FDA Panel Discusses Further Testing Of Popular Birth Control Device

DENVER (CBS4) - During a daylong hearing in Silver Spring, Maryland, members of the Food and Drug Administration's Obstetrics and Gynecology Devices Panel heard testimony for and against a popular form of permanent birth control called Essure.

A summary of that hearing indicates that Bayer HealthCare, the maker of the Essure device, presented information about product development and physician training, statistics about safety and effectiveness of Essure, as well as real world experience of the benefits and risks of the implant.

FDA staff members made a presentation about the pre-market review of the product, and safety and effectiveness data it's collected pertaining to Essure.

Then the panel members heard from patients, family members, patient advocates, clinicians, non-profit organization and medical professionals offering a range of views on the benefits and risks of Essure. Numerous patients spoke of adverse events experienced after having Essure implanted.

The panel then discussed recommendations on ways to mitigate the potential risks from the project. The panel expressed a desire for more study of the product, they also called for more information to get in the hands of patients including access to confirmation tests and access to physicians trained in device removal.

There was discussion of modifying the patient labeling to support the decision-making process. And the panel talked about which populations were suited to the product, patients who are not good candidates for laparoscopic or general surgery; and which populations who a less well suited to the product, including women with known metal sensitivity, autoimmune disease, history of pelvic inflammation, and a history of abnormal uterine bleeding.

LINK: Summary of FDA Panel Hearing

The FDA tells CBS4 that there is no timeline for action on the panel discussion, but that this is a top priority for the agency.

In an email an agency spokesperson said, "After considering the recommendations of the advisory committee and docket feedback, the FDA intends to issue communications to inform the manufacturer and the public of any further actions taken by the Agency."

For thousands of Colorado women and their families, the FDA hearing was vindication for the years they've been complaining of side-effects from Essure.

"We're finally being heard. It's been a long battle… years… of trying to be heard," said Debra Logan, administrator of the Essure Problems Facebook page that has 20,000 members, and founder of the Colorado Essure Problems Facebook page.

Essure is a tiny coil that's designed to be inserted into the fallopian tubes, scar tissue forms around the coil, blocking the tube and preventing pregnancy. CBS4 talked to four women who say the implants caused them years of physical and emotional pain.

"We are suffering, and we are standing strong, and we're in support of each other. But we need this taken off the market," said Cassandra Carr, who had a hysterectomy to remove the coils.

Ultimately, these women would like the device recalled, but until that time, they would like the FDA to strip the device of its Class III Medical Device status. The status protects Bayer Healthcare from being sued.

"If that status was taken away from them it would mean that women could go after Essure and Bayer for all the pain and suffering that they've caused us," Logan explained.

Bayer Healthcare says that 750,000 procedures have been done around the world. The FDA has gotten more than 5,000 adverse reports about Essure, but that's less than one percent of the procedures done.

"It doesn't matter if it's one percent whose lives are being ruined. As a human being care about us as one person or a million," Carr added.

LINK: FDA Essure Webpage

Libby Smith is a Special Projects Producer at CBS4. If you have a story you'd like to tell CBS4 about, call 303-863-TIPS (8477) or visit the News Tips section.