Silicone breast implants have made a big comeback in cosmetic procedures, a little more than six years after the U.S. Food and Drug Administration lifted its ban on most use of the devices.
In 2012, 72% of the 330,631 breast augmentation procedures in the U.S. used silicone implants, while 28% used saline, or sterile salt water. In 2006, the year the ban was lifted, only 19% of procedures used silicone, according to new statistics released Tuesday by the American Society for Aesthetic Plastic Surgery, a group of more than 2,600 plastic surgeons.
Surgeons and patients say silicone implants look and feel more like natural breasts. But the FDA banned their use in cosmetic procedures in 1992 after complaints that the devices ruptured - and among concerns that they could lead to health problems, including connective-tissue diseases like rheumatoid arthritis. Those links were never confirmed and when the FDA lifted the ban, it said silicone implants are “safe and effective.” During the ban, silicone implants continued to be allowed for use in breast reconstruction.
Still, in a 2011 report, the FDA noted that about 20% of patients who receive silicone implants for breast augmentation will need them removed within 10 years, and as many as 50% of women who receive them for breast reconstruction will require removal after 10 years. Potential complications of the devices include infection, scarring and a hardening of the area around the implant called capsular contracture.
In recent years, there have been advances in silicone-implant technology. Last month, the FDA approved a new “form-stable” implant from drug and device maker Allergan Inc. AGN +0.26% that surgeons say has more of a natural teardrop shape - especially useful in reconstruction surgery after a single-side mastectomy when a doctor wants to match the shape of a patient's remaining natural breast.
The implants are also firmer. “If you cut one of these in half and you squeeze it, the silicone will protrude from the open end, but if you release the pressure, it goes right back in,” says Robert X. Murphy, Jr., president-elect of the American Society of Plastic Surgeons, which has more than 7,000 member surgeons. “The old silicone would just drip out and leak all over the place.” Dr. Murphy, who has no financial links to any of the implant companies, said that, if there is a rupture, the new devices are easier to remove and “took away the concerns to a large degree that there would be free silicone in the body.”
A similar device from implant maker Sientra Inc., which some surgeons dub “gummy-bear” implants, was approved in March 2012.
Louise Moore, a 52-year-old administrative assistant from Gardena, Calif., says she was sold on the silicone implant after her surgeon had her hold one in one hand and a saline implant in the other. The saline implant, she says, was “more mushy. I didn't feel like it was going to hold me firm like I wanted.” Ms. Moore, who had her augmentation surgery in September 2012 after losing 80 pounds, said she was reassured, after talking with her doctor, that the implants were safe.
Breast augmentation was the most frequent cosmetic surgical procedure in 2012, according to the aesthetic plastic surgery society's new statistics. The average physician fee for the procedure in the U.S. was about $3,500 for saline implants and $3,900 for silicone ones. That doesn't include anesthesia and other related costs.
The statistics, which also covered many other types of surgery and other less-invasive procedures, were based on a survey of 772 actively practicing plastic surgeons, dermatologists and otolaryngologists. Overall, the group said that the total number of cosmetic surgical procedures grew 3.1% in 2012. Most cosmetic procedures aren't covered by health insurance.
The typical breast augmentation patient is in her “mid-to-late 30s who has had one or more children,” says Leo R. McCafferty, a plastic surgeon in private practice in Pittsburgh and the president of the American Society for Aesthetic Plastic Surgery. “They are interested in having their breasts back to the way they were,” he says. Just 1.1% of all procedures were done on women 18 and younger in 2012, according to the new statistics. Regardless of their age, Dr. McCafferty says he likes to see his patients yearly for follow-ups, for life, to check for any changes. If there is concern of a rupture, an ultrasound or MRI will be done. (A tear can usually be seen on a scan.)
Scot Glasberg, a plastic surgeon in private practice in New York, says a major reason women get a second surgery is that they request it. “Often women get implants and then they want to be larger,” he says.
Saline implants are more prone to rippling and other texture changes that can sometimes be seen through the skin, surgeons say. But they are more appropriate for some patients. They can be made larger. Also, some patients are simply more comfortable having saline implants, partly because of the earlier health concerns with silicone. When a saline implant ruptures, it deflates and the saline is absorbed by the body.
Gregory Evans, president of the American Society of Plastic Surgeons and chief of the Aesthetic & Plastic Surgery Institute at the University of California, Irvine, says he is more likely to use saline implants in very young women, who may change their minds. Saline implants require a much smaller incision, meaning less scarring. (The shell of the implant is inserted and only then is it filled with saline.) Removing it is also easier. “At age 24 they may decide they don't want to have implants,” he says.
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