Myrl Jeffcoat wisgroup_leader@yahoo.com

Thanks to Sandra Laliberte, for sending us her letter to the FDA.

Myrl

http://www.webstarmagic.com/wisletter.htm

http://www.myrljeffcoat.com

I am dumbfounded about how the FDA has a mandate to look out for the safety of the consumers yet very quietly has been agreeing to let mentor stop studies of women.

It is also being reported in the new york times that plastic surgeons want the MRI'S condition dropped as well as it interferes in there eyes with women getting an implant put in, which I seriously doubt.

What is amazing is how the FDA is dropping two of the most important conditions that was decided upon the fast tracking approval of Mentors breast implant devices.

I think it is high time the FDA comes clean to consumers on what and why the reasons are they have such great interest in pandering to the manufacturers and plastic surgeons for a device that is not a life saving device but a device that only benefits the pockets of plastic surgeons and the manufacturer.

It has become blatantly obvious with the tainted panels that are put together that womens safety is not an issue but approving these devices were more of an issue for anyone other than women.

You (the FDA) and Doctors claim women need choice! I wonder when it is you will do what is mandated of your office. The FDA nor women have got the right to yell choice when the health regulatory agencies around this world don't do there jobs and demand proper studies and data to prove these bags of garbage are safe.

Then and only then can women say they want a choice.

I suppose the 10 year study is out the window but then it was probably never going to be required anyways, the FDA was hoping to make the women quiet by stating this and was hoping it would just go on quietly where you and the manufacturers changed the conditions that you publicly did through a press release.

Another question about the MRI's plastic surgeons are lobbying you to end as a condition can anyone please explain to us how in the world a woman having an MRI hinders anything with a plastic surgeon? As my father said the plastic surgeon does not pay for it the women are responsible. Actually after the plastic surgeon gets his hooks into a woman anything there after is not his or hers concern they tend to ignore any patients who contact them with problems, and usually tell the woman it is all in her head. So why the issue with MRI'S

I would assume then that the plastic surgeons and manufacturers to date must not be happy with the MRI's of patients and the data collected other wise they would not be asking for the conditions to be changed.

Or they have not entered all the women into a study as required and they got you to agree.

And what are MRI'S showing is there maybe some ruptures and they don't want that to be known. My point is this it is simple the FDA is supposed to make sure the product is safe not reasonably safe but SAFE!!! So what is the reasons for dropping one of the most important conditions you set out?

Do you plan on doing what the plastic surgeons want which is dropping the second most important condition which is the MRI'S.

Maybe if funding to the FDA was halted the FDA would start doing the job they were mandated to doing and that is to protect consumers not the bottom line for the manufactures and plastic surgeons.

I wonder if you can answer another question how is that an asian country saw the same data as the FDA and Health canada yet very quickly said no to approving the implants?

How is it that they could see the data was not enough to proof safety yet the western health regulatory agencies could hardly wait to approve them.

I guess they took the safety of there women more importantly than the FDA does.