Improved Implants (Sort Of)
Yes, they're back, but they still require a heck of a lot of scrutiny
Saline-filled implants, on the other hand, stay more rigid and remind some users of overfilled water balloons. Typically hidden under a layer of muscle and breast tissue, saline devices can often be seen and felt under the skin if there's not enough tissue to camouflage them. "For extremely thin women and mastectomy patients with virtually no breast tissue, silicone is a better bet," says Roxanne Guy, president of the American Society of Plastic Surgeons and Pardue's surgeon. That's why the FDA had allowed breast--reconstruction patients, such as those who have undergone a mastectomy, to get silicone implants during the ban if they agreed to be monitored in clinical trials.
Today's silicone implants bear little resemblance to more leak-prone implants of the '80s. The shell is thicker and more durable, and the gel inside is solid enough to cut through. "The implant retains its shape to give better results, and the higherviscosity silicone is less likely to migrate into breast tissue if the product ruptures," says Joshua Levine, ceo and president of Mentor, an implant maker.
While salt water poses little risk, silicone can travel through tissues and trigger an immune response, potentially causing hard lumps in the breast tissue, pain, and inflammation. "There's no compelling evidence linking rupture to these consequences, but we can't be 100 percent certain that it doesn't happen," says Tillman.
There's also the possibility an implant could burst from, say, the force of a high-impact car accident or a fall. In very rare cases, extreme pressure could cause the silicone to flow through the breast tissue into the armpit and surrounding lymph nodes. Silicone that gets stuck in these areas, Moelleken says, has been known to cause extensive pain and irreversible nerve damage.
Most often, silicone implant leaks cause no symptoms and the wearer is none the wiser. While saline leaks cause fluid to whoosh out quickly, deflating the breast noticeably, the thick silicone gel usually remains firmly within the implant. Still, the FDA recommends that any ruptured implant be removed for safety reasons. The silicone implant makers report a 1 to 2 percent rupture rate--similar to that of saline implants--in the first three years. After 12 years, the rate rises to 15 percent.
To ensure that silicone leaks are discovered promptly, the FDA recommended that women who opt for silicone implants get an MRI-- mammograms and physical exams can't detect leaking silicone-- within the first three years of implantation and then every two years after that. "MRI is quite effective at detecting silent leakage and whether silicone has moved outside the shell of the implant," says Ellen Mendelson, chief of breast imaging at Northwestern Memorial Hospital in Chicago.
Screening puts an even heftier price tag on breast implants. While insurance covers implants for breast reconstruction, it typically does not cover cosmetic procedures. At $1,600 to $1,800 a pair, silicone implants cost more than double the saline ones. And surgery to implant them can run anywhere from $4,500 to $12,000. The MRI scans for monitoring can cost upwards of $1,000.
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