FDA Holds Hearing On Permanent Birth Control

DENVER (CBS4) – Women who say their lives have been destroyed by a popular form of permanent birth control are getting a chance to testify before the Food and Drug Administration.

The FDA is taking a closer look at a wide range of problems reported with the permanent birth control implant called Essure. The problems include chronic pain, bleeding, headaches, and in some cases unwanted pregnancy.

“We’re finally being heard. It’s been a long battle … years … of trying to be heard,” said Debra Logan who had Essure and then had major surgery to get the implants removed.

Essure has been on the market since 2002. It’s a tiny coil that is implanted in the fallopian tubes, scar tissue forms around the coil blocking the tubes and preventing pregnancy. The FDA says it has gotten more than 5,000 complaints about Essure, including coils migrating, perforating the fallopian tubes, and allergic reactions to the nickel alloy that the coil is made out of.

CBS4 talked to four women who got the procedure and say it has altered their lives forever.

“I now have daily headaches,” said Cassandra Carr, a mother of two who had a hysterectomy to remove the coils.

“I’m in pain all the time. I have back pain. I have hip pain,” said Pamela Ackerman, who currently has the coils but plans to get them surgically removed.

“I started going to all these different doctors for migraines..vertigo.. I had MRI’s done,” said Leah Spencer, who said doctors diagnosed her with a myriad of other ailments before she was able to make the connection to Essure.

“I still have lingering issues. I still have a constant hip pain,” said Debra Logan, who said doctors didn’t believe that her pain was connected to Essure.

Essure is made by Bayer Healthcare. In a statement, Bayer said that its highest priority is patient safety. “We sympathize greatly with any woman who has experienced problems with Essure.”

The statement goes on to say,” The safety and efficacy of Essure, approved by the FDA in 2002 and the only FDA-approved non-surgical permanent birth control method, is supported by more than a decade of science, with more than 10,000 women studied since the device was first developed, and more than a decade of real world clinical experience.”

The FDA called for the hearing in part to respond to a Facebook page called Essure Problems that has 20,000 members, mostly women who complain about the health problems they link to the device. Now those women have a voice with the FDA.

“Just listen to us. We may not be millions of people that are hurt by it, but we are people. We’re humans … we are hurt … so listen and take care of us,” Ackerman added.

The women who talked to CBS4 would ultimately like to see the device taken off the market. The FDA is not considering that during this hearing. The panel will discuss whether use of the implant should be limited, and whether Bayer should conduct more studies.

LINK: Meeting Materials for The Obstetrics and Gynecology Devices Panel

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