Under pressure from silicone implant manufacturers, The FDA approved the use of new generation silicone breast implants in November 2006. This will mean "big money for easy surgery" for plastic surgeons. Dr. Edward Melmed comments in the LA times that despite FDA approval, silicone implants are still unsafe and will require replacement surgery at least once in a lifetime. Dr. Edmond also reports that the FDA requires manufacturers to study 80,000 women within the next 10 years...the administration seems to have adopted the policy "Approve now, test later".
"Despite these known hazards, the Food and Drug Administration, under pressure from implant manufacturers, plastic surgeons and patients, is allowing as of Jan. 1 a new generation of silicone implants in women age 22 and over. The new generations of implants, we are assured, are less likely to rupture. However, this claim has been made for every previous generation. To monitor women's health, the FDA will require women who receive implants to have regular MRIs and has recommended that the implants be replaced every 10 years. It is a pity that women will become the experimental lab rats for these implants. They, not the manufacturers, will have to pay for the MRIs and replacements as recommended. Most plastic surgeons vehemently deny any connection between health complaints and leaking silicone implants. But I have seen a disturbing number of patients with symptoms, including fatigue, short-term memory loss, joint and muscle pains, skin rashes, disturbed sleep patterns, depression and hair loss, that clear up when implants are removed."
Wednesday, January 3, 2007
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