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UPDATE: Fitzpatrick’s E-Free Act Would Take Essure Off the Market

— October 27, 2015

Rep. Mike Fitzpatrick (R-PA) is planning to introduce the E-Free Act to Congress on November 4, 2015. This bipartisan bill would ban the dangerous Bayer product Essure from the market. Essure has caused thousands of women intense suffering despited continuous assurances from Bayer that the product is safe. While the FDA had a hearing to discuss that issue in September, no Essure victims were allowed to speak. Representatives from the advocacy groups, Essure Problems, are in Washington D.C. this week meeting with Congress to share their stories and lend support to Fitzpatrick’s bill.

U.S. Representative Mike Fitzpatrick (R-PA) is set to introduce a bipartisan bill to Congress regarding the dangerous Bayer HealthCare product Essure. This purportedly “permanent” birth control device not only doesn’t work, but has caused countless women incredible suffering. Fitzpatrick’s E-Free Act would take Essure off the market.

Essure is a flexible, nickel-titanium coil that is surgically implanted into the fallopian tubes. The resulting scar tissue is supposed to render the user sterile. However, studies have shown that the failure rate (i.e., number of women who’ve become pregnant) is almost 10%. Furthermore, the coil often migrates causing perforation damage and the nickel is causing multiple serious allergic reactions.


Fitzpatrick chose the November 4 introduction for the E-Free Act as that is the 13th anniversary of Essure getting premarket approval from the FDA, despite the review panel’s misgivings. The FDA held a committee hearing on September 24 to review Essure’s safety and efficacy, but no recommendations have yet been made to the agency.

Fitzpatrick issued a statement saying, “Bayer is a trusted name in the industry. However, right now, one of their products, the Essure device, is harming women and needs to be removed from the market. I believe it is imperative to the continued success of their brand and the other work they do to immediately end production of a product that poses such a danger to patient safety.”

One of the Congressman’s spokespeople said that his office has heard from hundreds of women complaining about Essure. Bayer’s spokeswoman, Tara DiFlumeri, countered that by stating that more than 10 years of research support Essure’s safety.

“Bayer stands by the positive benefit-risk profile of Essure and we look forward to working closely with the FDA as it considers the advice of its Obstetrics and Gynecology Panel of the Medical Devices Advisory Committee,” she said. Bayer’s highest priority is patient safety and we sympathize greatly with any woman who may have experienced problems following an Essure procedure.”

Sure, there’s more than 10 years of Essure research out there. Internal documents have shown that Bayer “adjusted” some of that research, skewing it such that the FDA would grant premarket approval.

Bayer is no more sympathetic to the women victimized by its irresponsibility than is the FDA, which, despite its claims, turns a blind eye toward the suffering. Victims of Essure were not allowed to speak at the September 24 hearing; only medical professionals and industry representatives were heard. CORRECTION: Representatives from the Essure Problems Facebook group, a patient advocacy group, were given the standard amount of time to speak before the panel. The author apologizes for the error in reporting.

Members of the group expressed concerns that they were not allowed a chance to answer questions from the panel after the presentation. In an email exchange with Deborah Kotz, FDA Press Officer, I learned the following:

“The panel meeting followed a standard format including the open public hearing sessions. As per FDA guidance, the Chair or a panel member may question the person concerning his or her presentation after each presentation. Whether the panel members chose to do that at this meeting was at their own discretion. Here is a link to the transcript if you’d like to fully explore what took place at the open public hearing as well as during the panel deliberations at the end of the meeting.”

I also asked Ms. Kotz if she had any comments on the stories these women are telling regarding the negative impacts of the Essure product. She was kind enough to answer:

“Over the past several years, the FDA has been examining the growing number of safety concerns with Essure raised by members of the patient community and some physicians.

The FDA takes all reports of safety concerns seriously and held an advisory committee meeting in September to hear expert scientific and clinical opinions on the risks and benefits of the device and to hear more from women who have used Essure. Our primary concern is the safety and well-being of patients as we consider the scientific evidence and patient perspectives around these devices. In terms of next steps, the FDA plans to review the latest medical literature on the Essure device as well as input from panel members and the public during our recent advisory committee meeting,  to determine what future actions may be appropriate. This is a high priority issue for the agency. FDA intends to issue communications to keep the manufacturer and public  informed of any further actions taken by the Agency.”

I sincerely appreciate Ms. Kotz’ time in answering my question. I only hope that this review is handled expeditiously as each day, more women are facing pain, health issues and even hysterectomies due to Essure.

The FDA may try to get away with silencing Essure victims, but Congress will hear these brave women this week. Below is a press release from Essure Problems, an advocacy group comprised of women injured by Essure:

“Four administrators of the Essure Problems Facebook page, Angie Firmalino, Amanda Dykeman, Lisa Saenz, and Melanie Goshgarian, their congressional liaison and E-Sister Amanda Rusmisell, E-Sister and scientist Tess Shulman, attorneys Marcus Susen and Holly Ennis, and local DC E-Sister Lisa Fouser, will be attending multiple congressional meetings tomorrow and Wednesday. The goal of their meetings is to gain support for Congressman Fitzpatrick’s E-Free Act. Congresswoman Rosa DeLauro has co signed the E-Free Act, and they will be presenting it to congress on November 4th, 2015, on the 13 year anniversary of the approval of Essure. The act asks that the FDA revoke PMA status for Essure and also remove it from the market. The meetings are listed below.

They will also be handing out packets to every single congressman and woman’s office. The packet can be viewed by clicking here.”


Bill would ban Bayer’s Essure contraceptive

Essure Problems Press Release 10/26/15

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