Are silicone implants safe for you?
Silicone gel-filled implants should not be allowed on the market because the manufacturers have not met the legal benchmark for proving safety, 20 consumer groups and individuals said in a petition. In April, an FDA advisory committee voted 5-4 against Inamed's implants, while urging approval for Mentor's implants (Memory Gel) by a 7-2 vote. The FDA is considering those recommendations and is expected to make a final decision soon. So if you have been considering silicone implants, you might want to wait for the confusion to clear up. (Related article: How to make plastic surgery decisions?)
The New York Times is also reporting that two ex-employees of Mentor, John C. Karjanis and Cynthia Fain, have made sworn depositions that Mentor employees manipulated data to hide risks of implants. They charge that workers worked in unsanitary conditions and defective products were hidden so that senior management would not know what was going on.
This is very common practice among American companies since they are often desperate to get FDA approval for their products. Similar charges are being made against other companies like Merck and Pfizer that apparently hid risks of their drugs like Vioxx, Celebrex, and Bextra resulting in as many as 50,000 deaths in the US alone. Another drugmaker Biogen hid risks of a MS drug Tysabri that eventually was recalled after deaths of patients.
The editor-in-chief of New England Journal of Medicine, Dr. Jeffrey M. Drazen, has charged that even leading companies like Pfizer, GlaxoSmithKline, and Merck are "making a mockery" of efforts to create more transparency in clinical trials.
According to American Society of Aesthetic Plastic Surgeons (ASAPS), nearly 335,000 women chose augmentation plastic surgery in 2004. More than 62,000 women had reconstruction plastic surgery in 2004, according to American Society of Plastic Surgeons (ASPS). Such procedures have been proven in numerous studies to have many psychological and physical benefits for women who have undergone a mastectomy.
Mentor claims that Memory Gel silicone gel-filled products provide an option for patients seeking a more realistic feel and appearance. Mentor's gelatin-like, cohesive implants are designed to mimic the soft tissues of the human body. While the personal needs of each patient vary, experienced physicians are able to use Memory Gel products to provide both augmentation and reconstruction surgery patients a realistic contour.
So what is my recommendation?
Talk to your plastic surgeon and discuss all the pros and cons of each type of implants. It is better to err on the side of safety. In any case, it is not yet known that FDA will approve Mentor's product though FDA typically tends to side with businesses rather than American people.
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Technorati tag: Plastic Surgery
The New York Times is also reporting that two ex-employees of Mentor, John C. Karjanis and Cynthia Fain, have made sworn depositions that Mentor employees manipulated data to hide risks of implants. They charge that workers worked in unsanitary conditions and defective products were hidden so that senior management would not know what was going on.
This is very common practice among American companies since they are often desperate to get FDA approval for their products. Similar charges are being made against other companies like Merck and Pfizer that apparently hid risks of their drugs like Vioxx, Celebrex, and Bextra resulting in as many as 50,000 deaths in the US alone. Another drugmaker Biogen hid risks of a MS drug Tysabri that eventually was recalled after deaths of patients.
The editor-in-chief of New England Journal of Medicine, Dr. Jeffrey M. Drazen, has charged that even leading companies like Pfizer, GlaxoSmithKline, and Merck are "making a mockery" of efforts to create more transparency in clinical trials.
According to American Society of Aesthetic Plastic Surgeons (ASAPS), nearly 335,000 women chose augmentation plastic surgery in 2004. More than 62,000 women had reconstruction plastic surgery in 2004, according to American Society of Plastic Surgeons (ASPS). Such procedures have been proven in numerous studies to have many psychological and physical benefits for women who have undergone a mastectomy.
Mentor claims that Memory Gel silicone gel-filled products provide an option for patients seeking a more realistic feel and appearance. Mentor's gelatin-like, cohesive implants are designed to mimic the soft tissues of the human body. While the personal needs of each patient vary, experienced physicians are able to use Memory Gel products to provide both augmentation and reconstruction surgery patients a realistic contour.
So what is my recommendation?
Talk to your plastic surgeon and discuss all the pros and cons of each type of implants. It is better to err on the side of safety. In any case, it is not yet known that FDA will approve Mentor's product though FDA typically tends to side with businesses rather than American people.
Related articles
Brava system
Plastic surgery goes mainstream
Plastic surgery as a gift
Technorati tag: Plastic Surgery
posted by eCreativa Media @ 5/24/2005 01:24:00 PM
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