In what many would consider a long overdue move, the FDA has recommended a black box warning for Bayer’s Essure contraceptive device. The move comes after an ongoing public outcry and an FDA hearing last fall. The black box warning, if it does indeed make it to the Essure label, is the strongest warning that can be placed by the FDA and is designed to call ...
A Black Box Warning for Essure? Finally.
Posted March 4, 2016 in Drug and Medical Device Lawsuits | essure | Essure | Product News and Recalls
Essure Now Faces Congressional Ban
Posted January 28, 2016 in Drug and Medical Device Lawsuits | essure | Essure | Product News and Recalls
Plenty of medications and medical devices have faced the wrath of a displeased public. Thanks to the amplifying power of technology, it is now nearly impossible to ignore an organized group of citizens who have determined that a product or company is not aligned with their best interests. Recalls, black box warnings, and changes to entire product lines have occurred as consumers have confronted company after company; forcing them to ...
Essure Battle Heats Up as Study Cites ‘Serious Safety Concern’
Posted October 27, 2015 in Drug and Medical Device Lawsuits | essure | Essure | Product News and Recalls
The reports of problems with Essure started almost as soon as the device was approved nearly 14 years ago. Essure, a device implanted in the fallopian tube, was hyped as a revolution in female sterilization. Up until its development and release, the only option a woman had to permanently terminate her ability to have children was surgical sterilization. Essure was supposed to have the same effect with no surgery in ...
Essure Lawsuit Filed in Philadelphia Court
Posted July 11, 2015 in Drug and Medical Device Lawsuits | Essure | essure | Product News and Recalls
When the first Essure lawsuit was filed in Florida, few would have guessed that it would have ignited a movement. The internet, however, is an incredibly powerful tool for social organization and before long, women all over the country were connecting with each other and discovering that they were far from the only ones that had been injured by the device. One such group on Facebook boasts over 17,000 members.
Essure was developed as a non-surgical alternative to standard sterilization surgery. ...
continue reading...Essure Battle May Be Shifting as FDA Schedules Hearing
Posted July 9, 2015 in Drug and Medical Device Lawsuits | essure | Essure | Product News and Recalls
The fight over Essure may be entering a new phase as the US Food and Drug Administration announced a public meeting to review the data surrounding the female sterilization device. This represents a significant victory for the thousands of women who have been campaigning, primarily via social media, for more attention to be paid to them, their injuries, and the role they believe Essure played in ...
New Look at Long-Term Essure Data Adds Fuel to Fire
Posted May 26, 2015 in Drug and Medical Device Lawsuits | Essure | essure | Product News and Recalls
The female contraceptive market is a crowded one. A variety of options exist, each one tailored to meet a woman’s specific needs or desires for her particular contraceptive method. Some are physical, some are chemical, and others use a combined approach. As a result, a conversation with a physician or gynecologist about contraception can run the gamut.
About 13 years ago, one of the methods that would have come up during such a conversation was Essure. Essure is a small coil ...
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