The FDA reports that it received 5,093 reports on Essure, mostly from women who received the implant, from Nov. 4, 2002, to May 31, 2015. The most common complaints included "pain/abdominal pain (3,353), heavier menses/menstrual irregularities (1,408), headache (1,383), fatigue (966) and weight fluctuations (936)." The most frequent device problems were "patient device incompatibility (941) (for example, possible nickel allergy), migration of the device or device component (482), device operating differently than expected (301), device breakage (259) and malposition of the device (133)."The women I talked to reported far more problems, like cysts, hair and tooth loss, heart problems, vomiting, panic attacks, and loss of mental function. I mentioned in the article that U.S. Rep. Mike Fitzpatrick, R-Pa., was planning to introduce a bill to address those concerns called "The E-Free Act." At the time, his office wouldn't give details on exactly what the bill would do.
WASHINGTON, D.C. – Congressman Mike Fitzpatrick (PA-8) joined women harmed by the medical device Essure Wednesday outside the United States Capitol to announce the introduction of the E-Free Act - legislation to remove the product from the market.
“Can you imagine such debilitating pain, fatigue and depression that you feel as if your children have lost you as a parent? For women impacted by the medical device Essure and its documented damaging side effects, this unimaginable situation is a stark reality,” said Fitzpatrick. “That’s why, 13 years to the day after Essure was given pre-market approval, I’ve introduced the E-Free Act to remove this device from the market before it can hurt any more women.”
Essure is a permanent sterilization device for women produced by Bayer. This medical device is a nickel-based metal coil designed to be inserted in the fallopian tube and cause tissue scarring. Since it was approved by the Food and Drug Administration (FDA) on November 4, 2002, the FDA has received over 5,000 formal complaints related to the device. Tens of thousands of women have reported symptoms including extreme pelvic and abdominal pain, migraines, autoimmune reactions, loss of teeth and hair, the metal coil breaking and migrating throughout the body, and the coil cutting into the uterus and other organs in the abdominal cavity. The deaths of at least four women and five unborn children have been attributed to Essure.
“The failures of Essure are well documented and wide ranging. Yet, in the face of all these facts, this device remains on the market; certified with the FDA’s stamp of approval. That’s unacceptable to me and unacceptable to the tens of thousands of “Essure Sisters” who are living with this device’s effects,” said Fitzpatrick. “If the FDA or manufacturer aren’t willing to act in the best interest of these women, Congress must.”
Essure Problems, a group of over 23,000 women who joined together online to share stories of how Essure impacted their lives, has led a grassroots lobbying effort to bring awareness to the issue and stop the harm caused by the device.
“The Essure Problems group is so very grateful for the support of Congressman Fitzpatrick. The women harmed represent every party, every nationality, every color, and every walk of life. We have been able to stand side by side and unite and work together for this cause,” said Amanda Rusmisell, victim and Legislative Liaison of the Essure Problems group. “Tens of thousands of otherwise healthy young women have been significantly harmed by the medical device Essure - most of them requiring multiple surgeries, most often, hysterectomy. We are asking Congress to help push the FDA to revoke the approval for this dangerous and ineffective medical device.”
Fitzpatrick is an outspoken advocate for medical device safety and has previously pushed back against the FDA’s approval process for power morcellators which have been proven to spread undetected cancer in women. After receiving a bipartisan letter led by Fitzpatrick, the Government Accountability Office is in the process of investigating the device and its approval process.