. The news she was given astounded her: without knowing it, Kristiana had become pregnant and was 25 weeks into gestation.
Kristiana had chosen to have Essure, a nonsurgical contraceptive device, implanted in her uterus back in 2013. Since it was released in 2002, Essure was marketed under the promise of permanently preventing pregnancy, boasting a 99% success rate. However, just five months after implanting Essure, Kristiana’s doctor discovered that her Fallopian tube was not blocked. To be safe, she began taking a second form of birth control.
So when she was informed in 2015 that she was 25 weeks into a new pregnancy, Kristiana and her husband were not only alarmed, but terribly confused. They did not have long to resolve their feelings, however; just five days after the discovery, Kristiana’s water broke and she began to bleed heavily. A trip to the ER ended in the stillbirth of their daughter, Ariel Grace, at just1 lb 5 oz. in weight and 13 1/4 in. long.
“It was the worst, worst thing that could ever happen. It was the worst time of my life,” Burrell said.
The Burrell family is far from alone in their situation. Since it was released, Essure has harmed more than 25,000 women. Essure users have reported extreme pelvic and abdominal pain, migraines, autoimmune reactions, loss of teeth and hair. In cases like Kristiana’s, the device’s coil also damages the uterus and other organs in the abdominal cavity. If a pregnancy has begun, that damage will cut off blood supply to the baby.
In response to the thousands of cases, Pennsylvania Congressman Mike Fitzpatrick and New York Congresswoman Louise Slaughter have introduced the E-Free Act to Congress. This bill, officially known as H.R. 503, is intended to remove Essure from the market. The bill was introduced on June 7 of this year, just two days after the Burrells buried their daughter. Fittingly, it is more popularly known as Ariel Grace’s Law.
Congressman Fitzpatrick is known for his vocal leadership leading voice in the fight to reform the FDA’s review and approval process for medical devices. Ariel Grace’s Law is one of several bills he introduced this summer, aimed to reform the FDA’s review process and create higher standards of accountability for products marketed for women’s health.
In his speech before Congress, Fitzpatrick said, “The institutions and regulations that are designed to protect our constituents from unsafe devices in these cases and others have failed. It is time we take action to address them.”
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For sexually active women, he effectiveness of birth control depends on how perfectly they use it. For this reason, there are two kinds of effectiveness rates. One measurement is for perfect use, as the method is tested in the lab or used in real life with no mistakes.
The other is typical use, the average including people who don’t always use the method correctly or every time sexual intercourse takes place.Get Answer »