ParfumGigi@aol.com
17 janvier, 2007 18:18
FDA WARNING
FDA has approved four breast implants for marketing in the U.S.:
In May 2000, Mentor and Allergan (formerly named) received approval for saline-filled breast implants. These implants were approved for breast augmentation in women 18 years or older and for breast reconstruction in women of any age.
In November 2006, Allergan and Mentor received approval for their silicone gel-filled breast implants. These implants were approved for breast augmentation in women 22 years or older and for breast reconstruction in women of any age.
All breast implants other than these four approved devices are considered investigational devices, including the more-cohesive "gummy bear" implants. For a woman to receive an investigational breast implant in the United States, she must enroll in a clinical study.
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Today's silicone breast implants have thicker consistencies than the ones banned 15 years ago.
Despite approval of silicone implants, the FDA warns patients to consider the following:
Breast implants are not lifetime devices, and a woman likely will need additional surgeries on her breast at least once over her lifetime.
Many of the changes to a woman's breast following implantation are irreversible.
Rupture of a silicone gel-filled breast implant is most often silent, which means that usually neither the woman nor her surgeon will know that her implants have ruptured.
A woman will need regular screening MRI examinations over her lifetime to determine if a silent rupture has occurred. The device labeling states a woman should have her first MRI three years after her initial implant surgery and then every two years thereafter. The cost of an MRI screening over a woman's lifetime may exceed the cost of her initial surgery and may not be covered by medical insurance. The labeling also states, if an implant rupture is noted on an MRI, the implant should be removed and replaced, if needed.
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