October 19th, 2015– Pennsylvania Congressman Mike Fitzpatrick is joining in the fight to get Essure recalled from the market. Fitzpatrick has officially drafted legislation, entitled the E-Free Act, which he will introduce in the next few weeks. If the bill is passed, it will call for removing Essure’s pre-market approval within 60 days.
Essure’s E-Free Act
The E-Free Act, which will be introduced this week in the House of Representatives, seeks to revoke the FDA’s PMA status granted to Essure’s developer Conceptus in 2002. The company has received serious public backlash ever since the approval, led initially by famous activist Erin Brockovich, and furthered by Angie Firmalino at Essure Problems. This PMA status is crucial for Bayer and activists because it provides a legal shield against thousands of women who have reported serious complications from the device including organ perforation and unintended pregnancy from suing Bayer.
Public Pressure to Review Essure’s Safety
Pressure has mounted for the FDA to review Essure’s status, in large part due to the 17,000 adverse events reported to the FDA for complications such as pain, heavy bleeding, skin allergies to nickel, depression, and other serious symptoms. Questions still remain about Conceptus’ PMA approval back in 2002 as well. Brockovich was one of several to raise concerns about the research that led to the FDA’s fast track approval of Essure, noting that the original company only reported 22 of the 168 adverse events during clinical trials, four of the actual 64 unintended pregnancies, and even misreporting one patient’s age by 20 years.
Massachusetts General Hospital surgeon Dr. Peter Schalock questioned whether or not Bayer, or Conceptus, ever tested the device for nickel allergies, and at the FDA Essure meeting, even went so far as to ask Bayer representatives, “Are we just making this up just for fun or is there data?” In addition, the National Institute of Health reports that 17% of all women have an allergy to nickel. Although the panel for the FDA did strongly suggest that more testing be done involving Essure, they didn’t request that the device be pulled from the market. While the FDA is not required to take the advice of the panel, they generally follow panel recommendations.
Essure Call to Action
Last month’s hearing was just the beginning of anti-Essure advocates’ call to action regarding this device. Congressman Mike Fitzpatrick has heard the call with with a law that reads:
“No later than 60 days after the date of enactment 8 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 (21 U.S.C. 360e(e)) withdrawing approval for Essure System.”
Essure Problems is asking other women who have experienced complications from the device to also send their Representatives this letter. The more women who send out this letter, the more attention the E-Free Act will get, so if you have suffered from Essure, don’t let Bayer get away with their serious mishandling of this device. In addition to Essure, Congressman Fitzpatrick will also be drafting separate legislation to ban the power morcellator. We will be keeping you updated on the status of both bills.
If you, or a loved one, had the Essure implant and suffered adverse side effects, you may be entitled to compensatory damages. Don’t let the manufacturer practice profit over people.