Essure Problems 

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Essure Problems is officially done working with, 

or relying on, the FDA.  The FDA has failed us.

Today the FDA released their final guidance on Essure. The guidance includes a “suggested” black box warning along with a patient decision checklist. Once again, we find that the FDA has done a pitifully insufficient job. Our group, Essure Problems, has submitted countless pieces of information and evidence about the safety hazards associated with the device. However, like previous times before, the FDA has shown us that they will not implement any new or accurate warnings in the labeling to include the numerous adverse events caused by Essure. As they normally do, they have succumbed to the easy way out, by making “suggestions” in this guidance that barely change the way Essure is marketed today. Not a single suggestion regarding the known dangers of Essure were implemented on the black box warning.  We also feel that they will in no way enforce or require Bayer to have this done in a timely manner, whatever that may be. What it boils down to is the FDA continuously relies on insufficient and apparently fraudulent clinical trial data, supplied by the manufacturer, that is significantly outdated and inaccurate.

At this point, we would like to announce that our group, Essure Problems, is officially done trying to work with the FDA. There is no point in meeting with them again, or trying to discuss any new action. The multiple emails sent in the past months following the September 24, 2015 meeting have fallen on deaf ears. Not a single reply came in from any of the numerous FDA officials.

Our fight against Essure and their manufacturer Bayer, now includes a fight against the FDA. The FDA has failed us too many times. Enough is enough. Their blatant attempt to choose industry over people is clear, and we will no longer stand for it. Their ties to manufacturers are abhorrent and are in complete disregard of the patients they are entrusted to protect.

Not only are we calling for a complete boycott of all Bayer products, we want to see congress force the hand of the FDA in regards to Essure.  We also want to see support of new bills that will introduce better legislation regarding medical devices.                                       

Our focus now lies in Washington. There are a couple of bills that have been introduced in the House that we are supporting and lobbying for. The first bill is Ariel Grace’s Law H.R.5403. This bill is applicable to all Class III medical devices. It is an amendment to an already existing statute which merely amends the statute to allow access to courts for those injured by defective medical devices. We are also in support of the Medical Device Guardians Act of 2016. This bill will eliminate conflicts of interest at the FDA, protect individual practitioners from liability when reporting adverse outcomes associated with the use of medical devices, and prosecuting failures to “self-report” from practitioners.

We are looking to partner with other medical device advocacy groups and create one large unified army of patients who are fed up with the current state of the FDA, and current laws surrounding medical devices. We have started a Facebook group called Medical Device Problems, and have already partnered with several other patient groups. If your group would like to join forces, please feel free to join.

Angie Firmalino

Essure Problems