Silicone Implants Getting Second Look
October 6, 2003
Since 1992, when the Food and Drug Administration (FDA) pulled silicone breast implants from the market due to various safety concerns, their availability has been largely limited to patients requiring medical reconstructive surgery in research trials. Now, Inamed Corp., which makes silicone and saline implants, has asked the FDA to approve its silicone-filled implants for cosmetic uses.
If approved, manufacturers could encounter strong demand:
- The number of breast augmentation surgeries -- now nearly all performed with saline implants -- has grown seven-fold over the last 10 years; members the American Society of Plastic Surgeons performed 225,818 breast augmentations in 2002, compared with 32,607 in 1992.
- In countries where silicone implants have wider approval, more than 90 percent of patients choose them over the saline versions.
- A 2000 report by the federal Institute of Medicine found no link between silicone implants and systemic neurological or connective-tissue diseases, but said complications such as infections, scar tissue and leaking were causes for concern.
- Another 2000 study, by the FDA, found that of the 344 women participating, those who had ruptured silicone implants (diagnosed by imaging in the study) showed no symptoms before the leaks were detected.
- Women with MRI diagnosed breast implant rupture were no more likely than women with intact implants to report that they had either persistent symptoms or doctor-diagnosed illnesses that were listed.
The agency also found that when silicone migrated through the body, women were more likely to report having a soft-tissue syndrome called fibromyalgia, with symptoms including pain and fatigue.
Source: Anna Wilde Mathews, "FDA Is Reconsidering Use of Silicone Implants," Wall Street Journal, October 2, 2003.
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