Health Canada and the FDA On Implant Approval

Hi everyone I did an interview last night with a reporter and I came to realize while talking with her that the Health Canada Regulatory agency along with the FDA regulatory agency went and set avery reckless precident when they decided to approve Inameds and Mentors breast implants.

They recklessly decided it is Ok to approve now and study later so this is very dangerous to all consumers in the U.S. and in Canada, they also with the approval decided corporate america is more important than womens lives and health.

When political lobbying and donations be it corruption of government officials,scientists, and Doctors becomes more important we are in a sad state of affairs.

I find the plastic surgeons who insert these devices to actually be lower than the manufacturers because they knowingly insert these, knowing they are not safe, and knowing they will cause disfigurement, diseases, re-operations, even in some cases toxic shock resulting in deaths. In all of this they have never been held accountable for there lies or actions. I was asked last night if I thought we could do anything to stop this or to change it and I said honestly no I don't, and I said the reason why is because unlike the manufacturers and the plastic surgeons we don't have the money to fight it or to buy what we want.

Health Canada and the FDA lied, they touted studies that were and have been shown factually to be flawed mainly because of manufacturer bought involvement and the same with the plastic surgeons bought involvement.

The FDA and Health Canada have had since 1992 to demand adequate studies since the moratorium came in and yet we aresitting here with inadequate studies from Inamed and Mentor of only 3and 4 years. Even those studies eliminated alot of women, mastectomy women were not studied with one of them I think they had around 30 don't quote me on that but that is not a study.

Women have not been followed in the study after being implanted I have talked to many and even on the FDA's adverse section women have stated after entering the study and having a rupture they were not followed through. I recently talked with a woman who is a relative of mine she had implants in two years ago I did not know this till 2 weeks ago she said oh they are not silicone they are gel I shook my head and said what do you mean they are not silicone, I then asked her how she got them when health canada had supposed strict guidlines that onlymedically necessary women could get approval then enter into thestudy she got hers because she said she wanted to feel better about herself, this is not a medical condition like a mastectomy. It is also another case where the plastic surgeon got automatic approval.

I feel Health Canada knew all along that all would be approved and that the guidlines were a farce just like the tainted panel they had convened for hearings on whether mentor or inamed should get approval. I feel Health Canada broke the law and they violated there own rules. So now the FDA and Health Canada has granted approval for women to be used as lab rats so where do we go from here, won't itbe a scarey thing to watch, the next will be pharma companies demanding they get approval on all drugs then test later.

Sandra