BAYER HAS ANNOUNCED THAT IT WILL DISCONTINUE SELLING ESSURE STERILIZATION COIL IN THE UNITED STATES BY THE END OF THE YEAR, ALLEGED NEWS. [1] This follows years of litigation and sustained pressure from thousands of women who have reported injuries and other adverse side effects from the Essure sterilization coil: alleged News. [1]
In a press release, Bayer announced that it would cease selling or distributing Essure after December 31st 2018: Alleged News. [1] Bayer also notified the U.S. Food and Drug Administration (FDA) of its decision to withdraw the device: Alleged News. [1]
Nearly 27 000 adverse events
Since Essure was first approved in 2002 by the FDA, the FDA has received nearly 27 thousand adverse events reports associated with the device: Alleged News. [1] These include reports of persistent abdominal pain, severe allergic and autoimmune reactions, bleeding, bloating, hair loss, headaches, device migration (the coil moves unplanned to other parts of the body), device breakage (the device breaks within the body), perforation (a hole made by boring or piercing) of the uterus (womb), fallopian tubes (typically a pair of tubes along which eggs travel from the ovaries to the womb) or other organs, Alleged News. [1]
Bayer has also independently received over 30 000 complaints for the device; Alleged News. [1]
Thousands of Women
Thousands of women coalesced through Facebook groups and organized protests to speak out against Essure and have called on the FDA and Congress to ban the device: Alleged News. [1] One Facebook group with the name Essure Problems has 36 000 members; Alleged News. [1] As of mid-April, 16 800 women have joined lawsuits against Bayer, suing for various adverse side effects or injuries sustained while using Essure: Alleged News. [1] Bayer reportedly faces at least two Essure-related class-action lawsuits in Canada; Alleged News. [1]
Side Effects of Essure
During clinical trials for Essure, many women reported adverse side effects after having the device inserted, including pain, nausea/vomiting,
dizziness/light headed and bleeding.
Since the device has been on the market, many women reported experiencing adverse side effects/ events including
Persistent Pain
Severe autoimmune responses
Rashes
Hair Loss
Weight Gain
Bloating
Fatigue
Ectopic Pregnancy
Other symptoms, Alleged News
Reports of device migration, device breakage or perforated organs among women using Essure, Alleged News [1]
Hysterectomy (Surgery with total loss of womb)
The FDA has received approximately 9 000 reports of cases where women using Essure were required to undergo surgery to have the device removed, in most cases via hysterectomy; Alleged News. [1]
Adverse events reports have recorded four deaths and five miscarriages among women who have had an Essure insertion, though it is reportedly uncertain whether Essure was directly responsible in these cases, Alleged News. [1]
Nickel Allergies
Essure contains Nickel, a common allergen, and initially the FDA required Conceptus - the company which originally developed Essure sterilization - to include in the Essure label a contraindication for the device for women with known Nickel allergies, meaning that women with known Nickel allergies were not eligible to have the coil installed: Alleged News. [1] However, in 2011, Conceptus successfully lobbied the FDA to change the contraindication to a warning, meaning that doctors would be cautioned against inserting Essure in women with known Nickel allergies, but were no longer required to test for it: Alleged News. [1] Studies have reportedly shown that nearly 20 percent of adults are allergic to Nickel: Alleged News. [1] in 2013 Bayer acquired Conceptus for $1.1 billion; Alleged News. [1]
Safe Contraceptive Options for Women
For women who are concerned for their reproductive health, safe and natural contraceptive options for Women are discussed in the book 'Value-Based Sexual Expression'. These include the 'Billings Ovulation Method' [see pages 25 to 30], Ovulation Home Test [pages 30 to 32].
https://drive.google.com/file/d/0B_JEo1vAsAPsdGJxUE1mdVRBdUk/view
Contraceptive methods and dangers
Contraceptive methods and dangers are discussed in 'Value-Based Sexual Expression' on pages 25, 26, 32 to 35.
https://drive.google.com/file/d/0B_JEo1vAsAPsdGJxUE1mdVRBdUk/view
[1] Bayer to Stop Selling Controversial Sterilization Device Following Mounting Lawsuits and Complaints: Alleged News
https://www.pop.org/bayer-to-stop-selling-controversial-sterilization-device-following-mounting-lawsuits-and-complaints/
With thanks to www.pop.org
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