Essure birth control: Jacksonville woman celebrating FDA ruling on controversial birth control method

A Jacksonville woman who lobbied Congress to take the controversial birth control device Essure off the market is celebrating the new restrictions on the device.

The Food and Drug Administration announced Monday it would add a boxed warning — its most serious type — to alert doctors and patients to problems reported with the nickel-titanium implant.

The FDA ordered its manufacturer, Bayer, to make sure all women are adequately informed of the risks associated with the device.

For Jacksonville's Rebecca Howell, Monday's decision is personal.

“I screamed, I cried, I was just excited," Howell said.

Howell says she suffered painful side effects from the implantable birth control. She had a hysterectomy at 30.

"I felt less like a woman, less like a human,” Howell said, “I became depressed. It was only my faith in God -- and my loving family -- that kept me from ending it all."

While the FDA Monday fell short of pulling the device entirely, it did enact sweeping restrictions.

Howell told Action News Jax: "It’s not our goal, but it’s a step in the right direction [TO] leading toward the final nail in the coffin for Essure.”

Starting immediately, women must be told about the risks in advance before the device is implanted.

The FDA also ordered Bayer to make sure that providers comply. If they do not, there could be criminal and civil penalties.

The company faces numerous lawsuits. In 2016, a “black box” warning was added to the label.

On Monday, Bayer issued this statement, which reads in part: “Patients deserve the most accurate and comprehensive information to help them make their healthcare decisions, and Bayer has educated and continues to educate healthcare providers about the importance of appropriately counseling each patient on the benefits and risks of Essure."

Essure has been sold for more than a decade and is frequently pitched to women as the only non-surgical option for permanent birth control.

It consists of two nickel-titanium coils inserted into the fallopian tubes, where they spur growth of scar tissue and block sperm from fertilizing a woman's eggs. Bayer estimates 750,000 women have received the device since 2002.

The Associated Press contributed to this report.