Social Media Trumps the FDA Adverse Event Reporting System

The FDA records the adverse events patients experiences from faulty medical devices but does little to rectify the problems

Tuesday, May 8, 2018 - The FDA has an adverse events reporting system that allows patients that have been injured by a medical device to report their incident. On paper, this seems like a good idea and the FDA closely monitors these reports. Theoretically, when the FDA receives a high number of complaints against a particular product, it takes action to correct the problem with the device's manufacturer. If the problem is not corrected the FDA can force the company to recall the device. The truth of the matter is, however, that the government can be influenced by many factors when evaluating the safety of a medical device and is about as fast to act on a problem as it would be for The Queen Mary to make a 180-degree turn. In other words, not very fast. Each adverse report is reported in a vacuum without giving a person the opportunity to share their bad experience and alert friends, to alert other friends, to alert still other friends, that may also be in danger by using the faulty medical device. Thankfully today there is social media and Facebook to help victims get their stories out to others that may be suffering in a similar manner. Rather than wait for a bureaucratic government agency to hem and haw, drag their feet and protect their jobs, tens of thousands of people are publishing their adverse Essure events on the Facebook Group, "Essure Problems."

When it comes to getting a grip on a problem, nothing beats going directly to the source and listening to a person's experience. In scanning the posts on the Facebook group, Essure Problems, one of the more frequently occurring complaints is the immediate rejection of the Essure Birth Control Coil because of allergic or auto-immune reactions. The first adverse symptoms reported are severe cramping and bloating, followed by painful blisters on the entire lower torso. Such an adverse event happens to thousands of Essure women and is the result of the body's reacting negatively to the Nickel plating used on the device. Another side effect is that Essure doesn't always adhere to the Fallopian tube and travels to other organs, often perforating an infecting them to the point that the organ has to be removed. A recent Essure Problems Facebook post cited the FDA's own adverse event report list of placed in the body where Essure has had to be surgically removed from. "Here is a list of FDA adverse event reports of some of the places Essure has migrated to. (Sometimes there are false positives so add a standard deviation of +/- 3). But look at these results. Gallbladder 6, bladder 134, intestine colon or bowel or ileum 254, peritoneal cavity 162, abdomen or abdominal cavity 528, pancreas 8, uterus 1101, rectum anus or vaginal cuff 36, liver 41, omentum 59, out of her Fallopian tube 39, appendix 29, rib 11, spine 26, Myometrium 85, fundus 47, heart 1, obstruction or resection 53. I still have to add the heart migration to this spreadsheet."

Thousands have women that have suffered from a faulty Essure birth control device have hired an Essure attorney and have taken action by filing a claim against Bayer, the manufacturer Essure. If you are currently using Essure, take a moment and visit the Essure Problems Facebook group to read what other women have to say.

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Social Media Trumps the FDA Adverse Event Reporting System

The FDA records the adverse events patients experiences from faulty medical devices but does little to rectify the problems

More Recent Essure Complications Lawsuit News:

No-Cost, No-Obligation Essure Lawsuit Case Review If You or a Loved One Suffered from Essure Problems