In my opinion black box warnings are useless and nothing more than a cop out for physicians. It's a way for them to avoid lawsuits by claiming they disclosed the warnings to patients and they consented. However, in my experience, they don't always disclose that a drug or device carries the warning. For example, many women were never told that Depo-Provera was given a black box. Its prolonged use can cause osteoporosis and it thins out the lining of the vaginal wall, making you more susceptible to disease and infection. How many women would still prefer that form of contraception during the 3 month waiting period after Essure implantation had they been fully informed??
As for the requirement of more clinical research to further understand if there is a better patient selection suited for Essure, well that's just bullshit! There isn't a single woman on this planet that deserves to be implanted with Essure and I wouldn't wish it on my worst enemy.
For decades researchers have been trying to develop an occluding device intended to sterilize women without incisions and they have all failed due to safety concerns and placement failures. Essure is no different. There are literally hundreds of adverse event reports documenting device migration in the FDA MAUDE database and according to one FOIA document obtained by Essure Problems several have gone unreported...
...factor in all of the perforations that is said to be the most common complication in any operative hysteroscopic procedure and I would say the percentage rate of any subset of women eligible to receive Essure falls around ZERO!! It's no coincidence that Conceptus did not consider the migration complaints in their risk analysis for the design of Essure. They KNEW that the biggest challenge they would face would be migrations and tried to conceal that information!
This is unacceptable and the FDA has once again failed us! We will not be silenced and we will continue to flood the FDA with information as well as pull in support from our representatives in Congress to have Essure removed from the market. We will rally our sisters to Boycott Bayer and we will call for the resignation of Dr William Maisel, chief scientist and deputy center director for science at FDA's CDRH.
Maisel has no business calling the shots in women's health as he has no regard for women's safety, proven by his arrest when he was convicted of hiring a prostitute. During our meeting with members of the FDA last month Maisel is the only person in that room that made me feel completely uncomfortable. I could tell by his mannerisms and the way he defended Essure and rushed us through our meeting that he had absolutely no intentions of taking what I had said into consideration. That was proven when he allowed Essure to stay on the market.
Make no mistake, E-Sisters will not back down and we will stop at nothing to protect the lives of women and their unborn children. Our gloves are off.
*These views are my own and do not necessarily represent the views of Essure Problems. -AD
