Holy Hormones Journal: In this case the story tells the story. Once again – falsified clinical trial, fast track, death, damage, adverse reactions and finally a review. By the way so you know PMA is short of “Pre-Medical Approval.” And of course, once again the pharma company Bayer is not held liable for any harm to the thousands of women affected. Sounds like Gardasil, the HPV vaccine right?
Essure is the ONLY other form of permanent female sterilization in the world. Essure is a Micro-coil that consists of a stainless steel inner coil, a Nickel Titanium (nitinol) expanding, super elastic outer coil, and polyethylene (PET) fibers. They insert them into your Fallopian tubes. The PET fibers are wound in and around the inner coil. As if the nickel and other junk weren’t bad enough, the PET fibers create irritation, which then induces scar tissue to grow over the coils, blocking fertilization.
Essure doesn’t contain hormones, no surgery, can be done in an office setting in 10 min with no down time and BAM you’re sterilized for life! Sounds AMAZING right….? WRONG! What the Doctors don’t disclose and the FDA didn’t want to mention is the PET fibers in Essure causes chronic inflammation, which in turn causes your body to not only kick out a foreign body but fight an”infection” too. Your glands go into overdrive creating fighting cells to rid the body of what it can and to adapt to what it can’t.
In the FDA/Conceptus meeting minutes labeling and disclosure of the issues was mentioned and tossed aside as if labeling the issues shouldn’t really be necessary….
DR.BLANCO “So would you recommend some form of labeling because of the information that’s been presented in terms of fibrosis, continued inflammation, not something easily you know, would you recommend any labeling over and beyond a typical permanent forgive me method?”
You see, they knew women would shy away. When you can’t fight off the infection, your cells and genes mutate to accommodate creating a whole body system of issues! The same with people exposed to pesticides and chemicals, women with Essure have a series of issues. They have diagnosis ranging from autoimmune disorders, neurological disorders, kidney, adrenal, thyroids, heart disorders and yes, even cancer…all linking to Essure! Source
An Open Letter To The FDA Why Essure’s PMA Must Be Revoked
By Holly Ennis
The clinical trials conducted were also GROSSLY inadequate and defective. Several panel members were horrified regarding Essure’s ‘clinical trials’. It is unconscionable that a medical device, which is permanently implanted into a female’s body, would have so pathetically few participants studied for such an inadequate period of time. How can the FDA ensure a product is safe when information was obtained on fewer than two hundred women after two years? How can Bayer have ZERO data on any nickel testing performed to ensure the product was safe? What about studies regarding the PET fibers in Essure? What studies were done on these exact fibers used to ensure they were safe? This alone should MANDATE the PMA to be revoked as the studies grossly fall below any acceptable standards. Certain panel members were appropriately outraged. Dermatologist Dr. Peter Schalock from Massachusetts General Hospital asked in outrage, “How can Bayer and the FDA have no knowledge of nickel allergies? Where did you test these people? How did you test these people? What did you test them with? Are we just making this up just for fun or is there data?” The well-respected president of the National Center for Health Research Diana Zuckerman even accused researchers of falsifying evidence during clinical research, an accusation that Bayer strongly denied. Source
FDA to Release Essure Safety Review in February
Posted by FDA News & Recalls.& filed under
The U.S. Food and Drug Administration announced it will decide what action to take regarding Bayer’s permanent birth control device Essure in February 2016. According to the FDA, the review will be based on information gathered at its Obstetrics and Gynecology Devices Panel held this past September in addition to a number of studies and other data.
The FDA convened the September panel meeting after it found 5,000 adverse events were linked to Essure, including the death of women and fetuses. In addition, thousands of women reported a number of complications linked to the two metal coils implanted into the fallopian tubes. These range from painful sex to organ perforation. Women with severe allergic reactions to the metal even suffered autoimmune disorders.
The agency says Essure is a “high priority issue.”
“We wish to acknowledge the numerous stakeholders who testified at the September panel meeting and the many others who have expressed their viewpoints and shared their experiences with us,” the FDA said in its announcement. “Patient health and well-being is our first priority regarding this device and all medical devices.”
Several administrators and members of the Facebook group Essure Problems spoke at the FDA’s September panel meeting, urging the agency to pull the device from the market. The women say they were never warned about the risks. The group has 24,000 members and continues to grow.
Meanwhile, Bayer continues to stand by its product.
“Essure is supported by more than a decade of science and real world clinical experience,” a Bayer spokesperson told ABC 15. “Bayer has been in regular communication with the FDA about the risk-benefit profile of Essure and the informational needs of both healthcare providers and patients.”
Women Fight for the Right to Sue Bayer
Normally, when a drug or device harms a patient, the injured party may decide to file a lawsuit if they were not warned of side effects or dangers. In the case of Essure, thousands of women are barred from seeking compensation for devastating complications because it is a class III device.
“I felt very betrayed and misled, not only by my doctor but by the manufacturer,” Firmalino said during the FDA panel meeting in September. “I honestly had no idea that these devices could expel from our fallopian tubes and perforate organs or embed in other areas of the body.”
Women are calling not only for others to be warned about the device’s dangers but also for the PMA (Pre-Market Approval) to be revoked.