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FDA to give strongest possible warning about Essure contraceptive

The FDA will demand a new boxed warning, like the one on cigarette containers, for the sterilization device.
Wed Mar 2, 2016 - 1:01 pm EST
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WASHINGTON, D.C., March 1, 2016 (LifeSiteNews) – First, the FDA approved a dangerous new contraceptive coil, "Essure," without verifying its clinical trials, which were sponsored by the coil's own manufacturer. Then the FDA agreed, at the manufacturer's request, to drop a requirement to protect women with nickel sensitivity from Essure's nickel-titanium coils. Even after receiving well over five thousand complaints of serious, sometimes life-threatening complications from Essure, including five deaths, the FDA refused to take the coil off the consumer market.

Now the FDA is asking Essure's manufacturer to test its own product for "safety."

The one thing the FDA will do is put a new boxed warning – the most serious kind, like on a pack of cigarettes – on Essure's label. 

Essure is marketed as a "permanent birth control" method, designed to induce sterility. The device consists of an arrangement of metal coils that irritate the fallopian tubes, creating scar tissue that blocks a woman's eggs from being released. In some cases, Essure acts as an abortifacient, blocking implantation of an already conceived baby.

The German conglomerate Bayer, which bought Essure's original manufacturer for over one billion dollars after the coil's success, says 750,000 women have had the contraceptive coils implanted.

Since the FDA approved Essure for consumer use in 2002, well over 5,000 women have reported severe pelvic pain, dangerous coil migration through the fallopian tubes into the abdomen, hair loss, irregular heavy bleeding, serious allergic reaction causing autoimmune problems, ectopic pregnancies, unintended pregnancies resulting in severe complications and miscarriages, pelvic complications, puncture of the uterus, perforation of the fallopian tubes, organ damage, mood disorders, fatigue, depression, weight gain, headaches, rashes, itching, internal injuries, and even death.

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A Facebook page called "Essure Problems" has grown to over 27,000 members.

Hundreds of women have petitioned the FDA to take Essure off the market to protect women. Last fall, a major public hearing was held on the dangers to women from the device. At that hearing, women who participated in clinic trials for the Essure coil say their reports about side effects were changed and falsified so as to make the device look safe.

But, critics say, the sexual revolution outranks women's health.

The FDA did not verify the clinical trials' survey reports, which were provided by Essure's original manufacturer. In fact, at the request of the manufacturer, the FDA agreed to remove a requirement of testing for nickel sensitivity before implantation – despite the National Institutes of Health's warning that up to 17 percent of women are allergic to nickel.

Critics also say requiring Essure's manufacturer to measure the product's safety, especially after its original manufacturer falsified the product's original trials, is to have the fox guard the henhouse.

American Life League's Vice President Jim Sedlak told LifeSiteNews, "In our society, with its over-emphasis on the supposed need for sexual intercourse, Essure is the ridiculous conclusion. In an effort to thwart forever the natural outcome of sexual intimacy, women actually have two coils shoved in their fallopian tubes and hope their body forms scar tissue around the coils to fully block the tubes. And then they complain because it causes pain and bleeding. Well, the coils are not supposed to be there. They are foreign objects blocking a natural bodily function. The pain is the body telling her something is wrong. The body wants them out of there."

Furthermore, Bayer will be using the major surgery of tubal ligation or tubectomy as the acceptable measuring standard for "safety."

The FDA is seeking public input for 60 days on the language for the boxed warning and a liability "checklist" for doctors to verify that women have been warned of the device's risks.

"Please, men and women, stop fooling with nature," Sedlak said. "There is a purpose for sexual activity – the future of the human race. At least five people have died from using Essure. Nobody has ever died from not having sex."


  abortion, contraception, essure

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