26 octobre, 2006 03:59

New Petition I sent to All Members Of parliament tonight

We petition all female members of:

The Canadian Parliament

Canadian Department of Health

Who have indicated their approval of the sale and promotion of silicone gel breast implants either publicly by vote or comment;

Who believe that silicone breast implants have been proven safe for human use;

To consent publicly to become part of the Mentor and Inamed studies on implants.

To receive one set of silicone gel breast implants, to remain in your bodies no less than 10 years.

We petition the male members of:

The Canadian Parliament

Canadian Department of Health

Who have indicated their approval of the sale and promotion of silicone gel breast implants either publicly by vote or comment;

Who believe that silicone breast implants have been proven safe for human use;

To immediately encourage and insist that every female member of their families who have reached the age of 18 to participate in the on-going studies of Mentor and Inamed.

That each female member of the family would receive one set of silicone gel breast implants, to remain in their bodies no less than 10 years.

The reasons behind this petition are as follows:

The three panel members Health Canada allowed to sit on the panel who were in direct violation of the Conflict Clause.

Harold J. Brandon

Served as consult at FDA advisory panel hearing on silicone breast implants licensing applications. Received funding from manufacturers for research and consulting.

Michael A Brook

Answered questions as an Inamed paid consultant, from the FDA Panel On Breast Implants (APRIL 2005) about platinum in silicones, based on chemical literature. Made no statements declaring support of, or opposition to, licensing of silicone gel filled breast implants.

Acted as independent expert, to advice Inamed with regard to their pre market approval applications for silicone gel filled implants to the U.S. FDA on several occasions since 2003.

Submitted a paper, currently under review, entitled platinum in silicone breast implants. That discusses the chemistry of platinum as described in the scientific literature.

Mitchell Brown

Received portion of the travel and hotel expenses from manufacturers for speaking engagements and training of surgeons in the use of cohesive gel breast implants 2003, 2004, 2005. Currently preparing a paper on his clinical experience with patients with cohesive gel breast implants.

Mentor and Inamed are 2 American companies and our Government has made a choice that Corporate America and the plastic surgery associations financial gain is more important than the Health and lives of women in Canada.

The conservative government ran on an accountability platform to win this last election.

And the only accountability we have seen is to the Manufacturers Inamed, Mentor and the Plastic Surgeons Association.

Accountability should be given to the Women in this Country and it starts with releasing all details of the Mentor and Inamed's study data. Especially after what was released by the FDA at their panel hearings on these very same two companies.

Quote:

The FDA did not approve Inamed implants as they were concerned about Inamed not providing enough safety data, how in the world can health Canada claim they have years of studies and yet the FDA state other wise? Here is a quote from Inamed on the FDA'S ruling of the Implant applications of Mentor and Inamed: The panel decision was sharply questioned by Inamed officials, who had been criticised the day before for not having sufficiently long-term data.

''I am stunned by a bizarre and inexplicable decision by some panellists, who yesterday were demanding long-term data and today accepted shorter-term data," Dan Cohen, Inamed's vice president for global, corporate, and government affairs, told Bloomberg News after the meeting in Gaithersburg, MD. ''They had partial three-year data, and we have four-year data. Our rates are similar."

The quote above was made April 2005

I find it hard to believe that Mentor did anything extensive as far as producing long term studies to health Canada since April 2005.

FDA noted three critical problems in its 2005 review of the Inamed application: long term failure rates for the device couldn't be accurately projected due to a short duration of study, the reasons implants failed were not determined, and the impact of silicone leakage on a woman's health was unclear. In its most recent application, Inamed included data indicating that symptoms of connective tissue disease were evident as well.

The same basic issues remain unresolved for Mentor's device. Mentor Corporation provided short-term failure rates, which were encouraging, but this conclusion was based on an unpublished study conducted on a very select group of patients, all of whom were operated on by a single surgeon. FDA noted many other problems with Mentor 's data, including a failure to study women over time and the exclusion of women who had implants removed - which could include additional implant failures. As a result of these limitations, FDA does not know the true failure rate for Mentor's device, nor the implications of implant rupture. The FDA memorandum also cited specific signs and symptoms of connective tissue disease in augmentation patients with the implanted Mentor device. We are thus extremely concerned that the risks of this device are far disproportionate to the benefit that a woman undergoing breast augmentation would realise.

For both Inamed and Mentor's devices, the inability to project long term failure rates and the causes of failures is a major concern. Given that there are typically no symptoms when silicone breast implants rupture, the cost in morbidity and expense to a woman may be very substantial, as prudent medical practice could entail routine MRI to detect ruptures, in addition to periodic surgeries to adjust or replace implants.

The one thing in the press release that health Canada gave yesterday that I found important was the category they placed implants in that being a 4 that means they are classed as a potentially high risk medical device if this is so why would they approve these non life threatening medical devices?

It is a sad day when in Canada our Government has decided to put the special interests of corporate America ahead of the safety and well being of Canadian women.

Health Canada also would not go as far as to say they were safe, they instead beat around the bush on that issue and stated to discuss the risks with the plastic surgeon, it is very well known these Doctors do not discuss risks I know that by the hundreds of women I talk with who are contemplating implants.

Plastic surgeons like to put a spin on it called women have a right to choose, this is not so. Women's choices do not, and should not, be what is the deciding factor in an unstudied medical device they don't get that right it is up to our Health agency and the Government to provide and demand that the manufacturers show the device is safe, anything less in my mind is negligent.

How many times do we have to hear a new implant! better than the last ones before, it becomes painstakingly obvious that there is no safe implant on the market.

My name is Sandra Laliberte

Saskatchewan

306-544-2422

I received breast implants in 1989 after a bilateral mastectomy to date I have had 19 operations. I have been diagnosed with Multiple sclerosis, meniers disease, granuloma annulare my asthma is getting serious. I have broken blood vessels and horrid skin rashes. I am also cathed permanently for 4 weeks with one week of due to a neurogenic bladder. I have also been told recently I may have arthritis as well. My life has been hell since I had the implants in for reconstruction to say the least. I can not imagine another woman ever going through what I have and this is another reason I am doing this. I have severe dizziness that can lay me up for days to weeks and the very last thing that I really hate to discuss is how severely deformed and mutilated I now am.

I expect the best from our government and that means the Health Canada department as well. I truly believe that the studies produced will be no better than the ones given to the FDA.

Why should any Canadian Tax Payer be stuck with the burden of added medical costs when these new women will experience re-operations, illnesses possibly, ruptures, and multiple visits to there health care provider?

If this Government can not come out and say that this non-life saving medical device is safe then what is the reasons for approving this? Especially when Mentor and Inamed were just given a 10-year period to do studies and a year to even beginning this.

Canadian women deserve more than they are getting our lives matter!