Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements. All clinical trials must report all data.
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Wednesday, October 28, 2015

Bayer Essure Failure Rate 10%: E-Free Act



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

By Jay W. Belle Isle - Oct 27, 2015
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.
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.”

The medical device industry has insinuated itself into our local, state and national government by lobbying for legislation that would protect it from accountability for unsafe and ineffective products. In addition, the FDA that is charged with protecting patients by regulating the industry is deeply financially conflicted with both Director Shuren (his wife Allison is a partner in a DC lawfirm specializing in medical devices and FDA clearance) and the members of advisory panels that are salaried by the medical industrial complex. There is no process for harmed patients to be heard.

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