A Jacksonville woman who has been outspoken about wanting the controversial birth control Essure device taken off the market said she is encouraged by a draft proposal that aims to withdraw pre-market approval for the device.
Pennsylvania Rep. Mike Fitzpatrick’s office confirmed to Action News Jax that he plans to introduce a bill called the “E-Free Act” to Congress in the next few days.
The language of the bill says: “Not later than 60 days after the enactment of this act, the commissioner of Food and Drugs shall issue an order under section 515(e) of the federal Food, Drug and Cosmetic Act withdrawing approval for Essure system.”
It’s the answer that Rebecca Howell said she has been looking for because it shows support from elected leaders, regardless of the outcome.
"I've got to act to save other women,” Howell said.
Howell said she suffered painful side effects from Essure and needed a hysterectomy at age 30 because of the device.
"There were times I would get out of bed to crawl to the bathroom in pain, in tears,” Howell said.
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Howell testified last month to an FDA panel about her experience, along with medical experts, patients and representatives from Essure’s manufacture, Bayer HealthCare.
In a statement, Bayer HealthCare said: “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, health care 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."
Action News Jax reached out to the FDA to find out long it may take the panel to release its findings and in a statement the agency said: "In terms of next steps, this is a high priority issue for the agency. We plan to review the panel recommendations and docket feedback – with more than 2,000 comments -- to determine the best course of action. The docket closes on October 24. After considering the recommendations of the advisory panel, public speaker testimony, and docket feedback, the FDA intends to issue communications to inform the manufacturer and the public of any further actions taken by the Agency."
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