Essure, Bayer’s controversial birth-control device’s life on the market may be nearing an end. Despite getting the sense that they were being shut out of the vital September 24th Food and Drug Administration (FDA) advisory panel meeting in Bethesda, Maryland, the work of Angie Firmalino, Angela Lynch, and other leaders of the 20,000-plus Facebook group “Essure Problems” may bear fruit after all. According to Legislative Director Justin Rusk, Republican Pennsylvania Congressman Mike Fitzpatrick has told Ms. Firmalino that he will introduce the E-Free Act in the House of Representatives the week of October 20th. The bill seeks to revoke the FDA’s “pre-market approval” (PMA) status granted to Essure’s developer Conceptus in 2002. Bayer acquired Conceptus in 2013, and the company has faced massive public backlash ever since, led initially by celebrity activist Erin Brockovich, and furthered by the “Angies” at Essure Problems. The PMA status is vital for Bayer and the activists, as it provides a legal shield against thousands of women who have reported complications from the device, including unintended pregnancy, from suing Bayer.
Pressure has mounted to review Essure’s status, in large part due to the 17,000 adverse events reported to the FDA for issues such as pain, bleeding, skin allergies to nickel, Essure’s primary component, depression, and other symptoms. Questions remain as well, however, about the FDA’s approval as far back as 2002. Brockovich was one of many to raise concern about the research that led to the FDA’s “fast track” approval of the device, noting that Conceptus only reported 22 of the 168 adverse events during clinical trials, four of the actual 64 unwanted pregnancies, and even misreporting one subject’s age by 20 years. Also, Massachusetts General Hospital surgeon Dr. Peter Schalock questioned whether or not Bayer (or Conceptus) ever tested the device for nickel allergies, even to the point of asking Bayer representatives, “Are we just making this up just for fun or is there data?” The National Institute of Health reports that 17 percent of all women have an allergy to nickel. Although the panel strongly recommended that more testing be completed involving the device, it did not request that Essure be pulled from the market. While the FDA is not required to take the advice provided by advisory panels, the agency generally follows panel recommendations.
Needless to say, last month’s hearing only stoked the anti-Essure advocates’ call to action. Having heard the call, Congressman Fitzpatrick’s law simply reads: “Not 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 also asking others who have experienced complications from the device to also send their Representatives this letter (which is provided in Word Doc. Format at the bottom of the page). In addition to Essure, Fitzpatrick is also drafting separate legislation that would ban another controversial gynecological device, the power morcellator. Legal Reader will be tracking both bills and we will keep you updated throughout the legislative process.
Downloadable E-Free Act letter:
Philadelphia Inquirer -Hooman Noorchashm, M.D., Ph.D. and Amy J. Reed, M.D., Ph.D.
The Legal Examiner (Sarasota) – Joseph H. Saunders