A federal lawmaker is working on legislation that would allow women to sue a birth control manufacturer.
Two years ago, Channel 2 Action News first investigated complaints about the permanent birth control Essure having life-altering side effects.
Channel 2’s Erica Byfield met with six women Friday who say they’ve all been a victim of those side effects. They say they've lost hair, teeth, and been in horrible pain, and they don’t want anyone else to feel that way.
“There are some days that I can’t get out of bed,” Jennifer Morgan said.
“People just want to die. They would rather die than go through this pain,” said Savannah Greene.
All six women are mothers who say they now have a lifelong bond because they had the permanent birth control procedure that forever changed their lives.
“I developed paralysis in my feet, numbness in my legs,” said Catherine Lockhart.
The FDA approved Essure in 2002. It is said to be a less expensive and easier alternative to tubal ligation.
It uses coils made of nickel and polyester fibers.
Doctors place the coils in the fallopian tubes and eventually tissue grows over them, blocking the tubes.
There are more than 200 doctors in metro Atlanta who implant Essure.
“I wake up every day in agony from my fingers to my hands,” Catrice Jones said.
Most of these women say within hours they felt intense pain that lasted for years. Four of them had the coils removed. Two say they will soon.
“If they think that it is fine, get it implanted and let me know how they feel, let me know what side effects they end up having,” Danielle Johnson said.
Because of the way the FDA classified Essure, it is difficult to sue. Byfield confirmed a federal lawmaker will introduce a bill in the hopes of changing that.
Rep. Mike Fitzpatrick's staff told Byfield plans to introduce a bill in Washington D.C. in the coming weeks.
Two years ago the FDA said, “There is no literature that has indicated any wide spread complications."
But the FDA made a complete reversal on Friday, sending us this statement:
"As per FDA's policy, we do not comment on proposed or pending Congressional legislation. In terms of next steps, the FDA plans to review the latest medical literature on the Essure device as well as input from panel members and the public during our recent advisory committee meeting, to determine what future actions may be appropriate. This is a high priority issue for the agency. FDA intends to issue communications to keep the manufacturer and public informed of any further actions taken by the Agency."
A spokesman for Bayer, who bought Essure in 2013, also sent Byfield a statement:
"The safety and efficacy of Essure, the only FDA-approved method of permanent birth control with a non-surgical procedure, is supported by more than a decade of science, as well as real world clinical experience, with the product studied with more than 10,000 women since Essure was first developed. With the approval of Essure in 2002, healthcare providers are able to provide appropriate women an option for a permanent birth control method that not only avoids entry into the abdominal cavity, but also the requirement for general anesthesia and its associated complications.
"Bayer stands by the positive benefit-risk profile of Essure, and we look forward to working closely with the FDA as it considers the advice of its Obstetrics and Gynecology Panel of the Medical Devices Advisory Committee.
"Bayer's highest priority is patient safety, and we sympathize greatly with any woman who may have experienced problems following an Essure procedure. For women who experience adverse events following an Essure procedure, the support and follow up care they receive is critical. The first step a patient should take is to talk with her physician. A dedicated consumer support line is also available at 1-877-ESSURE1 (1-877-377-8731). Women with questions about the Essure procedure can call and speak directly with a registered nurse."
