Women who say they have been harmed by Essure permanent birth control called on the Food and Drug Administration to recall the device Thursday.
The FDA’s Obstetrics and Gynecology Devices panel heard from women, doctors and health care professionals for and against the permanent form of birth control as the number of reports of serious complications associated with it continues to rise.
Bayer Health Care, the current manufacturer of the device, also testified at the hearing, presenting their research and standing up for the efficacy and effectiveness of Essure.
Take a look at the timeline below to see the our in-depth Essure coverage.
The FDA said that more than 5,000 adverse event reports have been filed with the agency about Essure since it was approved in 2002.
An FDA representative testified Thursday that more than 330 women have reported unintended pregnancies to the FDA, including 69 ectopic pregnancies.
The agency has received more than a dozen reports of deaths related to the device, including premature infants, women who have died from complications and one suicide. Bayer maintains that there have been no deaths directly due to the Essure inserts.
Women report severe bleeding, rashes, chronic pelvic pain, auto-immune disorders and unintended pregnancies. Many women report having all of their reproductive organs removed in a hysterectomy procedure in order to remove the device.
Essure is marketed as permanent birth control without surgery, but ABC15 has followed the story for two years, as a group of a few hundred women who say they've been harmed by the device has grown to more than 20,500.
During the Essure procedure, two metal coils are inserted inside a woman’s fallopian tubes and scar tissue forms to block conception.
At the hearing Thursday, patient after patient told the FDA panel their stories, including several women who participated in the original clinical trials to get Essure approved. They believe the side effects they experienced were not adequately reported.
Women told stories of severe complications and the often disastrous affect they had on their health and families.
The majority of patients implanted with Essure don’t experience serious side effects, but, for the women who do, they are serious.
Many of the women who testified against Essure asked the FDA panel to consider whether it’s worth sacrificing their health so severely to provide birth control for other women when there are other options available.
A Bayer spokesperson told ABC15 today that the company is not in a position to questions the credibility of patients’ experiences. “We want to ensure that any Essure patient who is experiencing pain gets the medical attention and treatment she needs regardless of the cause,” the spokesperson said in a statement.
Bayer representatives testified that there have been more than 1 million Essure system sold worldwide and said there is over a decade of research to support the efficacy of the device.
More than 10,000 women have participated in Essure studies and there are over 3,000 women currently enrolled in further studies of the device, according to Bayer.
But, several doctors and health care industry advocates who spoke Thursday called on the FDA to require more research.
Cynthia Pearson, Executive Director of the National Women’s Health Network called on the FDA to require Bayer to significantly revise their product labeling and patient information booklet to include the kind of severe side effects that have been reported.
She also asked the agency to force Bayer to fund a national registry of Essure patients so that more data can be collected and analyzed about Essure that is not controlled by the manufacturer.
The FDA panel will deliberate Thursday afternoon and present any recommendations for modifications to the physician or patient labeling, and if they believe more research needs to be done on the device.
To see all of ABC15’s reporting on Essure, click here.
