Plastic surgeons are excited about a new type of silicone breast implant, which they say provides more natural looking breasts with lower complication rates. Silicone implants have been unavailable in the U.S. since 1992 due to safety concerns, but the FDA is currently considering their reintroduction. Because of the FDA restrictions, the new implants are only available to women who agree to take part in a clinical study, the results of which could be used in information presented to the FDA for the implant's approval.
The authors of a new study appearing in the journal Plastic and Reconstructive Surgery say that the new cohesive gel implants represent a significant step beyond the older style silicone implants and the newer saline implants. "It is an extreme understatement to say our patients are happy with the more cohesive gel implants," said study author Mitchell Brown. "These implants simply look and feel much more natural than saline implants. My patients are thrilled with their results."
Another benefit touted by the study authors is the availability of a wider variety of shapes and sizes to more closely match breast shapes and chest dimensions. Surgeons can use a patient's breast measurements to custom select an implant specific to each breast. And in addition to the cosmetic advantages of the new implants, they are also claimed to have a lower complication rate.
In the study, only 3 percent of the breast augmentation patients experienced complications and most were minor, with only one patient requiring re-operation. According to Brown, this rate of re-operation for breast reconstruction patients is remarkably low considering the inherent challenges of breast reconstruction. "The more cohesive gel implants are going to play a major role in aesthetic and reconstructive breast surgery if they are approved for sale in North America," he said. "We have already seen their potential through studies in Europe. Now, through our own research, we are finding with these implants, re-operation is rare, the complication rate is low and patients are extremely pleased with their outcome."
One of the surgeons participating in the trial was equally as enthusiastic but said that some re-education was needed. "I think this is a great device," said Walter Erhardt, MD. "It's not perfect and there is going to be a learning curve for surgeons in terms of educating them on how to use the more cohesive gel implants. A big criticism of previous implants has been silent rupture and re-operation rates. In my opinion, this product has a good chance for a greater longevity rate as well as less complications."
Source: American Society of Plastic Surgeons