A study conducted by researchers at Northwestern University has concluded that the FDA has largely failed in its responsibility of protecting women from faulty or poorly designed medical devices.
Of the 18 devices approved between 2000 and 2015 for high risk application to women’s medical care; including fetal monitoring, contraception, and uterine bleeding:
A federal judge in Philadelphia has determined that an Essure lawsuit filed against pharmaceutical giant Bayer has enough merit to proceed. Bayer had previously moved for the case to be dismissed.
The judge sided with Bayer on most of its motion. The plaintiffs had originally brought 12 claims against the company and, using an FDA provision specific to devices granted premarket approval, Bayer argued that Essure was effectively protected from any ...
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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 ...
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 ...
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 ...
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. ...
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