A U.S. Congressman introduced a bill Wednesday aimed at taking Essure permanent birth control off the market. November 4th marks the 13th anniversary of the device's approval by the FDA.
Pennsylvania Congressman Mike Fitzpatrick introduced the E-Free Act, which would force the Food and Drug Administration to revoke Essure’s Premarket Approval, as the number of reports of serious complications associated with it continues to rise.
“If the FDA and the manufacturer of the device aren’t willing to remove this device from the market, then Congress will,” he said in a press release.
Essure was given Premarket Approval by the FDA in 2002, shielding it from product liability and litigation.
Take a look at the interactive timeline below to see all of ABC15's coverage of Essure.
The bill would require the FDA Commissioner to withdraw that approval within 60 days of it passing.
Whether or not the bill passes and becomes law,Dr. DianaZuckerman, President of the National Center for Health Research in Washington, said, “It sends an important message that Congress is concerned about this product and is looking at what the FDA is doing.”
Zuckermanhas questioned the clinical trials related to Essure for years.
Essure is marketed as permanent birth control without surgery. During the procedure, two metal coils are placed inside the fallopian tubes to block conception.
Women report severe bleeding and pelvic pain, chronic pelvic pain, auto-immune disorders and unintended pregnancies. Many women report having hysterectomies, removing their reproductive organs, to remove the device.
The FDA has received more the 5,000 adverse event reports related to Essure since it was approved in 2002 and reports that more than 330 women have reported unintended pregnancies after being implanted with the device, including 69 ectopic pregnancies.
Women, doctors and health care professionals for and against the permanent form of birth control testified to the FDA’s Obstetics and Gynecology Devices panel, as well as Bayer Health Care, the current manufacturer of the device.
The FDA has not yet announced its recommendations as a result of that hearing.
Bayer stands behind the device, which has been sold more than 1 million times worldwide. A spokesperson told ABC15 Wednesday that the safety and efficacy of Essure is supported by more than a decade of science and real world clinical experience.
See Bayer’s complete statement below.
The FDA said it does not comment on pending or proposed legislation.
Bayer’s complete 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.