Indianapolis Star, Tuesday, November 28, 2006
By Shari Rudavsky
Jeffrey Wagner, a surgeon with Wagner and Associates Plastic and Reconstructive Surgery of Indiana on the Northeast side, discusses the FDA approval of silicone breast implants.
Question: What is the significance of the FDA’s approval of silicone breast implants?
Answer: Breast augmentation is one of the most popular cosmetic surgeries performed today. It’s been performed for the past 14 years with saline implants, which have been very safe and effective. Silicone implants were taken off the market in 1992, for possible concerns about their safety. For the past 14 years, research has been conducted on them. Now the FDA has reviewed that data and concluded that they are safe and efficacious.
Q: How do they differ from saline?
A: Saline is good, but silicone has a more natural feel. Saline can provide a very natural appearance, but they don’t have quite a natural feel. Even the inexperienced examiner can usually tell they’re there by touch. With silicone, you have a much more natural feel. There’s also a lower incidence of one problem that we see with saline implants, which is rippling, a kind of wrinkling of the implant that you can see. Silicone is better for those two reasons, but there are trade-offs.
Q: What are the trade-offs?
A: While the incidence of rupture (with silicone) is low, only around 3 percent, you can’t tell if they’ve ruptured. Neither the doctor nor the patient can tell. When saline implants rupture, they deflate and it’s just a saline solution, which leaks into the tissues, and that’s very safe. The silicone gel doesn’t just reabsorb. Another problem is they’re inflated from the time you get them out of packaging, so you have to make a slightly larger incision.
Q: So will doctors have to check for ruptures?
A: That’s going to be a significant thing. The best way to determine whether a gel implant has ruptured is with an MRI. It’s being recommended that patients who have silicone implants have an MRI three years after implant surgery and every two years after that. And that’s a biggie, because the cost of these MRIs may likely exceed the cost of surgery.
Q: Which one will you recommend?
A: Now we know enough about these implants to let patients make a good informed decision about whether they want them. They’re a very good option, and in some patients they may be the option of choice, but saline implants are a good option, too. This will not spell the end of saline implants.