U.S. Representative Mike Fitzpatrick (R-PA, 8th District) will hold a press conference today to announce his “E-Free Act,” a bipartisan bill to Congress that would ban the Essure contraceptive device. Essure, which is manufactured by Bayer, is a flexible, nickel-titanium coil that is inserted into the fallopian tubes as a nonsurgical, permanent form of birth control.
Fitzpatrick, who claims his office has received hundreds of complaints from women about the device, says he will introduce the bill targeting Essure because of the harm it does to women, including pain and other health care problems, as well as the harm it is doing to Bayer’s reputation. “I believe it is imperative to the continued success of their [Bayer’s] brand and the other work they do to immediately end production of a product that poses such a danger to patient safety,” as he was quoted in the Pittsburgh Business Times.
According to Fitzpatrick, October 13 was the date chosen to introduce the bill to commemorate the 13th anniversary of Essure receiving premarket approval from the U.S. Food and Drug Administration (FDA). Premarket approval is the FDA’s most stringent review, involving a process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. Class III medical devices are defined as those that “support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury,” according to the FDA.
The FDA approved Essure in 2002, and although it was designed to be a permanent form of birth control, many women, calling themselves the E-sisters, have chosen to have it removed, long claiming that the FDA and Bayer have dismissed their concerns. Many of these E-sisters post pictures and notes about the day they became “E-Free” on a Facebook group page with almost 24,000 members named “Essure Problems.”
But now the FDA appears to finally be taking them seriously, updating the short- and long-term risks of Essure on its website, as well as adverse reports through May 2015. The agency also held a public advisory meeting of its Obstetrics and Gynecology Devices Panel on September 24 to review data and hear public comments from women who have experience with Essure.