Monitor silicone implants
Detroit Free Press: Maybe there will be enough warnings in place.
Maybe there will be enough follow-up and monitoring.
Maybe a new version and better training will lead to fewer problems.
That's a lot of "maybes" for the Food and Drug Administration to consider as it mulls whether to put silicone breast implants back on the market, after a scientific advisory panel -- on a split vote -- gave its OK Wednesday.
Even a decade after they were banned, no irrefutable evidence links silicone implants to diseases such as lupus or fibromyalgia, connective tissue diseases that are already more common in women. As studies unfolded, though, it became clear that the implants had a relatively high failure rate; at least one woman in every five with implants has to return for surgery within three years, due to a rupture or buildup of scar tissue or both.
Saline filler
Nonetheless, some women still want implants. And similar post-surgical problems apparently occur with the ones that remain on the market, which use saline as a filler but are not nearly as satisfactory in appearance as those that contain silicone gel.
Inamed Corp., the company pitching to put silicone implants on the market, says it has an improved product that will break less often, and new medical techniques to teach doctors that further reduce ruptures. The company also has agreed to make sure women better understand the surgical risks and will maintain a customer registry.
The registry is the key to proceeding. Car companies keep track of their customers; firms that sell medical devices should do the same. Women interested in implants can study the known risks and make their choices. But they should have reassurance that they will be found and notified if, over the long haul, silicone is found to present a danger that doesn't seem obvious now.
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