Essure contraceptive implant: Should it stay or should it go?

Posted at 9:18 AM, May 07, 2015
and last updated 2015-05-07 09:18:34-04

A breakthrough contraceptive implant made its way on the market more than 10 years ago.

Thirteen years later, thousands of women want Essure to go, the New York Times reported.

Essure, manufactured by Bayer Healthcare Pharmaceuticals, is a device implanted into women who wish to avoid pregnancy. The stabilization process can be done in a doctor's office, and takes only 10 minutes or so.

Once implanted, Essure acts as a permanent birth control. The device is made of flexible metal inserts and is placed into the fallopian tubes. Scar tissue forms around the coiled inserts for about three months, and creates a barrier between a man's sperm and a woman's eggs, according to the Food and Drug Administration.

Essure, according to the New York Times, is the source of serious complications and injuries for some 4,000 women who've had the procedure. Reports include severe back and pelvic pain, heavy prolonged menstrual periods, damage to the fallopian tubes and other organs, and death.

They’re describing it in stark terms: “It's a constant pain that doesn't go away,” one woman said. “It felt like barbed wire inside of me,” according to another. “It's excruciating,” a third woman said.

Scripps Investigators found a dozen women who wanted to speak out about Essure. Some were too ill to attend the group interview. Seven made it. They all described Essure as a destructive force in their lives.

READ MORE: The women's stories

Women from various United States cities are urging the FDA to remove Essure from the market, and to spread word to the public of its snags.

In Ohio, Kelly Hatmaker is part of the Ohio Essure sisters Facebook group. She had Essure implanted inside her body in April 2014.

"There was no downtime. I wouldn't have to be put under." Hatmaker said.

At 35 years old, she's considering a hysterectomy.

"I didn't think I would have to make that choice."

Bayer markets Essure as a procedure with no surgery, and with few side effects. Hatmaker; however, is calling Bayer's bluff and fighting to get the procedure recalled.

"I am one of those women suffering," she said. "Chronic pelvic pain, heavy menstrual bleeding, fatigue, memory fog, all kinds of symptoms and things that I didn't have a year ago. I know my body. I know what has changed in a year's time and there's no other explanation. I haven't had anything else done.”

KNXV TV station in Phoenix, Arizona, found a case in which a woman died while undergoing the Esure procedure.

Hatmaker said she was never informed of the scary side effect - something she never would have imagined.

"No one should have to die because they chose to quit their family making," she said.

RELATED: Woman dies, report filed with the FDA on Essure coils

According to KNXV, investigators said the death occurred while a doctor was implanting Essure into the woman. A report was submitted to the FDA on February 20, in which a doctor describes the woman's death during the implantation procedure.

The report shows “the patient suddenly coded,” when the doctor was attempting to insert the second coil. A preliminary autopsy report showed the uterus was perforated and there was 500 cc of blood in her abdomen.

“Prior to coding the patient was noted to be shaking a lot and experienced generalized seizure activity,” the report said.

Before the procedure, the report said the woman had no known medical conditions and her vital signs were normal.

The pathologist; however, reported that the cause of death was likely not related to the procedure and Bayer, wrote in its response to the FDA, “we are unable to confirm any quality defect or device malfunction at this time.”

“Death is not a known failure mode related to Essure,” the company’s response said.

A Bayer spokesperson told KNXV that a medical examiner concluded the cause of death was not due to the actual Essure inserts, but they refused to verify that statement.

Bayer told KNXV the information they received about the incident is confidential. The FDA does not release patient information in adverse event reports.

Bayer’s complete statement:
Bayer is aware of a woman who died while undergoing an Essure procedure. We extend our deepest sympathies to her family. While we do not know the exact cause of this tragic event, the medical examiner has determined that the cause of death was not due to the actual Essure inserts. Patient safety is our top priority at Bayer.  We encourage anyone who has questions about Essure to call the Bayer Medical hotline at 1-888-84BAYER for further information.

According to the FDA, patients experiencing problems involving Essure should:
* Seek a thorough evaluation from their health care provider and be sure to receive the proper follow-up.
* Submit a voluntary report about any problems experienced with Essure through MedWatch, the FDA Safety Information and Adverse Event Reporting program. The FDA reviews the MedWatch reports and takes any necessary action to protect public health. Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices.

(E.W. Scripps Company reporter John Genovese contributed to this report.)