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Essure’s Shelf Life in the US Soon to Expire

Essure’s Shelf Life in the US  Soon to Expire July 24, 2018. By Jane Mundy.
Bayer says it will no longer sell Essure in the U.S. due to decline in sales. Bayer doesn’t say, however, that its decision comes after the FDA threatened the drug giant with civil and criminal penalties if it didn’t warn patients about adverse Essure side effects.
Read [ Essure’s Shelf Life in the US Soon to Expire ]

"Essure Problems" Women Bring FDA's Data to Meeting that FDA were Unaware Of

"Essure Problems" Women Bring FDA's Data to Meeting that FDA were Unaware Of March 8, 2018. By Jane Mundy.
York, PA: Last month a group of women, including "Essure Problems" Facebook representatives and Madris Tomes from Device Events, met with FDA chief Scott Gottlieb in an attempt to have the Essure sterilization device withdrawn from the U.S. market. At the meeting, Tomes presented data from the FDA's own MAUDE ((Manufacturer and User Facility Device Experience) database that the FDA and their legal counsel in attendance were seemingly unaware of. One would think the FDA may be embarrassed being caught off-guard like this, to say the least.
Read [ "Essure Problems" Women Bring FDA's Data to Meeting that FDA were Unaware Of ]

More Pressure to Withdraw Essure

More Pressure to Withdraw Essure February 14, 2018. By Jane Mundy.
Washington, DC. Essure critics last week met with FDA chief Scott Gottlieb to discuss problems with the sterilization device, particularly Bayer's failure to warn of Essure's serious complications. But Gottlieb said they need to wait for Bayer to finish its safety study - in 2023! Perhaps those critics should have brought to the meeting lawyers, guns and money.
Read [ More Pressure to Withdraw Essure ]

Court Rules in Favor of Essure Contraceptive Device Maker

Court Rules in Favor of Essure Contraceptive Device Maker January 4, 2018. By Jane Mundy.
Jefferson City, MO:A St. Louis Circuit Judge in 2016 ruled that an Essure lawsuit filed by 92 women against Bayer could proceed in Missouri, but now that may not be the case. All the plaintiffs claimed they suffered injuries after having the permanent birth control device implanted, and they contended that Bayer is subject to jurisdiction in this state because it does business, generates revenue and conducts marketing for Essure in Missouri.
Read [ Court Rules in Favor of Essure Contraceptive Device Maker ]

“I want this Mirena IUD out, over and done with.”

“I want this Mirena IUD out, over and done with.” December 30, 2017. By Jane Mundy.
Toronto, ON. Nickey followed her doctor’s orders, and the Mirena manufacturer’s orders: five years after the IUD was implanted, she made an appointment to have it removed. But it wasn’t that easy. Next month will be the fourth, and she hopes final, attempt to have all of the birth control device removed from her uterus.
Read [ “I want this Mirena IUD out, over and done with.” ]

“Physicians tell us they are working on how best to remove Essure,” says member of Essure Support Group

“Physicians tell us they are working on how best to remove Essure,” says member of Essure Support Group December 5, 2017. By Jane Mundy.
Moline, IL: To give some idea of the damage Essure has done, Amanda’s support group—Essure Problems-- has grown from 250 women when she joined to over 35,000 members. “We have physicians visit our Facebook page, telling us they once implanted the device and are now trying to perfect their removal technique,” she says.
Read [ “Physicians tell us they are working on how best to remove Essure,” says member of Essure Support Group ]

Lawsuit Alleges Hormone Coated Mirena IUD Can Lead to Blindness

Lawsuit Alleges Hormone Coated Mirena IUD Can Lead to Blindness November 9, 2017. By Brenda Craig.
Oakland, CA: The next twelve months will be critical for Mirena IUS (Intrauterine System) contraceptive plaintiffs currently engaged in a Multi-District Litigation lawsuit against Bayer alleging the hormone coated device leads to an intracranial condition with the potential to cause permanent blindness in some users.
Read [ Lawsuit Alleges Hormone Coated Mirena IUD Can Lead to Blindness ]

Bayer Reports Spike in Essure Lawsuits and Congress Questions FDA

Bayer Reports Spike in Essure Lawsuits and Congress Questions FDA November 8, 2017. By Jane Mundy.
Decatur, IL: Litigation involving Essure is taking its toll on Bayer. In less than a year, the permanent birth control device manufacturer has seen lawsuits more than double, and it has been removed from every global market, except in the U.S.
Read [ Bayer Reports Spike in Essure Lawsuits and Congress Questions FDA ]

Mirena IUD Lawsuit Alleges Grievous Mirena IUD Side Effects

Mirena IUD Lawsuit Alleges Grievous Mirena IUD Side Effects November 5, 2017. By Gordon Gibb.
New York, NY: A Mirena side effects lawsuit filed late last month accuses the manufacturer of the popular IUD of not doing enough to warn consumers about the potential for pseudotumor cerebri, or PTC, associated with the long-term birth control device. According to Court records the plaintiff has suffered from vision problems and a build-up of fluid since acquiring the device.
Read [ Mirena IUD Lawsuit Alleges Grievous Mirena IUD Side Effects ]

Bayer Bans Essure Outside US, Is FDA Lagging?

Bayer Bans Essure Outside US, Is FDA Lagging? October 10, 2017. By Jane Mundy.
Richmond, VA: Bayer has stopped selling its Essure outside of the U.S. citing “lack of interest” and “commercial reasons”. But those reasons may not be quite accurate. Many countries have banned the permanent sterilization device due to product and safety concerns. So, why is it safe for women in America?
Read [ Bayer Bans Essure Outside US, Is FDA Lagging? ]

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