Due to the high number of injuries and death associated with the use of a contraceptive device known as Essure, a U.S. Congressman and woman are planning to introduce a bill that will force the product off the market.
LifeSiteNews is reporting on the plans of Rep. Mike Fitzpatrick to introduce the “E-Free Act” on November 4 which will order the Food and Drug Administration to remove the premarket approval (PMA) for the Essure device.
Premarket approval is crucial for Bayer because it provides them with a legal shield against thousands of claims from women who have suffered serious adverse events from the device. Without that shield, the company can be held liable for these injuries.
Essure, which is produced by Bayer, is a metal coil that is inserted into a woman’s fallopian tubes, intentionally irritating the tubes to create enough scar tissue to prevent eggs from implanting in a woman’s womb.
However, since its introduction in 2002, thousands of women have been hurt by the device.
“The FDA has received over 5,000 formal complaints related to the device and over 22,000 women have joined together on Facebook to share their stories of how the Essure device ruined their lives,” the Congressman wrote in a letter to his colleagues. “Essure has caused at least five fetal deaths in women who became pregnant after Essure was placed. At least four women have been killed by Essure.”
In addition, “Tens of thousands of others have reported symptoms such as extreme pelvic and abdominal pain, bleeding, migraines, severe allergic and hypersensitivity reactions to nickel, autoimmune reactions, loss of teeth and hair, the metal coil cutting into the uterus and other organs in the abdominal cavity, and the metal coil breaking and migrating throughout the body.”
Just this past summer, the FDA expanded its list of descriptions about Essure, adding that in addition to its benefits, there were serious long-term health dangers associated with it, including ectopic pregnancies, unintended pregnancies resulting in severe complications and miscarriages, pelvic complications, pain, migration of the metal inserts through the fallopian tubes into the abdomen, puncture of the uterus, perforation of the fallopian tubes, hemorrhage, organ damage, fatigue, depression, weight gain, menstrual irregularities, headaches, rashes, itching, severe pelvic pain, and even death.”
A co-sponsor of the bill is Democratic representative Rosa DeLauro, a pro-abortion Catholic, who is joining Fitzpatrick in the effort to gain bipartisan support for the bill.
Women hurt by the device are also joining the fight to gain support on Capital Hill. According to latest press release from the Schmidt National Law Group, four administrators from the Essure Problems website and Facebook page, along with scientist Tess Shulman and several attorneys, attended multiple congressional meetings this week with the goal of securing more support for the E-Free Act. In addition to the meetings, the group handed out packets of information about Essure to every congressman and woman.
The women of Essure Problems are determined to fight regardless of the outcome of the E-Free Act.
“If this legislation does not pass, you will not see the end of Essure Problems,” they write. “While it would be quite a blow to the group, these women are determined to recall this dangerous device, so they will ultimately find another way to do so.”
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